19 A timeline for change: A discussion of Affordable Care Act provisions Janice A. Anderson and Joseph T. Van Leer 32 Ignore at your peril what others know about your organization Leon Goldman 37 Complying with the ADA’s accessibility standards: What you need to know Kara M. Maciel and Jordan B. Schwartz 51 Reconsidering FCOI: What PHS’s final rule means to investigators Ofer Amit and Draco Forte A PUBLICATION OF THE HEALTH CARE COMPLIANCE ASSOCIATION WWW.HCCA-INFO.ORG Meet Lanny A. Breuer Assistant Attorney General, Criminal Division, U.S. Department of Justice See page 14 Compliance TODAY June 2012
Transcript
19A timeline for change:
A discussion of Affordable Care Act
provisionsJanice A. Anderson
and Joseph T. Van Leer
32Ignore at your
peril what others know about your
organizationLeon Goldman
37Complying with the ADA’s accessibility
standards: What you need to know
Kara M. Maciel and Jordan B. Schwartz
51Reconsidering
FCOI: What PHS’s final rule means to investigators
Ofer Amit and Draco Forte
a publication of the health care compliance association www.hcca-info.org
Meet Lanny A. Breuer Assistant Attorney General, Criminal Division, U.S. Department of Justice
See page 14
ComplianceTODAY June 2012
HCCA’s website was recently redesigned and includes a more user-friendly experience. Check it out now!
You will need your new HCCA login and password information to access the “My account” section of the website. You should have received an email in mid-May with this information.
If you are having trouble logging in or have website questions, call 888.580.8373 or email [email protected].
New features and bene� ts:
www.hcca-info.org
• Online membership renewal
• Easily view and track your CEUs online
• Register for events with ease
• Order HCCA products to be shipped directly to you
• Enrich your experience by uploading your bio and pro� le picture
• Find content quicker and easier with a new search box and improved navigation
Have you checked out HCCA’s new website yet?
New features and bene� ts:Get
connected to HCCA
now!
888-580-8373 | www.hcca-info.org 3
Com
pli
ance
Tod
ay
Jun
e 20
12
by Roy Snell, CHC, CCEP-F
When the wheels come off, it’s a good idea to pull over to the side of the road
Compliance program activities can go badly. For example, an investigation that creates an incident when a pow-
erful person claims you are not conducting the investigation properly. All elements of a compliance program can occasionally create tumult. What I often see when the wheels
come off at work is that people imme-diately start flailing their arms, light their hair on fire, and run around. The problem often gets worse. There are times when trouble starts that you should do nothing…maybe for just a little while. I completely understand it’s not always possible. I agree we
have to be careful not to be seen as weak or obstructionist by creating a little delay. But as bad as excessively or inappropriately delaying action can be, overreacting can be equally as bad.
There was a problem I experienced yes-terday, a highly visible problem not related to compliance, but it related to this philosophy of being calm. When the problem was discov-ered, people lit their hair on fire, ran around,
and flailed their arms. What they were doing was unintentionally escalating the problem. Our medium-sized problem was headed for the big time. We needed time to think. I asked myself if it was at all possible to do nothing, and it seemed like an option. I told those who wanted immediate and strong action to be taken that if matters got worse, I would take the drastic action they were looking for. It’s 24 hours later, and there is still peace in the vil-lage. If I can make it two more days, then the entire matter will be over.
When there is trouble, people look at your face to see how bad the situation is. If nothing else, your suggestion that everyone calm down and think first will give them the impression that you’ve got it together. People who report to you, people you report to, and your peers can become animated in the face of a chal-lenge. They want immediate action. They want a strong reaction. They get the sense that they know exactly what to do and that you must rush to do it. They may be correct about what to do, but they are often wrong about the sense of urgency. Me, I look to see if I can buy time. If I can buy 24 hours, I can often increase peace in the village significantly.
Letter from the Ceo
Snell
Contact Roy Snell at roy.snell @ hcca-info.org.
Thank you!
Has someone done something great for you, for the compliance profession, or for HCCA? If you would like to give recognition by submitting a public “Thank You,” please send it to margaret.dragon @ hcca-info.org. Entries should be 50 words or fewer.
4 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
June 2012Contents
features
Departments
CoLumns
14 Meet Lanny A. BreuerBy Compliance Today
19 A timeline for change: A discussion of Affordable Care Act provisionsBy Janice a. anderson and Joseph t. Van LeerA look at the ACA’s quality-of-care initiatives most likely to affect how care is rendered and how providers are paid.
32 Ignore at your peril what others know about your organization [Ceu]
By Leon GoldmanProactive use of data mining provides a wealth of information on physician-industry interactions, conflicts of interest, and other risk areas.
37 Complying with the ADA’s accessibility standards: What you need to know [Ceu]
By Kara m. maciel and Jordan B. schwartzUnderstanding the new federal requirements that took effect March 15, 2012.
51 Reconsidering FCOI: What PHS’s final rule means to investigatorsBy ofer amit and Draco forteFive tips for avoiding institutional risk for financial conflicts of interest in research facilities.
3 Letter from the CEOroy sneLL
31 Exhaleshawn DeGroot
45 Social networkingJohn faLCetano
6 News
12 People on the move
72 HCCA congratulates newly certified designees
78 HCCA welcomes new members
81 Takeaways
82 Events calendar
888-580-8373 | www.hcca-info.org 5
Com
pli
ance
Tod
ay
Jun
e 20
12
…the Justice Department has increased enforcement in several areas of white
collar crime, so having an effective compliance program has never been
more important than it is today.“ ”
artiCLes
55 CMS issues long-awaited compliance program guidance revisionsBy Brenda J. tranchidaA change from “should” to “must” in the most recent regulations makes effective compliance programs mandatory for more providers.
65 DMEPOS reimbursement appeals and the compliance officer By natarsha nesbitt and nathaniel LacktmanInvolving the compliance officer can lead to fewer claim denials and greater success in the Medicare appeals process.
69 Off-label drug promotion: The False Claims Act and Anti-Kickback Statute By David restainoTargeted auditing can help reveal the “grey areas” and risks of off-label drug promotion.
74 How to keep the Pharmacy department compliant [Ceu]
By Denise fletcherStay ahead of problems by proactively auditing the use of drug codes and billing units.
Editorial Board
Gabriel Imperato, Esq., CHC, CT Contributing Editor, Managing Partner, Broad and Cassel
Ofer Amit, MSEM, CHRC, Research Compliance Administrator, Baptist Health South Florida
Janice A. Anderson, JD, BSN, Shareholder, Polsinelli Shughart, PC
Christine Bachrach CHC, Chief Compliance Officer, University of Maryland
Medicare Fraud Strike Force charges 107 individuals for approximately $452 million in false billingIn May, U.S. Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius announced in a press release that a nationwide takedown by Medicare Fraud Strike Force operations in seven cities resulted in charges against 107 individuals, including doctors, nurses, and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $452 million in false billing.
Assistant Attorney General
Lanny A. Breuer of the Justice Department’s Criminal Division, FBI Deputy Director Sean Joyce, Deputy Inspector General for Investigations Gary Cantrell of the HHS Office of Inspector General (HHS-OIG) and Dr. Peter Budetti, Deputy Administrator for Program Integrity of the Centers for Medicare and Medicaid Services (CMS) joined Attorney General Holder and Secretary Sebelius for the announcement.
This coordinated take-down involved the highest amount of false Medicare
billings in a single takedown in strike force history.
According to the gov-ernment’s press release, HHS also suspended or took other administrative action against 52 providers follow-ing a data-driven analysis and credible allegations of fraud. The new health care law, the Affordable Care Act, signifi-cantly increased HHS’s ability to suspend payments until an investigation is complete. Use this link to review DOJ press releases:www.justice.gov/opa/pr/2012/May
HHS settles case with Phoenix Cardiac Surgery for lack of HIPAA safeguardsIn April, the U.S. Department of Health and Human Services (HHS) announced in a press release that Phoenix Cardiac Surgery, PC, of Phoenix and Prescott, Arizona, agreed to pay HHS a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients.
The settlement with the physician practice follows an extensive investigation by the HHS Office for Civil Rights (OCR) for potential viola-tions of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules.
The incident giving rise to OCR’s investigation was a report that the physician prac-tice was posting clinical and surgical appointments for its patients on an Internet-based calendar that was publicly accessible. On further inves-tigation, OCR found that Phoenix Cardiac Surgery had implemented few policies and procedures to comply with the HIPAA Privacy and Security Rules, and had limited safe-guards in place to protect
patients’ electronic protected health information (ePHI).
“This case is significant because it highlights a multi-year, continuing failure on the part of this provider to comply with the requirements of the Privacy and Security Rules,” said Leon Rodriguez, director of OCR. “We hope that health care providers pay careful attention to this resolution agreement and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compli-ance no matter the size of a covered entity.”
read the latest news online · www.hcca-info.org/news
888-580-8373 | www.hcca-info.org 7
Com
pli
ance
Tod
ay
Jun
e 20
12
news
read the latest news online · www.hcca-info.org/news
OCR’s investigation of Phoenix Cardiac Surgery also revealed the following issues:
· Failure to implement adequate policies and procedures to appropriately safeguard patient information;
· Failure to document that it trained any employees on its policies and procedures on the HIPAA Privacy and Security Rules;
· Failure to identify a security official and conduct a risk analysis; and
· Failure to obtain business associate agree-ments with Internet-based email and calendar services where the provision of the service included storage of and access to its ePHI.Under the HHS resolution agreement, in
addition to the monetary settlement, Phoenix Cardiac Surgery has agreed to implement a corrective action plan that includes a review of recently developed policies and other actions to come into full compliance with the HIPAA Privacy and Security Rules.
Use this link to review the complete press release: www.hhs.gov/news/press/2012pres/
04/20120417a.html
In April, the National Labor Relations Board issued the following statement: In light of conflicting decisions at the district court level, the DC Circuit Court of Appeals has tempo-rarily enjoined the NLRB’s rule requiring the posting of employee rights, which had been scheduled to take effect on April 30, 2012.
In view of the DC Circuit’s order, and in light of the strong interest in the uniform implementation and administration of agency rules, regional offices will not implement the rule, pending the resolution of the issues before the court. Visit the NLRB’s website at www.nlrb.gov for more information.
Cms to publicly report on consumer experiences with medicare-certified home health agenciesResults from the Centers for Medicare & Medicaid Services’s (CMS) national survey that asks patients about their experiences with Medicare-certified home health agencies are now available on the agency’s Quality Care Finder website: www.medicare.gov/quality-care-finder
The Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) Survey, which will be updated every four months with new survey data, will complement the clinical measures already avail-able on the agency’s Home Health Compare website: www.medicare.gov/homehealthcompare/search.aspx
Cms to cover new technology for medicare patients with heart valve damageThe Centers for Medicare & Medicaid Services (CMS) will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. The cov-erage decision, announced today by CMS Acting Administrator Marilyn Tavenner, offers important new technology to some of Medicare’s sickest patients.
Aortic valve replacements are used in patients whose aortic heart valves are dam-aged, causing the valve to narrow — a condition known as “aortic stenosis.” Once patients expe-rience symptoms of aortic stenosis, treatment is critical to improve their chances of survival. Until recently, aortic stenosis has been treat-able only through invasive surgery. In contrast, TAVR allows doctors to replace a patient’s aortic valve through a small opening in the leg. This less invasive procedure gives patients who cannot undergo open heart surgery a new way to repair their damaged heart valve. Use this link to review CMS press releases: www.cms.gov/
apps/media/press_releases.asp
News from CMS
Employee rights posting delayed
8 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
September 30–October 2, 2012Renaissance Harborplace Hotel | Baltimore, MD
Visit www.hcca-info.org to learn more
The Fraud and Compliance Forum is jointly sponsored by the Health Care Compliance Association (HCCA) and the American Health Lawyers Association (AHLA). It will include an explicit designation of a session as “compliance focused” or “legal focused.” The Planning Committee has included enough sessions in each designation that an individual could attend all “compliance” sessions or all “legal” sessions for the entire program. Yet an attendee also has the option of selecting a diversity of sessions and networking with an expanded group of individuals. The Fraud and Compliance Forum has the benefit of combining the quality of HCCA and AHLA sessions with the expanded networking power of a combined program.
Save the date
Managed Care Compliance ConferenceFebruary 24–26, 2013Hyatt Regency Phoenix | Phoenix, AZ
Learn essential information for those involved with the management of compliance at health plans. Plan to attend if you are a compliance professional from a health plan (all levels from officers to consultants), in-house and external counsel for a health plan, internal auditor from a health plan, regulatory compliance personnel, or managed care lawyer.
find the latest conference information online · www.hcca-info.org/events
research Compliance Conference: June 3–6Learn best practices and the latest thinking on:
· New Rules for IRBs — What the (A)NPRM Could Mean for Your Institution
· Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities — The Impact on Clinical Research Sites
· Clinical Research Enforcement Initiatives and False Claims Act Update
· Successful FDA Inspections: How to Prevent and Respond to Common FDA Observations in a Form 483 or Warning Letter
· Recent Developments in Clinical Trial Regulation and Oversight
www.hcca-research-conference.org
fraud & Compliance forum: september 30–october 2The Fraud & Compliance Conference is jointly sponsored by HCCA and the American Health Lawyers Association (AHLA). Sessions will be explicitly designated as “compliance focused” or “legally focused.” An individual could attend all “compliance” sessions or all “legal” sessions for the entire program, or select diverse sessions and network with an expanded group of indi-viduals. Draft agenda will be available in early June at www.fraudcomplianceforum.org.
Clinical practice Compliance Conference: october 14–16 (formerly known as the Physician Practice/Clinic Compliance Conference)Participants may attend sessions about:
· Compliance program development and man-agement as it relates to physician practices
· Current government initiatives in the field of health care compliance specific to physician’s and their group practices
· Correct documentation · Billing and coding practices for physicians · Best practices utilized in physician practices
www.hcca-physician-conference.org
Basic Compliance academies Due to the popularity of our Academies, we have added one more for the 2012 year. It will take place November 12–15 in Orlando. For more information and other dates visit www.hcca-info.org/academy.
research academy: august 13–16Focus on compliance issues related solely to research. With a wide range of research-related issues becoming hot topics with enforcement agencies, this Academy provides attendees with the opportunity to get information on many areas that affect research compliance officers and their staff on a day-to-day basis. A small audience encourages hands-on edu-cational techniques, small group interaction, and networking. For more information visit www.hcca-info.org/academy.
health Care privacy academy: June 25–28 & october 22–23Covers a broad spectrum of laws and regula-tions that affect health care organizations. Topics include areas such as HIPAA Privacy, the Federal Privacy Act, Graham Leach Bliley, and more. The faculty has many years of experience in health care compliance and is well versed in health care privacy. In addition to participant experience in the privacy arena, this Academy will provide the information to prepare a participant for health care privacy certification (CHPC®). For more information visit www.hcca-info.org/academy.
hCCa conference news
hCCa news
10 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
find the latest hCCa website updates online · www.hcca-info.org
resources available on the Compliance institute websiteWhether or not you attended this year’s annual conference, you will find many helpful resources on the Compliance Institute website. Below are a few highlights:
· CEU application forms and information · Speaker handouts from more than 130 sessions · Conference brochure · Handouts from past Compliance Institutes · Registration for the 17thAnnual Compliance
Institute in National Harbor, MD (Washington DC metro area) April 21–24, 2013
· Photo album for this year’s Compliance Institute
· DVD or online audio recordings of 120 Compliance Institute sessions for purchase
new websiteCheck out HCCA’s new website. There are many new features that will make member-ship renewal, entering CEUs, and registration easier. The first time you log on to the new website (after May 16th), you will be prompted to reset your password. For more information on the website and passwords, please contact service @ hcca-info.org or 888-580-8373.
member DirectoryNow that you’re back from the Compliance Institute, make sure to follow up with all the net-working contacts you made. If you need contact information for another member, be sure to check out the Member Directory in the “My Account” section of our website.
hCCa website newsContact Tracey Page at 952-405-7936 or email her at tracey.page @ hcca-info.org with any questions about HCCA’s website.
hCCa news
Don’t forget to earn your ChC Ceus for this issueComplete the Compliance Today CEU quiz for the articles below from this issue:
· ignore at your peril what others know about your organization, by Leon Goldman (page 32)
· Complying with the aDa’s accessibility standards: what you need to know, by Kara M. Maciel and Jordan B. Schwartz (page 37)
· how to keep the pharmacy department compliant by Denise Fletcher (page 74)
to complete the quiz: Visit www.hcca-info.org/quiz, then select a quiz, fill in your contact information, and answer the questions. The online quiz is self-scoring and you will see your results immediately.
You may also fax or mail the completed quiz to CCB:
fax: 952-988-0146
maiL: Compliance Certification Board 6500 Barrie Road, Suite 250 Minneapolis, MN 55435 United States
Questions? Call CCB at 888-580-8373.
To receive one (1) CEU for successfully completing the quiz, you must answer at least three questions correctly. Quizzes received after the expiration date indicated on the quiz will not be accepted. Each quiz is valid for 12 months, starting with the month of issue. Only the first attempt at each quiz will be accepted.
888-580-8373 | www.hcca-info.org 11
Com
pli
ance
Tod
ay
Jun
e 20
12
find the latest hCCanet updates online · www.hcca-info.org/HCCAnet
hCCanet just surpassed 10,000 members! · HCCAnet was launched in 2008 and is open
to the Compliance and Ethics community at no charge. It provides robust discussion tools and a library containing over 3,000 compliance and ethics-related documents. “The growth we’ve seen in membership is fantastic, but more important is the fact that this resource is helping to solve real prob-lems and improve compliance and ethics programs,” says Roy Snell, CEO of HCCA.
remember to update your profile · For instructions on how to update your
HCCAnet profile using your LinkedIn® account, go to www.hcca-info.org/hccanetlinkedin
popular hCCanet discussions · 2012 HCCA Compliance Institute Forum
– Knowing what your Business Associates are doing
with your PHI: http://bit.ly/baphi
· Auditing and Monitoring Health Care Forum – Under Pressure, New York Moves to Soften Tough
Medicaid Audits: http://bit.ly/nymedicaidaudits
· Behavioral Health Care Compliance – Diagnosis in group therapy note documentation:
http://bit.ly/therapynote
· Chief Compliance & Ethics Officer Health Care Network
– Physician self care or treatment to family member:
http://bit.ly/physicianselfcare
· HIPAA Forum – BAA for Board of Trustees: http://bit.ly/baaprivacy
– Drug Screens: http://bit.ly/drugscreens
– CMS S&C (Survey & Certification) Letter 12–18:
http://bit.ly/cms1218
– Discussions to Review Recent CMS S&C Letter
and Transmittal on Patient Privacy: http://bit.ly/scletter
· Hospital Network – Emergency Department Admissions - Compliance
newsContact Eric Newman at 952-405-7938 or email him at eric.newman @ hcca-info.org with any questions about HCCAnet.
HCCAnet (www.hcca-info.org/HCCAnet) is the most comprehensive social network for health care compliance professionals. Subscribe to dozens of discussion groups and get your compliance questions answered. Stay informed on the latest health care compliance news and information. Network with your colleagues and stay connected with our mobile app.
hCCa news
learn more and register at
www.hcca-info.org/webconferences
need a quick and cost-effective way to earn CeU credits?
Want the latest news on breaking issues and best practices?
all of this from the convenience of your own office?
Try one of HCCA’s upcoming Web Conferences, and earn 1.2 CEU credits for each 90-minute session.
12 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12peopLe on the moVe
· Cheyenne L. Ross was promoted to Vice President of Compliance at Bridgeway Health Solutions. Bridgeway is a health maintenance orga-nization that provides acute and long-term care services to people who are enrolled with Medicaid and Medicare.
· Nyack Hospital recently announced it has appointed Jennifer Morris as its Chief Compliance Officer.
· In April, TMG Health, the leading national provider of expert solutions for govern-ment sponsored health plans, announced the appoint-ment of Patricia Savitsky as Senior Vice President and Chief Compliance Officer. According to the company’s press release, Stavitsky will be based in TMG Health’s National Operations Center, in Dunmore, PA. Savitsky is responsible for develop-ing and implementing the company’s corporate com-pliance plan in conjunction with the CEO, Board of Directors, and the Corporate Compliance Committee. In addition, Savitsky will provide executive-level oversight of the Compliance and Internal Audit departments.
· Michael J. Holston was recently named Chief Ethics and Compliance Officer at Merck, effective June 25, 2012.
He will succeed Richard S. Bowles, who has decided to retire from the company after more than 35 years with Merck and the former Schering-Plough. In his new role, Holston will report directly to Kenneth C. Frazier, Merck’s Chairman and Chief Executive Officer, and will serve on the company’s Executive Committee. He will be responsible for driving high ethical standards and compli-ance across the company’s business globally.
“Ethical business practices and good corporate gover-nance are important to us and our stakeholders, and we are committed to adhering to the laws and regulations govern-ing our activities worldwide,” said Frazier. “We are delighted to welcome Mike as our new Chief Ethics and Compliance Officer. His extensive experi-ence managing compliance
with healthcare laws across international businesses and his background with Merck and our industry make Mike a terrific leader for our Ethics and Compliance organiza-tion and a member of our Executive Committee.
“I also want to thank Rick Bowles for nearly four decades of dedicated service to Merck and Schering-Plough. His strong leadership established the global compliance organi-zation for the combined new company following the merger with Schering-Plough. He developed the right structure, capabilities, and leadership for the function, creating a solid base upon which Mike can continue to build a world class Ethics and Compliance organi-zation going forward.”
Holston most recently served as Executive Vice President and General Counsel for Hewlett-Packard, where he oversaw compliance, govern-ment affairs, privacy, ethics operations, and legal affairs.
received a promotion? have a new hire in your department? ·
If you’ve received a promotion, award, or degree; accepted a new position; or added a new staff member to your Compliance department, please let us know. It’s a great way to keep the Compliance community up-to-date. Send your updates to margaret.dragon @ hcca-info.org.
peopLe on the Move
Help Keep Your Compliance Program Fully Staffed
List Your Job Openings Online with HCCAIt’s hard to have an effective compliance program when you have openings on your team. Help fill those openings quickly—list your compliance job opportunities with the Health Care Compliance Association.
