H.R. 4 update

H.R. 4 update

The Associated Press published this informative update on Senate leadership efforts to enact a bill similar to H.R. 4 permitting the Secretary of Health and Human Services to negotiate Medicare Part D drug prices. According to this article, the Senate minority leadership is contemplating a filibuster.

Extension of HIPAA in the Offing?

Government HIT magazine reports that the AHIC privacy work group may recommend extending the HIPAA privacy rule to the new health information exchanges such as RHIOs, the NHIN, and Dossia. The workgroup is considering how to do so. The model is already exists.

When Congress enacted HIPAA in 1996, RHIOs etc. did not exist, but health care claims clearinghouses did. Clearinghouses are the hubs through which electronic claims transactions are routed from providers to payers. (Since 1996, other more direct options have been created.) HHS decided in the HIPAA Privacy Rule (45 C.F.R. § 164.500(b)) that clearinghouses may either configure themselves principally as covered entities or as business associates. It strikes me that the same successful approach should be applied to these new health information clearinghouse.

Of course, Congress would have to amend HIPAA to adopt this approach. but Senator Akaka indicated at the February 1, 2007, personal health record privacy hearing that he is open to that idea.

Senate Finance Committee Approves Medicare drug “negotiation” bill

Last night, by an 13-8 margin, the Senate Finance Committee approved the Chairman’s mark to S. 3 which would strike a provision from the Medicare Part D law that prohibits the Government from interfering in price negotiations between Medicare Part D plans and drug manufacturers and wholesalers. The Senate is scheduled to consider the bill next week. The House already has approved a similar bill, H.R. 4. The Administration has stated that the President will veto the bill if enacted by Congress.

Interesting Initiative

CAQH has created a 100 member coalition called the Committee on Operating Rules for Information Exchange that has developed a standard operating rules to be used with the HIPAA 270 and 271 transactions in order to provide providers with useful eligibility and benefits information electronically. These operating rules have now been established, and this week the VA announced that it will participate in the program. If you are a health plan or a health care provider, this initiative appears to be worth your investigation assuming that you are not already involved.

Interesting HSA Development

The consumer driven plans in the FEHB Program seed their enrollees’ health savings accounts with contributions from the plan. Enrollees could make additional contributions up to the annual limit with after tax dollars and then claim a deduction on their tax returns.

Last Friday, OPM released a benefits administration letter announcing it is implementing payroll technology that will allow these enrollees to make pre-tax contributions to their health savings accounts via the Federal Flexible Benefits Plan. This new technology is being implemented across the government throughout this year.

Reducing Waste in the System

At the OPM FEHBP Carrier Conference last month, Medco CEO David Snow explained the of reducing waste in the health care system will provide the funding for new technologies, such as human genome research applications. (Remember that April 25 is National DNA Day!) Mr. Snow pointed out how new genetic based testing will pinpoint the proper dosage of medication. Three physician researchers at the VA Outcomes Group and faculty members at Dartmouth Medical School wrote an interesting article in the Washington Post health section today headlined “Finding More Cancer isn’t the Answer.” Much public emphasis is placed on finding cancer early, but the authors point out that in some cases finding cancer early does save lives but in other cases it is irrelevant because either the cancer is very aggressive or it’s not particularly dangerous. The trick is to identify and use the testing that will save lives. I trust that this is where the various quality initiatives that are part of the Government’s quality transparency initiative will play an important role.

Biogeneric compromise in the works

The New York Times reports today that the leaders of Congress are crafting a compromise bill that will open the pathway for generic versions of biological drugs. Biological drugs, the fastest growing and most expensive segment of the pharmacetical market, were not even on the radar screen when Congress passed the Hatch-Waxman Act in 1984. That Act gave birth to the thriving generic drug industry.

Generic drugs are chemically identical to their branded counterparts, and no additional human testing is required to market them. The only prerequisite is patent expiration for the branded drug. The biotechnology industry claims that the complexities of biological drugs necessitates human testing of generic versions. The Times reports that

“Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original.”

Dr. Woodcock gave this testimony at a hearing held on March 26, 2006 before the House Oversight and Government Reform Committee. Stay tuned.

AARP Bangs the Drum for H.R. 4

AARP turned up the heat on the Senate this week to pass its own bill akin to H.R. 4 that would permit the Government to “negotiate” Medicare Part D drug prices. UPI reports that a Senate bill should be introduced soon after the Senate reconvenes on April 10.

Medicare Pay for Performance Program

On Tuesday, CMS released information on its Physician Quality Reporting Initiative (PQRI). PQRI offers Medicare participating physicians a 1.5% bonus on the Medicare fee schedule for participating in the quality improvement study beginning July 1, 2007. There are 74 PQRI measures. Many of the measures relate to elderly patients, the principal Medicare population, but several of them apply to younger patients and even children. PQRI is required by the Tax Relief and Health Care Act of 2006.

HIT News.com reports that “At a webinar last December, Thomas B. Valuck, MD, a CMS medical officer and senior advisor said CMS is searching for the “sweet spot” that might entice more doctors to participate in P4P. ‘CMS is currently analyzing what the ultimate amount would be to engage the majority of physicians in voluntary participation,” Valuck said. ‘The 1.5 percent incentive is just a start. It could take as much as 20 percent to motivate physicians.’”