How Pharmacy Benefit Managers Affect Drug Pricing and Access … · 2018-09-20 · How Pharmacy...

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How Pharmacy Benefit Managers Affect Drug Pricing and Access to TreatmentPresented by: Ally Lopshire, JDFederal Affairs Manager, Policy & ResearchSeptember 2018

What is a PBM?• Hired by health plans to manage prescription drug

benefit programs and provide other services pursuant to negotiated contract.

• Act as intermediaries between health plans, manufacturers, and pharmacies.

• Develop formularies and determine patient access to drug therapies.

SOURCES: Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; Compliant, Burnett v. Express Scripts, No. 16-cv-04948 (S.D.N.Y. June 6, 2016), https://www.bloomberglaw.com/public/desktop/document/Burnett_et_al_v_Express_Scripts_Inc_et_al_Docket_No_116cv04948_SD?1483629860.

What is Their Role?• Initial purpose 1960s-1970s: purely administrative. • As drug costs continued to rise, PBMs offered services

that promised health plans less expensive drug programs and lower costs.

• Now handle everything from negotiating price concessions with manufacturers to creating pharmacy networks to determining which drugs are covered by which plans.

SOURCES: Britschgi C. Pharmacy benefit managers could be in legislative crosshairs. Watchdog.org. http://watchdog.org/285187/pharmacy-benefit-managers-legislative-crosshairs/. January 3, 2017. Accessed January 10, 2017. Kingery A. The basics of pharmacy benefits management (PBM) 2009. Oral presentation at: Virginia CE Forum. https://www11.anthem.com/shared/va/f5/s1/t0/pw_b135247.pdf; Compliant, Burnett v. Express Scripts, No. 16-cv-04948 (S.D.N.Y. June 6, 2016), https://www.bloomberglaw.com/public/desktop/document/Burnett_et_al_v_Express_Scripts_Inc_et_al_Docket_No_116cv04948_SD?1483629860.

Who are the PBMs?

SOURCE: Insurance companies start to bring PBM in-house: CVS Health’s PBM business could be under threat. Forbes. July 28, 2015. http://www.forbes.com/sites/greatspeculations/2015/07/28/insurance-companies-start-to-bring-pbm-in-house-cvs-healths-pbm-business-could-be-under-threat/#69b4f3d23df2. Accessed January 10, 2017.

PBM Market Share by Total Prescription Claims in 2015, Forbes

SOURCES: Insurance companies start to bring PBM in-house: CVS Health’s PBM business could be under threat. Forbes. July 28, 2015. http://www.forbes.com/sites/greatspeculations/2015/07/28/insurance-companies-start-to-bring-pbm-in-house-cvs-healths-pbm-business-could-be-under-threat/#69b4f3d23df2. Accessed January 10, 2017; Britschgi C. Pharmacy benefit managers could be in legislative crosshairs. Watchdog.org. http://watchdog.org/285187/pharmacy-benefit-managers-legislative-crosshairs/. January 3, 2017.

Who are the PBMs?• Express Scripts (ESI), CVS, and UnitedHealth capture

over 70% of PBM market share. • ESI Revenue in 2015: $101.85 billion.• In March 2015, UnitedHealth Group (3rd largest PBM)

acquired Catamaran (4th largest PBM), increasing the PBM market concentration.

• In Dec. 2017, CVS bought Aetna for about $69 billion.

SOURCES: Insurance companies start to bring PBM in-house: CVS Health’s PBM business could be under threat. Forbes. July 28, 2015. http://www.forbes.com/sites/greatspeculations/2015/07/28/insurance-companies-start-to-bring-pbm-in-house-cvs-healths-pbm-business-could-be-under-threat/#69b4f3d23df2. Accessed January 10, 2017; Britschgi C. Pharmacy benefit managers could be in legislative crosshairs. Watchdog.org. http://watchdog.org/285187/pharmacy-benefit-managers-legislative-crosshairs/. January 3, 2017.

