OIG Posts New Information on Accountable Care Organizations

On March 31st, OIG posted new information on Accountable Care Organizations. Thhe links provided below will take you directly to the new material.

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Federal Agencies Address Legal Issues Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program
http://oig.hhs.gov/fraud/aco.asp

Today, as part of a cross-agency, coordinated effort, several Federal agencies issued documents addressing legal issues regarding Accountable Care Organizations participating in the Medicare Shared Savings Program
(Shared Savings Program).

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would establish accountable care organizations (ACO) under the Shared Savings Program. The CMS proposed rule is available online at
http://www.cms.gov/sharedsavingsprogram

CMS and HHS Office of Inspector General (OIG) jointly issued a notice with comment period outlining proposals for waivers of certain Federal laws-the physician self-referral law, the anti-kickback statute, and certain provisions of the civil monetary penalty law-in connection with the Shared Savings Program. CMS and OIG are also asking for comments on further waiver design considerations for the Shared Savings Program and for the separate waiver authority for the Center for Medicare and Medicaid Innovation under section 1115A of the Social Security Act. The joint notice with comment period is available online at
http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1

The Federal Trade Commission and the Department of Justice jointly issued a "Proposed Statement of Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program" (Antitrust Policy Statement). The Antitrust Policy Statement is available online at:
http://www.ftc.gov/opp/aco/
 
And the Internal Revenue Service (IRS) issued a notice requesting comments regarding the need for guidance on participation by tax-exempt organizations in the Shared Savings Program through ACOs. The IRS notice
is available online at
http://www.irs.gov/newsroom/article/0,,id=222814,00.html

Emerging Health Care Competition and Consumer Issues

Public Workshops and Roundtables: Emerging Health Care Competition and Consumer Issues SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') announces it will hold two workshops and roundtables in the fall of 2008 on emerging health care competition and consumer issues. They will focus on two distinct areas in which competition and consumer protection policies are implicated: (1) competition provided by developing an abbreviated regulatory approval pathway for follow-on biologic drugs; and (2) competition among health care providers based on quality information. The workshops and roundtables will be held at and administered by the FTC and their dates will be announced in a separate public notice. This notice poses a series of questions for which the FTC seeks public comment. The Commission will consider these comments as it prepares for the public workshops and roundtables. In the spring of 2009, the FTC will release a report that analyzes the potential impacts on the marketplace of various policy options in these two areas. DATES: Specific dates for the workshops and roundtables will be announced shortly, along with an agenda. Comments on the questions contained in this Notice must be received on or before September 30, 2008. In addition, any interested person may submit written comments to any of the topics addressed during the workshops. Comments directed at a particular subject considered in a workshop or roundtable must be received no later than 30 days after the date of that workshop or roundtable.

Telemarketing Sales Rule (``TSR''); Final Rule Amendments

SUMMARY: The Commission adopts two final amendments to the TSR. The first is an amendment making explicit a prohibition in the TSR on telemarketing calls that deliver prerecorded messages without a consumer's express written agreement to receive such calls. This amendment also requires that all prerecorded telemarketing calls provide specified opt-out mechanisms so that consumers can opt out of future calls. The amendment is necessary because the reasonable consumer would consider prerecorded telemarketing messages to be coercive or abusive of such consumer's right to privacy. The second amendment modifies the method for measuring the maximum call abandonment rate prescribed by the TSR's call abandonment safe harbor. The new method will permit sellers and telemarketers to calculate call abandonment rates for a live calling campaign over a thirty-day period, or any part thereof. This amendment is necessary because the current ``per day'' standard effectively precludes the use of predictive dialers with small calling lists. DATES: The amendments are effective October 1, 2008.