COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS
HEALTH CARE COMMITTEE MEETING MINUTES
Tuesday, December 9, 2003:
Sidley Austin Brown and Woods, 1501 K Street, NW, Washington, DC 20006
CALL TO ORDER :The meeting was called to order by Robert Carretta at 1 PM.
ATTENDANCE: William Abbott (Bracco Diagnostics), Glenn Alto (CIS-US, Inc.), Uwe Beinlich (AEA Technology-QSA Inc.), Roy Brown (TCI Medical), Robert Carretta (Amersham Health), Gail Daubert (Reed Smith), William Dickie (MDS Nordion), Hugh Evans (AEA Technology-QSA Inc.), Wendy Graham-Coco (Molecular Insight Pharmaceuticals), Michael Guastella (via teleconference - Nuclear Pharmacy Services), Casey Hastings (Alpine Group), Mary-Sumpter Johnson (BMS-MI), Rudy Karrin (BMS-MI), Todd Kealy (MDS Nordion), Henry Kramer (via teleconference -Executive Director, CORAR), Jane Majcher (Amersham Health), Sandy March (Bracco Diagnostics), Ken Maynard (SNM), Denise Merlino (Merlino Healthcare Consulting Corp.), Jeff Norenberg (NANP), Chris Ondeck (NANP), Bill Regan (BMS-MI), Lisa Saake (TycoHealthCare/ Mallinckrodt), David Sager (Amersham Health), Gordon Schatz (Reed Smith), Katherine Seifert (Cardinal Health), J. Paul Shea (CTI Molecular Imagining Inc.), Jack Slosky (BMS-MI), Bill Uffelman (SNM), W. Christopher Wagner (TycoHealthCare/Mallinckrodt), Richard White (Alpine Group), and Elroy Wolff (Counsel, CORAR - Sidley Austin Brown & Wood).
II. Antitrust Review by Counsel: Mr. Elroy Wolff made a presentation to the members concerning the antitrust laws and their applicability to associations, emphasizing the critical importance of full compliance with the antitrust laws.
III. Approval of Minutes from May 7, 2003 Meeting Minutes were approved.
IV. Administrative
a. 2004 Health Care Committee Budget: The CORAR 2004 Health Care Committee Budget of $440,000 was approved.
b. 2004 Committee Chairman: Dr. Robert Carretta and Dr. Jack Slosky
c. Terms of Chairman: To coincide with the 2 year terms of Congress
d. Consultants/Utilized Services: The following consultants and utilized services for the CORAR Health Care Committee were approved for 2004: Alpine Group, Reed Smith, and Hyman Phelps and McNamara.
e. Periodic Review of Consultants and Utilized Services: Action: Proposed a review process for contracted consultants and utilized services. Acct: Dave Sager
V. Medicare Legislation Gordon Schatz, Gail Dauber, Reed Smith; and Rich White of the Alpine Group presented a power point presentation that covered the following issues for the members: 1) General Review , 2) Clarification to Definition of Radiopharmaceuticals Under HOPPS, 3) Changes to Payment of Drugs Under HOPPS and 4) Changes to Payment of Drugs Under Medicare Payment Part B. Action: Review a letter (prepared by Gordon Schatz) to put CORAR on the record regarding certain codes and repayment rates. Letter to be mailed by no later than December 18, 2003 Acct: Committee Members Completion Date: Dec. 12, 2003
VI. Review of Final HOPPS Rule: The following issues were discussed:
1) Ramifications of Medicare Bill on HOPPS Rule
2) Other HOPPS Issues, 3) further refinement of priority procedure APCs (e.g. cardiac, renal)
3) CMS calculated costs and payment levels for radiopharmaceuticals and Nuclear Medicine Procedures,
4) Moran Data Study
Action Prepare a list of drugs for HOPPS Payment Rates letter and submit list to Gordon Schatz. Acct: Committee members Completion Date: December 31, 2003
Next Steps include: 1) APC Advisory Panel Meeting – January, 2004, 2) HCPCS codes and descriptors for radiopharmaceuticals – HCPCS Panel, and 3) 2005 HOPPS update.
VII. Payment for Drugs under Medicare Part B: The following issues were discussed:
1) Medicare Physician Fee Schedule / Practice Expense Changes
2) Single Drug Pricer-Update
VIII. Other Payment and Coverage Policy Issues: The following issues were discussed:
1) Nuclear Medicine APC Task Force-Update - William Uffelman, SNM, discussed that the task force plans on engaging members and companies more; seeks to establish a more formal structure
2) Medicare Coverage Process-Update
3) Coding Reforms (CPT-5 and ICD-10)-Update
IX. Food and Drug Administration Issues: The following issues were discussed:
1) Update on Guidance for Medical Imaging Drugs (a. Guidance document is slated to be released early Spring 2004, b. Possible Action: There is an interest in putting together a public meeting as an educational session on the Guidance document; to include FDA CORAR/MICAA, manufacturers, researchers, general community invite, etc.)
2) Update on Elimination of MIDAC (Currently there is a draft letter to MIDAC from MICAA/CORAR to discuss some possibilities of reinstating MIDAC, if not that measure, then possible suggestions for SGE’s are to be submitted. Plan to have the letter out by end of December/ first of January. Action Submit names of potential candidates for MIDAC to Alan Kirschenbaum Acct: Committee members Completion Date: December 31, 2003
3) Special Government Employees
4) Other FDA Issues (a. update on Division of Medical Imaging and Radiopharmaceutical Drug Products, b, May want to conduct another survey of the members on Division approval time-lines)
5) Compounding Update - There was a hearing in October 2003 held by the Senate HELP
committee, Senator Bond held the hearing to discuss compounding frauds and problems; comments for the record are due by 1/5/04: CORAR did not want to take action on this.
6) Hatch/Waxman changes included in Medicare bill: (Alan Kirschenbaum will
be sending out a memo within the next week to clarify and explain the changes that were included)
7) Update on other FDA developments: a. Good Review Management Guidance, b. Rule on patent listing and 30-month stays, c. Affirmation of 505(b)(2) policy, d. Proposed rule on adverse event reporting requirements, e. February 2004, Pediatric Advisory board meeting is scheduled –who is on the panel for medical imaging; f. who are the SGE’s - what consultants can be added.
X. New Business
Outreach to Medical Specialty Societies: Action CORAR will make an effort to build relationships and collaborate on special issues; a priority for 2004; reach out to SNM, ACNP, ACR, etc. Acct: Robert Carretta and Jack Slosky
XI. Adjournment The meeting was adjourned at 5:30 p.m.
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DRAFT
COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS
HEALTH CARE COMMITTEE
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