Company Revenue1 Walmart $485,873

2 Berkshire Hathaway $223,604

3 Apple $215,639

4 Exxon Mobil $205,004

5 McKesson $192,487

6 UnitedHealth $184,840

7 CVS Health $177,5268 General Motors $166,380

9 AT&T $163,786

10 Ford Motor $151,800

Company Revenue11 AmerisourceBergen $146,850

12 Amazon.com $135,987

13 General Electric $126,661

14 Verizon $125,980

15 Cardinal Health $121,546

16 Costco $118,719

17 Walgreens Boots $117,351

18 Kroger $115,337

19 Chevron $107,567

20 Fannie Mae $107,162

Company Revenue21 J.P. Morgan Chase $105,486

22 Express Scripts $100,288

23 Home Depot $94,595

24 Boeing $94,571

25 Wells Fargo $94,176

26 Bank of America $93,662

27 Alphabet $90,272

28 Microsoft $85,320

29 Anthem $84,863

30 Citigroup $82,386

Fortune 500 List: Top 30

The Drug Supply ChainManufacturer

PharmaciesPatients

Wholesaler

Drug Payment Drug Shipment

Drug Payment

Drug Shipment

Dispense Drug

Copay/Coinsurance

Drug FlowCash Flow

*WAC (Wholesale Acquisition Cost): List price for a drug that manufacturers use to charge wholesalers; does not reflect discounts wholesalers may receive (i.e. for purchasing in bulk).

PharmaciesPatients

Health Plans PBM

Premium

Drug Coverage

Reimbursement + Admin Fee

Manage DrugProgram

Reimbursement +

Disp Fee

Pharmacy Network

Cash FlowServices

Drug Benefit Programs

Manufacturer

Health Plans PBM

Manage DrugProgram

Share of Rebate

Drug FlowServices

Cash Flow

Rebate

The Rebate System

Manufacturer

PharmaciesPatients

WholesalerHealth Plans PBM

Drug PaymentDrug Shipment

Drug Payment

Drug Shipment

Dispense Drug

Copay/Coinsurance

Premium

Drug Coverage

Manage DrugProgram

Share of Rebate

Reimbursement +

Disp Fee

Pharmacy Network

Drug FlowServices

Cash Flow

Rebate

Putting It All Together

SOURCES: PCMA. Policy & Issues: PBM Cost-Saving Tools. https://www.pcmanet.org/policy-issues/. Accessed January 10, 2017; Visante. Pharmacy benefit managers (PBMs): Generating savings for plan sponsors and consumers. https://www.pcmanet.org/wpcontent/uploads/2016/08/visante-pbm-savings-feb-2016.pdf. Published February 2016. Accessed January 10, 2017.

PBM Claims• PBMs claim to drive down drug costs by:▫ Negotiating discounts for health plans and patients.▫ Designing formularies and negotiating/obtaining rebates.▫ Increasing use of mail-order and specialty pharmacies.▫ Offering more affordable pharmacy channels.▫ Encouraging use of generics and affordable brands.▫ Managing high-cost specialty medications.

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; Compliant, Boss v. CVS Health Corp., No. 2:17-cv-01823 (D.N.J. March 17, 2017), https://www.bloomberglaw.com/public/desktop/document/BOSS_et_al_v_CVS_Health_Corporation_et_al_Docket_No_217cv01823_DN?1496256418.

PBM Realities• But we know that costs are skyrocketing, patients are paying

more at the pharmacy counter, and access is more restricted.• Use position to negotiate contracts with manufacturers/health

plans/pharmacies that maximize profits at expense of physicians and patients.

• Sources of PBM Revenue/Profit:▫ Spread Pricing▫ Manufacturer Rebates▫ Mail-Order Pharmacies▫ Administrative and Service Fees

SOURCES: Clarity: PBM practices. National Community Pharmacists Association. http://www.pbmwatch.com/uploads/8/2/7/8/8278205/ncpa_pbm_practices_that_drive_up_costs.pptx. Accessed January 10, 2017; FisherBroyles. PBMs and drug pricing: Congress and major U.S. employers start to unravel the hidden pricing mechanisms of PBMs. Lexology. http://www.lexology.com/library/detail.aspx?g=2ae6941d-65a0-4ce1-a7ad-b2031f9a4764. September 16, 2016; Spread pricing: marking up drug claims. National Community Pharmacists Association. http://www.ncpanet.org/advocacy/pbm-resources/spread-pricing---marking-up-drug-claims. Accessed January 10, 2017.

Spread Pricing• Spread Pricing: Difference between what PBM charges a

health plan for a certain drug and what it reimburses a pharmacy for dispensing it.

• Pharmacies typically have no idea what health plans are paying for a drug and health plans don't know how much pharmacies are reimbursed for dispensing it.

