AHLA

Institute on Medicare and Medicaid Payment Issues ● March 26-28, 2014  

    

GG. Physician Orders Timothy P. Blanchard Blanchard Manning LLP Orcas, WA

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© 2014 Blanchard Manning LLP.

Medicare and Medicaid Institute

American Health Lawyers Association

March 26-28, 2014

Timothy P. Blanchard, MHA, JD

Physician Orders

Plan for Discussion

What are physician’s orders and why they matter?

“Verbal orders”

Authentication of orders

“Standing orders”

Orders for diagnostic services

Hospital inpatient admission orders

Note some services with special rules

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What Are Physicians Orders?

No general statutory or regulatory definition

Communication from a physician directing that a service be provided

– in writing, by telephone, by electronic mail

– electronic medical record entries

– physician order entry (POE)

– may be relayed by the physician’s staff

– a prescription for medicine or device

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Why Do Physician Orders Matter?

Three functions for Medicare purposes

– Communicating directives regarding the medical care of the patient

– Demonstrating “under the care of a physician” and active involvement of physician in the care of the patient

– Evidence of medical necessity

Conditions of Participation and/or Payment

Medical practice rules, scope of practice

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When Are Orders Effective?

As a “communication”

– Is it the “message” or its successful transmission?

When it is received

– When it is entered in the medical record

– When the fax, e-mail, courier message or telephone call is received?

– When given orally– i.e., “verbal orders”

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“Verbal Orders” – Erroneous Term of Art

Meaning spoken or oral orders

“Hospitals are expected to develop appropriate policies and procedures that govern … minimize their use,” including:

– Read-back verification practice

– “Promptly documented in the patient’s medical record by the individual receiving the order” -- legal qualification to accept

Not always allowed, e.g., IDTFs, seclusion, restraints …

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COP Instructions (Hospitals)

“Verbal orders, if used, must be used infrequently. This means that the use of verbal orders must not be a common practice. Verbal orders pose an increased risk of miscommunication that could contribute to a medication or other error, resulting in a patient adverse event. Verbal orders should be used only to meet the care needs of the patient when it is impossible or impractical for the ordering practitioner to write the order or enter it into an electronic prescribing system without delaying treatment. Verbal orders are not to be used for the convenience of the ordering practitioner.” (Emphasis added.)

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Authentication of Physician’s Orders

(Medical Records) COP for Hospitals

– “All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.”

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Authentication: Condition of Payment

“For medical review purposes, Medicare requires that services provided/ordered be authenticated by the author. . . . Stamped signatures are not acceptable.” Program Integrity Manual § 3.3.2.4

If specific signature is required– “If the signature is missing from an order, MACs and

CERT shall disregard the order during the review of the claim (e.g., the reviewer will proceed as if the order was not received).”

If no specific signature is required– Unsubstantiated medical necessity

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Authentication of Orders

Authentication within 48 hours (unless state law/hospital policy provided otherwise) no longer required by Medicare, BUT

– Prompt authentication of medical record entries important to establish accuracy.

– Allows necessary corrections to be made based on fresh recollection.

Special rules may require earlier times (e.g., prior to discharge or prior delivery).

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Standing Orders

What, when, why, how, when not?

CMS recognizes that “there is no standard definition for standing orders”

– “the lack of a standard definition for these terms and their interchangeable and indistinct use by hospitals and health care professionals may result in confusion regarding what is or is not subject to [Medicare COPs].” (SOM at A-0457)

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Medicare COP Regulations: § 482.24(c)(3)

Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if:

– (i) … such orders and protocols have been reviewed and approved by the medical staff and the hospital's nursing and pharmacy leadership;

– (ii) … such orders and protocols are consistent with nationally recognized and evidence-based guidelines;

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§ 482.24(c)(3) (continued)

– (iii) … periodic and regular review … is conducted by the medical staff and … nursing and pharmacy leadership to determine the continuing usefulness and safety …; and

– (iv) … such orders and protocols are dated, timed, and authenticated promptly in the patient's medical record by the ordering practitioner or by another practitioner responsible for the care of the patient …

Not all pre-printed and electronic order sets are a type of “standing order” covered by the regulation

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Types of “Standing Orders”

Individual Physician’s Established Patient, PRN Orders

Hospital-Wide PRN/Emergency Orders

Individual Physician’s Established Patient, Treatment Protocol Orders

Individual Physician’s Standard Procedure/Admission Orders

Hospital Triage Patient Orders

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Individual Physician's Est. Patient PRN

Entered by an individual physician

For a specific established patient

Directing a specific intervention in the event specified circumstances arise

Nursing is not called to exercise discretion outside scope of practice or to exercise medical judgment

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Hospital-Wide PRN/Emergency

Hospital policy permits treatment to be initiated, by a nurse, for example, without a prior specific order from the treating physician

– Typically initiated when a patient’s condition meets certain pre-defined clinical criteria.

