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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

CFR Citation: 42 CFR Part 411

RIN ID: RIN 0938-AM21

CMS ID: [CMS-1809-F4]

NOTICE: RULES

ACTION: Medicare and medicaid:

DOCUMENT ACTION: Final rule; extension of partial delay in effective date.

SUBJECT CATEGORY: Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date

DATES: Effective date: The effective date of the last sentence in Sec. 411.354(d)(1) of the final rule published in the Federal Register on January 4, 2001 (66 FR 856), is delayed to July 7, 2004.

DOCUMENT SUMMARY: This final rule further delays for 6 months, until July 7, 2004, the effective date of the last sentence of 42 CFR 411.354(d)(1). This section was promulgated in the final rule entitled ``Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships,'' published in the Federal Register on January 4, 2001. A 1year delay of the effective date of the last sentence in this section was published in the Federal Register on December 3, 2001. A 6month delay, until July 7, 2003, was published in the Federal Register on November 22, 2002. An additional 6month delay, until January 7, 2004, was published on April 25, 2003. This further extension of the delay in the effective date of that sentence will give us additional time to reconsider the definition of compensation that is ``set in advance'' as it relates to percentage compensation methodologies in order to avoid unnecessarily disrupting existing contractual arrangements for physician services. Accordingly, the last sentence of Sec. 411.354(d)(1), which would have become effective January 7, 2004, will not become effective until July 7, 2004. We expect that the definition of ``set in advance'' will be addressed definitively before July 7, 2004 in a final rule with comment period, entitled ``Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships'' (Phase II).

SUMMARY: Physicians referrals to health care entities with which they have financial relationships; effective date partial delay extended,

SUPPLEMENTAL INFORMATION

This Federal Register document is available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. The Web site address is: http://www.access.gpo.gov/nara/index.html .

In addition, the information in this final rule will be available soon after publication in the Federal Register on our MEDLEARN Web site: http://cms.hhs.gov/medlearn/refphys.asp. I. Background

The final rule, entitled ``Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships,'' published in the Federal Register on January 4, 2001 (66 FR 856), interpreted certain provisions of section 1877 of the Social Security Act (the Act). Under section 1877, if a physician or a member of a physician's immediate family has a financial relationship with a health care entity, the physician may not make referrals to that entity for the furnishing of designated health services (DHS) under the Medicare program, and the entity may not bill for the services, unless an exception applies. Many of the statutory and new regulatory exceptions that apply to compensation relationships require that the amount of compensation be ``set in advance.'' Section 411.354(d)(1) of the final rule defines the term ``set in advance.''

The last sentence of Sec. 411.354(d)(1) reads: ``Percentage compensation arrangements do not constitute compensation that is `set in advance' in which the percentage compensation is based on fluctuating or indeterminate measures or in which the arrangement results in the seller receiving different payment amounts for the same service from the same purchaser.'' Many of the comments we received regarding the January 4, 2001 physician selfreferral final rule indicated that physicians are commonly paid for their professional services using a formula that takes into account a percentage of a fluctuating or indeterminate measure (for example, revenues billed or collected for physician services). According to the
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commenters, this compensation methodology is frequently used by hospitals, physician group practices, academic medical centers, and medical foundations. Several commenters pointed out that this aspect of the final rule, which is applicable to academic medical centers and medical foundations (among others), is inconsistent with the compensation methods permitted under the statute for many physician group practices and employed physicians (that is, neither section 1877(h)(4)(B)(i) of the Act nor section 1877(e)(2) of the Act contains the ``set in advance'' requirement). We understand that hospitals, academic medical centers, medical foundations and other health care entities would have to restructure or renegotiate thousands of physician contracts to comply with the language in Sec. 411.354(d)(1) regarding percentage compensation arrangements.

Accordingly, we published a 1year delay of the effective date of the last sentence in Sec. 411.354(d)(1) in the Federal Register on December 3, 2001 (66 FR 60154), an additional 6month delay in the effective date on November 22, 2002 (67 FR 70322), and a further 6 month delay on April 25, 2003 (68 FR 20347) in order to reconsider the definition of compensation that is ``set in advance'' as it relates to percentage compensation methodologies.

II. Provisions of this Final Rule

To avoid any unnecessary disruption to existing contractual arrangements while we consider modifying this provision, we are further postponing, for an additional 6 months, until July 7, 2004, the effective date of the last sentence of Sec. 411.354(d)(1). This delay is intended to avoid disruptions in the health care industry, and potential attendant problems for Medicare beneficiaries, which could be caused by allowing the last sentence of Sec. 411.354(d)(1) to become effective on January 7, 2004. In the meantime, compensation that is required to be ``set in advance'' for purposes of compliance with section 1877 of the Act may continue to be based on percentage compensation methodologies, including those in which the compensation is based on a percentage of a fluctuating or indeterminate measure. We note that the remaining provisions of Sec. 411.354(d)(1) will still apply and that all other requirements for exceptions must be satisfied (including, for example, the fair market value and ``volume and value'' requirements.)

III. Waiver of Proposed Rulemaking

We ordinarily publish a notice of proposed rulemaking and invite public comment on the proposed rule. This procedure can be waived, however, if an agency finds good cause that the notice and comment rulemaking procedure is impracticable, unnecessary, or contrary to the public interest and if the agency incorporates in the rule a statement of such a finding and the reasons supporting that finding.

Our implementation of this action without opportunity for public comment is based on the good cause exception in 5 U.S.C. 553(b). We find that seeking public comment on this action would be impracticable and unnecessary. We believe public comment is unnecessary because we are implementing this additional delay of effective date as a result of our review of the public comments that we received on the January 4, 2001 physician selfreferral final rule. As discussed above, we understand from those comments and the comments we received on the December 3, 2001 interim final rule that, unless we further delay the effective date of the last sentence of Sec. 411.354(d)(1), hospitals, academic medical centers, and other entities will have to renegotiate numerous contracts for physician services, potentially causing significant disruption within the health care industry. We are concerned that the disruption could unnecessarily inconvenience Medicare beneficiaries or interfere with their medical care and treatment. We do not believe that it is necessary to offer yet another opportunity for public comment on the same issue in the limited context of whether to delay this sentence of the regulation. In addition, given the imminence of the January 7, 2004 effective date, we find that seeking public comment on this delay in effective date would be impracticable because it would generate uncertainty regarding an imminent effective date. This uncertainty could cause health care providers to renegotiate thousands of contracts with physicians in an effort to comply with the regulation by January 7, 2004 if the proposed delay is not finalized until after the opportunity for public comment. Thus, providing the opportunity for public comment could result in the very disruption that this delay of effective date is intended to avoid. (Catalog of Federal Domestic Assistance Program No. 93.773 MedicareHospital Insurance Program; Program No. 93.774, Medicare Supplementary Medical Insurance Program; and Program No. 93.778, Medical Assistance Program)

Dated: September 29, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.

Approved: October 27, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 0331469 Filed 122303; 8:45 am]
BILLING CODE 412001P

FOR FURTHER INFORMATION CONTACT Karen Raschke, (410) 786-0016.