Spread Pricing

Network Participation

Reimbursement + Disp. Fee

= (Drug Price - 16%) + $3 admin fee

NOT EQUAL

= (Drug Price - 18%) + $2 disp. fee

= ($200 - 16%) + $3 admin fee= $171 per drug claim

= ($200 - 18%) + $2 disp. fee= $166 per drug dispensed

PBM pockets $5 every time that drug is

dispensed as pure profit.

Manage Drug ProgramPharmaciesHealth

Plans PBM

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; Compliant, Boss v. CVS Health Corp., No. 2:17-cv-01823 (D.N.J. March 17, 2017), https://www.bloomberglaw.com/public/desktop/document/BOSS_et_al_v_CVS_Health_Corporation_et_al_Docket_No_217cv01823_DN?1496256418.

The Rebate System• Rebate: A retroactive discount paid in a lump sum by a

manufacturer to a PBM in exchange for preferred placement on the PBM’s formulary. ▫ Rebate amount is negotiated percentage off list price (WAC).▫ Manufacturer promises to pay to PBM a percentage rebate (of drug

list price) for every prescription of their drug that is filled.

• Motivates PBMs to base drug utilization on rebates (aka profits) rather than patient care or reducing drug costs. ▫ Efficacy, safety, and patient cost not as important as rebate amount.

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure. https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; PhRMA. Commercially-insured patients pay undiscounted list prices for one in five brand prescriptions, accounting for half of out-of-pocket spending on brand medicines. http://www.phrma.org/press-release/new-data-show-more-than-half-of-patients-out-of-pocket-spending-for-brand-medicines-is-based-on-list-price. Published March 2017.

Consequences of The Rebate System• Rebate system gives PBMs strong financial incentives when

designing/managing formularies. ▫ Has profound effect on patient access to affordable treatment.

• Leads to practices like step therapy, prior authorization, non-medical switching, etc. ▫ Step Therapy: Must step through most profitable medications first.▫ Non-Medical Switching: Contract could change from year to year;

forces stable patients to change medications because PBM obtained more profitable contract with different manufacturer.

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure. https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; PhRMA. Commercially-insured patients pay undiscounted list prices for one in five brand prescriptions, accounting for half of out-of-pocket spending on brand medicines. http://www.phrma.org/press-release/new-data-show-more-than-half-of-patients-out-of-pocket-spending-for-brand-medicines-is-based-on-list-price. Published March 2017.

Consequences of The Rebate System• Negatively influences list prices.▫ Higher the list price, higher the rebate – which increases chances of

getting onto PBM formulary.▫ Becomes market influence that manufacturers must take into

account when setting list price (WAC). • Patient cost-sharing obligations are based off list price, not

rebated (net) price, which forces patients to pay inflated out-of-pocket amount. ▫ Patients with coinsurance/deductibles are forced to pay particularly

unfair amount for their prescriptions.

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017.

The Rebate Argument• PBMs cite ability to negotiate rebates as cost-reducing mechanism

for health plans and patients.• BUT more rebates are being paid now more than ever and drug

costs continue to rise. ▫ Price protection/rebate percentage and price escalation fees actually

make more money for the PBM if the list price goes up.▫ Premiums are rising faster than ever ; coinsurance/deductibles are

higher as well.• Rebates are not always passed back to health plans, even though

many plan-PBM contracts contain rebate terms.▫ Question is why?

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; see also Vandervelde A. and Blalock E. The pharmaceutical supply chain: Gross drug expenditures realized by stakeholders. Berkeley Research Group. http://www.thinkbrg.com/assets/htmldocuments/Vandervelde_PhRMA-January-2017_WEB-FINAL.pdf. Published January 2017.

• PBM only contractually obligated to pass on “rebate” as specifically defined in health plan contract.

• Health plans do not know amount of rebates PBMs actually collect from manufacturers.▫ PBMs exploit this non-transparency to “reclassify” rebates in

manufacturer contract as "fees,“ payment for services, etc.▫ Designating portion of rebate as “fee” etc. allows PBM to keep a

large part of rebate as profit.