– Part of an emergency response or an evidence-based treatment regimen.

– “Where it is not practical for a nurse to obtain either a written, authenticated order or a verbal order prior to the provision of care.”

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Established Patient Treatment Protocols

Specific treatment regimen for a specific patient with specified dosage adjustments based on a protocol or algorithm.

Nursing adjusts dosage administered based on laboratory test results and protocol without additional discrete orders.

Nurses are implementing, not changing, physician's orders.

Beware of medical necessity concerns.17

OIG Concerns Regarding Standing Orders

“Although standing orders are not prohibited in connection with an extended course of treatment, too often they have led to abusive practices. Standing orders in and of themselves are not usually acceptable documentation that tests are reasonable and necessary... As a result of the potential problems standing orders may cause, the use of standing orders is discouraged.”

63 Fed. Reg. 45076, 45081 (Aug. 24, 1998).

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Coverage Policy Concerns

Example: physician-ordered insulin treatment protocol for frail diabetics in SNFs

Glucose testing claims denied – physicians allegedly “not using the results”

ALJs, however, thoughtfully disagreed– e.g., Extendicare Health Services, Inc. (Aug. 12, 2004)

CMS specific rule on SNF glucose testing – See 42 CFR § 424.24(f); Claims Proc. Manual, Ch. 7, §

90.1; NCD Manual § 190.20 (2005)

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Indiv. Physician’s Std. Proc./Admission

Standard set of orders entered by a physician for every patient scheduled to receive a particular procedure/treatment or to be admitted for a particular condition.

Standardized--not “standing”--because they are ordered specifically for each patient.

Not subject to the “standing orders” conditions, unless they include elements of standing orders triggering applicability.

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Hospital Triage Patient Orders

Hospital policies authorizing specified testing/treatment w/o a specific order.

Appropriate for well-defined clinical scenarios such as “protocols for triaging and initiating required screening examinations and stabilizing treatment for emergency department patients presenting with symptoms suggestive of acute asthma, myocardial infarction, stroke, etc.”

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COP Conditions for Standing Orders

Review and Approval of Standing Orders

Consistent with Nationally Recognized Evidence-Based Guidelines

Specific Clinical Criteria – “Under no circumstances may a hospital use standing

orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.”

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COP Conditions for Standing Orders

Policies/Procedures for Standing Orders

– Initiation of Services under Standing Orders

• Not really “orders,” but linguistic confusion likely.

– Authentication Subsequent to Initiation

• “Responsible practitioner must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation.”

– Acknowledgment of Initiation of Services

• “Acknowledg[e] and authenticat[e] the initiation of each standing order after the fact.” (?)

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COP Conditions for Standing Orders

Entry in the Medical Record– “The medical record is expected to include the

standing order that was used for the patient, in order to fully and accurately document the care provided.”

Periodic Monitoring– Latest standard of practice. Preventable adverse events.

– Has standing order has been “initiated and executed in a manner consistent with the order’s protocol, and if not, whether the protocol needs revision and/or staff need more training in the correct procedures.”

Training and Instruction of Personnel24

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Authentication Standardized Order Sets

Standardized order sets include, but are not limited to, “standing orders”

Ordering practitioners must:

– Sign, date, and time the last page of the orders, last page must identify the total number of pages in the order set, AND

– Sign or initial any internal pages where selections or changes have been made

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Orders for Diagnostic Services

“All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.”

42 C.F.R. § 410.32(a).

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Conditional or “Reflex Testing” Orders

An order may conditionally request an additional diagnostic test if the result of the initial test yields to a certain value determined by the treating physician – BPM, Ch. 15, § 80.6.1

OIG Compliance Guidance for Clinical Labs advises that:

– “the condition under which the reflex test will be performed should be clearly indicated on the requisition form.”