Benefits include:
•Listing is posted for 90 days to maximize exposure
•Targeted audience
•Your ad is also included in our monthly HCCA Jobs Newsletter, which reaches more than 14,000 emails
Don’t leave your compliance positions open any longer than necessary. Post your job listings with HCCA today.
Visit www.hcca-info.org/newjobs Or call us at 888-580-8373
14 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12featurefeature
an interview by Compliance Today
Meet Lanny A. BreuerCompliance Today conducted this interview with Mr. Breuer in April 2012.
Ct: How did you choose your profes-sion? Why did you become a lawyer and a prosecutor?
LB: Coming out of law school, I knew that I wanted to be a prosecutor, and I started my career as an Assistant District Attorney in Manhattan. I think one reason I was drawn to the legal profession, and to public service, was the experience of my mother and father. They both witnessed the devastation of the Holocaust and the injustice of Hitler’s regime, and they came to this country with nothing.
They instilled in me a strong desire to pursue justice and uphold the rule of law.
Ct: As head of the Criminal Division, you oversee hundreds of attorneys who prosecute criminal cases across the country. How do you determine their enforcement priorities?
LB: I’m proud to say that the Criminal Division now has nearly 600 lawyers. These lawyers are in roughly 15 different sections, each of which has a particular focus area. I have installed new leadership in many of these sections, and I work very closely with my leadership team to determine priority areas for each section. In an era of limited
Lanny A. BreuerAssistant Attorney General, Criminal Division, U.S. Department of Justice
888-580-8373 | www.hcca-info.org 15
Com
pli
ance
Tod
ay
Jun
e 20
12
featurefeature
an interview by Compliance Today
resources, one of our goals has been to pursue high-impact cases across the country.
Ct: You have to work closely with the nation’s U.S. Attorneys’ Offices when it comes to prosecuting criminal cases in their dis-tricts. How would you describe that working relationship?
LB: It has been a real priority of mine as Assistant Attorney General (AAG) to develop strong working relationships with the nation’s U.S. Attorneys, and I think that the Criminal Division and the U.S. Attorneys’ Offices have built great partner-ships in that time. In many districts, Criminal Division prosecutors are working cases with Assistant U.S. Attorneys, and I couldn’t be happier about the way in which the Division has become a resource for the U.S Attorneys’ Offices, and vice versa.
Ct: Your office works closely internation-ally to address criminal conduct around the globe, such as prosecuting those who violate the Foreign Corrupt Practices Act (FCPA). Can you tell our readers a little about how your office is involved internationally?
LB: Given the increasingly transnational nature of organized crime, intellectual prop-erty crime, and other threats, the work we do internationally is absolutely essential. The Criminal Division has three offices devoted
entirely to international work — one that places legal advisors in countries across the globe to help them in developing and sustaining their criminal justice institutions; another that places law enforcement specialists in countries around the world to help them improve their police work; and a third that handles, among other things, all of our extraditions and requests for foreign mutual legal assistance. In addition, prosecutors in our litigating sections work very closely with our international law enforcement
counterparts, in countries around the world.
Ct: What value does the compliance pro-gram bring to organizations?
LB: Strong com-pliance programs help prevent ille-gal activity from occurring within an organization, and they ensure that any miscon-duct that does occur is uncov-ered quickly and handled respon-
sibly. In recent years, the Justice Department has increased enforcement in several areas of white collar crime, so having an effective compliance program has never been more important than it is today.
Ct: Foreign Corrupt Practices Act enforce-ment is certainly one example of increased enforcement. The number of enforcement actions has increased dramatically in the past few years. Why is this? Do you expect this trend to continue?
Strong compliance programs help prevent illegal activity from occurring within an
organization, and they ensure that any misconduct that does
occur is uncovered quickly and handled responsibly. In recent
years, the Justice Department has increased enforcement in several
areas of white collar crime, so having an effective compliance program has never been more
important than it is today.
16 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12featurefeature
LB: Since 2009, fighting corruption at home and abroad has been a top priority for the Justice Department generally, and for the Criminal Division, and I think you see that reflected in the number of FCPA investigations and resolutions we have had in that period. I can’t say whether the number of enforcement actions will increase or decrease in any given year, but I can tell you that I absolutely expect the trend of robust and fair enforcement of the FCPA to continue.
Ct: Health care fraud is another area where we have seen a significant increase in pros-ecutions. How would you describe the Justice Department’s approach to fight-ing health care fraud, a problem that some estimate to be in the billions of dollars?
LB: The Justice Department has a smart, disciplined approach to fight-ing health care fraud. In 2009, Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius launched the Health Care Fraud Prevention & Enforcement Action Team (HEAT) initiative, and since that time, we have had record prosecutions and civil recoveries. Our Medicare Fraud Strike Force, which uses data and analysis techniques to identify aber-rational billing patterns to target Medicare fraud in “hot spots” around the country, is now in nine different cities nationwide. I think our heightened focus on Medicare fraud comes from a belief that we simply cannot allow people to get away with robbing a pro-gram that is so central to our economy and important for our citizens.
Ct: The Organization for Economic Cooperation and Development (OECD) Working Group on Bribery’s Good Practice Guidance, which the Criminal Division cham-pioned, has helped establish international compliance program standards relating to anticorruption efforts. Would the Department of Justice consider working with OECD to pro-mote such standards on a basis that would be broader, including such global issues such as anti-cartel programs?
LB: We have seen real results from the OECD’s Good Practice Guidance, and we are always looking for ways to strengthen our international partnerships and advance the
rule of law. You would need to ask my colleagues in the Antitrust Division about anti-cartel stan-dards, but I can tell you, in gen-eral, that bringing governments together through organizations
like the OECD to promote cooperation and universal principals is something I strongly support.
Ct: In company compliance programs, many of us use actual disciplinary cases to communicate important messages to our employees. We find they learn best from pub-licizing actual examples; however, we have to be very careful to protect the privacy of the employees involved in the actual cases. Could the Department of Justice take the same approach in communicating to companies what parts of compliance programs in actual cases helped earn credit, and what practices were looked upon as defective?
I think our heightened focus on Medicare fraud comes from a belief that we simply cannot allow people to get away with robbing a program that is so central to our economy and important for our citizens.
888-580-8373 | www.hcca-info.org 17
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
LB: I think we have managed to achieve great transparency in the FCPA area, both with our advisory opinions and through our Fraud Section’s website, which posts all the pleadings in our FCPA cases. These include deferred-prosecution, non-prosecution and plea agreements, which often require the implementation of a compliance program and set forth certain minimum elements reflecting what the Department believes to be the basic components of an effective program. That said, we are always open to exploring new ways to increase transparency about our enforcement efforts. In fact, we are currently working on a detailed new FCPA guide, which we will be releasing later this year. Maintaining a regular dialogue with industry groups and businesses on important issues, such as compliance pro-grams, is a priority for us.
Ct: Finally, compliance professionals are on the front lines, helping their organization prevent criminal conduct and promoting a culture of compliance. They are under a great deal of stress. A recent SCCE/HCCA survey reported that 60% have considered quitting or have woken in the middle of the night worried about work-related issues. Do you have any advice you would like to share with them?
LB: I think that as long as people are doing their jobs conscientiously, and to the best of their ability, they can feel proud. That goes for compliance professionals, as it does for others who have positions of responsibility. To the extent that there is something about the com-pliance profession that is uniquely stressful, I can only recommend doing what I try to do: maintain a healthy balance between work and family, and do your best work every day.
DON’T GOHALFWAY.GO GO GO GO 360360360360..
www.compliance360.com
COMPLIANCE PROGRAM EFFECTIVENESS WITH COMPLIANCE 360: You’ve established a compliance program – but can you prove that it’s working? Regulators now look beyond the
presence of a compliance program, demanding concrete evidence that your program is effective. Partial compliance
is non-compliance. You need a comprehensive, unifi ed solution that helps you identify and fi x the gaps… before
something falls through them.
Learn more at the Compliance Effectiveness Resource Center: visit www.compliance360.com/EffectiveCompliance.
GET THE 360° VIEW.
C O M P L I A N C E 3 6 0® G R C S O L U T I O N S
C360 SAIG HCCA Compliance Program Effectiveness Ad 03-20-12.indd 1 3/20/12 10:12 AM
888-580-8373 | www.hcca-info.org 19
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
DON’T GOHALFWAY.GO GO GO GO 360360360360..
www.compliance360.com
COMPLIANCE PROGRAM EFFECTIVENESS WITH COMPLIANCE 360: You’ve established a compliance program – but can you prove that it’s working? Regulators now look beyond the
presence of a compliance program, demanding concrete evidence that your program is effective. Partial compliance
is non-compliance. You need a comprehensive, unifi ed solution that helps you identify and fi x the gaps… before
something falls through them.
Learn more at the Compliance Effectiveness Resource Center: visit www.compliance360.com/EffectiveCompliance.
GET THE 360° VIEW.
C O M P L I A N C E 3 6 0® G R C S O L U T I O N S
C360 SAIG HCCA Compliance Program Effectiveness Ad 03-20-12.indd 1 3/20/12 10:12 AM
The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010
(collectively known as the Affordable Care Act or ACA) were enacted in March of 2010, thus adopting into law many quality-related initiatives aimed at transforming our health care system from one based on volume to one based on value. Although these programs directly resulted from Congress enacting the ACA, some of the initiatives discussed in this article had foundations laid long before health care reform became law.
The ACA contains important changes, many of which are the subject of much public debate, including the health insurance mandate, creation of state-based insurance exchanges, and expansion of Medicaid eli-gibility to 133% of the federal poverty level, thereby increasing access to affordable health
insurance. However, this article will focus on other ACA provisions that are less controversial and may not be known to the general public. These provisions implement certain quality-of-care initiatives most likely to directly affect how health care pro-viders will deliver and get paid for the care they render to patients in the future.
This article will describe many of the ACA’s quality-of-care provi-sions applicable to hospitals, based on their implementation schedule. We will address each of these provisions according to the federal fiscal year in which they will be implemented, which runs from October 1 through September 30. This means that, for initiatives that com-mence at the beginning of a federal fiscal year, the change actually occurs October 1 of the preceding calendar year (e.g., federal fiscal year 2013 begins on October, 2012). The timeline (see figure 1, page 20) shows the
by Janice A. Anderson, Esq. and Joseph T. Van Leer, Esq.
A timeline for change: A discussion of Affordable Care Act provisions
» Be aware of reimbursement changes and the timeline driven by the Affordable Care Act to take steps to preserve reimbursement to the extent possible.
» By 2015, up to 6% of hospital reimbursement will be at risk for poorly performing hospitals.
» EHR incentive payments are available until 2015, then hospitals will be subject to penalties.
» The Value Based Purchasing program has already started and reimbursement will decline, commencing October 1, 2012, unless hospitals can perform well.
» CMS will implement another penalty, based on the hospital readmission rate for certain discharges, starting October 1, 2012.
Janice A. Anderson (janderson @ polsinelli) is a Shareholder and Joseph T.
Van Leer (jvanleer @ polsinelli.com) is an Associate in the Chicago offices of
Polsinelli Shughart PC.
Anderson
Van Leer
20 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
implementation schedule for many of these programs.
fy2012Bundled PaymentsStarting on January 1, 2012 and running through December 31, 2016, CMS initiated a new Medicare demonstration project using bundled payments for episodes of care that may include hospitalizations, post-acute care, and physician services. Under the bundled payment pilot program, providers can opt to receive a single payment for an entire episode of care. Bundled payments align the finan-cial incentives of those delivering care, and is intended to improve quality, reduce cost, and eliminate the fragmented delivery of care for medical conditions for which a bundled pay-ment is used.
In order to participate in the program, pro-viders must have submitted letters of intent no later than November 2011. Providers must then submit an application. The application for Model 1 was due November 18, 2011. The application for Models 2, 3, and 4 became available online on April 23, 2012 and must be
submitted by June 28, 2012. The program will utilize four models, which vary as to scope and type of payment. These include:
· Model 1 — Retrospective bundled pay-ment for the acute inpatient stay only
· Model 2 — Retrospective bundled pay-ment for hospitals, physicians, and post-acute providers for an episode of care
· Model 3 — Retrospective bundled pay-ment for post-acute care where the bundle does not include the acute inpatient hospital stay
· Model 4 — Prospective bundled payment for hospitals and physicians for the acute inpatient hospital stay only
Models 1, 2, and 3 use a retrospective pay-ment to allow for the payment of the traditional fee-for-service amounts while care is being delivered. CMS will reconcile the retrospec-tive payment against a pre-determined target amount for the entire episode after the episode is completed. The target price would consider the base diagnosis-related group (MS-DRG) payment including payment adjustments and outlier payments. Model 4, which uses a
figure 1: timeline for implementation of various aCa programs
888-580-8373 | www.hcca-info.org 21
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
prospective payment, substitutes a bundled payment instead of the traditional fee-for-service payment for the entire episode of care. The episode of care may be defined by the provider seeking to participate in the bundled payment initiative and may vary, depending on the model. In some cases, applicants may define both the length of the episode and types of ben-eficiaries included.
Bundled payments allow providers to share gains from efficiency improvements with those who partner with them to redesign care. In the retrospective models, CMS expects providers to discount their charges initially and increase the discounts each year. In addi-tion, providers must adhere to certain quality measures determined by CMS before any shared savings will be distributed.
Providers and suppliers selected for bun-dled payments will be required to enter into agreements for a period of 3 years, with the possibility of an additional 2-year extension. A recent report issued by the Congressional Budget Office indicates that bundled payments can result in significant savings to the Medicare program.1 CMS has published a Request for Application which includes more detail on the models and their specific criteria and can be found at http://innovations.cms.gov/initiatives/Bundled-Payments/index.html.
Accountable Care OrganizationsOne of the most talked-about components of health care reform was the implementation of accountable care organizations (ACOs). Although the industry largely rejected the pro-posed rules issued by CMS in April, 2011, the final rules issued in November, 2012 contain several improvements that may make the pro-gram more attractive.
Beginning in 2012, health care organiza-tions may apply to become ACOs. ACOs are intended to be integrated, shared savings programs where participants agree to be
accountable for the quality and the cost of care provided to Medicare fee-for-service benefi-ciaries. If they succeed, the participants in the ACO will be rewarded for keeping costs down while achieving quality and patient satisfac-tion goals, and they can share in a portion of the savings achieved by the ACO.
An ACO may consist of many independent providers and suppliers, including hospitals, physicians, post-acute care providers, etc. However, there must be at least 5,000 ben-eficiaries who receive most of their primary care services from a physician participating in the ACO. Several safe harbors grant relief to the ACO and its participants from fraud and abuse, antitrust, and tax-exemption concerns.
In the first year, an ACO’s receipt of shared savings will be tied to its reporting on 33 qual-ity measures, but in years after, the ACO’s high performance on some or all of the quality measures will be required. Additionally, for the first 3-year contract term, ACOs can choose one of two tracks. The one-sided model allows the ACO to have an upside share savings opportu-nity without downside risk; however, the shared savings opportunity is less under this model (50% of the excess shared savings up to a cap). The two-sided model requires the ACO to share in 60% of both savings and losses, up to a cap.
ACOs cannot succeed without significant buy-in from all participants, including hospi-tals, physicians, post-acute care providers, etc. It is expected that the program, if successful, could result in further consolidation through-out the health care industry.
Electronic Health Record Incentive programThe Medicare and Medicaid EHR Incentive program provides payments to eligible hos-pitals and eligible professionals to adopt, implement, upgrade, and demonstrate mean-ingful use of certified EHR technology. CMS will utilize the Stage 1 Meaningful Use requirements in FY2012.
22 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
Incentive payments under the Medicare program are available to eligible hospitals in 2012 (the payments actually began in 2011) if the hospital achieves meaningful use. The amount of the payment is based on a number of factors, but begins with a $2 million base payment. Hospitals still can earn the maxi-mum pay-out for the full 4-year opportunity if they begin in 2012, but the total payments will decrease for hospitals that start receiving payments in 2014 and later. Hospitals also may participate in both the Medicare and Medicaid programs, if they meet the criteria to do so.
Assessment of community health needsFor tax years beginning after March 23, 2012, tax-exempt hospital organizations must con-duct a community health needs assessment (CHNA) every three years. The assessment must include a description of the community served by the hospital facility and the health needs identified for the community. A hospital or organization that fails to satisfy the require-ments related to the conduct of CHNA will be penalized through a $50,000 excise tax which, for health systems, can apply to each individual facility in the system.
fy2013Inpatient and Outpatient Quality Reporting programsThe Inpatient and Outpatient Quality Reporting programs (IQR and OQR, respec-tively) were enacted by Congress to improve data collection on quality of care for hospitals. Although the programs have been around for several years, CMS will expand upon them in several significant ways in 2013. The pro-gram reduces payments by 2% of the Inpatient Prospective Payment System (IPPS) market basket update and 2% of the increase to the Outpatient Prospective Payment System (OPPS) fee schedule conversion factor for hos-pitals that do not successfully report on the
required quality metrics. For FY2013, several new metrics have been added, and hospitals must successfully report on 57 IPPS measures and 23 OPPS measures.
Besides adding more metrics to the required reporting, beginning in FY2014, CMS plans to add a metric that evaluates spending-per-benefi-ciary. This metric aggregates the total spending for Medicare beneficiaries (adjusted for age, severity of illness, and other factors) using an episode of care that runs from three days prior to an inpatient admission (called an “index hos-pitalization”) through 30 days post-discharge. The spending calculation will take into account all related and unrelated Part A and Part B ser-vices provided to Medicare beneficiaries during the episode, with some limited exceptions, such as statistical outliers and transfers from one acute care hospital to another. Although trans-fers from one acute care hospital to another will be excluded at first, CMS will consider inclusion of such transfers at a later date.
CMS will allocate the costs that occur during an episode, including costs attrib-uted to a readmission during an episode of care (and any transfers to another hospital that occur during a readmission), regardless of whether the readmission is related to the index hospitalization. CMS will also attribute costs for transfers to sub-acute facilities (e.g., a skilled nursing facility or a long-term acute care hospital) to the index hospitalization.
To calculate a hospital’s per-beneficiary spending amount, CMS will divide the sum of all adjusted Medicare Part A and Part B pay-ments during each episode attributed to an index hospitalization by the total number of episodes for that hospital. The operative metric used to report a hospital’s spending-per-beneficiary is the “spending-per-beneficiary ratio,” which is calculated by dividing the hos-pital’s spending-per-beneficiary amount by the median spending-per-beneficiary for all hospi-tals nationally. CMS will post the data for the
888-580-8373 | www.hcca-info.org 23
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
beneficiary spending measure on the Hospital Compare website.
Value Based PurchasingBeginning in FY2013, Medicare’s Value Based Purchasing program (VBP) officially begins, changing the diagnosis-related group (DRG) payment rates for hospitals for discharges occurring on or after October 1, 2012. Using measures already reported under the IQR, CMS will measure a hospital’s level of per-formance to readjust DRG payment rates, rewarding high performing hospitals while penalizing those that do not perform as well.
The payments under the VBP program will come from an across-the-board reduc-tion in hospital’s DRG payments. In FY2013, a hospital’s DRG payments will be reduced by 1% with an opportunity to “earn back” this amount or more, based on the hospital’s total performance score (TPS). CMS will categorize measures into domains. The amount at risk under the VBP grows annually thereafter, reaching a cap of 2% by FY2017. For FY2013, CMS identified two domains that will be mea-sured — the Clinical Process of Care domain and the Patient Experience of Care domain.
The measures in each domain will be reviewed during both a baseline period and a performance period. The baseline period is the time period CMS will use to establish both a “threshold” score and a “benchmark” score. The threshold score is the median score for all hospitals nationally during the base-line period, and the benchmark is the score for the top 10% of hospitals nationally during the same baseline period. A hospital’s own baseline score is also measured, and that will be used to determine how much the hospital improved during the performance period. The baseline period for the first two domains for FY2013 is July 1, 2009 to March 31, 2010.
The performance period is the time period used to judge the hospital’s performance for
purposes of adjusting its DRG payments. A hospital is judged both on its improvement from its own baseline score (improvement score) and on its achievement as compared to the national threshold and benchmark (achievement score). The performance period for the Clinical Process of Care domain and Patient Experience of Care domain started on July 1, 2011 and ended March 31, 2012. Thus, hospitals will soon learn how their DRG rates for FY2013 will be changed, based on their value-based performance.
For FY2013, the Clinical Process of Care domain includes 12 measures selected from the IQR program. Some of these measures include:
· Fibrinolytic therapy received within 30 minutes of hospital arrival for heart attack patients
· Prophylactic antibiotic selection for surgi-cal patients
· Surgery patients with recommended venous thromboembolism prophylaxis ordered
· Blood cultures performed in the Emergency Department prior to receiving an initial antibiotic in hospital
Also for FY2013, the Patient Experience of Care domain includes eight measures from the Hospital Consumers Assessment of Healthcare Providers Survey (HCAHPS). Some of these measures include the HCAHPS’ survey ques-tions regarding:
· Communication with doctors · Responsiveness of hospital staff · Discharge information · Quietness of the hospital environment
A scoring example is provided (see figure 2, page 25). Here, Hospital 1’s performance improved from 0.4297 to 0.8163 in the per-formance period, and its achievement score is 0.8163. This puts the hospital’s score above
Learn more & register at www.hcca-info.org
2012 Basic compliance AcAdemies
Registration for each Academy is limited to 75 attendeesHcca’s compliance academy is a four-day intensive program focusing on subject areas at the heart of health care compliance practice. courses are designed for participants who have a basic knowledge of compliance concepts and some professional experience in a compliance function.
certification exams are offered following each AcademyBe recognized for your experience and knowledge in health care compliance! Take advantage of the opportunity to sit for an optional certification exam on the last day of your academy. Get certified in Healthcare compliance (cHc)® at the Basic compliance academy, certified in Healthcare Research compliance (cHRc)® at the Research academy, or certified in Healthcare privacy compliance (cHpc)® at the privacy academy.
