House Bill Would Enhance Medicare Part D Drug Coverage

 July 26, 2010 – A new bill with the potential to increase coverage for off-label indications for certain Part D drugs has been introduced in Congress. The Part D Off-Label Prescription Drug Parity Act (H.R. 5732) would expand the complete set of Medicare off-label drug coverage requirements (which currently fully apply only to anti-cancer drugs) to all drugs covered by Part D.

Currently, Medicare Advantage and stand-alone Medicare prescription drug plans must consider coverage of an off-label indication for an anti-cancer drug covered by Part D if the use is supported in statutorily-defined drug compendia or by articles published in certain peer-reviewed clinical journals. (These are the same criteria that apply to anti-cancer drugs eligible for coverage by Medicare Part B.) The mandate to consider peer-reviewed clinical journal articles gives the plans access to the most up-to-date published medical literature and is of benefit because important studies can be made available to the Medicare contractors for consideration of coverage ahead of compendia review cycles.

However, for drugs other than anti-cancer drugs, the plans are currently required to consider only the information presented by the four approved compendia; consideration of clinical journal articles is not mandated for these drugs. H.R. 5732 would require the Medicare Part D contractors to include studies published in peer-reviewed clinical journals in the data they consider when making coverage decisions related to off-label indications of all drugs, not just anti-cancer drugs.

H.R. 5732 was introduced in Congress on July 14 and referred to the Committee on Energy and Commerce and the Committee on Ways and Means for consideration by those Committees and recommendations for further action. If ultimately enacted as written, the bill has an effective date of January 1, 2011.


Division of Drug Marketing, Advertising and Communication Turns Up the Heat

The FDA's Division of Drug Marketing, Advertising and Communication (DDMAC) began seeking physicians’ help in monitoring drug advertising.  Pharmaceutical manufacturers could face increased scrutiny on advertising directed toward healthcare professionals now that the FDA’s DDMAC is seeking help from physicians to identify prescription drug advertising that violates the agency’s standards. The “Bad Ad Program,” launched Tuesday, is intended to expand the agency’s regulatory activities on drug promotion, which rely on industry to submit materials or file complaints, FDA Commissioner Margaret Hamburg says in a “Dear Colleague” letter.    All regulated entities should take note of these activities in addition to manufacturer's.  If your operation is generating consumer/patient oriented communications it is suggested that all such information should be reviewed from the perspective of DDMAC guidelines.  The FDA has most recently established stardards around web based communications.


APHA Legislative/Regulatory Recap of 2009

D2 is actively involved with several major pharma and pharmacy associations such as NACDS, HDMA, APHA, NCPDP, GS1, BIO and others.

In this edition of SpecialtyRxFacts we are providing our readers a link to a recently published recap of major 2009 legislative and regulatory initiatives.  APHA has done an excellent job in covering all major topics including:

  1. Congressional Activity in 2009, with special focus on Health Care Reform
  2. Department of Health and Human Services (HHS) in 2009
  3. Centers for Medicare & Medicaid Services (CMS) in 2009
  4. Drug Enforcement Administration (DEA) in 2009
  5. Food and Drug Administration (FDA) in 2009
  6. Internal Revenue Service (IRS) in 2009
  7. Environmental Protection Agency (EPA) in 2009
  8. Department of Defense (DoD) in 2009
  9. Federal Trade Commission (FTC) in 2009
  10. Court Cases in 2009

We invite you to click on this link and see for yourself:


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Support the Bill to Remove the Prompt Pay Discount from ASP

Senators Arlen Specter (D-PA) and Pat Roberts (R-KS) introduced a bill (S. 1221) June 11, 2009, in the Senate to address the Average Sales Price (ASP) issue with Part B drugs by removing prompt pay discounts extended to wholesalers from the ASP calculation. Including prompt pay discounts in the ASP calculation threatens community oncology practices by artificially lowering the reimbursement rate for chemotherapy treatments.

This bill is a companion to H.R. 1392, introduced in the House of Representatives earlier this year, which supports. H.R. 1392 was introduced by Reps. Gene Green (D-TX), Ed Whitfield (R-KY), Diana DeGette (D-CO), Mike Ross (D-AR), Edolphus Towns (D-NY), Mike Rogers (R-MI), Betty Sutton (D-OH), Bart Gordon (D-TN), Lee Terry (R-NE), and Ralph Hall (R-TX) and currently has 46 co-sponsors. That bill would also change the ASP methodology used by Medicare to set prices for Part B drugs and biologicals to better align drug reimbursement with actual cost.

Drug manufacturers are currently required to net out prompt pay discounts paid to wholesale distributors before reporting ASP figures to the Centers for Medicare and Medicaid Services (CMS), even though the wholesaler prompt pay discount is not passed along to physicians. Physician drug reimbursements are lowered by approximately two percent by this provision in the ASP calculation, which is the customary amount of the wholesale distributor prompt pay discount.
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