Healthcare Law Briefs

Meeting the Challenge of Health Law

	What's Inside
	U.S. Supreme Court Upholds "Any Willing Provider" Statute
	Updated CMS Quarterly Provider Update
	HHS Publishes Draft Guidance on Medical Research

Healthcare Law Briefs

*READ PAST ISSUES OF THE HEALTHCARE LAW BRIEFS

1. U.S. Supreme Court Upholds "Any Willing Provider" Statute

The Supreme Court affirmed the Sixth Circuit's ruling, which rejected the Kentucky Association of Health Plans' argument that Kentucky's "Any willing provider" statute was preempted by ERISA. The opinion, written by Justice Scalia, attempts to establish clearer standards for when an insurance-related statute is saved from being preempted by ERISA. Kentucky Association of Health Plans v. Miller, 2003 U.S. Lexis 2710, April 2, 2003.

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2. Updated CMS Quarterly Provider Update

From the March 28, 2003 -- Updated CMS Quarterly Provider Update (QPU)

The CMS Quarterly Provider Update (QPU) was updated on Friday, March 28, 2003, to include the following recently published regulations and instructions. To view the entire text of these documents, or for more information, visit the QPU at http://cms.hhs.gov/providerupdate/whatsnew.asp

REGULATIONS PUBLISHED

CMS-1230-N, entitled "Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003," was published. This regulation is a Meeting Notice.

CMS-1474-N, entitled "Medicare Program; Town Hall Meeting on the Inpatient Rehabilitation Facility Prospective Payment System," was published. This regulation is a Meeting Notice.

CMS-1885-FC, entitled "Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003," was published. This regulation affects Ambulatory Surgical Centers.

CMS-6012-N5, entitled "Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics; Meeting Announcement," was published. This regulation is a Meeting Notice.

CMS-9016-N, entitled "Quarterly Listing of Program Issuances-October 2002 Through December 2002," was published. This regulation affects All Providers.

INSTRUCTIONS RELEASED -- MID-QUARTER

Transmittal AB-03-037, entitled "Provider Education Article: Medicare Payments for Part B Mental Health Services," was released. This instruction affects Physicians and Non-Physician Practitioners.

Transmittal AB-03-040, entitled "Provider Education Article: "Hospice Care Enhances Dignity and Peace As Life Nears Its End"," was released. This instruction affects Hospitals, Physicians, and Skilled Nursing Facilities.

INSTRUCTIONS RELEASED -- CLARIFICATION AND/OR CORRECTION

Transmittal 1878 of the Intermediary Manual: Part 3 - Claims Process, entitled "Section 3615.7, Intestinal and Multi-Visceral Transplants," was released. This instruction affects Hospitals.

Transmittal AB-03-038, entitled "Reporting Benefit Integrity (BI) Workload in CROWD," was released. This instruction affects All Providers.

Transmittal AB-03-039, entitled "Procedure for Granting Extensions to File Requests for Appeal Under the New 120-day Timeframe Created by �521 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000," was released. This instruction affects Ambulances, Clinical Diagnostic Laboratories, Durable Medical Equipment, Prosthetics, Orthotics and Supplies, Independent Diagnostic Testing Facilities, Non-Physician Practitioners, Outpatient Physical Therapy, and Physicians.

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3. HHS Publishes Draft Guidance on Medical Research

The Office of Public Health and Science of the U.S. Department of Health and Human Services (HHS) published proposed guidance regarding research involving human research projects.

A significant purpose of the draft guidance, which is "nonbinding and does not change any existing regulations or requirements", is to provide guidance regarding financial conflicts of interest.

The guidance also proposes the following other actions:

Establish criteria to decide what constitutes an institutional conflict of interest, "including identifying leadership positions for which the individual's financial interests are such that they may need to be treated as institutional financial interests";
Establish clear channels of communication between conflict of interest committees and IRBs;
Set policies for providing information, recommendations, or findings from conflict of interest committee deliberations to IRBs;
Implement procedures for disclosing institutional financial relationships to conflict of interest committees;
Use independent organizations to hold or administer the institution's financial interest; and
Establish policies regarding the types of relationships that may be held by parties involved in the research and circumstances under which those financial relationships and interests may be held.