Boston, mAAugust 13–16, 2012
ReseaRch Basic compliance academy
san diego, cAJune 25–28, 2012
Orlando, FLOctober 22–25, 2012
pRivacy Basic compliance academies
scottsdale, AZ SOLD OUT
June 4–7, 2012
New York, NY SOLD OUT
August 6–9, 2012
Las Vegas, NVSeptember 10–13, 2012
Boston, mAOctober 1–4, 2012
Orlando, FL (session A)
November 5–8, 2012
Orlando, FL (session B) JUST ADDeD
November 12–15, 2012
san diego, cADecember 10–13, 2012
Basic compliance academies
888-580-8373 | www.hcca-info.org 25
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
the threshold but below the benchmark, and CMS will use a formula to determine the score with that range. Thus, in the example, the hospital earns an achievement score of 6 and an improvement score of 7. CMS awards the hospital the higher of its achievement score or its improvement score. Accordingly, Hospital 1 would receive 7 points for this measure.
DRG payment rates are changed based on the hospital’s TPS which aggregates the total points for each domain and divides the total earned points by the total possible points to determine the domain score. CMS will then weight each domain using a pre-set weight-ing methodology to determine the TPS. For FY2013, the TPS will be calculated using a weighting methodology of 70% for the Clinical Process of Care domain and 30% for Patient Experience of Care domain.
CMS conducted a “dry run” of the FY2013 VBP program in February and March 2012. There is not much a hospital can do now to influence its final DRG payment rates for FY2013, because the performance period concluded March 31, 2012, and hospitals are expected to learn of their actual DRG payment rate for FY2013 by November 1, 2012. However, the program continues each year thereafter, increasing the amount at risk for the hospital
based on its performance. Thus, hospitals would be well-advised to take steps now to inject quality controls into their operations so that they can be assured of high performance going forward.
Readmissions Reduction programThe ACA established the Medicare Hospital Inpatient Readmissions Reduction program, which will further reduce DRG payments for acute care hospitals that have higher-than-expected readmission rates for certain conditions. Under the program, CMS will reduce hospitals’ base operating DRG pay-ments by an adjustment factor that accounts for excess readmissions. The payment reduc-tion is capped at 1% in FY2013, but increases to 3% by FY2015. The measures that will be evaluated for excess readmissions for the first year of the program include the 30-day risk standardized readmission measures for acute myocardial infarction (AMI), heart failure, and pneumonia.
For purposes of this program, readmissions are those that occur within 30 days from a dis-charge, which is the same timeframe currently used for readmission measures under the IQR program. Notably, all related readmissions within this timeframe will be counted, unless
Hospital earns: 6 points for achievement 7 points for improvementHospital score: maximum of either achievement or improvement = 7 points on this measure
Hospital
baseline .4297
.8163
1 2 3 4 5 6 7 8 9 10
performance
Score
Achievement Threshold
Achievement Range
0 1 2 3 4 5 6 7 8 9Improvement Range
Achievement Range
Benchmark.6548 .9191
Score
figure 2: measure: ami-7a — fibrinolytic therapy
26 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
they meet some limited exceptions. Many of the details of the program are undefined, and CMS plans to finalize the remaining details of the program in its FY2013 rule-making cycle.
Independent Payment Advisory BoardOne of the more controversial provisions of the ACA was the creation of the Independent Payment Advisory Board (IPAB) which was designed to stem the growth of Medicare spending. The IPAB is intended to be responsi-ble for recommending reductions in spending growth. Although IPAB is prohibited from recommending changes that would ration care or increase taxes, cost-sharing requirements, or beneficiary premiums, many fear that these limitations will not be followed, and there is widespread concern that too much authority is delegated to the IPAB.
The ACA requires the 15-member IPAB board to make specific recommendations annually to reduce spending growth if the projected Medicare growth rate exceeds the projected annual target determined by the chief actuary of CMS. These recommendations must be given to Congress and the President by January 15 each year. Congress can either adopt the IPAB’s recommendations or enact changes that result in the same savings for Medicare. If Congress fails to act, however, Health and Human Services (HHS) must implement IPAB’s proposals by August 15 of the same year, without any further review by either the courts or the Executive branch of government. Thus, in the absence of Congressional action, recommendations by the IPAB automatically become law. The ACA requires that the IPAB begin its work in 2013, with 2015 targeted as the first year that its rec-ommendations would be implemented.
The future of the IPAB is presently uncer-tain, as several proposals have been made to repeal its creation.2 In fact, the Medicare Decisions Accountability Act of 2011, approved
by the House Energy and Commerce Committee, includes among its provisions the repeal of the IPAB. In addition, President Obama has not appointed any members of the IPAB yet, and the Secretary of HHS indicated that it is unlikely IPAB will make recommen-dations before 2018.
Electronic Health Record Incentive programFull incentive payments are still available to eligible hospitals in 2013, but they begin to be phased down, using a transition factor over a 4-year period beginning in 2014. On February 23, 2012, CMS released the proposed rule for Stage 2 Meaningful Use rules, which CMS plans to implement in FY2013 for many providers who are to advance to Stage 2. However, in the pro-posed rule, HHS announced that it may delay implementation of the Stage 2 requirements for providers that began participation in 2011.
fy2014Value Based PurchasingBeginning in FY2014, 1.25% of DRG payments will be at risk under VBP. CMS also will add a new Outcomes domain to the VBP, which will consist of three mortality measures using a baseline period of one year (from July 1, 2009 to June 30, 2010), and a similar year-long performance period of July 1, 2011 to June 30, 2012. The scoring and other metrics under the VBP are not expected to change for FY2014, but CMS will adjust the weighting of the domains as follows:
· Clinical Process of Care domain — 45% · Patient Experience of Care domain — 30% · Outcomes domain — 25%
Payment cutsIn FY2014, the individual mandate under the health reform law begins, which is expected to reduce the amount of uncompensated care for most hospitals. Thus, in FY2014, the Medicare Disproportionate Share Hospital
888-580-8373 | www.hcca-info.org 27
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
(DSH) payments will be cut across the board, but the DSH payments to a specific hospital may increase subsequently, based on the per-cent of the population that is uninsured and the amount of uncompensated care that the hospital provides. This is meant to compensate hospitals that do not see the expected reduc-tion in uncompensated care and thus shoulder a larger proportion of the burden of provid-ing uncompensated care. Similarly, the ACA also mandated a reduction in state Medicaid DSH allotments. HHS is required to develop a methodology for distributing these DSH reductions in manner that imposes the largest reductions for those states with the lowest per-centage of uninsured.
DSH payments are based on a complex statutory formula meant to give additional compensation to hospitals that provide a high percentage of care to indigent patients. These reductions are anticipated to total $22.1 billion over 10 years. The cuts are meant to offset increases in insured individuals as a result of the individual mandate and Medicaid expansion taking place in FY2014. Many hospitals are concerned about the impact these reductions may have on their bottom-line. This is particularly true for public hospitals and other safety-net providers.
Electronic Health Record Incentive programEHR incentive payments to eligible hospitals also continue in 2014; however, CMS will apply a transition factor that reduces the incentive payment to 75% of what otherwise would have been paid, as if 2014 were the second payment year for the hospital. Thus, hospitals beginning participation in 2014 will not realize optimal payments under the EHR incentive program.
fy2015Value Based PurchasingIn FY2015, 1.5% of hospital DRG payments will be at risk under the VBP program. There
timeline takeawaysThe focus on changing payment policy in the name of value and improving patient outcomes will likely pose difficulties for many providers, because these changes are occurring rapidly. Nevertheless, many of these initiatives, albeit challenging, are expected to make valuable improvements to our health care delivery system. These policy changes, like many others, can also cause hospitals a significant loss of revenue, unless they have taken steps to perform well under them. This requires constant vigilance to learn about the changing rules and active efforts to change how care is delivered to ensure high-level performance.
· 2012 – Bundled Payment program begins – ACOs and Shared Savings program begin – Hospitals may be eligible for full payout of
the EHR incentive – A community health needs assessment is
required every three years, or a $50,000 penalty may be assessed
– 2% Medicare market basket update pay-ment reduction (IPPS) for failing to report IQR measures
– 2% Medicare market basket update pay-ment reduction (OPPS) for failing to report OQR measures
· 2013 – 2% Medicare market basket update pay-
ment reduction (IPPS) for failing to report IQR measures
– 2% Medicare market basket update pay-ment reduction (OPPS) for failing to report OQR measures
– Hospitals must begin demonstrating mean-ingful use of EHR this year to receive full pay-out
– IPAB program begins – 1% decrease in Medicare DRG payments
(to fund VBP program) – 1% penalty (decrease in base operating
DRG payment) for hospitals with higher-than-expected readmissions
(continued on next page)
28 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
are also certain hospital-acquired conditions (HAC) measures and Agency for Healthcare Research and Quality (AHRQ) patient safety indicators, inpatient quality indicators, and composite measures that had been proposed by CMS to be added to the Outcomes domain
for FY2014, but then were withdrawn. It is likely that CMS may include these measures in future years, possibly as early as FY2015.
Furthermore, CMS intends to incorporate a fourth, Efficiency domain, which is expected to be included by 2015. This domain will likely consist of the spending-per-beneficiary mea-sure added to the IQR program in FY2013, which CMS proposed to add to the VBP for FY2014, but then was withdrawn.
Electronic Health Record programHospitals may still receive an EHR incentive payment in 2015, but it will be subject to a reduction factor of 50%, due to the application of the transition factor. Hospitals that do not successfully demonstrate meaningful use will incur a 25% reduction of their market basket update. This penalty increases each year there-after if meaningful use is not achieved, until, by 2017, 75% of the market basket update is at risk.
Hospital-acquired conditionsOne component of lowering health care costs and improving outcomes is penalizing hos-pitals if a patient experiences a complication that is deemed to be reasonably preventable and was not present on admission. Thus, under current payment policy, hospitals do not receive the additional payment for treating a patient’s complications if one of several hospi-tal-acquired conditions (HACs) occurs during a hospital admission.
Starting in FY2015 (beginning with dis-charges on or after October 1, 2014), hospitals will incur a 1% penalty of their total Medicare payment if the hospital ranks in the top 25% nationally for HACs. This information will also be posted publicly. A hospital will be compared with the national average to deter-mine if it falls in the top quartile.
1. Lyle Nelson: Congressional Budget Office, Lessons from Medicare’s Demonstration Projects on Value-Based Payment (2012). Available at http://www.cbo.gov/publication/42925
timeline takeaways (continued)
· 2014 – 2% Medicare market basket update pay-
ment reduction (IPPS) for failing to report IQR measures
– 2% Medicare market basket update pay-ment reduction (OPPS) for failing to report OQR measures
– Hospitals may still begin participation in the EHR Incentive program, but payments will be subject to a 25% reduction
– 1.25% decrease in Medicare DRG pay-ments (to fund VBP program)
– 2% penalty (decrease in base operating DRG payment) for hospitals with higher-than-expected readmissions
for failing to report OQR measures – 1% penalty for hospitals in the top 25% for
HACs – 3% penalty (decrease in base operating
DRG payment) for hospitals with higher-than-expected patient readmissions
– Hospitals may still receive reduced EHR incentive payments if they begin participa-tion in 2015, but payments will be reduced by 50%. Hospitals that do not success-fully demonstrate meaningful use will be subject to a 25% reduction market basket update.
– 1.5% decrease in Medicare DRG payments (to fund VBP program)
2. See, for example, Medicare Decisions Accountability Act, H.R. 451, 112th Cong. (2012).
With a clear view of your compliance you can see straight through to performance improvement. When you’re forced to rely on point solutions or worse—a system retrofitted to the health care industry—for managing your governance, risk and compliance program, the lack of visibility can make it seem as if the program is managing you.
MediRegs ComplyTrack™, created specifically for the health care industry by Wolters Kluwer, is a complete solution for complete visibility. With web-based workflow software, the most compre-hensive regulatory content in the industry, and support at every level by health care compliance experts, you can move beyond reacting to chang-ing compliance landscape to proactively improving performance throughout your organization.
Visit MediRegs.com and see how our solution can help turn your organization from reactive to proactive, starting today.
ComplyTrack™ delivers industry-leading solutions for professionals in:
n Compliance
n Risk
n Internal Audit
n Privacy & Security
n Audit & Compliance Committee
n Legal
n Health Information Management
Compliance Today ComplyTrack ad 4-12.indd 1 4/2/2012 4:46:31 PM
Compliance & Ethics Institute October 14–17, 2012 | Las Vegas, Nevada | ARIA in Las Vegas
Learn more & register online atwww.complianceethicsinstitute.org
Pepsi Co
Microsoft
UPS
Molson Coors Brewing Co
Allstate Insurance Company
Waste Management
Bausch & Lomb
The Boeing Company
TIAA-CREF
Morgan Stanley
BAE Systems
Paychex, Inc
Adecco
Comverse
Lockheed Martin Corp
Qualcomm
Accenture
Navistar, Inc
OvER 90 SESSIONS ANd MORE THAN
130 SPEAkERS
Join us at this year’s annual meeting and hear from leading companies, including
*Register on or before July 11, 2012, to save $575
888-580-8373 | www.hcca-info.org 31
Com
pli
ance
Tod
ay
Jun
e 20
12
In the cycle of life, adult children will often repeat to a parent the words they heard the most. My word was “balance.” Phrases such
as, “Make a choice, you can’t do it all” or “You can’t be everywhere, every time, for every-thing” have come back to haunt me.
Stephanie Hochstetler, Manager of Quality Assurance & Compliance, Privacy & Compliance Officer at the CDH Proton Center is concerned about maintaining balance. The center, located in Warrenville, Illinois, is one of three proton centers in the ProCure network. Proton therapy is a form of
cancer radiation treatment that targets pro-tons directly into a tumor, thus preventing the tumor from dividing and growing. Under the direction of the corporate compliance officer, the officers of each center take a coordinated and consistent systems approach to compliance, privacy, and quality.
What keeps Stephanie up at night?Not knowing what she doesn’t know! Stephanie wonders if the right monitors are in place to identify issues in a timely manner. Being timely with the response and action is key to a successful compliance program and compli-ance officer. The center’s structure consists of Stephanie wearing multiple hats—compliance, privacy, quality, risk management, and orga-nizational development. Another view would be that the role is very integrated, addressing numerous components of compliance involved with the recent OIG quality initiatives. For Stephanie, finding that balance, covering the
bases, and accepting that she is human is how she remains logical with her approach.
How does Stephanie cope?She immediately changes her perspective when spending time with her two-year-old. The innocence of youth and their ability to alter adult voices in conversation without coercion is impressive! For personal time, Stephanie used to belong to a gym, but recently traded her membership for monthly massages. Massage is a fabulous form of mental and physical therapy.
Words of advice from StephanieWhen she attended her first HCCA Compliance Institute, she became overwhelmed. She returned to Illinois thinking her center’s compliance program had a lot of gaps. The humanity instinct resonated within her, and she determined that their program is making great progress. They will get there as long as they don’t bite off more than they can chew. Stephanie added, “Do your best every day and you won’t earn a striped jumpsuit!” The second piece of advice Stephanie offered was for compliance officers to join list-serves and take advantage of free webinars. The webinars help to put HCCA Academy and Compliance Institute information into context.
In closing, even the government is seeking balance, at least in the CMS proposed rules on Value Based Purchasing in the name of qual-ity, not just quantity. Conversely, the number of hours worked and the pile of papers on your desk do not equate to quality, nor lead to a healthy work-life balance. The moral of this story is, “Do your best every day (with pas-sion and balance) and you won’t earn a striped jumpsuit!”
by Shawn DeGroot
Balance
exhaLe
DeGroot
Shawn DeGroot, CHC-F, CCEP, CHRC (SDegroot1 @ regionalhealth.com) is
Vice President of Corporate Responsibility at Regional Health, Rapid City, SD.
Shawn also serves as President of the HCCA Board of Directors. Compliance & Ethics Institute October 14–17, 2012 | Las Vegas, Nevada | ARIA in Las Vegas
Learn more & register online atwww.complianceethicsinstitute.org
Pepsi Co
Microsoft
UPS
Molson Coors Brewing Co
Allstate Insurance Company
Waste Management
Bausch & Lomb
The Boeing Company
TIAA-CREF
Morgan Stanley
BAE Systems
Paychex, Inc
Adecco
Comverse
Lockheed Martin Corp
Qualcomm
Accenture
Navistar, Inc
OvER 90 SESSIONS ANd MORE THAN
130 SPEAkERS
Join us at this year’s annual meeting and hear from leading companies, including
*Register on or before July 11, 2012, to save $575
32 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
We should no longer be surprised to learn that information about us resides in many databases and
that this information is being used by busi-nesses, government, and others to learn more about our behavior, our buying practices, and
our preferences for the purpose of their making better decisions about how to interact more effectively with us. In regard to health care providers, there has been a wealth of infor-mation for years in the non-public realm held by payers, manufactur-ers, health departments, and others.
Payers were able to look at health care prac-tices of providers via administrative data and other tracking tools. Manufacturers, through various sources, were able to look at pre-scribing behavior and purchasing practices. Although such data would clearly be useful to compliance programs and many others, it was proprietary and difficult to get to, if available at all.
More recently, data about physicians and other providers has become increasingly public and available as the call for more trans-parency in health care gains momentum. These data are growing, and more and more people are using them to learn about the relationships of physicians and other provid-ers with industry. The focus of this article is to look at the evolution of this data, who is using it, and why it is important that health care providers, senior leadership, and compli-ance programs are able to mine the data and discover what others will know—or already know—about them.
sunshine lawsSunshine laws can be defined as: “U.S. federal and state laws requiring regula-tory authorities’ meetings, decisions, and records to be made available to the public.”1 These laws began appearing in the 1970s, and today there are laws governing public access to government records in all 50 states. This set the stage for the public wanting access to available information that might impact their lives and the decisions they make.
Over the past decade or so, there has been increasing information and discussion about
by Leon Goldman, MD
Ignore at your peril what others know about your organization
» Health care transparency is increasingly making more physician information publicly accessible.
» The Physician Payment Sunshine Act will force over 1,500 companies to disclose in 2013.
» Regulators, media, and the public are already using this data.
» Data mining creates a strategic information asset.
» Comprehensive risk management must combine internal and external data analysis.
Goldman
Leon Goldman, MD (leon @ kyru.us) is a Product Advisor for Kyruus, Inc.
and Principal, Goldman Healthcare Compliance Consulting, LLC in Boston.
He is also a Kallman Executive Fellow, Center for Business Ethics at Bentley
University in Waltham, Massachusetts.
888-580-8373 | www.hcca-info.org 33
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
the power of physician–industry interactions on prescribing and medical decision-making.2 Depending on one’s perspective, these rela-tionships can have either good or bad effects on the behavior of health care providers. Both the public and legislators have expressed their concern for the potential negative impact these relationships have had on patient care and patient care costs.3
One result of this has been a number of state laws covering physician-industry inter-actions; Vermont4 and Massachusetts5 are examples. Most of these laws also contain provisions requiring the disclosure to the state of any payments made by these companies to health care providers and for the state to post the information publicly. Further, the available data has increased as a result of a significant number of settlement agreements between both pharmaceutical and medical device manufacturers and the federal government. One common provision of these agreements has been to require the companies to post pay-ments on a public web site so that anyone can search them and see who is being paid, how much, and for what.
Additionally, there has been a push on the federal level to have a national public database of industry payments to health care providers. This first began in 2007 when U.S. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) introduced a bill at the national level. It was not acted upon, and a second attempt to have a national “Sunshine law” was attempted in 2009. The goal of a national database was finally realized when it became part of the Patient Protection and Affordable Care Act (PPACA) passed in 2010. With this provision of the PPACA, a national database is scheduled to be available by March of 2013.6 This database will contain extensive information about all kinds of financial rela-tionships including, but not limited to, travel, consulting fees, honoraria, research funding
or grants, education or conference funding, stocks or stock options, ownership or invest-ment interest, and royalties or licenses.7 This will be an extensive database that could easily be mined by anyone interested; one such interested party is likely to be the Office of the Inspector General of Health and Human Services (OIG).
public databasesThe number of public databases that report on health care providers is growing. Many have appeared as a result of the Corporate Integrity Agreements (CIAs) between the federal gov-ernment and pharmaceutical companies and medical device manufacturers. As part of the CIAs, these companies have been required to publish payments to providers on their websites and to allow the public access to the information. It is tedious to go through these lists, but some groups, such as ProPublica (http://projects.propublica.org/docdollars) have done so and have begun publishing the informa-tion in aggregate as a searchable website. In addition, through the Sunshine laws, other information is being gathered and made more easily available to the public. Sites (such as clinicaltrials.gov) allow individuals to search on what clinical trials a provider might be involved in or what trials a company is spon-soring, another rich database from which to draw information. There are also databases maintained by state boards of registration in medicine that contain a rich source of disci-plinary information.
No matter where you look, databases are proliferating and the more they become public, the more they will be mined. But while many of these databases are individually searchable, it is tedious to gather all the information about a single individual manually. Although each bit of data may be interesting, it is not particu-larly useful information on which to base a decision.
Data miningData mining is part of a larger growing field of knowledge discovery in databases (KDD),8 which is the process of analyzing data to discover patterns, create models, and make predictions. It is increasingly used in all fields, because it allows for better analysis and use of data as information from which decisions and predictions can be made. Data mining is increasingly used in health care to make business decisions, plan strategy, and monitor provider performance. The Centers for Medicare & Medicaid Services (CMS), through contractors such as the Zone Program Integrity Contractors (ZPICs), uses such pro-cesses to identify behaviors that suggest fraud and abuse might be occurring, and then CMS focuses resources for a more in depth investigation. It is not the intent of this article to look at the various algorithms or software available for such analyses. Suffice it to say that this is a growing field and, with rapidly expanding publicly available databases, it is likely that more and more parties will be mining the data, looking for patterns and models that might predict behavior or iden-tify problems that need to be addressed. KDD is an important concept for compliance programs to utilize as part of their risk assess-ment processes. Given the limited resources of most departments and programs, KDD allows them to better focus their resources in areas that most need compliance help or may repre-sent the greatest risk.