The Rebate Game:Hiding Money Through Reclassification

SOURCES: ERISA Advisory Council. PBM Compensation and Fee Disclosure. https://www.dol.gov/sites/default/files/ebsa/about-ebsa/about-us/erisa-advisory-council/2014ACreport1.pdf. Published November 2014. Barlas S. Employers and drugstores press for pbm transparency: A Labor Department Advisory Committee has recommended changes. Pharmacy and Therapeutics. 2015;40(3):206-208. Published January 3, 2017. Accessed January 10, 2017; Eickelberg HC. The prescription drug supply chain black box: How it works and why you should care. American Health Policy Institute. http://www.americanhealthpolicy.org/Content/documents/resources/December%202015_AHPI%20Study_Understanding_the_Pharma_Black_Box.pdf. Published 2015. Accessed January 10, 2017; Balto D. Vermont H. 97. http://legislature.vermont.gov/assets/Documents/2016/WorkGroups/Senate%20Health%20and%20Welfare/Committee%20Bill%20Health%20Care/Pharmacy%20Benefit%20Managers%20(PBMs)/W~David%20Balto~PBM%20Presentation~2-26-2015.pdf. Published 2016.

The Transparency Problem• Lack of Transparency = Unfair pricing practices by PBMs

designed to increase profits.

• Without transparency, extremely difficult to determine PBM revenue sources and amounts. ▫ PBMs do not disclose pharmacy and manufacturer contract terms

to health plans, making it much harder for health plans to monitor and address drug pricing and costs.

SOURCE: Lopez L. These companies you've never heard of are about to incite another massive drug price outrage. Business Insider. September 12, 2016. http://www.businessinsider.com/scrutiny-express-scripts-pbms-drug-price-fury-2016-9. Accessed January 10, 2017.

PBM Position on Transparency"We love transparency for our patients. Our patients

should know exactly what they're going to pay when they go to the pharmacy counter. We love transparency for

our clients—they can come in. They can audit their contracts. They know exactly what they're going to be

required to pay. What we don't want is transparency for our competitors.“ – Steve Miller, Chief Medical Officer,

Express Scripts

• Coalition of patient and provider groups that joined forces to address rising prescription drug costs and decreased patient access to affordable treatments by advocating for targeted reforms in the drug market.

• ATAP Mission: Reduce drug costs and ensure patient access to affordable treatment by regulating harmful practices by PBMs and other key players in the delivery system and reforming the prescription drug market through educational outreach and grassroots advocacy initiatives at both the state and federal level.

Solving the Problem:Alliance for Transparent & Affordable Prescriptions (ATAP)

ATAP Member Organizations

Members from ATAP Attending Meeting with MedPAC on PBMs

and the Rebate System.

ØCoalition of State Rheumatology OrganizationsØAmerican College of RheumatologyØGlobal Healthy Living FoundationØRheumatology Nurses Society ØNational Organization of Rheumatology Managers ØFlorida Society of Rheumatology ØAssociation of Women in Rheumatology ØNew York State Rheumatology Society ØCalifornia Rheumatology AllianceØNorth Carolina Rheumatology AssociationØAmerican Psychiatric AssociationØTennessee Rheumatology SocietyØRheumatology Alliance of LouisianaØAmerican Academy of DermatologyØAmerican Association of Clinical Urologists ØUS Pain FoundationØLupus and Allied Diseases AssociationØAmerican Bone HealthØKentuckiana Rheumatology AssociationØOhio Association of RheumatologyØInternational Foundation for Autoimmune & Autoinflammatory Arthritis

ATAP Policy RecommendationsIncreased transparency and appropriate oversight in how manufacturers, PBMs, and insurers determine the price and cost of drugs.

• Mandated disclosure of price concession.• Uniform definition of “rebate”, “fee”, other relevant terms.

Reduced costs to patients.• Calculate patient cost-sharing using net price, not list price.• Prohibit clawbacks and pharmacy “gag clauses.”

Improved patient access to treatment.• Formularies based on effectiveness, safety, and ease of administration, NOT rebates.• Formulary transparency.• Non-medical switching restrictions, step therapy regulation, physician overrides.

Regulation and restriction of unfair and deceptive PBM practices. • State licensure/registration, fiduciary duty requirement. • Regulation and transparency standards for PBM payment methodologies.• Addressing development and implementation of accumulator adjustment programs.

• Work with Congress and the Department of Health and Human Services to establish, with stakeholder input and subject to public comment, agreed upon definitions to bring clarity and transparency to what constitutes a "rebate" versus a "fee" versus any other of the classifications that a PBM may have for money flowing to and from it. Once definitional clarity exists, disclosure will be meaningful.

