WASHINGTON WIRE

September 24, 2004
Issue 31

In this issue, you'll find:

Pfizer VP Breaks with Company Policy to Champion Drug Reimportation
Low-Income Beneficiaries to be Mailed Medicare Drug Cards
NIH to Stop Potential Conflicts of Interest
CMS to Make NCD Documents Public
Hearings
Words

Top Story

Pfizer VP Breaks with Company Policy to Champion Drug Reimportation

On Thursday, September 23, 2004, during a Capitol Hill press conference, Dr. Peter Rost, a vice president of marketing for Pfizer, stated his strong support for drug reimportation legislation.

The press conference was part of an eleventh-hour effort by Senate supporters to bring drug reimportation legislation to the floor before the 108th Congress adjourns. Such legislation was passed by the House in 2003, and Senator Byron Dorgan (D-ND), a sponsor of the bipartisan reimportation bill, is still optimistic his bill will be considered, despite statements otherwise by Senate Majority Leader William Frist (R-TN). (Frist Statement Dooms Vote on Drug Reimportation- Weekly Washington Wire 9/10/04.)

Dr. Peter Rost was joined on Thursday by the eight sponsors of the House reimportation bill, as well as Senators Dorgan and Olympia Snowe (R-ME). Dr. Rost, attending the event using vacation time from Pfizer, stated that "holding up the vote on reimportation has a high cost not just in dollars, but in American lives." He went on to state that European countries have participated in drug reimportation for years and have encountered no safety problems.

Earlier this week, sponsors of the Senate bill, including Senators Byron Dorgan, Olympia Snowe, Edward Kennedy (D-MA), John McCain (R-AZ), Lincoln Chafee (R-RI) and Senate Minority Leader Tom Daschle (D-SD), sent a letter to Majority Leader Frist urging him to permit a vote on their legislation. They also expressed disappointment over a recent remark by Frist in which he stated that prospects for such a vote are "doubtful" this year. Some feel that Frist is backing down from a commitment made in March to hold a floor vote on a reimportation bill by the end of the Congressional session.

Health Care News and Publications

Low-Income Beneficiaries to be Mailed Medicare Drug Cards

On Wednesday, September 22, 2004, the Department of Health and Human Services (HHS) announced that next month nearly two million low-income Medicare beneficiaries will receive a drug discount card in the mail, as well as information on eligibility for a $600 per year subsidy.

Sponsors of 19 drug discount cards are taking part in this initiative and will begin sending out the enrollment packages in mid-October to Medicare beneficiaries in the Medicare Savings Program (which provides assistance for low-income beneficiaries below 200% of the FPL) who have not yet enrolled in the discount card program. It is assumed by CMS that MSP beneficiaries qualify for the $600 subsidy. These individuals can begin using the cards on November 1, 2004.

In recent months, advocates have urged the Centers for Medicare and Medicaid Services (CMS) to implement an automatic enrollment process for low-income beneficiaries, despite a statutory provision prohibiting auto-enrollment into the card program. Beneficiaries will still have to contact the card sponsor or CMS to activate their cards. To date, only 4.4 million people have signed up for the drug card program, despite the Administration's prediction of 7.3 million enrollees by the end of the year.

In a statement released by the AARP on Wednesday, the group applauded CMS's efforts to facilitate enrollment in the Medicare drug card program and stated the next logical step would be to also auto-enroll people in the MSP into Medicare drug plans next year.

NIH to Stop Potential Conflicts of Interest

On Friday, September 24, 2004, National Institutes of Health (NIH) Director, Dr. Elias Zerhouni, is expected to announce a new policy, effective immediately, prohibiting NIH employees from collaborating with pharmaceutical and biotechnology companies.

Journalists and government investigators have discovered multiple, non-disclosed arrangements between NIH researchers, scientists, and doctors and pharmaceutical and biotech companies. A policy released late Thursday evening announced a one-year moratorium ceasing all such relationships immediately. In addition, a new oversight system will be developed to prevent future conflicts of interest and ethics violations. It is suspected that more than 100 scientists, unknown to agency administrators, were involved in undisclosed or unapproved relationships with biotech and pharmaceutical companies.

The House Energy and Commerce Oversight and Investigations Subcommittee has been investigating the allegations since December 2003. The investigations revealed that one employee was paid over $500,000 over a course of five years, while another employee was paid $600 an hour to be an expert witness without prior agency approval.

CMS to Make NCD Documents Public

In the September 24, 2004 Federal Register, CMS published a notice stating their intent to make public "guidance documents" used in national coverage determinations (NCDs).

Under the Medicare Modernization Act of 2003 (MMA), the Secretary of Health and Human Services is required to make available to the public factors that are considered in making National Coverage Determinations or whether items or services are reasonable and necessary. The term "guidance document" refers to documents prepared by CMS staff, potential requestors of NCDs, and other documents related to coverage determinations.

CMS plans to provide notice of the new guidance documents as well as make them available on their website. The public will have the opportunity to comments on all guidance documents. Such documents will usually not be considered in effect until the agency has reviewed all public comments.

Upcoming Events

Hearings

Tuesday, September 28, 2004

Special Committee on Aging
10:00AM
628 Dirksen Senate Office Building
"Combating The Flu: Keeping Seniors Alive"

Wednesday, September 29, 2004

Committee on Commerce, Science, and Transportation--> Subcommittee on Science, Technology, and Space
2:00PM
253 Russell Senate Office Building
"Embryonic Stem Cell Research: Exploring the Controversy"

Thursday, September 30, 2004

Committee on Ways and Means - Subcommittee on Social Security
1:00PM
1100 Longworth House Office Building
"Commissioner of Social Security's Proposal to Improve the Disability Process"
(Joint hearing with the Subcommittee on Human Resources)

Words of the Week

Words

"Regretfully, they spelled my name wrong, so I didn't go any further to explore their claims of inaccuracy."

Sen. Byron Dorgan (D-ND) recounting a letter from the pharmaceutical company Pfizer that was addressed to "Senator Bryon Dorgan."[sic] The letter attempted to demonstrate inaccuracy of statements made by Dr. Peter Rost, the Pfizer VP who spoke out this week in favor of drug reimportation legislation, which Dorgan supports.

For More Information

For further information on any topics discussed or publications listed, or to get copies of anything mentioned in this alert, please call (202) 466-6550 and ask for the Legislative Practice Group.

Powers Pyles Sutter & Verville P.C. is a full service law firm specializing in health care and education law and located at 1875 Eye St., NW 12^th Floor, Washington DC 20006