Most of the publicly available databases resulting from CIAs and state laws are created independently and without any standardized structure that considers what it will take to get the data out. When you then gather these
multiple databases and try to extract the data, whether done manually or via automated pro-cesses, it quickly becomes apparent that a lot of work will be needed to remove duplicate entries, to merge different records that refer to a single individual, and to generally “clean” the database and remove ambiguities (or to “disambiguate” the data). For example, if one is gathering data on Dr. John J. Smith, how do you deal with records for a John Smith, a J.J. Smith and a John J. Smith? Are they actually one individual, two, or three? Similarly, how are payments treated? Are entries listed under “speaking” actually payments for a Speakers Bureau or an honorarium for speaking at a
national meeting, or a mixture of both? Does it matter?
Although it is not the purpose of this article, nor is there space enough
to deal with the intricacies of disambiguation of databases, it is important to realize that the process requires significant effort and needs to be done before useful information can be extracted across multiple databases. Without expending the effort, the result is a lot of data, but little useful information.
what it meansAs already noted previously, public data-bases are growing for a number of reasons, and organizations are starting to stitch the data together to develop new insights. By col-lecting the data from large numbers of these databases and using more sophisticated tools, one can begin to develop benchmarks and models. With these models, one can begin to identify correlations and clusters that point to relationships that warrant closer analysis. In a nice summary about the potential impact of the Physician Payment Sunshine Act, Tracy E.
No matter where you look, databases are proliferating
and the more they become public, the more they will be mined.
888-580-8373 | www.hcca-info.org 35
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
Miller points out the potential that database mining has for federal prosecutors.9 As she so aptly notes, it is important for compliance programs to take a proactive approach to this looming threat—not only through policy development, but also through a program of active mining of these databases, asking questions, and developing models to focus on potential problem areas. As the saying goes: “Forewarned is forearmed.”
Consider what one might learn by ana-lyzing and correlating data about financial relationships with provider prescribing data. Or, correlating financial relationships with purchasing practices at a hospital. Wouldn’t a compliance officer or conflicts officer, or even a CEO like to know that their institution’s physicians are at, above, or below the national average per physician payment by industry for consulting? This information cannot be evalu-ated in a vacuum. Industry interaction has many positive effects and some physicians, by virtue of their expertise, should be col-laborating with life science companies to drive innovation. However, the days of remaining ignorant to such relationships has passed. Table 1 (below) shows examples of how data mining across multiple databases can be used to extract national averages against which an organization can measure itself and identify potential high-risk areas to investigate more thoroughly.
table 1: national averages for physician-industry interactions
assessment Characteristic traditional (regulatory) assessment
% of physicians interacting with industry
28%
Interactions per physician 2.7
Total amount per physician $6,350
Average amount per interaction $2,340
Follow-up requirements Ensure corrective actions are taken to address identified deficiencies
Provided by Kyruus, Inc. From data for 2009, 2010, and 2011
As a former compliance officer, I would have welcomed such information to bench-mark the physician staff of my organization. In addition, for an institution with NIH research funding, such tools allow for better knowledge of relationships that might trigger identifying a conflict of interest and verifying individual disclosures, which can be inaccurate.10
ConclusionWith the proliferation of public databases and aggressive data mining of the information by public advocacy groups, news media, and the government, it becomes increasingly impor-tant for compliance programs to also mine existing data. The data can provide a useful risk assessment tool for compliance officers and can focus investigative efforts to maxi-mize the use of scarce personnel resources. Using the information, the Compliance office and the organization can partner with its phy-sician staff on a transparency effort that will strengthen relationships with patients, the community, and regulators.
1 From Investopedia. Available at http://www.investopedia.com/terms/s/sunshinelaws.asp
2 Pauline Norris, Andrew Herxheimer , Joel Lexchin , and Peter Mansfield: “Drug Promotion – What We Know, What We Have Yet to Learn – Reviews of Materials in the WHO/HAI Database on Drug Promotion.” EDM Research Series, No. 032. Available at http://apps.who.int/medicinedocs/en/d/Js8109e/2.html
3 Eric G. Campbell: “Doctors and Drug Companies – Scrutinizing Influential Relationships,” N Eng J Med 2007; 357(18):1796-1797
4 Steinbrook R. “A Higher Bar – Vermont’s New Law on Marketing Prescribed Products,” N Eng J Med 2009; 361(1):8-9
5 The Commonwealth of Massachusetts: General Law – Chapter 111N “Pharmaceutical and Medical Device Manufacturer Conduct.” Available at http://www.malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter111n/Section6
6 Policy and Medicine: Physician Payment Sunshine Provisions: Patient Protection Affordable Care Act Passed the House. March 22, 2010. Available at http://www.policymed.com/2010/03/physician-payment-sunshine-provisions-patient-protection-affordable-care-act.html.
7 Pew Prescription Project: Fact Sheet on Physician Payment Sunshine Act. March 23, 2010, Available at http://prescriptionproject.org/sunshine_act.
8 Usama Fayyaad, Gregory Piatetsky-Shapro, and Padhraic Smyth: “From Data Mining to Knowledge Discovery in Databases.” American Association for Artificial Intelligence, AI Magazine 1996;17:37-54
9 Tracy E. Miller: “The Payment Sunshine Act: Assessing the Compliance Risks for Healthcare Providers.” AHLA Connections, August, 2011. Available at http://www.cadwalader.com/assets/article/080111MillerPaymentSunshineAct.pdf
10 Okike K, Kocher MS, Wei EX, Mehlman CT, and Bhandari M: “Accuracy of Conflict-of-Interest Disclosures Reported by Physicians.” N Engl J Med 2009;361(15):1466-1474
Kyruus helps healthcare organizations manage compliance in the age of transparency Over 1.5M industry payment records are now in the public domain. Self-reported conflict-of-interest disclosures can differ by as much as 25% - 79% from publicly available industry payment data. New NIH FCOI and CMS PPSA regulations increase the need for powerful data mining and analytics capabilities.
Big Data. Better Compliance Results.
Data-Driven Solutions for COI Management Leading healthcare and academic institutions use Kyruus and the most comprehensive, nationwide database on physician-industry interactions to: • Engage physicians. • Automate the process of COI monitoring
and evaluation. • Benchmark against peer institutions.
Discover the public profile of your organization at www.kyruus.com/hcca. Don’t miss the article, “Ignore what others know about your organization at your peril” in this issue of Compliance Today. For more information about Kyruus and our innovative solutions, visit us on the web at: kyruus.com [email protected] | (617)419-2060 kyruus!
888-580-8373 | www.hcca-info.org 37
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
Accessibility of doctor’s offices, medi-cal clinics, hospitals, and other health care providers (collectively, health care
providers) is legally required in order to provide medical care to individuals who have disabilities. Under Title III of the Americans with Disabilities Act1 (ADA), health care providers, as places of public accommodation, are required to provide their services to individuals with disabilities in an accessible manner. Importantly, state and local laws may impose stricter accessibility obligations on health care providers beyond that imposed by the ADA. This article focuses on federal law, but health care providers should be familiar with their specific state and local laws and how the laws impact its medical offices.
Specifically, the ADA requires that health care providers allow individuals who have dis-abilities full and equal access to their health care services and facilities, and provide reasonable modifications to policies, practices, and proce-dures when necessary, unless the modifications would alter the essential nature of the services. This article will discuss certain policies and pro-cedures that should be implemented by health
care providers to ensure appropri-ate accessibility, as well as frequently asked questions raised by practitioners in providing health services to indi-viduals with disabilities.
BackgroundThe ADA and its regulations have applied to private health care pro-viders since 1991. In 2010, however, the U.S. Department of Justice (DOJ) revised the regulations implement-ing the ADA.2 The revised regulations contain new requirements and impose additional obligations on health care providers and, thus, require modification of business policies and procedures, when necessary to serve patients with disabilities. The revised regulations also contain the 2010 Standards for Accessible Design (the 2010 Standards), which revise the standards originally promulgated by the DOJ in 1991 (the 1991 Standards).3
Effective March 15, 2012, the 2010 Standards set new minimum requirements for newly designed and constructed places of public accommodations to be readily accessible to and usable by individuals who have disabilities.
by Kara M. Maciel and Jordan B. Schwartz
Complying with the ADA’s accessibility standards: What you need to know
» Understand how the ADA’s new 2010 standards affect health care providers.
» Modify policies to allow for use of mobility devices.
» Provide effective communication to individuals with disabilities.
» Make medical space accessible for individuals with disabilities.
» Focus on effective training of staff.
Kara M. Maciel (kmaciel @ ebglaw.com) is a Member, and Jordan B. Schwartz
(jschwartz @ ebglaw.com) is an Associate, with EpsteinBeckerGreen in
Washington DC.
Maciel
Schwartz
38 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
Among other things, the 2010 Standards require that health care providers remove physical barriers for individuals with disabilities to the extent that it is readily achievable to do so. Readily achievable means “easily accomplishable without much difficulty or expense.” This requirement is based on the size and resources of a business. So, businesses with more resources are expected to remove more barriers than businesses with fewer resources.
Pursuant to the ADA’s “safe harbor” exemp-tion, elements of existing facilities that comply with the 1991 Standards are not required to comply with the 2010 Standards until such facilities are subject to future alterations. An alteration is defined as remodeling, renovating, rehabilitating, reconstructing, changing or rear-ranging structural parts or elements, changing or rearranging plan configuration of walls and full-height partitions, or making other changes that affect (or could affect) the usability of the facility. Examples include restriping a park-ing lot, moving walls, moving a fixed ATM to another location, installing a new counters or shelves, changing a doorway entrance, replac-ing fixtures, flooring or carpeting. Normal maintenance, such as reroofing, painting, or wallpapering, is not an alteration.
However, all future renovations and altera-tions that begin on or after March 15, 2012 must be done in accordance with the 2010 Standards, to the maximum extent feasible. Therefore, for example, if a doctor’s office restripes its parking lot, following this alteration, the parking lot must comply with the 2010 Standards. Similarly, if a hospital relocates a fixed ATM, all of its ATM’s must then comply with the 2010 Standards. Notably, any private entity that owns, leases, or operates medical office space is responsible for complying with Title III of the ADA. Thus, even if a health care provider leases its office space, this does not serve to absolve liability, because both tenants and landlords are equally responsible for ADA compliance. It is possible, however, to enter
into a private agreement whereby the tenant is made responsible for the areas of the facility that it uses and controls, such as reception areas and examination rooms, while the landlord is respon-sible for more common space, such as restrooms utilized by the entire facility.
The 2010 Standards also contain new requirements for elements in existing facili-ties that were not addressed in the original 1991 Standards. These include recreation facili-ties, such as play areas and exercise machines. Because these elements were not included in the 1991 Standards, they are not subject to the “safe harbor” exemption. Therefore, to the extent any such facilities exist, they must comply with the 2010 Standards.
The DOJ enforces the ADA through investi-gations and injunctive relief. Moreover, the ADA provides a private right of action for individuals to seek injunctive relief and attorneys’ fees (but not monetary damages) against medical prac-tices, if barriers prevent the full and equal access to health care services. As a result of recent changes in the ADA and the spread of individ-ual plaintiff lawsuits across the country, health care providers will see an increase in potential litigation and DOJ investigations under Title III.
modification of policies to ensure equal accessHealth care providers are not only obligated to make structural changes to comply with the ADA, but also must modify policies and procedures to ensure that individuals with disabilities receive equal access to patient care. For example, and as explained below, even if your practice does not permit pets or animals in a waiting room or exam room, providers should modify this policy to permit service animals. Other modifications include mobility devices and effective communication methods.
Mobility devicesHealth care providers must permit the use of manually powered devices intended for use
888-580-8373 | www.hcca-info.org 39
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
by individuals who have disabilities, such as wheelchairs and similar devices. Additionally, reasonable modifications in policies, practices, and procedures must be made to allow for the use of “other power driven mobility devices,” unless a health care provider can demonstrate that the mobility device in question cannot be operated in accordance with legitimate safety requirements. The term “other power-driven mobility device” refers to any mobility device powered by batteries, fuel, or other engines, whether or not they are designed primarily for use by individuals with mobility disabilities (e.g., golf carts or Segways).
Legitimate safety requirements, such as time restrictions or speed limits, may be imposed or even be a basis to deny such use. However, such safety requirements must be based on actual risks and not on mere specu-lation, stereotypes, or generalizations about a particular class of devices or how they will be operated by individuals using them. In making such a determination, it would be pru-dent to consider the following factors:
· the type, size, weight, or speed of the device;
· the facility’s volume of pedestrian traffic; · the facility’s design and operational charac-
teristics; and · whether the use of the device creates a
substantial risk of serious harm to the environment.
Although it is permissible to ask an indi-vidual using an “other power-driven mobility device” for a credible assurance that the device is required because of a disability, a verbal assurance from that individual that is not con-tradicted by your observation is sufficient.
Service animalsService animals (defined as dogs) must be per-mitted when the tasks the animals’ perform are related to a disability. In addition to the
provisions about service dogs, the DOJ’s revised ADA regulations have a new, separate provision about miniature horses that have been individu-ally trained to do work or perform tasks for people who have disabilities. (Miniature horses generally range in height from 24 to 34 inches measured to the shoulders and generally weigh between 70 and 100 pounds.) Thus, health care providers must modify their policies to permit the use of service animals by persons with dis-abilities. Thus, even if a health care provider maintains a “no pets” policy in its offices, clin-ics, or hospitals, it must allow access to a patient using a service animal.
A medical practice may not require proof or certification of medical documentation as condition of entry. A service animal may only be excluded if the dog is out of control and the owner cannot gain control of the animal, or if the dog is not housebroken. In situa-tions where it is not apparent that the dog is a service animal, the only two permissible inquiries that may be made are: (1) whether the animal is required because of a disabil-ity; and (2) the specific work or task that the animal has been trained to perform.
effective communication to individuals with disabilities
The ADA’s revised regulations require health care providers to take steps necessary to communicate effectively with patients who have vision, hearing, and/or speech disabili-ties. Examples of common auxiliary aids and services that could be provided for patients include sign language interpreters (in person or through video remote interpreting (VRI) services), note takers, computer-aided tran-scription services, exchange of written notes, telephone handset amplifiers, assistive listening devices and systems, telephones compatible with hearing aids, closed caption decoders, and video-based telecommunications products and systems, including text telephones (TTYs), video
40 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12feature
phones, and captioned telephones or equally effective telecommunications devices.
The type of auxiliary aid or service neces-sary to ensure effective communication will vary in accordance with the method of communica-tion used by the individual, the nature, length and complexity of the communication involved, and the context in which the communication is taking place. To be effective, auxiliary aids and services must be provided in accessible for-mats, in a timely manner, and in such a way as to protect the privacy and independence of the individual who has a disability. The health care provider cannot impose a surcharge to cover the cost of the auxiliary aid or service provided. Rather, the health care provider is financially responsible for the cost, unless the provider can demonstrate that it would be an undue financial burden. However, even if it is determined that a particular auxiliary aid or service is an undue financial burden, the health care provider must still provide effective communication by using a different auxiliary aid or service.
specific areas of medical staff training under the aDaThere are, of course, numerous particular ele-ments of patient care for individuals who have disabilities. Health care providers must make their staff aware of these issues and provide them with appropriate training, both during an employee’s initial orientation and periodically thereafter. Below are some common issues that should be reviewed with your staff to ensure compliance with the ADA when providing care to individuals who have disabilities:
· Accessible public areas: Health care pro-viders must instruct their staff to ensure all areas of their space are accessible. This includes entry doors, an accessible route to and through the waiting area and examina-tion room, adequate floor space inside the exam room for side transfers and the use of lift equipment, and accessible restrooms.
· Refusing treatment based on unavail-ability of accessible medical equipment: Medical staff should be instructed that they may not deny a service to a patient who has a disability who otherwise would be ser-viced. Instead, the physician must examine the patient just as they would any other patient, and include equipment (e.g., an accessible exam table, accessible stretcher, a patient lift) or provide trained staff who can assist the patient. Refusing such treatment based on lack of accessible medical equip-ment will not suffice under the law.
· Examination of patients with disabilities: It is important that both the medical provider and staff be trained on how to provide medi-cal services in an accessible manner. Such training would include how to operate acces-sible equipment, how to assist with transfers and positioning of individuals who need special assistance, and how not to discrimi-nate against individuals with disabilities. For example, staff must be specifically trained on the proper procedures to examine a patient in a wheelchair. If the patient is unable to get onto the exam table independently, it does not suffice to simply perform the examination while the patient is in the wheelchair, because examining a patient in this manner may be less thorough than on an exam table and does not provide equal access to medical services as a non-disabled patient. Consequently, a transfer system should be provided, and staff should be trained on how to operate that system and how to maneuver a patient onto the exam table.
· Accessible exam tables: A health care pro-vider must be able to provide its services in an accessible manner to individuals with disabilities. In order to do so, accessible equipment may be necessary. However, the number of accessible exam tables needed may depend on various factors, includ-ing the size of the practice, the number of
888-580-8373 | www.hcca-info.org 41
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
patients, and the number of exam rooms. One accessible exam table may be sufficient in a small doctor’s practice, while more will likely be necessary in a larger clinic. Thus, it is not a requirement that every examination room have accessible examination tables.
As the obligations of a medical practice to comply with the accessibility requirements under the ADA are complex and centered on design elements, having a thorough under-standing of what is necessary is key to avoiding a discrimination complaint or lawsuit. The best
way to ensure ADA compliance is through effective staff training, which should be com-menced immediately upon hire and should be a recurring theme throughout an individual’s employment. This is the best—and likely the only way—for for staff to be made aware of the various ways the ADA’s 2010 Standards affect health care providers, including accessibility design requirements, effective communication, and most importantly, patient care.
1 See 42 U.S.C. §§ 12181-12189.2 See 28 CFR, Part 36.3 See 28 CFR, Part 36, Subpart D; see also 28 CFR, Part 36, Appendix D,
for the 1991 Standards.
2012 Regional ConferencesStart planning now for HCCA’s upcoming
TO START YOUR FREE TRIAL CALL 800.372.1033 OR vISIT www.bna.com/hlrc-hcca
Industry-leading health law news and analysis. Compliance guidance and enforcement action. Compliance checklists. Keep an eye on the fast-moving health law landscape and focus in on the critical details you need — all with one comprehensive resource.
8201 HLRC Print Ad for HCCA June.indd 1 3/29/12 4:46 PM
888-580-8373 | www.hcca-info.org 45
Com
pli
ance
Tod
ay
Jun
e 20
12
Today I thought I would focus on one of the communities in the HCCAnetsm, the HIPAA: Health Insurance
Portability and Accountability Act Forum. As with any community,
the HIPAA com-munity consists of a group of individuals who interact through social media to pursue mutual interest
related to HIPAA.Participants in this community ask ques-
tions, like one recently posted: How often should we get Business Associate Agreements signed? Participants also discuss hot topics or the results of recent studies, like one that
focused on security compliance and the increasing regulatory activity.
The HCCAnet communities are a great place to meet peers, learn, and tap an excellent resource for compliance and ethics profession-als. In the different communities, you can find a wealth of information that can benefit your compliance program. I encourage you to join a
community the next time you visit the HCCAnet.
Remember, our social network site is of great value to anyone interested in compliance, and a great way to make friends, obtain needed compliance documents, get answers
to your questions, or just talk with peers. Visit our social network; you will be glad you did.
To participate in discussions or to just talk with your peers, visit the HCCAnet at http://community.hcca-info.org/HCCA/Communities/DiscussionGroups
by John Falcetano
Communities
soCiaL networKinG
Falcetano
John Falcetano, CHC-F, CIA, CCEP-F, CHRC, CHPC, CICA
(jfalceta @ vidanthealth.com) is Chief Audit/Compliance Officer for Vidant Health
in Greenville, NC, and Vice President of the HCCA Board of Directors.
authors wanted for Compliance TodayEvery month Compliance Today offers health care compliance professionals information on a wide variety of enforcement, regulatory, legal, and compliance program development and management issues.
We are particularly interested in articles covering compliance concerns involving hospitals, outpatient services, behavioral health, rehab, physician practices, long-term care/homecare/hospice, ambulatory surgery centers, and more.
Articles generally run between 1,000–2,500 words; this is a guide, not a limit. The author’s contact information must be included in the article as well
as the article title. Submit your article as a Word document with limited formatting.
email margaret.dragon @ hcca-info.org with your topic ideas, format questions, and more.
authors earn Ceus: CCB awards 2 Ceus to authors of articles published in Compliance Today.
19A timeline for change:
A discussion of Affordable Care Act
provisionsJanice A. Anderson, Esq.
and Joseph T. Van Leer, Esq.
32Ignore at your
peril what others know about your
organizationLeon Goldman, MD
37Complying with the ADA’s accessibility
standards: What you need to know
Kara M. Maciel and Jordan B. Schwartz
51Reconsidering
FCOI: What PHS’s final rule means to investigators
Ofer Amit, MSEM, CHRC and Draco Forte, M.Ed., CHRC
a publication of the health care compliance association www.hcca-info.org
Meet Lanny A. Breuer Assistant Attorney General, Criminal Division, U.S. Department of Justice
See page 14
ComplianceTODAY June 2012
In the different communities, you can find
a wealth of information that can benefit your compliance program.
cabriogypsy / Apr 30, 8:41 am
General session started out w/the Compliance Baby video & now the IG is speaking at #HCCAci. This year has been off to a great start!
RubyGentry2 / May 03, 9:25 am
I enjoyed the conference � rst time attending. i thought i would have to take baby steps. HCCA your staff made me feel right at home@#HCCAci
knm2798 / Apr 30, 10:17 am
#hccaci Aaron Beam was fantastic. What a powerful presentation.
trumantinsley / May 01, 10:02 am
Very informative general sessions this morning. Great start to another day at #HCCAci
GrinNoCat / Apr 30, 4:23 pm
1st time at HCCA conference and a new member too. I have been pleasantly surprised by the content and organization! #hccaci
Lacktman / Apr 30, 8:32 am
HCCA general session is packed! #HCCAci
RCHPPrivacy / Apr 30, 5:29 pm
#HCCAci Good sessions and great app this year!