• Work with Congress and CMS to implement mandatory pass-through policies that would require PBMs to pass back a specified amount of rebates to the health plans to be applied at the point of sale to reduce patients’ out-of-pocket expenses.

• Maintain access to Part B drugs by monitoring and appropriately addressing proposed changes to the current structure to ensure only changes that maximize benefits to patients are enacted.

• Monitor and address vertical consolidation within the prescription drug market, particularly with respect to mergers between PBMs and insurance companies.

Solving the Problem:Federal Advocacy Strategy

SOURCES: S. 637 – Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. Congress.gov. https://www.congress.gov/bill/115th-congress/senate-bill/637?q=%7B%22search%22%3A%5B%22%5C%22pbm%5C%22%22%5D%7D&r=2. Accessed May 30, 2017; H.R.1316 - Prescription Drug Price Transparency Act. Congress.gov. https://www.congress.gov/bill/115th-congress/house-bill/1316?q=%7B%22search%22%3A%5B%22%5C%22pbm%5C%22%22%5D%7D&r=1. Accessed May 30, 2017.

• S. 637: “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017” (Wyden [D-OR])▫ Would require PBMs to publicly disclose information regarding amount

of rebates received from manufacturers and percent that gets passed back to health plans.

▫ Would establish, following 2-year reporting period, a minimum rebate percentage that PBMs would be required to pass onto insurers.

• H.R. 1316: “Prescription Drug Price Transparency Act” (Collins [R-GA-9])▫ Targets transparency in pricing standards for reimbursement and PBM

ownership interest in pharmacies.

Solving the Problem:Federal Legislation

Solving the Problem:Federal Advocacy

• ATAP’s strategy at the state level is two-fold:▫ Identify states that may be interested in ATAP PBM transparency state model bill

and actively work with lawmakers and other stakeholders in those states to implement it.

▫ Track and support PBM-related state bills introduced this session.▫ Work at a state level to educate lawmakers and employers about the prescription

drug market and its impact on drug costs.• Our state policy team has developed a state model bill that focuses on

mandated disclosures and increased state regulation of PBMs.▫ Working in multiple states to get a version of the model introduced.▫ Investigatory: aimed at gaining meaningful information about interworking of

rebate system and PBM contracts.

Solving the Problem:State Advocacy

• Establishes fiduciary duty for PBMs to plan sponsors, must notify a contracting plan sponsor of conflict of interests.

• Requires PBMs to disclose certain information on price concessions to contracting plan sponsor, state.▫ Amount of manufacturer rebates, discounts, or price concessions

received, aggregate amount of fees received from manufacturers. ▫ Amount passed back to contracting health plans versus the amount that

were retained by the PBM. ▫ Amount to pharmacy versus from plans (spread).

Solving the Problem:Summary of ATAP State Model Bill

• Over 20 states have passed PBM bills (gag clause, clawbacks, registration) so far this session.▫ ATAP has actively supported majority of these, sending letters

of support and talking with state legislators about PBMs.

• More PBMs bills currently pending in a few states.▫ Couple of bills still under consideration are related to PBM

rebate transparency; ATAP is working with lawmakers to improve, pass these bills.

Solving the Problem:State Legislation

• PBMs required to register with Department of Consumer Services (DCBS)▫ HB 2388 (passed May 2017): grants DCBS authority to deny, revoke, or suspend

registration for certain conduct (e.g. engaging in dishonesty, fraud or gross negligence; refusing to produce accounts, records or files for examination).

▫ Allows DCBS to create regulations to establish process for pharmacies to file complaint alleging PBM misconduct.

• HB 4005 (enacted March 2018): manufacturer transparency bill▫ Establishes Task Force on the Fair Pricing of Prescription Drugs ▫ “Task force shall develop a strategy to create transparency for drug prices across the

entire supply chain of pharmaceutical products, including but not limited to manufacturers, insurers, pharmacy benefit managers, distributors, wholesalers and retail pharmacies.”

Solving the Problem:Oregon Legislation

Gag clauses

Gag clauses & clawbacks

PBM Registration

Passed 2018 Session

Passed 2018

Currently Pending

Passed 2017

States that Prohibit Gag Clauses

Passed 2018

Currently Pending

Passed 2017

States that Prohibit Copay Clawbacks

Passed 2018

Currently Pending

Passed 2017

States that Prohibit Pharmacy Clawbacks

Solving the Problem:State Legislation

Finally, the End!

Questions??