TITLE:   Use of Program Safeguard Contractors (PSC) Under the Medicare Integrity Program (MIP) to Establish Local Coverage Policy, B-282777, September 2, 1999
BNUMBER:  B-282777
DATE:  September 2, 1999
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Use of Program Safeguard Contractors (PSC) Under the Medicare Integrity
Program (MIP) to Establish Local Coverage Policy, B-282777, September 2,
1999

B-282777

September 2, 1999

The Honorable Pete Stark
Ranking Minority Member
Subcommittee on Health
Committee on Ways and Means
House of Representatives

Subject: Use of Program Safeguard Contractors (PSC) Under the Medicare
Integrity Program (MIP) to Establish Local Coverage Policy

Dear Mr. Stark:

This responds to your May 11, 1999, letter regarding the Health Care
Financing Administration's (HCFA's) plans for operating the Medicare
Integrity Program (MIP). Essentially, you asked if the law authorizing the
MIP permits HCFA to assign responsibility for local Medicare coverage policy
to the payment safeguard contractors (PSCs) who will run MIP under contract
to HCFA. You also asked if HCFA's proposed MIP regulations would provide an
adequate legal basis for HCFA to conduct local coverage policy-making
through the PSCs.

Whether a particular service or product is reimbursable under Medicare is
currently determined through a combination of decision-making by HCFA and
its contractors. HCFA sets broad coverage policy on a national level. Within
the limits established by statute and HCFA guidance, however, local policies
are permitted to vary based on local variations in clinical practice. At
present, the medical directors of the Medicare carriers, which are the
contractors that administer Medicare for HCFA, set local coverage policy.
HCFA has said that it is possible that in the future, the setting of local
coverage policy will be done through a unit within the PSC, although the
carrier medical directors will remain involved.

In our view, while the law establishing the MIP and its legislative history
are silent concerning the responsibility for local coverage policy-making
under Medicare, the law can reasonably be read, as HCFA does, to make this a
legitimate function under MIP. Section 1893 of the Social Security Act makes
"medical review" of provider activity a function of the PSCs, and "medical
review" has been consistently interpreted by HCFA to include determination
of local coverage policy. Similarly, we believe that the proposed MIP
regulations provide an adequate basis for HCFA's action. A more detailed
discussion follows.

The MIP was authorized by section 1893 of the Social Security Act, as added
by the Health Insurance Portability and Accountability Act of 1996, to
prevent and combat Medicare fraud and abuse. [1] Under this law, HCFA is
authorized (as designee of the Secretary of Health and Human Services) to
enter into contracts with eligible private entities, which HCFA calls PSCs,
to carry out specified activities promoting the integrity of the Medicare
program. One of these activities is "medical review." [2]

Although neither HIPAA nor its legislative history expressly mentions local
Medicare coverage policy-making in the context of the MIP, the authority for
PSCs to conduct medical review of provider activity provides a reasonable
basis for HCFA's position that local coverage decisions may be made within
the MIP framework. "Medical review" involves ensuring that medical services
provided to beneficiaries are necessary and appropriate, which in turn
describes setting local coverage policy. As the HCFA Administrator said in
her April 20, 1999, letter responding to your inquiry to her about this
issue, HCFA defines "medical review" as "the processes necessary to ensure
both the appropriate utilization of services and that services meet
professionally recognized standards of care . . . ." HCFA says further that
"[i]ssuing local medical review policies is an integral part of medical
review" that "has always been paid for and developed . . . as part of the
program safeguard budget . . . ."

HCFA's interpretation is reasonable even though we found no evidence in the
law or its history that, in providing for the PSCs to conduct medical
review, Members of Congress expected or were aware that the effect would be
to allow HCFA to give the PSCs a major role in setting local coverage
policy. HCFA's use of the term "medical review" to include local coverage
determinations has been consistent; it was not adopted solely to support its
current interpretation of the MIP authority. For example, HCFA said in
December 1996 (after enactment of HIPAA but before implementation of the MIP
program) that managed care plans must abide by both national coverage
decisions and "specific written policies made by the Medicare carrier or
intermediary with jurisdiction for claims in the geographic area served by
the plan . . . sometimes called ‘local medical review
determinations.'" [3]

By the same token, HCFA's proposed rule is broad enough to permit local
coverage policy-making to be conducted through the PSCs. On March 20, 1998,
HCFA published a proposed rule [4] to implement section 1893 of the Social
Security Act, as added by HIPAA. Under the rule, contracts between HCFA and
the PSCs would set forth generally what functions a PSC is to perform, with
specifics to be spelled out in task orders. As authorized by section 1893,
[5] the proposed rule includes medical and utilization reviews among the
functions that may be included in such a contract. Moreover, the preamble to
the rule indicates that the PSC may perform some or all of the functions
currently performed by fiscal intermediaries or carriers. [6]

If you or your staff have any questions, please contact me at (202) 512-5400
or Craig Winslow, Assistant General Counsel, at (202) 512-8225.

Sincerely yours,

Robert Murphy
General Counsel

Notes

1. Pub. L. No. 104-191, sect. 202, 110 Stat. 1936, 1996-98 (classified as 42
U.S.C. sect. 1395ddd).

2. Specifically, MIP contractors are authorized to conduct "[r]eview of
activities of providers of services or other individuals and entities
furnishing items and services [under Medicare] including medical and
utilization review and fraud
review . . . ." Section 1893(b)(1).

3. HCFA Operational Policy Letter No. 46, December 19, 1996. In the same
vein, this document goes on to use the term "medical review policies" as a
synonym for "local coverage policies": "the plan must apply the medical
review policies of the contractor in the area where the beneficiary lives."

4. 63 Fed. Reg. 13,590.

5. See supra, note 2.

6. We understand that thirteen eligible entities were recently selected to
serve as PSCs and six task orders were issued at that time. None of these
task orders provides for PSCs to engage in local coverage policy-making, and
HCFA officials said that they have no plans at this time to issue such task
orders.