Highlights from HCCA’s 16th Annual2012 Compliance InstituteSee more photos from the Institute at www.compliance-institute.org/pastCIs/2012
Don’t miss HCCA’s 2013 Compliance Institute in Washington DC Register today at www.compliance-institute.org
46 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
cabriogypsy / Apr 30, 8:41 am
General session started out w/the Compliance Baby video & now the IG is speaking at #HCCAci. This year has been off to a great start!
RubyGentry2 / May 03, 9:25 am
I enjoyed the conference � rst time attending. i thought i would have to take baby steps. HCCA your staff made me feel right at home@#HCCAci
knm2798 / Apr 30, 10:17 am
#hccaci Aaron Beam was fantastic. What a powerful presentation.
trumantinsley / May 01, 10:02 am
Very informative general sessions this morning. Great start to another day at #HCCAci
GrinNoCat / Apr 30, 4:23 pm
1st time at HCCA conference and a new member too. I have been pleasantly surprised by the content and organization! #hccaci
Lacktman / Apr 30, 8:32 am
HCCA general session is packed! #HCCAci
RCHPPrivacy / Apr 30, 5:29 pm
#HCCAci Good sessions and great app this year!
Highlights from HCCA’s 16th Annual2012 Compliance InstituteSee more photos from the Institute at www.compliance-institute.org/pastCIs/2012
Don’t miss HCCA’s 2013 Compliance Institute in Washington DC Register today at www.compliance-institute.org
888-580-8373 | www.hcca-info.org 47
Com
pli
ance
Tod
ay
Jun
e 20
12
48 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
HCCA would like to thank our 2012 Compliance institute sponsors
ConferenCe supporters
meDia sponsors
siLVer sponsors
GoLD sponsors
pLatinum sponsors
The Education You
NEEDThe Resource You
TRUSTHCCA Live Learning CenterAs your educational leader in the world of health care compliance, The HCCA Live Learning Center is your ultimate online educational resource. Gaining knowledge and best practices in the world of health care compliance has never been easier.
HCCA recorded over 120 sessions at this year’s 16th Annual Compliance Institute with speaker handouts and have made them available to you on the HCCA Live Learning Center.
If you attended the Institute then it would have been dif�cult to attend all the sessions and absorb all the valuable knowledge presented. If you didn’t attend the Institute, then you missed valuable information that you NEED to enrich your professional development.
Purchase your conference resources NOW!
www.softconference.com/hcca
2 0 1 2
C
M
Y
CM
MY
CY
CMY
K
FullPage.pdf 1 27/04/2012 10:48:07 AM
Join us in DC for the single most comprehensive compliance conference designed specifi cally to meet the needs of today’s health care compliance professionals and their staff.
REGISTER NOW AT www.compliance-institute.org
EARLY BIRD REGISTRATIONRegister by or on January 7, 2012, and save $575!
Compliance Institute April 21–24, 2013 7 National Harbor, MD (DC Metro Area) 7 Gaylord National
Health Care Compliance Association’s 17th Annual
888-580-8373 | www.hcca-info.org 51
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
In August 2011, the Department of Health and Human Services (HHS) announced a final rule that amends Public Health Service
(PHS)1 requirements that pertain to both the responsibilities of PHS-funding applicants for promoting objectivity in research2 and to the responsibilities of prospective PHS contractors.3 Our discussion here will focus on the former: PHS’s requirements regarding the promotion of objectivity in research. Like its predecessor—frequently referred to as the 1995 Regulation—the final rule intends to promote objectivity in research by setting the expectation that, following its implementation, “…the design, conduct, and reporting of research…will be free from bias resulting from Investigator financial conflicts of interest.”4 Nonetheless, the Final Rule includes a number of provisions that add to or are materially different from those in the 1995 Regulation. Among the changes are a revised definition of the term significant financial interest (SFI), the addition of training requirements, expansion of the scope of
required disclosures, and the inclusion of specific reporting and public disclosure requirements. Compliance with the final rule is required by August 24, 2012.
Research institutions, sponsors, and governing bodies are aware of the ethical concerns that finan-cial interests of investigators and key research personnel can bring to bear. Most are cognizant of the effect that conflicting financial inter-ests for researchers (whether real or perceived) could have on the value, integrity, and reputation of their research programs. To this end, both the FDA rules5 and the Common Rule6 lay out separate criteria for the disclosure and management of financial interests by investi-gators and certain others involved in research. As explored in more detail in this article, the FDA rules and the Common Rule differ from the final rule in scope, application, standards, and assigned responsibilities.
By way of a summary, the FDA rules require that applicants for FDA approval must take appropriate steps to minimize bias in
by Ofer Amit, MSEM, CHRC; and Draco Forte, MEd, CHRC
Reconsidering FCOI: What PHS’s final rule means to investigators
» Relationships between researchers and sponsors are not inherently bad.
» Threshold for Significant Financial Interest (SFI) set at $5,000.
» SFI connected to Investigator’s institutional responsibilities must be disclosed.
» Non-compliance can delay funding or require repayment of funds.
» Disclosure of SFI is not only required; it is also good research practice.
Amit
Forte
Ofer Amit (OferA @ baptisthealth.net) is Research Compliance Administrator with
Baptist Health South Florida in Miami. Draco Forte (draco.forte @ snrdenton.com)
is Director, Health & Life Sciences with SNR Denton, US, LLP in Chicago.
52 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12Feature
the design, conduct, reporting and analysis of research. Thus, it is incumbent upon the research sponsor to disclose to the FDA the financial arrangements it has with the investi-gators in the study and other interests, if any, that investigators may have in the product under study. The sponsor must also disclose to the FDA steps taken to minimize potential bias that may arise from these arrangements or interests. Alternatively, the sponsor can cer-tify to the FDA that investigators do not have inappropriate financial arrangements or inter-ests. The Common Rule, on the other hand, prohibits participation of Institutional Review Board (IRB) members in initial or continuing review of projects in which they have conflicting inter-ests.7 However, the Common Rule does not define conflict of inter-est. The Office of Human Research Protections (OHRP) thus published guidance related to how IRBs, research institutions, and inves-tigators can manage financial relationships and interests that may impact human subjects research.
One of the key elements of the final rule, which applies to all PHS funding applicants and recipients, is the re-definition of the thresh-old for SFI. The final rule distinguishes between financial interests in publicly traded entities and those in non-publicly traded entities. It considers an SFI to be an amount in excess of $5,000 received from a publicly traded entity, when aggregated over the 12-month period pre-ceding a disclosure, for any remuneration for services and equity interests.
Consider a scenario in which an inves-tigator is holding shares of Boston Scientific
(a public company that makes less-invasive medical devices) and is speaking at a vari-ety of company events. Over the 12 months prior to a disclosure, he/she received from Boston Scientific $3,000 in honoraria and $3,000 in dividends due to his/her holdings. In this case, the aggregate amount of the remunerations from Boston Scientific exceed $5,000—thus constituting a reportable SFI.
The final rule is more stringent regarding equity interest (e.g., stock, stock option, or other ownership interest) in a non-publicly traded entity and deems any holding of such interest a SFI.8 For example, if an investigator is among a limited number of investors who hold shares
in a startup com-pany, this holding, regardless of size, is considered a SFI. Intellectual property rights and interests (e.g., patents, copyrights, etc.) may also be considered a SFI upon receipt of the income. Although
not dubbed a SFI, the final rule also requires dis-closure of any reimbursed or sponsored travel.
Additionally, the final rule mandates that investigators complete training on SFI. The final rule is not specific on the train-ing’s content, delivery method, or supporting documentation. It places the responsibility for obtaining such training with the investigator and requires completion prior to engaging in research related to a PHS-funded award and at least every four years.9
Further, the final rule expands the investi-gator’s disclosure requirements. In doing so, the final rule defines the term “investigator’s institutional responsibilities” as “Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution
The requirements for reporting and public disclosure
are expanded as well. The institution must make
its policy on financial conflicts of interest available via a
publicly accessible website.
888-580-8373 | www.hcca-info.org 53
Com
pli
ance
Tod
ay
Jun
e 20
12
feature
in its policy on financial conflicts of inter-est.”10 This definition means, in practicality, that any and every financial interest that the investigator has in connection with his/her institutional responsibilities should be consid-ered for disclosure purposes.
The requirements for reporting and public disclosure are expanded as well. The institu-tion must make its policy on financial conflicts of interest available via a publicly accessible website. In addition, prior to spending PHS research funds and at any point thereafter, the institution must allow public access to the investigators’ SFI disclosures that:
· constitute a financial conflict of interest (FCOI),
· are related to the specific study, and · pertain to interests held by the investigator at
the time of disclosure.
The institution must report to the fund-ing agency any SFI of a study’s investigator(s) that it found conflicting prior to expenditure of PHS research funds. Note that failure to comply with this rule may result in delay or withdrawal of funding for the PHS sponsored projects, or place the institution at risk for enforcement actions from the funding and other federal agencies.
This article discusses only select provi-sions in 42 CFR 50, Subpart F, Promoting Objectivity in Research and in 45 CFR 94, Responsible Prospective Contractors. As an
investigator or research team member you should take the following actions to help implement an institutional policy in compli-ance with the final rule:
· Inventory all financial relationships you have in connection with your research responsi-bilities. Include financial relationships that your family members may have because, for final rule purposes, their financial interests may be considered yours.
· Inquire about training on SFI. Your institu-tion may provide training on its policy on FCOI in research. The training on SFI refer-enced in this article is required separately and in addition to training on your institu-tion’s policy.
· Make yourself available for training on your institution’s policy on FCOI in research when it is offered.
· When requested to make an SFI disclosure, make it promptly and fully.
· Work closely with institutional personnel responsible for receiving and vetting SFI dis-closures. They can provide guidance on this topic and help you throughout the process.
1 PHS is an office within the Department of Health and Human Services (HHS) that houses a number of HHS offices and agencies including, for example, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
mail HCCA 6500 Barrie Road, Suite 250 Minneapolis, MN 55435
to learn how to place an advertisment in Compliance Today, contact margaret Dragon:
email margaret.dragon @ hcca-info.org
phone 781-593-4924 19A timeline for change:
A discussion of Affordable Care Act
provisionsJanice A. Anderson, Esq.
and Joseph T. Van Leer, Esq.
32Ignore at your
peril what others know about your
organizationLeon Goldman, MD
37Complying with the ADA’s accessibility
standards: What you need to know
Kara M. Maciel and Jordan B. Schwartz
51Reconsidering
FCOI: What PHS’s final rule means to investigators
Ofer Amit, MSEM, CHRC and Draco Forte, M.Ed., CHRC
a publication of the health care compliance association www.hcca-info.org
Meet Lanny A. Breuer Assistant Attorney General, Criminal Division, U.S. Department of Justice
See page 14
ComplianceTODAY June 2012
� e Health Care Compliance Professional’s Manual gives you all the tools you need to plan and execute a customized compliance program that meets federal standards. Available via print or the Internet, the Manual walks you through the entire process, start to � nish, showing you how to dra� compliance policies, build a strong compliance infrastructure in your organization, document your e� orts, apply self-assessment techniques, create an e� ective education program, pinpoint areas of risk, conduct internal probes and much more.
The Health Care Compliance Professional’s Manual
• Con� dently use OIG publications and Federal Sentencing Guidelines to help you plan and execute a customized compliance strategy that meets strict federal standards
• Perform risk assessments within your program to help you uncover possible areas of risk
• Dra� your own compliance policies that will form the basis for your organization’s program
• Develop and reinforce a solid infrastructure, including guidelines for hiring the right personnel
• Design an e� ective education program that instills the importance of compliance
• Conduct your own internal probes to surface and cure questionable activities, thus mitigating possible penalties
• Keep continually up-to-date with the latest regulatory changes, including practical coverage of federal and state laws
SUBSCRIPTION SERVICE INCLUDED WITH PERIODIC UPDATES
• Hard-copy subscribers receive quarterly updates
• Internet subscribers receive updates as soon as they are issued
MEMBER PRICE: $379 NON-MEMBER PRICE: $419
www.hcca-info.org | 888-580-8373
The Health Care Compliance Professional’s Manual shows you how to:
888-580-8373 | www.hcca-info.org 55
Com
pli
ance
Tod
ay
Jun
e 20
12
The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and
Education Reconciliation Act of 2010 (Pub. L. 111-152), collectively known as the Affordable Care Act or ACA, significantly expanded
compliance risks for health care enti-ties in a number of areas. In addition, Section 6401 of the ACA provides that a “provider of medical or other items or services or supplier within a partic-ular industry sector or category” shall establish a compliance program as a condition of enrollment in Medicare,
Medicaid, or the Children’s Health Insurance Program (CHIP). The ACA further required the Secretary of Health and Human Services (HHS), in consultation with the HHS Office of Inspector General (OIG), to establish “core elements” for provider and supplier compli-ance programs within a particular industry or sector. In doing so, HHS has the discretion to
determine both the timeline for implementa-tion of the core elements and the requirement to have a compliance program. Section 6102 of the ACA also requires that nursing facilities have effective compliance and ethics programs in operation by March 23, 2013 (within 3 years of enactment of the ACA).
mandatory health care compliance programsIn September 2010, the Centers for Medicare & Medicaid Services (CMS) solicited com-ments from industry stakeholders on how CMS should approach these new compliance program requirements. CMS included this solicitation in a proposed regulation covering a number of program integrity-related provisions of the ACA.1 In February 2011, CMS published the final version of the regulation and stated, as it did in the proposed rule, that it intends to publish proposed regulations on the ACA mandatory compliance program provisions “at a later date.”2 To date, CMS has not pub-lished proposed regulations. CMS also failed to meet a specific statutory deadline (March 23, 2012) under Section 6102(b)(2) to promulgate compliance and ethics program regulations for nursing facilities. While the timing for imple-mentation and specific requirements may be
by Brenda J. Tranchida, Esq.
CMS issues long-awaited compliance program guidance revisions
Tranchida
» The new guidance incorporates 2011 regulatory changes and interpretive guidance.
» The compliance officer’s reporting role and entity’s governance responsibilities are more clearly defined.
» New requirements for oversight of first tier, downstream, and related entities; risk assessments; and use of metrics are highlighted.
» The factors and evidence CMS will use to assess the effectiveness of a compliance program are outlined.
» Other health care sectors that are required to have compliance programs may find this new guidance useful as well.
Brenda J. Tranchida (bjtranchida @ venable.com) is Of Counsel in the
Baltimore and Washington DC offices of Venable LLP. Formerly, she was a
senior executive at the Centers for Medicare & Medicaid Services, where she
was responsible for Medicare Advantage and Prescription Drug compliance
program policy and enforcement, and program audit activities.
56 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
in question, the ACA provides a clear statutory mandate for Medicare, Medicaid, and CHIP providers or suppliers and nursing facilities to have effective compliance and ethics programs.
In contrast, CMS has required Medicare Advantage (MA) managed care and pre-scription drug (Part D) plan entities, which provide benefits for 30 million of the nearly 50 million eligible Medicare beneficiaries, to establish compliance programs as a manda-tory condition of contracting with CMS since the beginning of these programs. CMS issued substantially revised regulatory requirements applicable to these entities, effective January 1, 2011, which specifically required entities to adopt and implement an “effective” com-pliance program and added more detailed requirements for each of the seven basic com-pliance program elements (Note: This article will not detail all of these specific regulatory changes). CMS’s updated regulations also clarified that an effective compliance program must include measures that prevent, detect, and correct program noncompliance and fraud, waste, and abuse.
In the last few years CMS has made these mandatory compliance programs a targeted focus of its enforcement and audit activities, including sanctioning several entities based, in part, on violations of these requirements. On February 8, 2012, CMS again turned its atten-tion to these mandatory compliance program requirements, issuing long-awaited proposed changes to guidance exactly 6 years to the day the guidance was first issued to this industry (public comments to these proposed changes were due to CMS by March 16, 2012). In addi-tion to offering further clarification on these requirements to MA and Part D plan entities, CMS’s proposed (and ultimately final) guid-ance to this industry will undoubtedly shed light on the specific approaches and require-ments CMS may apply to the other health care sectors (e.g., hospitals, physician practices,
nursing homes, etc.) affected by the mandates of Sections 6102 and 6401 of the ACA.
Cms proposed mandatory compliance program guidance revisionsCMS incorporated the specific language of the updated 2011 regulations into the appropriate sections of its manual guidance (Chapter 9 of the Medicare Prescription Drug Benefit Manual). Consistent with these regulatory changes, CMS also retitled the manual chapter (“Compliance Program Guidelines”) to reflect an overall focus on compliance programs that effectively prevent, detect, and correct program noncompli-ance as well as fraud, waste, and abuse, rather than the narrower title of the current version of the chapter (“Program to Control Fraud, Waste and Abuse”). In addition, CMS clarified that once the guidance is finalized, it intends to issue a new identical chapter for MA entities (Chapter 21 of the Medicare Managed Care Manual).
CMS’s updated guidance proposals also provide more specific direction concern-ing oversight of first tier, downstream, and related entities (FDRs) in a number of the seven compliance program elements. In addi-tion, more broadly, the proposals state that CMS’s requirements for sponsors to oversee its FDRs apply to those entities for which the sponsor has delegated “core functions” under its Medicare contracts. For these core function entities, CMS has updated its guid-ance language to provide that sponsors must specifically develop procedures to promote and ensure that all FDRs are in compliance with all applicable laws, rules, and regula-tions. A sponsor must have a risk assessment and management program, effective training and education, and effective internal controls and effective monitoring in place to exercise oversight of all of its FDRs and their associated personnel. CMS strongly recommends the use of metrics to conduct this oversight and to observe performance and operational trends.
888-580-8373 | www.hcca-info.org 57
Com
pli
ance
Tod
ay
Jun
e 20
12
The following summarizes the proposed changes in guidance that apply specifically to each of the seven compliance program elements.
written policies and procedures (element i)CMS’s proposed changes provide that the sponsor must be able to demonstrate “through written materials,” a strong ethical culture and commitment to compliance with all applicable laws, regulations, and requirements. In expanding on what written materials would be appropriate, CMS stated that typically an effective compliance program includes a resolution by the full governing body (updated annually) stating the sponsor’s commitment to compliant, lawful, and ethical conduct. In the last few years, CMS made it a standard operating practice to obtain these kinds of governing board resolutions from entities during any enforcement and/or audit corrective action activities, prior to releasing the entity from these oversight processes.
Also, CMS states that it expects the entity’s standards of conduct to “state the require-ment that personnel in its organization and first tier, downstream and related entities (FDRs) report violations of law, regulations or program requirements to the Sponsor.” In con-trast, the current guidance states that the code of conduct “should encourage” reporting and includes law enforcement and CMS contrac-tors as possible reporting sources.
This section of the updated guidance also has several new requirements, including:
· Sponsors must develop detailed policies and procedures to identify and address risks.
· Sponsors are required to be knowledgeable about Medicare requirements for each oper-ational and administrative area that may pose a risk of Medicare noncompliance and fraud, waste, and abuse.
· Sponsors must have policies and procedures to implement each regulatory requirement of an effective compliance program.
One of the most significant changes in these proposals is the requirement that the governing body and senior management be directly involved in the development and/or review of the compliance pol-icies and procedures and standards of conduct. CMS states that even if a board
committee develops/reviews these documents, they must be approved by the full governing body and senior management, including the “CEO and other senior officials.” (The current guidance only references the code of conduct and provides that this document should be approved by the governing body or a committee of the governing body). CMS also states that it strongly recommends a standardized process for governing body review of these documents at least annually. (In contrast, the current guidance only references the code of conduct and states it should be reviewed periodically.)
Finally, CMS’s proposals state that it expects compliance policies and procedures and stan-dards of conduct to be distributed to employees (including to FDR employees) within 90 days of hire, annually thereafter, and whenever these
While the timing for implementation and specific
requirements may be in question, the ACA provides a clear
statutory mandate for Medicare, Medicaid, and CHIP providers
or suppliers and nursing facilities to have effective compliance and
ethics programs.
58 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
documents are revised. In doing so, CMS is proposing to establish a specific 90-day dead-line for initial distribution to new hires and new FDRs. CMS has strengthened the language related to this distribution requirement from “should” to “expects” and has provided clar-ity that sponsors will be held accountable for ensuring FDR compliance with these require-ments. CMS also included new language that the sponsor must be able to demonstrate to CMS that all employees (including all FDR employees) have received these documents in a timely manner and, as a condition of employ-ment, have read and agreed to comply with these policies, procedures, and standards. CMS also expects contracts with FDRs to include provisions that address these distribu-tion requirements and states that a sponsor must periodically monitor and audit its own organization and its FDRs to ensure that there is documented proof that these distribution requirements are being met.
Compliance officer, Compliance committee, and high-level oversight (element ii)CMS’s 2011 regulations include new language that the compliance officer and Compliance committee must report directly to the entity’s chief executive or other senior management. CMS’s proposed guidance further addresses this relationship by requiring that the orga-nization must ensure that reports from the Medicare compliance officer reach the senior-most level of the company, typically the CEO or president. Reports can flow through divi-sional CEOs or presidents (e.g., president of the Medicare division of the company), but should not be routed through operational manage-ment, such as the chief operations officer (COO), chief financial officer (CFO), general counsel (GC), or other executives responsible for operational areas.
CMS’s proposed guidance also pro-vides that because of the direct reporting
requirement in regulations, the Medicare com-pliance officer’s reports to the governing body must be made through the Compliance infra-structure (i.e., from the Medicare compliance officer to the corporate compliance officer; from the Medicare Compliance committee to the cor-porate Compliance committee). Similarly, CMS’s proposed guidance also states that the com-pliance officer must (current guidance states “should”) have express authority to report directly to the entity’s senior-most leader and to the governing body at his/her discretion. Finally, while the current version of the manual includes language concerning guarding against conflicts of interest in roles performed, CMS’s proposed updates explicitly provide, “there is a conflict of interest where the compliance officer is also the CFO, COO or GC.”
