American College of Cardiology
 
 

Advocacy Weekly

March 27, 2000

Newsletter Archive

Legislative Affairs

Federal News
On March 21, the ACC voiced its concern about the future of anti-smoking efforts for children in light of the U.S. Supreme Court ruling on the Food and Drug Administration's (FDA) Tobacco Rule. The court ruled 5-4 against the FDA's authority to regulate tobacco products or cigarette company marketing practices. The court's ruling essentially halts the already implemented provisions of the FDA's 1996 Tobacco Rule, including the nationwide minimum age and photo identification requirements. In an ACC news release, ACC President George Beller, M.D., was quoted as saying that Congress must now "stand up to the interests of the tobacco lobby and work to keep tobacco products out of the hands of children." A copy of the ACC news release can be found at http://www.acc.org/advocacy/weekly/archives/stc/tobacco2000.html.





Continued markup of the Campbell-Conyers bill, (H.R. 1304, the "Quality Health Care Coalition Act") scheduled for March 22, was postponed. The House Judiciary Committee is scheduled to resume final consideration of H.R. 1304 on March 30. A full report of the committee's action will be included in the April 3 edition of Advocacy Weekly.




The House passed its version of the FY 01 budget resolution early March 24. The resolution sets aside $40 billion for a Medicare prescription drug benefit and calls for the Labor-HHS-Education funding bill to be considered first among the 13 appropriations bills. Agreement in the Senate Budget Committee has not been reached on the budget resolution. If agreement is not reached, Senate Majority Leader Trent Lott, R-Miss., has the authority to bring the resolution directly to the Senate floor for a vote after April 1.




State News

The ACC Chapter in Ohio submitted written testimony recently to its state's House Health, Retirement & Aging Committee. The bill in question, H.B. 570, amends the state's criteria for how cardiovascular technologists are trained and licensed but also expands their scope of practice. The Chapter is supportive of the training and licensing changes but has expressed its concerns that the scope of practice may allow the technologist to substitute for a cardiologist in certain catheterization procedures. The Ohio Chapter has also pointed out that the ambiguity in how the legislative language defines the term "supervision."




Arizona is on the verge of becoming the nation's fifth state to enact insurer liability legislation. H.B. 2600 contains a patient right-to-sue provision that passed through both chambers by overwhelming margins. Although Gov. Jane Hull opposes the liability provision, she said she will allow the bill to pass without her signature. Other key provisions include protecting physicians who advocate for their patients against HMO retaliation and a stipulation that HMO pay for prescriptions that are not on their formulary.




The Virginia House and Senate have passed bills that allow physicians to refuse to sign insurer contracts that contain "all products" clauses. Gov. Gilmore is expected to sign the bill (H.B. 1366).




A controversial bill under debate in Maine that would make it the first state in the nation to control the prices of prescription drugs has passed the Health and Human Services Committee on a straight party-line vote. The bill would create a board to set maximum wholesale and retail prices for prescription drugs linked to the prices paid by the federal government and to prices in Canadian provinces. Opponents say drug companies could decide not to do business in Maine if the state was alone in fixing prices.




Regulatory and Legal Affairs

HCFA plans to publish its controversial Medicare hospital outpatient prospective payment system final rule in the Federal Register by April 10. Hospital outpatient services, one of the fastest growing services under Medicare, are now reimbursed under a cost-based system. The new payment system will lump services into ambulatory payment classifications similar to the DRG system for inpatient services. The ACC continues to have concerns about outpatient PPS and will recommend a delay of the scheduled July 1 implementation date. A copy of the ACC's comments on the proposed rule is available at http://www.acc.org/advocacy/weekly/archives/stc/outpatient.html.





The ACC is concerned about the incompleteness of a list published March 10 by HCFA specifying drugs, biologicals, and medical devices eligible for higher payments under Medicare's new hospital outpatient prospective payment system. Legislation enacted last year required HCFA to reimburse hospitals at a higher rate for orphan drugs, cancer therapy drugs, biologicals and brachytherapy devices, radiopharmaceutical drugs, and new drugs, biologicals, or medical devices. These are temporary payments for a period of two to three years until actual hospital cost information can be gathered. The ACC will submit its recommendations and concerns to HCFA.




The Department of Health and Human Services' (HHS) final organ transplant rule took effect March 22. The final rule recognizes ACC concerns about moving from a regional to a national system of organ allocation by making it clear there is no requirement for a "single national list" for organ allocation and recognizing that "medical factors affecting the viability of the organ must be considered in designing allocation policies." (See October 25, 1999 Advocacy Weekly for more information about the rule.) The United Network for Organ Sharing (UNOS), the administrator of the transplant network under contract to HHS, announced that its Board of Directors approved a liver allocation plan in response to the final rule and will examine all other organ-specific allocation policies as required by the rule. More information about the final rule and UNOS are available on UNOS' Website, http://www.unos.org/.

Some states have responded to HHS' final rule by passing laws giving their residents first chance at donated organs. Wisconsin Gov., Tommy Thompson (R), announced March 14 that his state will sue HHS in an attempt to block implementation of the final rule. Last fall, the U.S. House Commerce Committee approved legislation that would strip HHS of most of its authority and give it to UNOS.





Despite receiving an unqualified or "clean" audit opinion, HCFA needs further improvements to establish adequate financial control and accountability for Medicare finances, according to a General Accounting Office (GAO) report. The report states that HCFA's financial management activities, including evaluation and follow-up on audit findings, contractor monitoring, and financial reporting, "are insufficient to resolve the internal control and financial reporting weaknesses identified through audits and other reviews." GAO's report, released March 15, is available through the GAO Daybook on its Web page, http://www.gao.gov/.




A U.S. Court of Appeals upheld a substantial part of a district court injunction against Food and Drug Administration (FDA) regulations that severely restrict drug and device manufacturers' statements regarding off-label uses. Washington Legal Foundation v. Henney (D.C. Cir. Feb. 11, 2000). The plaintiff in the case, Washington Legal Foundation, is reported to be considering legal action against the FDA based on statements they made regarding the decision in the Federal Register.




Practice Organization and Management

Adding power to the ACC Pennsylvania Chapter's fight, the American Medical Association (AMA) and the Pennsylvania Medical Society (Pa.MS) have formally requested that the U.S. Department of Justice launch an investigation into the market power and anti-competitive practices of two Pennsylvania-based Blue Cross and Blue Shield plans. There is concern that Independence Blue Cross (IBC) and Highmark, Inc. have maintained their dominance by virtue of a "division of markets" agreement, through which they have agreed not to compete in each other's territory.

The insurers dominate the state's two largest markets, with Highmark controlling over 60 percent of the Pittsburgh area market and IBC controlling more than 50 percent of the Philadelphia area market. As a result, the AMA and Pa. MS argue that the plans are: restricting patient choice, unilaterally dictating contract provisions, and continuing to realize substantial profits while raising premiums for patients and employers and reducing payments to those who provide patient care. The ACC Pennsylvania Chapter has been actively seeking relief from the insurer's unreasonable contracting practices.




Advocacy Weekly is a product of the Advocacy Division of the American College of Cardiology. Questions or comments regarding this publication should be directed to the Advocacy Division at 800-435-9203 or to advocacydiv@acc.org.