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Laboratory Requisitions vs. Orders

An order is “a communication from the treating physician/practitioner requesting that a diagnostic test be performed.”

According to CMS, a “requisition” is:

– “the actual paperwork, such as a form, which is provided to a clinical diagnostic laboratory that identifies the test or tests to be performed for a patient. … We believe it is ministerial in nature, … and serves as an administrative convenience to providers and patients.”

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Confusing Flip-Flop on Signature Rule

2010 policy change required signatures on lab requisitions.

2011 longstanding policy restored:

– Medicare does not require the signature of the ordering physician on a laboratory service requisition. While the signature of a physician on a requisition is one way of documenting that the treating physician ordered the service, it is not the only permissible way of documenting that the service has been ordered.

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Further Lab Order Confusion

Rationale for the 2010 policy change was: “eliminating uncertainty over whether the documentation is a requisition or an order”

But BPM, Ch. 15, § 80.6.1 says:

“No signature is required on orders for clinical diagnostic tests …, or for physician pathology”

Recommendation: Document orders (i.e., the communication) in properly authenticated medical record entries.

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Telephone Orders for Diagnostics (!)

“If the order is communicated via telephone, both the treating physician … or his/her office, and the testing facility must document the telephone call in their respective … medical records.”

– BPM Ch. 15, § 80.6.1.

See Nephropathology Associates PLC v. Sebelius, 2013 U.S. Dist. Lexis 90449 (E.D. Ark., June 27, 2013) (upholding denials)

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Changing/Clarifying Diagnostic Orders

Only when the interpreting physician documents the change in the report andone of the following conditions is satisfied:

– Test Design – Unless specified in the order

– Clear Error – Apparent to reasonable layperson

– Patient Condition – Canceling an order because the beneficiary’s physical condition will not permit performance of the test

Special pathology services exception 32

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Additional Testing Based on Results IF

Can’t contact ordering physician for orders

Need is based on abnormal results

– Both factors must be documented as must be why the additional testing was medically necessary.

Additional testing results communicated to the treating physician and used in treating the patient.

An IDTF may not add any procedures based on internal protocols.

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Hospital Inpatient Admitting Orders

Physician orders are now a Condition of Payment for Inpatient hospital services.

– 42 C.F.R. § 412.3

Physician Certification includes admitting orders and timing requirements requiring coordination with discharge orders

– 42 C.F.R. § 424.13(b) (must be authenticated prior to discharge)

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§ 412.3 Admitting Order Conditions

(a) “This physician order must be present in the medical record and be supported by the physician admission and progress notes, in order for the hospital to be paid for hospital inpatient services under Medicare Part A.”

(b) “The order must be furnished by a qualified and licensed practitioner who has admitting privileges at the hospital as permitted by State law, and who is knowledgeable about the patient’s hospital course, medical plan of care, and current condition.”

§ 412.3 Physician Order Conditions

(c) Physician order also constitutes a required component of physician certification of the medical necessity of hospital inpatient services under subpart B of Part 424

(d) “Physician order must be furnished at or before the time of the inpatient admission.”

(e) [2-midnights standards]

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Orders for DMEPOS: PIM, § 5.2. et seq.

Suppliers must have treating physician orders before dispensing a DMEPOS item.

May dispense some items on verbal order or prelim. written order w/ description of item, patient's name, physician's name, start date.

Detailed written order required before billing.

Other items require:

– Detailed written order before delivery

– Face-to-face encounter prior to completing order

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Some Services with Additional Rules

Home Health

Hospice

Skilled Nursing Facility

Physical Therapy, Occupational Therapy, Speech Pathology

Psychopharmacological drug administration

Seclusion and Restraint

Inpatient Psychiatric and Rehabilitation

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Final Things To Remember/Consider

Authentication policies for medical review

Payment/coverage policies vs. COPs vs. medical practice, malpractice, ethics

Establishing that ordered diagnostics are used in the treatment of the patient

Testing/approving proposed standing orders (treatment protocols)

Standardizing discharge order process

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Questions

Timothy P. BlanchardBlanchard Manning LLP

360.376.3260

tim@blanchardmanning.com

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