With respect to the governing body and senior management’s oversight responsibili-ties, the 2011 regulations require the governing body to be knowledgeable about the content and operation of the compliance program and to exercise “reasonable oversight.” In turn, the proposed guidance changes highlight this important area by adding two new sections to the guidance and adding “high-level oversight” to the title of this element section. The propos-als also provide at the outset that governing body and senior level engagement is critical to the meaningful and successful oversight of the entity’s Medicare operations, and that the governing body is ultimately accountable for ensuring the effectiveness of the compli-ance program. Also, the guidance states that on a least a quarterly basis, the products of the Compliance committee, including the status of the compliance program, must be reported to the governing body or a committee of the governing body responsible for oversight of the Medicare program. Among other provi-sions, CMS’s updated proposals state that the governing body must ensure that the Medicare compliance officer has unfettered access to the
888-580-8373 | www.hcca-info.org 59
Com
pli
ance
Tod
ay
Jun
e 20
12
governing body and that the scope of any del-egated activities from the full governing body to a governing body committee be clearly stated in the committee’s charter and reporting.
Also, in order to meet the new regulatory requirement to be knowledgeable about the content and operations of the compliance pro-gram, CMS’s proposals state that the governing body must receive training and education regarding the structure and operation of the compliance program in order to enable it to fulfill its duties and exercise independent judgment over compliance issues presented. The governing body also must be specifically knowledgeable about compliance risks and strategies, must make further inquiry and take appropriate action to address compliance issues presented to it, must understand the measurements of outcome, and must be able to gauge the compliance program’s effectiveness. The updated guidance also provides that the entity must ensure that CMS is able to validate, through review of governing body minutes, the level of governing body engagement in over-sight of the Medicare program.
Finally, the proposed guidance addition-ally focuses on governance by highlighting the importance of the role of the CEO, the president, or senior management in ensuring the compliance officer is integrated into the organization and has the resources necessary to operate a robust and effective program. The proposed guidance language also explicitly provides that the CEO “must receive regular reporting of all governmental compliance enforcement activity, from notices of noncom-pliance to formal enforcement actions.”
effective training and education (element iii)As noted below, many of the updates to Element III include modifying existing language from “should” to “must.” In addition, CMS’s proposals establish a new deadline for when general com-pliance training must be conducted — within
90 days of initial hire (or contracting, in the case of new FDRs). The training must be made part of orientation for new employees of both the entity and FDRs and for a newly appointed CEO, managers, or governing body members (current guidance uses the term “should”).
Sponsors must require that their FDRs either conduct their own compliance training or may choose to make their training available to these entities. Sponsors are accountable for ensuring that FDR employees have training that meets CMS and regulatory requirements, and must establish mechanisms for ensuring completion of training (e.g., contracting provisions, collecting attestations, focused monitoring and auditing, etc.). CMS expects sponsors to update the gen-eral compliance training annually, if needed, and whenever requirements change. Sponsors must (current guidance uses the term “should”) require that their FDRs administer their own specialized training or make the sponsor’s specialized training available to FDRs where appropriate.
For specialized training, sponsors must review and revise these kinds of special-ized training as needed, but at least annually. Sponsors must retain adequate records of their specialized employee training, including attendance logs, training materials, and results of any testing. Entities are responsible for maintaining records of the time, attendance, topic, and results of training (please note that although all of these areas are addressed simi-larly in current guidance, the current guidance uses the term “should ”).
With regard to anti-fraud, waste, and abuse training, CMS’s proposed guidance incorporates the specific language of anti-fraud, waste, and abuse training guidance that it issued in 2009, with little-to-no substantive changes. CMS’s proposals add, however, that although certain individuals may be deemed to have met the requirements for this kind of training as provided by CMS, these deemed
60 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
persons must still receive general Medicare compliance training and specialized compli-ance training in connection with their job responsibilities. Significantly, CMS’s guidance proposals also add a new section that contains a requirement that sponsors must implement mechanisms to measure the effectiveness of their training, including evaluating the training to determine whether it is effective, identifying any deficiencies, and undertaking remedial actions to correct any deficiencies.
effective lines of communications (element iV)CMS did not propose any significant changes to this section of the manual guidance other than to specifically incorporate the regulatory changes (e.g., language spe-cifically references requirements as being applicable to FDRs as well as to the entity’s own organization) and, in line with these changes, to propose guid-ance language that clearly indicates that certain provisions are now required by the use of the word “must” versus “should.”
well-publicized disciplinary standards (element V)Similarly, CMS did not propose any significant changes to this section of the manual guidance other than to specifically incorporate the regu-latory changes and, in line with these changes, to propose guidance language that clearly indicates that certain provisions are now required by the use of the word “must” versus “should.” For example, CMS’s proposed guid-ance states that sponsors “must” prominently
publicize compliance disciplinary standards to all managers and employees in their organiza-tions and to their FDRs. Also, all employees “must” be informed that violations of stan-dards will result in appropriate disciplinary action. Sponsors “must” be able to demon-strate to CMS that disciplinary standards are enforced in a timely, consistent, effective, and appropriate manner. Sponsors may do this by periodically reviewing and evaluating disciplinary records for fairness and consis-tency. Sponsors also must consistently take disciplinary action to ensure that the policy has a deterrence effect. CMS’s proposals also add language that sponsors “should” include
compliance as a measure of an employee’s job performance.
effective system for routine monitoring and auditing (element Vi)As it does in cur-rent guidance, CMS devotes a great deal of attention to this
element in its proposed updates. The proposed guidance reflects the changes to regulatory requirements in this element by now requir-ing that entities establish and implement an effective system for routine monitoring and identification of compliance risks. This system must include internal auditing and monitoring and external audits, as appropriate, to evaluate the entity’s (and its FDRs’) compliance with CMS requirements as well as the overall effec-tiveness of the compliance program. Many of the other changes in this element entail changing language from “should” to “must” to reflect the updated regulatory requirements.
With respect to the governing body and senior management’s
oversight responsibilities, the 2011 regulations require
the governing body to be knowledgeable about the
content and operation of the compliance program and to
exercise “reasonable oversight.”
888-580-8373 | www.hcca-info.org 61
Com
pli
ance
Tod
ay
Jun
e 20
12
The updated guidance proposals also include a new section devoted to risk assess-ment. Sponsors must establish and implement policies and procedures to conduct a formal assessment of major compliance and fraud, waste, and abuse risk areas, including the use of a risk assessment tool for each operational area. A comprehensive risk assessment must be conducted at least once a year, and there must be ongoing review of potential risks. Also, any risks identified through CMS audits and oversight and the entity’s own oversight mechanisms will be considered “priority risks” by CMS.
The proposals also require that enti-ties implement an internal audit function. Although many aspects of implementation are left up to the sponsor, CMS’s proposed guid-ance requires that sponsors must ensure that internal auditors:
· are independent, · do not engage in self-policing, · are knowledgeable of Medicare program
requirements, and · have access to relevant personnel, infor-
mation, records, and operational areas, including operations of FDRs.
The proposed guidance also adds a require-ment that sponsors develop a strategy to monitor and audit their FDRs, include in work plans the number of FDRs that will be audited each year, and define how the entities will be identified for audits. Sponsors also are required to ensure that their contracts with FDRs require record retention and provide rights of access to CMS. The proposed guidance also adds a new requirement for sponsors to perform a risk assessment to identify their highest risk FDRs from which to select a reasonable number to audit from among the highest risk groups. Sponsors also must ensure that corrective action is taken by FDRs when needed, either as a result of a sponsor monitoring or auditing, or
through audits performed by the FDRs them-selves. CMS proposals also make it clear, “[a]lthough FDRs may perform their own inter-nal auditing, the Sponsor remains obligated to perform its own auditing of FDRs.”
Significantly, CMS’s proposed guidance also adds a new section concerning the measurement of compliance and compliance program effec-tiveness. This section is not included in current guidance. More specifically, the guidance states that sponsors must evaluate the effectiveness of the compliance program at least annually and these results must be reported to senior manage-ment and the governing board. Also, sponsors must respond promptly to any identified weak-nesses in the compliance program and must take appropriate corrective measures to ensure a fully effective compliance program.
The proposed manual language also incor-porates guidance that was issued by CMS in 2010 concerning screening for excluded enti-ties. The proposed language requires sponsors to review the HHS OIG exclusion and GSA debarment lists prior to any new hiring or con-tracting, and monthly thereafter, and to have processes in place that identify and prevent payments for claims by excluded providers. This guidance also specifically requires that sponsors ensure that FDRs develop and imple-ment policies and procedures that require and document the review of these exclusion lists, including performing appropriate monitoring and auditing of FDRs to confirm that the FDRs comply with this requirement.
The proposed guidance also requires that sponsors have a special investigative unit (SIU). Sponsors must either establish a specific SIU or ensure that responsibilities generally conducted by an SIU are conducted by the Compliance department. SIUs are required to be accessible via phone, email, Internet, and mail, and sponsors must ensure that fraud, waste, and abuse allegations can be reported anonymously to the SIU. In addition, CMS’s
62 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
guidance adds fraud awareness training as an additional responsibility of the SIU.
prompt response to compliance issues (element Vii)The proposed guidance provides that spon-sors must undertake appropriate corrective action in response to noncompliance or fraud, waste, and abuse; and these corrective actions must be designed to correct the underlying problem that led to the issue and to prevent future noncompliance. CMS added new lan-guage that states that corrective action must be tailored to address the particular issue, must include timeframes for specific achievements, and must be documented. In addition, CMS’s updates require that the elements of the correc-tion action must be documented and include ramifications (i.e., effective disciplinary mea-sures) should the sponsor or its employees fail to implement the corrective action.
With regard to voluntary self-reporting of potential fraud or misconduct, the pro-posed guidance states that sponsors must conclude their own investigations of potential misconduct within a reasonable time period after the fraudulent activity is discovered (current guidance states sponsors “should initiate a reasonable inquiry immediately, but no later than two weeks from the date the potential misconduct is identified”). Also, if the sponsor concludes after conducting a reasonable inquiry that fraud or misconduct has occurred, the conduct must be referred to CMS’s designated contractor “promptly” (in contrast, the current version of the guidance states, “promptly but no later than 60 days after the determination”). For significant or serious noncompliance issues (versus fraud or misconduct), CMS’s proposals add language that it “expects” sponsors to report to CMS as soon as possible after the discovery.
CMS’s proposed guidance also adds a new section on identifying providers who have a
history of complaints. In this section, CMS states that sponsors are expected to maintain files on providers who have been the subject of complaints, investigations, violations, and prosecutions. Sponsors must comply with requests from law enforcement, CMS, and its contractors regarding monitoring providers that have been identified by CMS as poten-tially abusive or fraudulent. The proposed guidance has been updated to remove (with-out explanation) a number of other sections that addressed particular kinds of fraud, waste, and abuse (e.g., pharmacy benefit manager (PBM) and pharmacy-related fraud, waste, and abuse).
Defining effectivenessIn addition to the above highlighted proposals that affect each of the seven required elements, CMS’s proposed guidance updates provide significantly more information regarding the factors it will consider when evaluating whether an entity has an effective compliance program. As stated previously, this is par-ticularly important because the 2011 revised regulations specifically require entities to maintain and implement an effective compliance program. The following are proposed revisions to specific sections (as denoted) of Chapter 9 of the Medicare Prescription Drug Benefit Manual that specifically address or define effectiveness.
In order to be effective, a sponsor’s Medicare compliance program must:
· include all of the regulatory requirements; · be tailored to each sponsor’s unique organi-
zation, operations, and circumstances; · be fully implemented; and · be effective in preventing, detecting, and cor-
recting Medicare program noncompliance and fraud, waste, and abuse. (Section 30)
A compliance program will not be effective unless entities devote “adequate resources” to the compliance program. Adequate resources
888-580-8373 | www.hcca-info.org 63
Com
pli
ance
Tod
ay
Jun
e 20
12
(which CMS acknowledged may vary, based on a variety of factors), are defined by CMS as those that are sufficient to:
· assess the organization’s risks; · promote and enforce its standards of
conduct; · effectively train and educate its employees
and FDRs; · effectively establish lines of communica-
tion within its own organization, and with its FDRs;
· oversee FDRs’ compliance; · establish and implement an effective
system for routine auditing and monitor-ing; and
· identify and promptly respond to risks and findings. (Sections 30, 50.2.1)
To be effective, the standards of conduct should be written in a format that is easy to read and comprehend. (Section 50.1.2) Compliance policies and standards of conduct cannot be effective if they are not distributed to employees—and read and followed by them. Because distribution of compliance policies and procedures and standards of conduct is essen-tial to effectiveness, CMS expects sponsors to ensure that their employees and the employees of their FDRs, as a condition of employment, read, and agree to comply with all written com-pliance policies and procedures and standards of conduct within 90 days of the date of hire and annually thereafter. (Section 50.1.9)
To be effective, the Medicare compliance officer (MCO) should be a full-time employee and dedicated principally to the Medicare compliance program. The MCO must have training and/or experience working with Medicare Advantage or Part D programs and regulatory authorities. Further, senior leader-ship’s empowerment and support of the MCO is critical to his/her credibility and to his/her ability to establish and operate an effective compliance program. (Section 50.2.1)
Effective compliance programs “typically” include a resolution of the full governing body, stating the sponsor’s commitment to compli-ant, lawful, and ethical conduct. This should be updated annually, because governing body membership may change. (Section 50.1.1)
An effective compliance program cannot be achieved unless the CEO or president and other senior management, as appropriate, are engaged in the compliance program. It is critical that the CEO and senior management recognize the importance of the compliance program to the organization and that the compliance officer is crucial to protecting the organization and its governing body. A critical role of the CEO or president and senior man-agement is to ensure that the compliance officer is integrated into the organization and has the resources necessary to operate a robust and effective compliance program. (Section 50.2.4)
An effective compliance program estab-lishes an organizational culture of compliance that emanates from the top of the corporate structure; therefore, it is critical to an effective compliance program that the governing body and senior management be directly involved in the development and/or review of the compliance policies and procedures and stan-dards of conduct. Even if a board committee develops/reviews these documents, they must be approved by the full governing body and senior management, including the CEO and other senior officials. (Section 50.1.8)
Entities must conduct routine auditing and monitoring of their operational areas as well as the compliance program itself; effectiveness is “enhanced” by the use of performance mea-surements that evaluate the effectiveness of the compliance program. (Section 30)
Measurement and tracking of compliance efforts are crucial to an effective compliance pro-gram. Sponsors are expected to use dashboards, scorecards, and other self-assessment mecha-nisms to measure their operational compliance
64 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
and the operational compliance of their FDRs. These results must be shared with senior man-agement and the governing body. It is highly recommended that compliance performance be linked to staff, management, executive, and FDR compensation. (Section 50.6.7)
An effective program to control fraud, waste, and abuse includes policies and procedures to identify and address fraud, waste, and abuse at both the sponsor and FDR levels in the delivery of Parts C and D benefits. (Section 50.6.10)
summaryCMS’s long-awaited proposed guidance revisions provide a great deal more detail and clarity to MA and Part D Plan entities regarding their mandatory compliance pro-gram requirements. Overall, CMS’s proposed changes to its compliance program guidance:
· incorporate the 2011 updated regulations and add corresponding interpretive guid-ance concerning these new regulatory requirements;
· provide more clarity on the reporting role of the compliance officer and Compliance committee to senior management and the governing body;
· provide additional guidance regarding the monitoring, oversight, and training of FDRs;
· highlight the importance of the accountabil-ity and governance roles played by senior
management and the governing board, and provide more specific requirements for their engagement and involvement in overseeing the compliance program;
· provide new detailed guidance for conduct-ing risk assessments;
· highlight the requirement to use metrics in evaluating the sponsor’s training programs and compliance program effectiveness;
· provide specific information on what CMS expects to be provided during an audit or other evaluations of these programs to show compliance with its requirements; and
· specify what factors and evidence CMS will consider when evaluating whether a com-pliance program is effective.
Many of these proposed changes have no doubt been informed by CMS’s enforcement and audit oversight activities and experiences in this particular health care sector over the course of the last few years. Also, as noted above, CMS’s guidance updates in this sector are worth paying close attention to, because they will likely inform and influence its decision-making in promulgating regulations for mandatory compliance program requirements for the rest of the federal health care industry, as required by the new provisions of the ACA.
1. 75 Fed. Reg. 58204, September 23, 201022. 76 Fed. Reg. 5862, February 2, 2011
888-580-8373 | www.hcca-info.org 65
Com
pli
ance
Tod
ay
Jun
e 20
12
This article is the sixth in a series on DMEPOS compliance issues published in Compliance Today.
Among the many compliance concerns facing durable medical equipment, prosthetics, orthotics and supplies
(DMEPOS) suppliers, perhaps one of the most important is Medicare reimbursement and claims denials. After all, a well-developed refer-ral network and satisfied patient base is of little value if the claims generated by those patients’ orders do not get paid. With that in mind, DMEPOS suppliers should understand the levels of appeal available to challenge Medicare claim denials. Although the Medicare tiered appeals structure may at first seem intimidating, many DMEPOS suppliers are able to handle the first two levels of appeal in-house, drawing on outside legal counsel for those challenges that proceed to the third level of appeal and beyond.
Of particular benefit is when DMEPOS suppliers involve their compliance officer in the reimbursement appeals process. This
involvement need not be extensive or significantly time-consuming. Simply by communicating with the Compliance department, suppliers can enjoy the resources of a subject matter expert on the pending appeals, while simultaneously keeping the Compliance department abreast of key claims denial areas. The compli-ance officer can use that information when conducting targeted audits and developing the supplier’s annual com-pliance plan.
hot reimbursement issuesIn the current enforcement envi-ronment, DMEPOS suppliers face a seemingly endless barrage of reimburse-ment challenges on state and federal levels. A significant hot issue regarding Medicare reimbursement denials is how to meet the medical documentation requirements for claim submissions. One approach suppliers can use to help decrease their denial rate is to employ staff with clinical backgrounds who can reinforce on appeal the reasons why a claim should be paid by Medicare, if the claim is denied. Another approach suppliers can consider to improve documentation of medical
by Natarsha Nesbitt, Esq. and Nathaniel Lacktman, Esq., CCEP
DMEPOS reimbursement appeals and the compliance officer
» DMEPOS suppliers have five levels of Medicare claims appeals.
» DME MACs sometimes differ when interpreting the same Medicare rule.
» Suppliers should consider involving the Compliance department in claims appeals.
» Suppliers can draw on the Compliance department for reimbursement advice.
» Cooperation between Compliance and Reimbursement personnel can be a win-win.
Natarsha Nesbitt (natarsha.nesbitt @ gmail.com) is a health care lawyer in
Tampa and former corporate counsel to one of the nation’s largest DMEPOS
suppliers. Nathaniel (Nate) Lacktman (nlacktman @ foley.com) is Senior
Counsel in the Tampa office of Foley & Lardner LLP in and a member of the
firm’s Health Care Industry Team and Corporate Compliance practice group.
necessity is to educate their referral sources on the Medicare documentation requirements so the referral sources can better document medi-cal necessity in the patient records, thereby improving the supplier’s chance of a clean claim submission and prompt reimbursement.
Another hot button challenge currently faced by DMEPOS suppliers is the incon-sistent interpretation and application of Medicare regulations across the four Durable Medical Equipment Medicare Administrative Contractors (DME MACs). Each DME MAC has an ability to issue its own rules or Local Coverage Determinations, but the DME MACs must also follow the CMS-issued rules appli-cable to all DMEPOS suppliers nationwide. However, there are times when the four DME MACs differently interpret the same CMS-issued rules, which results in inconsistency across the four jurisdictions. This challenge is more significant for suppliers operating nationwide and who must interact with mul-tiple DME MACs.
An example of this challenge arises in medical necessity documentation and proof of delivery documentation. Some DME MACs adopt a narrow interpretation of the require-ments, while others have slightly differing positions. For example, some DME MACs accept a download from mail carriers such as the United States Postal Service, whereas other DME MACs do not. As a result of regional inconsistencies, DMEPOS suppliers must create separate and unique processes to satisfy the requirements for each of the four DME MACs. A supplier’s compliance officer can play an integral part to help the supplier’s reimbursement personnel understand and coordinate among the varying interpretations across the DME MACs.
Dmepos claims appeals processMedicare uses a tiered appeals process, afford-ing DMEPOS suppliers five levels of appeal
to challenge denied claims. Each level has its own unique characteristics and requirements. Overall, once a DME MAC makes an initial determination to deny a claim, a supplier has the right to an appeal. All appeals must be made in writing. For most levels, the supplier can itself file the appeal, but many choose to retain legal counsel around the third or fourth level. Below is a brief description of the five levels of appeal.
First level — RedeterminationThe first level of appeal is conducted by the DME MAC itself (but by a person other than the one who made the initial determination to deny the claim). A supplier must file the redetermination request within 120 days from the date of receipt of the initial determination. Suppliers can use form CMS-20027 to request the redetermination in writing, and should attach all supporting documentation to that request. The DME MAC will issue its deci-sion within 30 days of receiving the supplier’s reconsideration request.
Second level — ReconsiderationThe second level of appeal is conducted by the qualified independent contractor (QIC). The QIC for DMEPOS suppliers is RiverTrust Solutions. A supplier that wants to appeal an unfavorable redetermination must file the reconsideration request within 180 days from the date of receipt of the unfavorable Medicare redetermination notice. Suppliers can use form CMS-20033 to request the reconsideration in writing and should attach all supporting documentation to that request, including the unfavorable Medicare redetermination notice. It is particularly important to include all support-ing documentation at the reconsideration level because, without good cause, a supplier will not be able to provide any additional documents for review at subsequent levels of appeal. (This rule does not apply to witness oral testimony
888-580-8373 | www.hcca-info.org 67
Com
pli
ance
Tod
ay
Jun
e 20
12
given at the third level of appeal.) Generally, the QIC will issue its decision within 60 days of receiving the supplier’s reconsideration request. If the QIC cannot complete the decision in that timeframe, the supplier may escalate the appeal to the third level.
Third level — Administrative law judgeThe third level of appeal is a hearing before an administrative law judge (ALJ) in the Office of Medicare Hearings and Appeals. If at least $130 remains in controversy, a supplier may seek an ALJ hearing by filing a written appeal using form CMS-20034A/B (and may also file supplemental legal briefs). A sup-plier that wants to appeal an unfavorable reconsideration deci-sion must file the request for an ALJ hearing within 60 days from the date of receipt of the unfavorable reconsideration decision. A sup-plier can request an in-person hearing, but hearings typically occur by videoconference or telephone. Suppliers can also forgo a hear-ing and instead ask the ALJ to issue a decision on the written record. Generally, the ALJ will issue its decision within 90 days of receiving the supplier’s hearing request, but this dead-line is often extended. If the ALJ does not issue a decision in that timeframe, the supplier may escalate the appeal to the fourth level.
Fourth level — Medicare Appeals CouncilThe fourth level of appeal is a review by the Medicare Appeals Council (MAC). There are no requirements regarding the amount in controversy. A supplier may seek MAC review by filing a written appeal using form DAB-101
and may also file supplemental legal briefs. A supplier that wants MAC review of an unfa-vorable ALJ decision must file the request within 60 days from the date of receipt of the unfavorable ALJ decision. Generally, the MAC will issue its decision within 90 days of receiv-ing the supplier’s request, but this deadline may be extended. If the MAC does not issue a decision in that timeframe, the supplier may escalate the appeal to the fifth level.
Fifth level — Judicial review in federal district courtThe fifth and final level of appeal is judicial review by a federal dis-trict court judge. If at least $1,350 remains in contro-versy (for calendar
year 2012), a supplier may seek judicial review by filing a written request in federal district court. The amount-in-controversy requirement increases each year. A supplier that wants judicial review of an unfavorable MAC deci-sion must file the request within 60 days from the date of receipt of the unfavorable MAC decision.
Benefits of compliance officer involvementNot all compliance officers of DMEPOS sup-pliers are involved with the claims appeal process, but those suppliers that do involve their compliance officers can realize some additional benefits. For example, by making the compliance officer aware of the types of claims being denied (and the reasons there-for), the compliance officer can integrate those denials into the supplier’s annual compliance plan and compliance audits. In addition, the compliance officer can serve as a resource to
The knowledge, experience, and ability of compliance officers
to understand and interpret Medicare regulations allows
them not only to highlight the hot Medicare reimbursement issues, but also to recommend solutions.
68 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
the reimbursement team on specific subject matter expertise. This is particularly useful to address rule inconsistencies across the four regional DME MACs.
The knowledge, experience, and ability of compliance officers to understand and interpret Medicare regulations allows them not only to highlight the hot Medicare reimbursement issues, but also to recommend solutions. In this manner, the compliance officer can serve as a bridge of communication between the organi-zation, Medicare, and the DME MACs.
It is important that suppliers keep their compliance officers involved in the appeals process because compliance officers can track and trend claim denials and assist in efforts to demonstrate the frequency of the vary-ing interpretations of Medicare regulations across the four DME MACs. By doing so, the compliance officer can align the supplier’s
focus with that of Medicare, allowing the organization to react proactively to any issues that may arise.
ConclusionFor some DMEPOS suppliers, the Medicare appeals process may seem to be an impen-etrable, confusing morass. For other suppliers, the appeals process may appear routine, mun-dane, and simply a cost of doing business. Whatever a supplier’s comfort level with the appeals process itself, suppliers who involve their Compliance department in the appeals process (at least to a degree), may reap some useful rewards in enhanced communication, reduced claim denial rates, and improved appeal success rates. Ultimately, this coopera-tion between the supplier’s Compliance and Reimbursement departments can be a win-win for everyone at the organization.
THE HCCA HIPAA TRAINING HANDBOOK
Qty Cost
________ HCCA Members ($25 or see chart at left) $ __________
________ Non-Members ($30 per handbook) $ __________
________ Join HCCA! $ __________
Non-members, add $200 to join HCCA, and pay member prices for your order (regular dues $295/year)
Total: $
Bulk discounts available for HCCA members only. See chart at left to figure cost. All purchases receive free FedEx Ground shipping within continental U.S.
PLEASE TYPE OR PRINT
HCCA Member ID
First Name M.I. Last Name
Title
Organization
Street Address
City State Zip
Telephone
Fax
E-mail
Make check payable to HCCA and mail to:
HCCA, 6500 Barrie Road, Suite 250Minneapolis, MN 55435
Or fax order to: 952-988-0146
My organization is tax exempt
Check enclosed
Invoice me | Purchase Order #
I authorize HCCA to charge my credit card (choose below):
AmericanExpress Diners Club MasterCard Visa
Credit Card Account Number
Credit Card Expiration Date
Cardholder’s Name
Cardholder’s Signature
Federal Tax ID: 23-2882664
Prices subject to change without notice. HCCA is required to charge sales tax on purchases from Minnesota and Pennsylvania. Please calculate this in the cost of your order. The required sales tax in Pennsylvania is 7% and Minnesota is 6.5%.
The HCCA HIPAA Training Handbook� e Health Insurance Portability and Accountability Act (HIPAA) has had lasting impact on U.S. health care providers since its passage in 1996. Now HIPAA, along with HITECH, a� ect health care professionals on a daily basis. � is newly revised handbook is intended for anyone who needs a basic understanding of the privacy and security regulations governed by HIPAA and HITECH. Suitable for sta� training courses, it covers:
• Who must comply with HIPAA and HITECH• When and by whom is the use or disclosure of protected health
information (PHI) permitted?• What rights does an individual have regarding his or her PHI?• What are the basic safeguards required to protect the security of e-PHI?• What happens when a breach occurs?• And much more
� is handbook can prepare all health care professionals to help protect the privacy and security of their patients’ health information.
NOW AVAILABLE:
: visit www.hcca-info.org/books, or call 888-580-8373
888-580-8373 | www.hcca-info.org 69
Com
pli
ance
Tod
ay
Jun
e 20
12
Physicians sometimes prescribe a drug or medical device for a use that has not been approved by the Food and
Drug Administration, a so-called “off label” use. A great deal of focus has been placed on pharmaceutical manufacturers’ off-label pro-motion of drugs and the compliance issues
confronting those manufacturers. Often absent from that discussion is any recognition of the compliance issues challenging the recipients of those promotional activities, specifi-cally, the health care industry. Health care companies must be alert to the unique compliance questions facing
them (e.g., preventing their employees from bowing to the pressure and accepting some form of remuneration in exchange for increas-ing the use of a particular drug—even when the drug may have been illicitly promoted for non-approved, off-label uses).
the laws that create compliance incentivesIn some respects, compliance programs begin and end with the federal False Claims Act
(FCA)1 and Anti-Kickback Statute (AKS).2 Stated differently, government enforcement of these statutes emphasizes the need for com-pliance both for companies and their owners, officers, and managers. The FCA makes it a violation to:
· knowingly present or cause to be presented a false or fraudulent claim for payment or approval;
· knowingly make or use a false record or statement material to a payment of a false or fraudulent claim; and/or
· conspire to defraud the government by getting a false or fraudulent claim paid or allowed.
The concept of a “knowing” violation is broadly interpreted. Importantly, “relators” (i.e., whistleblowers) can bring a fraud action on behalf of the government. Similarly, the AKS makes it illegal to offer to pay to induce a person to purchase or order any item or ser-vice for which payment may be made under a federal health care program, or recommend purchasing or ordering such an item or service. Prosecutors do not need to prove that a defen-dant had actual knowledge of the AKS or a specific intent to violate the statute.
by David Restaino, Esq.
Off-label drug promotion: The False Claims Act and Anti-Kickback Statute
Restaino
» FDA restrictions on promoting “off-label” drug use are a compliance challenge.
» Compliance professionals need to be aware of the “grey areas” in drug promotion and watch for possible conflicts of interest.
» Medical professionals should keep their prescription choices from appearing biased.
» Regulatory safe harbors are helpful, and should be reviewed and understood.
» Creating “compliance assets” is the best path to avoid penalties.
David Restaino (drestaino @ foxrothschild.com) is a Partner in the Princeton,
New Jersey office of Fox Rothschild LLP.
70 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
Violations of the FCA and the AKS can result in penalties, convictions, and exclusion from federal health care programs.
Massive corporate penalties—many exceeding $100 million—have garnered recent headlines. The government’s use of exclusion from federal programs as a remedy would be a “career killer” for most individuals. This fact is highlighted by a recent example, in which three pharmaceutical executives personally paid over $30 million in combined penalties, yet chal-lenged the imposition of a 12-year ban from federal health care programs.3
policies and guidelines shape compliance effortsMedical practitioners retain the ability to pre-scribe drugs for off-label uses. Nevertheless, health care compliance officers should also be aware of other policies and guidance that con-cern the interaction between pharmaceutical manufacturers, their sales representatives, and the health care industry.
The Accreditation Council for Continuing Medical Education (ACCME) has policies and guidelines designed to ensure independence of continuing medical education programs. These require the disclosure of program sponsorship and conflicts of interest to avoid improper pref-erential status being given to a particular drug or medical device.
Additionally, the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) guidance, titled Compliance Program for Pharmaceutical Manufacturers,4 includes elements of an effective compliance program, (e.g., encouraging “hotline” reporting when sales representatives improperly promote off-label uses). Importantly, it also includes safe harbors that may shield the remuneration paid by manufacturers.
regulatory safe harbors impact promotional effortsIn assessing the legality of pharmaceutical pro-grams directed at the health care industry, savvy
compliance personnel recognize that the finan-cial incentives for manufacturers to promote off-label uses are such that there will always be tension in the “grey areas” of drug promotion. Accordingly, compliance personnel should stay abreast of the regulatory safe harbors which are, essentially, pronouncements that establish which promotional practices are acceptable.
Among other things, the safe harbors shield certain remuneration applicable to group pur-chasing organizations, discounts, personal services, management contracts, and a litany of other activities pertinent to the health care industry.5 Even particular arrangements that do not fall within a safe harbor are not, in and of themselves, illegal; rather, they will be sub-ject to greater government scrutiny.
Creating compliance assetsWhen approaching off-label issues and implementing compliance programs, several over-arching themes should be developed, including:
· enacting a compliance program, business code of conduct, and standard operating procedures;
· appointing a compliance officer and a com-pliance committee;
· imposing mandatory training; · reviewing and overseeing conference presen-
tations and the circulation of journal articles; · enforcing compliance accountability via per-
formance evaluations; · establishing an internal disclosure program.
In the health care industry, particular focus should be paid to:
· preventing unearned compensation to pharmacists;
· ensuring that fair market value is paid for all drugs;
· avoiding situations where over-filled drug vials or “free” quantities are nevertheless billed to Medicare at full value;
888-580-8373 | www.hcca-info.org 71
Com
pli
ance
Tod
ay
Jun
e 20
12
· scrutinizing the methods for coding drug reimbursement; and
· ensuring that the exchange of off-label infor-mation is undertaken only for medical or scientific reasons.
Compliance officials should also pay spe-cial attention to social media which, by its very nature, encourages dialogue outside of normal channels. It also presents additional chal-lenges for monitoring personnel, as well as the interaction with the public. Although the Food and Drug Administration (FDA) was intent on adopting guidelines,6 it has yet to act to final-ize any, leaving companies to guess the proper compliance approach for social media.
The next step is to seek out information and immediately deal with adverse results. In some respects, this should involve the use of audits to discover compliance issues, which also signals to staff that someone is watching (e.g., auditing contracts to ensure fair market value has been paid or that volume discounts are not masquerading as “trials”).
Audits, however, are not the only method to create a dynamic and responsive compli-ance system. There should be a process in place to implement—and test—the compliance plan to ensure its continuing viability. This is not an audit but, perhaps, it can be viewed as an audit of the compliance program itself, rather than the underlying substantive activi-ties. Also, it is just as important to manage the “compliance assets” by choosing the appropri-ate systems to tackle priorities.
Simply put, consider auditing the auditors. Finally, all good compliance programs anticipate new issues. To the extent you can, plan ahead.
1. 31 U.S.C. §§ 3729 to 3733.2. 42 U.S.C. §§ 1320a-7b.3. Friedman v. Sebelius, Docket No. 11-5028 (D.C. Cir.). Oral argument of
the defendants’ appeal was conducted on December 6, 2011, but an opinion had not yet been issued when this article went to press.
HCCA 2012–2013 BoArd of direCtorsEXECUTIVE COMMITTEE
shawn y. DeGroot, ChC-f, CCep, ChrCHCCA President | Vice President of Corporate Responsibility, Regional Health, Rapid City, SD
John falcetano, ChC-f, Cia, CCep-f, ChrC, ChpC, CiCaHCCA Vice President | Chief Audit/Compliance Officer, Vidant Health, Greenville, NC
Gabriel L. imperatoHCCA Second Vice President | Managing Partner, Broad and Cassel, Fort Lauderdale, FL
sara Kay wheeler, JD, ChCHCCA Treasurer | Partner, Attorney at Law, King & Spalding, Atlanta, GA
urton anderson, phD, CCepHCCA Secretary | Clark W. Thompson Jr. Professor in Accounting Education, McCombs School of Business, The University of Texas at Austin, Austin, TX
sheryl Vacca, ChC-f, ChrC, CCep, ChpCNon-Officer Board Member | Senior Vice President/Chief Compliance and Audit Services, University of California, Oakland, CA
frank sheeder, JD, CCepHCCA Immediate Past President | Partner, Attorney at Law, DLA Piper, Dallas, TX
EX-OFFICIO EXECUTIVE COMMITTEE
roy snell, ChC, CCep-fChief Executive Officer, Health Care Compliance Association, Minneapolis, MN
robert h. ossoff, DmD, mD, ChCAssistant Vice-Chancellor for Compliance & Corporate Integrity, Vanderbilt University Medical Center, Nashville, TN
Daniel roach, JDVice President, Compliance and Audit, Dignity Health, San Francisco, CA
Lori strauss, rn, msa, CpC, CpC-h, ChC, Chp, ChpCChief Corporate Compliance & Privacy Officer, University of Virginia Health System, Charlottesville, VA
Debbie troklus, ChrC, ChC-f, CCep-f, ChpC Managing Director, Aegis Compliance and Ethics Center, Chicago, IL
72
Congratulations, newly certified designees!achieving certification required a diligent effort by these individuals. Certified individuals promote organizational integrity through the development and operation of effective health care compliance programs.
CCB offers these certifications: Certified in healthcare Compliance (ChC)®, Certified in healthcare Compliance fellow (ChC-f)®, Certified in healthcare research Compliance (ChrC)®, and Certified in healthcare privacy Compliance (ChpC)®. to learn more, please contact us at ccb @ hcca-info.org, visit www.hcca-info.org/certification, or call 888-580-8373.
Certified in healthcare Compliance (ChC)®
· James Adamson
· Peter P. Aprato
· Dustin Alan Arnette
· Cecilia M. Baehm
· Arlene F. Baril
· Sherry E. Baskin
· Jeri L. Bates
· Tiffany Eileen Beaumont
· Cheryl Lynn Benander
· Louis J. Bevilacqua
· Karen J. Bommelje
· Andrew F. Braver
· Kelsey Corrine Brodsho
· Susanne L. Burton
· Susan L. Caldwell
· Michael A. Cassidy
· Vikram Chandna
· Misty Campbell Channell
· Margaret Chappell
· Wendy C. Chartrand
· William H. Cole
· Peter P. Connelly
· Kathleen M. Crites
· Kimberly A. Dickerson
· Roger E. Dulude
· Douglas J. Essex
· Robbie L. Evans
· Lenda M. Fagundes
· Monica R. Freedle
· Robert M. Freeze
· Edward M. Fried
· Karyn L. Fryer
· Allegra M. Gaines
· Tracy C. Gibson
· Jenny Gramling Givens
· Kristin N. Glover
· Jennifer Hammonds
· Ellen A. Hampton
· Lynn Handy
· Chad I. Harris
· Adraine N. Harris
· Vernita Haynes
· Alexandria C. Hennessey
· Patricia Hilbrands
· John K. Hilton
· Denise A. Holtz
· Margaret L. Hopkins
· Barbara Iacobelli
· Felicia M. Jackson
· Jared Breon Jacobs
· Stephen Johans
· Elimu Etumba Kajunju
· Peter N. Katz
· Christin J. Kieffer
· Denise Liane Klimek
· Deborah Lee Kocsis
· Joshua S. Kooistra
· Sheri P. Kowalski
· Jennifer J. Krusa
· Jenifer A. Kugler
· Sandra A. Laws
· Sheri Faye Lester
· Salome W. Lofty
· Shannon D. Lollar
· Janice M. Martin
· Audrey J. Mauduit
· Michele E. McDonald
· Inessa A. Moss
· Michael Osorio
· Joseph Passeneau
· Steve T. Paterson
· Lena Payne
· Jerry W. Peloquin
· Paige L. Pennington
· Margaret P. Pettit
· Alexandra M. Plasencia
· Susan I. Prior
· Jerry Orrison Pumphrey
· Carmen K. Quan
· Mark A. Rapanut
· Sonya Esperanza Reyes
· Bruce I. Ritchie
· Richard Robinson
· Pamela L. Rundell
· Susan G. Salluom
· Keely A. Scamperle
· Debra G. Selleh
· Nancy J. Sharp
· Michael Joseph Shearn
· Victor Shutack
· Thomas M. Spinelli
· Kristen Reese Taylor
· Keri A. Thoma
· Jan Steinhour Thompson
· Margarita Torres
· Susan G. Trevithick
· Matthew T. Uebele
· Jeffrey C. Van Luyn
· Jessica M. Vander Zanden
· Bonnie Rose Vaughn
· Japa A. Volchok
· Curtis D. Watkins
· Christine M. Weir
· Chedva Werblowsky
· Kayla L. Wiley
· Joseph F. Zielinski
Certified in healthcare research Compliance (ChrC)®
· Kimberly Y. Collins · Ellen M. Datena · Thelma Harrington · Kathy Kassar · Ileana Petisco
Certified in healthcare privacy Compliance (ChpC)®
· Mary Frances Arseneau
· Kara Lynne Bastien
· Kimberly R. Boyett
· Shallie Bryant
· Rosalyn Cerda
· Valerie Dawn Crossland
· Julia A. Dahlman
· Nancy J. Dallas
· Candace Pauline Davis
· Cassandra F. Davis
· Alice A. Ducey
· Catie H. Heindel
· Mary Beth Ireland
· Janice M. Kennedy
· Carol Ann Kramer
· Loretta G. Lebar
· Cheryl D. Lofton
· Rose M. Novak
· Thomas A. Reeder
· Angeli M. Rodriguez
· Daniel T. Roehler
· Phyllis Eileen Schubert
· Michael Robert Scott
· Michael Joseph Shearn
· Machelle D. Shields
· Michael Rene Tamayo
· Michelle Renee Teigen
· Glenda J. Thornton
· Melody Mae Thornton
· Kathleen M. Uhlorn
· Todd F. Wojtowicz
· Heather G. Woods
Want to become
SMThe Certifi ed in Healthcare Compliance (CHC)® designation demonstrates expertise in the healthcare compliance fi eld. Earn yours today:
• Meet eligibility requirements in both work experience and continuing education
• Pass the CHC exam
• Maintain your designation by earning approved continuing education credits
Certifi ed in Healthcare Compliance (CHC)® ?BE RECOGNIZED for your experience and knowledge!
For more details on earning and maintaining this designation, please fi nd the CHC Candidate Handbook or other information at www.hcca-info.org under the ‘Certifi cation’ tab.
74 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
The health care industry can be very treacherous right now. Many hospital leaders are putting more pressure on
all parts of the hospital to turn a profit. This includes the hospital’s pharmacy. This can be difficult, if not impossible, in the current health
care environment. In addition to increased personnel cost and acquisi-tion cost, the Compliance department is being forced to step up its efforts, and it is spending more time in the pharmacy than it has in the past. So how does a hospital’s Pharmacy department meet both set of demands?
One of the most important steps is embrac-ing the compliance component, because a noncompliant organization will be subjected to audits, overpayment recoupment demands, and if things are really out of hand, criminal penalties. Under the Health Care Reform Act, there is increased audit exposure for all types of health care providers. So, while there may be cost associated in meeting the Compliance department’s demands, doing so will result in a return on that investment. The return may be hard to quantify, but by living in a compliant culture, overpayment demands will be lessened and criminal allegations much less likely.
For a hospital, its Pharmacy department can be one of the hardest departments for Compliance to get its arms around. This is due to the many different types of drugs to be billed and the various reimbursement methodolo-gies employed by the Pharmacy department’s payers. Three areas must be looked at on a regular basis to ensure minimum compliance in the Pharmacy department. These are:
· the correct use of National Drug Codes (NDC),
· Healthcare Common Procedure Coding System (HCPCS) codes, and
· assuring billable unit accuracy.
In 2011, drug shortages hit a record high. With certain drugs in short supply, the first thing that comes to a compliance officer’s mind is the patient care issues, but drug short-ages can easily affect your billing. Because NDC codes are at the core of a hospital’s bill-ing procedures, ensuring the accuracy of the NDC codes used for billing is one of the most important compliance activities for a hospi-tal pharmacy. If a hospital is forced to switch sources in order to obtain these hard to find drugs, then it is vitally important to have a pro-cess in place to update the NDCs being used.
The NDC is specific to drug manufacturer, drug product, and package. This means the
by Denise Fletcher, Esq.
How to keep the Pharmacy department compliant
Fletcher
» Compliance is not an option.
» Improper use of NDC codes results in fraudulent billing.
» Using HCPCS codes with all drug claims equals optimum billing.
» Accurate reporting of billable units is crucial for compliant billing.
» The key to survival is being proactive.
Denise Fletcher, Esq. (dfletcher @ bf-law.com) is an attorney with the Health
Care Group at Brown & Fortunato, PC, a law firm based in Amarillo, Texas.
888-580-8373 | www.hcca-info.org 75
Com
pli
ance
Tod
ay
Jun
e 20
12
same drug in a different package will have dif-ferent a different NDC. The simple truth is that using the wrong NDC is a fraudulent billing practice. This is particularly true for Medicaid claims, because drug rebates for Medicaid patients are calculated based on the claims submitted by the provider. If the wrong NDC is used, then the claim could be overstated. The NDC reported must be the one found on the drug container. Making sure a hospital’s inventory control system accurately reflects the correct NDC is of upmost importance. Because this is the core of the hospital’s drug billing pro-cedures, it should be an area that is monitored frequently to ensure accuracy. If you start with bad data, you are certain to get a bad result.
Another important area to review would be the use of HCPCS codes. HCPCS codes are used for reimbursement of separately payable drugs. Not all drugs are separately payable, but the use of HCPCS codes can increase the accuracy of billing claims, even for items that are not separately billable. More accurate reim-bursement could result in additional revenue. In fact, CMS is strongly encouraging provid-ers to report a HCPCS code for all drugs, if a HCPCS code is available. In Transmittal 2386,1 CMS states:
More complete data from hospitals on the drugs and biological provided during an encounter would help improve payment accuracy for separately payable drugs and biologicals in the future….CMS notes that it makes packaging determinations for drugs and biological annually based on charge information reported with specific HCPCS codes on claims, so the accuracy of OPPS payment rates for drugs and bio-logical improves when hospitals report charges for all items and services that have HCPCS codes under those HCPCS codes, whether or not payment for the items and services is packaged or not. It is CMS’
standard rate setting methodology to rely on hospital cost and charge information as it is reported to CMS by hospitals through the claims data and cost reports. Precise billing and cost reporting by hospitals allow CMS to most accurately estimate the hospital costs for items and services upon which OPPS payments are based.
This may require a pharmacy department to change its current practice and include HCPCS codes for all drugs claims, whether separately payable or not. This will provide CMS with the information it needs to calculate correct and specific cost from claims data. As a result, specific procedures and processes will be paid more accurately in the future. In short, the use of accurate HCPCS codes will result in optimum reimbursement.
In addition, Chapter 17 of the Medicare Claims Processing Manual2 states:
Hospitals should report charges for all drugs, biologicals, and radiopharmaceu-ticals, regardless of whether the items are paid separately or packaged, using the correct HCPCS codes for the items used. It is also of great importance that hospitals billing for these products make certain that the reported units of service of the reported HCPCS code are consistent with the quantity of a drug, biological, or radio-pharmaceutical that was used in the care of the patient.
Using accurate billable units is another key component of compliant billing. Units should not be billed based on how a drug is packaged or the package size. Instead, drug units must be billed in accordance with the HCPCS descriptor. If the full dosage provided is less than the dosage for the code specifying the minimum dosage for the drug, the claim should be submitted with the minimum dosage amount. If the dosage is not
76 www.hcca-info.org 888-580-8373
Com
pli
ance
Tod
ay
Jun
e 20
12
an exact multiple of the HCPCS code descrip-tor, the claim unit should be rounded up to the next highest unit in the HCPCS code descriptor. The Recovery Audit Contractors are reviewing claims for the accurate use of billable units. This means it is only a matter of time before the fail-ure to monitor the accuracy of billable units will result in an overpayment demand.
These are not the only areas that must be addressed by the Compliance department to ensure optimum billing in accordance with the
law, but looking at these areas is the starting point of any good compliance review. The key to surviving in today’s tough environment is to stay one step ahead of the auditors. This can be accomplished by embracing compliance and constantly reviewing processes and procedures for accuracy and improvement.
1. CMS Manual System: Medicare Claims Processing Manual, Publication 100-04, Transmittal 2386. January 13, 2012. Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2386CP.pdf
hCCa training resources GUIDEBOOKS AND VIDEOS TO TRAIN YOUR HEALTH CARE WORKFORCE
Compliance and ethics: an introduction for health Care professionalsHCCA’s top-rated video covers 7 key compliance areas in a 23-minute program. Includes a trainer’s guide with suggested agendas and discussion outlines—suitable for new employee orientations and staff refreshers
a supplement to your Deficit reduction act Compliance training programThis 13-page handbook offers an easy way to educate your employees about the basics of Medicare and Medicaid, the Federal False Claims Act, and the whistleblower protections that help health care workers fight fraud.
hipaa privacy ComplianceThis 19-minute video plus 10 participant handbooks offer an in-depth review of the HIPAA Privacy Rule—updated in 2010 with guidelines for the new HITECH mandates.
hipaa security ComplianceThis 15-minute video plus 10 participant handbooks show how to meet the requirements of the HIPAA Security Rule—updated in 2010 with guidelines for the new HITECH mandates.
emtaLa 911: on Call!This 15-minute video plus 10 participant handbooks review EMTALA requirements for any facility that has walk-in patients with urgent care needs.
hCCa hipaa training handbookThis 36-page guide offers essential, basic knowledge of privacy and security regulations governed by HIPAA and HITECH that front-line health care workers need.
a Compelling Case for Clinical DocumentationEnhance quality of care and reimbursement processing with this award-winning training program that gives physicians the tools needed to consistently produce higher quality clinical documentation.
Guide to resident Compliance trainingThis guide offers a complete training program designed to introduce resident physicians to key compliance concepts.
Learn more & PLACE ORDERS ONLINE AT www.hcca-info.org
arizona · Daniel J. Caufield, Southern AZ VA Hlth Care Syst · Teri L. Jamison, Preferred Homecare · Ann K. Rees, Banner Health
CaLifornia · Chris Albini, Loma Linda USS · Joaquin E. Basauri, Kaiser Permanente · Bonnie Collis, Riverside Physician Network · Jenny G. Givens · Jane Gorwin, Kaiser Permanente · Jill Kimble, California Rural Indian Health Board · Orni Kliebphipat, UCLA Health System · Rebecca Lim, San Francisco Health Plan · Steve Mackey, USC Clinical Research Organization · Catherine L. Manske, CHW Medical Foundation · Ravi Mehta, SF Dept of Public Health · Erin Mills, WellPoint, Inc · Windy Nakamoto · Stacie Oakley, Coast Hlthcare Mgmt LLC · Marilyn Pollard, California Rural Indian Health Board · Scott Tafuri, The Permanente Medical Group · Kanner Tillman, Sherman Oaks Hospital · Ali Vand, Kaiser Permanente · Sharon Vandagriff, Health Record Services · Jessica Warshaw, Health Net, Inc · Elise Watts, UCLA Health System · Nanette Wong, San Francisco Health Plan · Diana Zilker, Kaiser · Vicki M. Zumwalt, Kaiser Permanente
CoLoraDo · Theresa OLonergan, Catholic Health Initiatives · Nichole Pascale, Denver Health and Hospital Authority · Rebecca Warren, The Memorial Hospital
ConneCtiCut · Rita Grimes, Visiting Nurse & Health Svs of CT · April Kennedy, Franklin Medical Group · William Moffat, Medsafe · Gisele Molloy, CareCentrix, Inc · Danie S. Plantin, Sunbridge Healthcare · Michele Urban, Johnson Memorial Hosp
fLoriDa · Ellen Adams, Manatee County Rural Health Services · Luis Alfonso, Palm Springs General Hospital · Lynn M. Barrett, Jones Walker · Cynthia L. DeVries, Lee Memorial Health System · Alan Heck, Physician Preferred Pharmacy · Robert R. O’Connell, Jr. · Barbara Peress, Royal Palm Dermatology · Thomas Rose, Pyramid Healthcare Solutions
GeorGia · Anne Barr, Southeast Georgia Health System · David Dover, Alere · C. Ann Harper · Melinda Hinton, East Atlanta Gastroenterology · Alysia Shirley, Memorial Health University Medical Center
iDaho · Kathryn F. Leavitt, Steele Memorial Medical Ctr
iLLinois · Anne Bennett · Lori Brown, Accretive Health · Patrick S. Coffey, Locke Lord LLP · AnnaLisa Daniele, Northwestern Univ - Feinberg School of Medicine · Candace Davis, Independent · Kristine Martens, Children’s Memorial Hospital · Paige Pfenninger, Alexian Brothers Health System · Linda Rice, Morris Hospital & Healthcare Centers · Jaspreet K. Saini, Northwestern Univ - Feinberg School of Medicine · Kathryn D. Short, Carlinville Area Hospital
inDiana · Cynthia S. Baker, Ear, Nose & Throat Assoc · Pam Collins, Clark Physician Group · Paula Koenig
iowa · Dennison W. Sass, VA Health Care System
KentuCKy · Adrena Woolwine, Univ of Kentucky
Louisiana · Megan L. Callahan, Stockwell Sievert Viccellio Clements & Shaddocl · Sarah Gordon, Lane Regional Medical Center
massaChusetts · Jonathan E. Anderman, Holland & Knight LLP · Anna Dunbar-Hester, Community Catalyst · Stephanie M. Garfield, Fresenius Medical Care · Gina Meili, Commonwealth Care Alliance · Brian G. Oates
maine · Denise Sadowski, Martins Point Health Care
maryLanD · Jon Goodyear · James L. Scott, American Coding Centers LLC · Huacheng Tu, The Law Office of Fred S. London, PC · Carolyn Tuttle, Kohler HealthCare Consulting
miChiGan · Joan Isaacs · Tammy Moore, OnHealthcare · Allison Myers · Christine Weir, Great Lakes Caring
minnesota · Thomas Beimers, Faegre Baker Daniels · Jenny Coig, Security Life Insurance Company of America · Lori Gjerde, Prime Therapeutics · Amy Hunt Tjornhom, UnitedHealthcare Medicare & Retirement · Elizabeth Knight, Catholic Charities of St. Paul & Mpls · Steven R. Mattson, Essentia Health · Sharon C. Meschke, St Cloud VA Health Care System
888-580-8373 | www.hcca-info.org 79
Com
pli
ance
Tod
ay
Jun
e 20
12
HCCA | The Association for Health Care Compliance Professionals
· Kimberly K. Otte, Mayo Clinic · David Walsh, UnitedHealth Group
missouri · Dana DeMasters, Liberty Hospital · Tony Krawat, Mercy Hospital St. Louis · Kimberly Pinar, Essence Health Care · Brett T. Pu, Special Design Healthcare · Anna T. Selby, Armstrong Teasdale LLP
montana · Pam Petersen, Daniels Memorial Hospital
neBrasKa · Emily R. Langdon, Parsonage Vandenack Williams LLC
new Jersey · Katherine Adams Erck · Lindsay Buntzen, Atlantic Health System · Cindy Coronel, Saint Clares Health System · Marcie L. Fitzpatrick, Veterans Affairs - Compliance & Business Integrity
· Eva Goldenberg, Atlantic Health System, Inc · Patrick Guilfoyle, UMDNJ-SOM Office of Ethics Compliance and Corporate Integrity
· Jarad Silverstein, Parker McCay PA
new mexiCo · Kimberly L. Hoover, Nor- Lea General Hospital · Tina Rigler, Molina Healthcare · Monica Wilson, University of New Mexico
new yorK · Robert E. Armada, Columbia Univ College of Dental Medicine · Alan Z. Fromm, Amneal Pharmaceuticals of NY LLC · William Gurin, HHC · Patricia M. Lamb, Montefiore · Sandra Meltzer, Medisys Management · Penelope Napolitano, Medisys Management LLC · Iva Perlman, NYC Health and Hospitals Corporation
north CaroLina · Miraf Bisetegne, East Carolina University, Brody School of Medicine · Greg Blackburn, Novant Health · Michelle Fontaine, Century Care Management · John Garver, Robinson Bradshaw & Hinson, PA · Steve Hudson, Steve W. Hudson, Inc. · Jennifer Hutchens, Robinson Bradshaw & Henson · Jennifer Pereira
ohio · Penny L. Cooper, Mercer Health · Ginger Gagne, O’Bleness Memorial Hospital · Francine W. Grisanti · Suzanne Jablonski, Univ of Toledo Medical Center · Sharon L. Reynolds, AdCare Health Systems · Kathy Swihart, Knox Community Hospital
oKLahoma · John Honaker, ProCure Proton Therapy Center
oreGon · Cynthia D. Adams, Kaiser Permanente · Terri Cook, Walmart
· Jeremy Henley, ID Experts · Ian P. Kelly, ID Experts · Timothy S. Molloy, Kaiser Permanente · Jason Porter, ID Experts · Karen L. Rasmussen, Providence Health & Services
pennsyLVania · Suzette Benedick, Valley Kidney Specialists, PC · Kelli A Daldo, Susquehanna Health · Kathleen Gillespie, Guardian Elder Care · Scott Jones, HPIX · Thomas McCarter, Executive Health Resources · Thomas Mercer, Executive Health Resources · Maria Woods, Publicis Touchpoint Solutions
rhoDe isLanD · Melissa Siple, Reckitt Benckiser Pharmaceuticals
south DaKota · Merrilyn Schroeder, Regional Health
tennessee · Daniel Garen, Wright Medical Technology, Inc. · Susan Izell, Catholic Health Initiatives · Corey Wilson, Cogent HMG
texas · Donna Anderson · Lisa Blackwell, Abilene Diagnostic Clinic · Sheryle Bonin, Brookdale Senior Living · Matt O. Bourgeois, MD Anderson Cancer Center · Sherri Davis-Sampson, San Jacinta Methodist Hospital · Gregory C. Ewing, Valley Baptist Health Sys · Steve Galvan, Rock Consulting Inc · Lucinda Gavito, Valley Baptist Health Sys · Alicia Krizan, TX Tech Univ Hlth Sciences Ctr · Scott Lundy, Cathedral Rock · Richard M. Morse, MD Anderson Cancer Center · Marilyn C Robertson, Brown McCarroll LLP · Caroline A. Spencer, Universal American Corp · James Vincent, NCI Information Systems
utah · Diana Snow, Univ of Utah
Vermont · Mandi A. Titus, Northeast Kingdom Human Services
washinGton · Tarra S. Carey, Peacehealth · Sue Clausen, UW Medicine/Univ of WA · Jenn Freeman, Qualis Health · Kassi J. Hays, Cancer Care Northwest · Jennifer Warren, Providence Health & Services
west VirGinia · Jennifer R Paxton, HCA - Parallon
wisConsin · Linda M. Exline, Security Health Plan · Sara Millar, Riverview Hospital · Kimberley Noon, Milwaukee Cntr for Independence
washinGton DC · Ted R. Lotchin, Arnold & Porter, LLP · Kaffin Tolver, MedStar Washington Hospital Center
s
HCCA’s Compliance 101 has what you need to begin building and maintaining an effective health care compliance program. This newly revised edition incorporates the latest changes to HIPAA brought about by the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, as well as changes in the Federal Sentencing Guidelines’ Sentencing of Organizations. This book is ideal for compliance professionals new to the field, compliance committee members, compliance liaisons, and board members.
Compliance 101 includes:
• The Seven Essential Elements
• Organizational Steps for an Effective Program
• Tailoring Your Compliance Program
• HIPAA and HITECH Privacy and Security Regulations
• Sample Compliance Materials
• Glossary of Compliance Terms
PAYMENT OPTIONS Check enclosed (payable to HCCA) My organization is tax exempt
Invoice me | Purchase Order #
I authorize HCCA to charge my credit card (choose below)
CREDIT CARD: AmericanExpress Diners Club MasterCard Visa
Credit Card Account Number
Credit Card Expiration Date
Cardholder’s Name
Cardholder’s Signature
Prices subject to change without notice. HCCA is required to charge sales tax on purchases from Minnesota. Please calculate this in the cost of your order. The required sales tax in Min-nesota is 6.875%. All purchases receive free FedEx Ground shipping within continental U.S.
(Federal Tax ID: 90-0778759)
COMPLIANCE 101, THIRD EDITIONQty Cost
HCCA Members ....................................................................................... $50
June 2012takeawaysTear out this page and keep for reference, or share with a colleague. Visit www.hcca-info.org for more information.
s
a timeline for change: a discussion of affordable Care act provisionsJanice A. Anderson, Esq. and Joseph T. Van Leer, Esq. (page 19)
» Be aware of reimbursement changes and the timeline driven by the Affordable Care Act to take steps to preserve reimbursement to the extent possible.
» By 2015, up to 6% of hospital reimbursement will be at risk for poorly performing hospitals.
» EHR incentive payments are available until 2015, then hospitals will be subject to penalties.
» The Value Based Purchasing program has already started and reimbursement will decline, commencing October 1, 2012, unless hospitals can perform well.
» CMS will implement another penalty, based on the hospital readmission rate for certain discharges, starting October 1, 2012.
ignore at your peril what others know about your organizationLeon Goldman, MD (page 32)
» Health care transparency is increasingly making more physician information publicly accessible.
» The Physician Payment Sunshine Act will force over 1,500 companies to disclose in 2013.
» Regulators, media, and the public are already using this data.
» Data mining creates a strategic information asset.
Complying with the aDa’s accessibility standards: what you need to knowKara M. Maciel and Jordan B. Schwartz (page 37)
» Understand how the ADA’s new 2010 standards affect health care providers.
» Modify policies to allow for use of mobility devices.
» Provide effective communication to individuals with disabilities.
» Make medical space accessible for individuals with disabilities.
» Focus on effective training of staff.
reconsidering fCoi: what phs’s final rule means to investigatorsOfer Amit, MSEM, CHRC and Draco Forte, MEd, CHRC (page 51)
» Relationships between researchers and sponsors are not inherently bad.
» Threshold for Significant Financial Interest (SFI) set at $5,000.
» SFI connected to Investigator’s institutional responsibilities must be disclosed.
» Non-compliance can delay funding or require repayment of funds.
» Disclosure of SFI is not only required; it is also good research practice.
Cms issues long-awaited compliance program guidance revisionsBrenda J. Tranchida, Esq. (page 55)
» The new guidance incorporates 2011 regulatory changes and interpretive guidance.
» The compliance officer’s reporting role and entity’s governance responsibilities are more clearly defined.
» New requirements for oversight of first tier, downstream, and related entities; risk assessments; and use of metrics are highlighted.
» The factors and evidence CMS will use to assess the effectiveness of a compliance program are outlined.
» Other health care sectors that are required to have compliance programs may find this new guidance useful as well.
Dmepos reimbursement appeals and the compliance officerNatarsha Nesbitt, Esq. and Nathaniel Lacktman, Esq., CCEP (page 65)
» DMEPOS suppliers have five levels of Medicare claims appeals.
» DME MACs sometimes differ when interpreting the same Medicare rule.
» Suppliers should consider involving the Compliance department in claims appeals.
» Suppliers can draw on the Compliance department for reimbursement advice.
» Cooperation between Compliance and Reimbursement personnel can be a win-win.
off-label drug promotion: the false Claims act and anti-Kickback statuteDavid Restaino, Esq. (page 69)
» FDA restrictions on promoting “off-label” drug use are a compliance challenge.
» Compliance professionals need to be aware of the “grey areas” in drug promotion and watch for possible conflicts of interest.
» Medical professionals should keep their prescription choices from appearing biased.
» Regulatory safe harbors are helpful, and should be reviewed and understood.
» Creating “compliance assets” is the best path to avoid penalties.
how to keep the pharmacy department compliantDenise Fletcher, Esq. (page 74)
» Compliance is not an option.
» Improper use of NDC codes results in fraudulent billing.
» Using HCPCS codes with all drug claims equals optimum billing.
» Accurate reporting of billable units is crucial for compliant billing.
» The key to survival is being proactive.
ComplianceTODAY
HCCA’s Compliance 101 has what you need to begin building and maintaining an effective health care compliance program. This newly revised edition incorporates the latest changes to HIPAA brought about by the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, as well as changes in the Federal Sentencing Guidelines’ Sentencing of Organizations. This book is ideal for compliance professionals new to the field, compliance committee members, compliance liaisons, and board members.
Compliance 101 includes:
• The Seven Essential Elements
• Organizational Steps for an Effective Program
• Tailoring Your Compliance Program
• HIPAA and HITECH Privacy and Security Regulations
• Sample Compliance Materials
• Glossary of Compliance Terms
PAYMENT OPTIONS Check enclosed (payable to HCCA) My organization is tax exempt
Invoice me | Purchase Order #
I authorize HCCA to charge my credit card (choose below)
CREDIT CARD: AmericanExpress Diners Club MasterCard Visa
Credit Card Account Number
Credit Card Expiration Date
Cardholder’s Name
Cardholder’s Signature
Prices subject to change without notice. HCCA is required to charge sales tax on purchases from Minnesota. Please calculate this in the cost of your order. The required sales tax in Min-nesota is 6.875%. All purchases receive free FedEx Ground shipping within continental U.S.
(Federal Tax ID: 90-0778759)
COMPLIANCE 101, THIRD EDITIONQty Cost
HCCA Members ....................................................................................... $50
________ Join HCCA: $200 ..................$ __________Non-members, add $200 to join HCCA, and pay member prices for your order (REGULAR DUES $295/YEAR)
SALES TAX FOR MN (6.875%) OR PA (8%) $ __________
TOTAL $ __________
Contact Information (PLEASE TYPE OR PRINT)
HCCA Member ID
First Name M.I. Last Name
Title
Organization
Street Address
City State Zip
Telephone
Fax
E-mail
Make check payable to HCCA and mail to:HCCA, 6500 Barrie Road, Suite 250Minneapolis, MN 55435
Or fax order to: 952-988-0146
My organization is tax exempt
Check enclosed
Invoice me | Purchase Order #
I authorize HCCA to charge my credit card (choose below): AmericanExpress Diners Club MasterCard Visa
Credit Card Account Number
Credit Card Expiration Date
Cardholder’s Name
Cardholder’s Signature
Prices subject to change without notice. HCCA will charge your credit card the correct amount if the total above is incorrect. All purchases within the continental U.S. receive free FedEx Ground shipping. Additional charges apply for international orders: please contact HCCA for more information. HCCA is required to charge sales tax on purchases from Minnesota. Please calculate this in the cost of your order: MN = 6.875%. (Federal Tax ID: 90-0778759)
Health Care Privacy Compliance Handbook� is book will help privacy professionals sort through the complex regulatory framework and signi� cant privacy issues facing health care organizations. Written by the faculty of HCCA’s Basic Privacy Compliance Academy, it o� ers up-to-date guidance on:
