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Despite ongoing court action, CMS is moving ahead with its Medicare-endorsed prescription drug discount card program.
The agency intends publishing its official drug card sponsor solicitation soon in the Federal Register. Applications will be due March 7, according to a draft copy of the notice published last month.
CMS plans to announce those entities it has chosen to endorse in May, following which card sponsor enrollment will begin Sept. 30, the draft notice states.
Upcoming revisions to the tripartisan drug plan could include higher beneficiary cost-sharing to reflect current fiscal confines judging by recent comments from the top health aide to incoming Senate Finance Committee Chairman Chuck Grassley (R-IA).
Speaking at a Dec. 19 Alliance for Health Reform briefing, Finance Committee Republican health policy director Linda Fishman indicated that while the costs associated with providing a drug benefit have escalated, cost-sharing levels have remained static.
Senate Minority Leader Thomas Daschle (D-SD) Jan. 7 unveiled his party's legislative agenda for the 108th Congress, and swiftly introduced Democratic bills to provide Medicare prescription drug coverage, bolster homeland security and expand health care coverage. The Democrats' prescription drug bill would also reform drug patent law and allow reimportation of drugs from Canada -- two proposals passed by the Senate last year but never taken up by the House.
Brand-name drug company Organon says FDA should allow in the Orange Book method-of-use patents that claim unapproved uses of a company's already approved drug. The company maintains that the agency's stance that these patents cannot be listed is at odds with the goals of drug patent law.
Johnson & Johnson wants FDA to require generic drugmakers to provide innovators with samples of generic drugs so that brand-name companies can determine if the generic drugs infringe on their patents. J&J argues that such a requirement would reduce unnecessary patent infringement litigation, and that it is unfair that generic drug companies can sample brand-name products but brand-name companies cannot sample generic products.
The trade associations representing the generic and brand-name drug industries are clashing over FDA's plan to allow drug substance patents that do not claim the drug substance used in the approved drug (such as different crystal forms known as polymorphs) to be listed in the Orange Book. While the generic drug trade association says these patents should not be allowed in the Orange Book, the brand-name drug company says FDA already allows such listings and should acknowledge that it does.
In a surprise move, the generic drug industry trade group has decided to oppose a key element of the president's generic drug reform plan -- a proposal for a single 30-month stay per generic drug application. The Generic Pharmaceutical Association (GPhA) says the administration's 30-month stay proposal, which the White House touts as a move to increase generic drug access, could instead delay generic drug entry.
A key Senate Democrat is rejecting AARP's proposal to use the Medicare Trust Fund to finance a comprehensive prescription drug benefit. The lawmaker's statements will likely end speculation on whether the trust funds will be touched to craft a drug benefit, since GOP House leaders also oppose the funding plan.
With the pharmaceutical industry already promising a fight, Sen. Byron Dorgan (D-ND), chair of a Senate Commerce and Transportation subcommittee, is planning to introduce a bill that would allow pharmacists and wholesalers to reimport drugs from Canada. The bill is likely to reignite controversy over reimportation, as the Pharmaceutical Research and Manufacturers of America (PhRMA) has promised to fight the impending bill, and an FDA source says the agency has safety concerns regarding the approach.
The state of Maine has won round one against a pharmaceutical industry bid to quash the state's prescription drug discount program for low-income residents.
In a Feb. 25 decision, the U.S. District Court for the District of Columbia has ruled in favor of the Healthy Maine Prescription Program (HMP), authorized by HHS to reduce prescription drug costs for needy residents ineligible for Medicaid.
Montana is taking several drug manufacturers to court over what the state believes is an abuse of the average wholesale price (AWP) system that it claims has cost Montana millions of dollars.
Top House lawmakers are reconsidering their stance on Medicare reform funding and may call for more resources to pay for prescription drug coverage, Medicare+Choice improvements, and provider payment adjustments, according to sources.
Pharmacy groups are "very likely" to resume their legal challenge over President Bush's prescription drug discount card following today's (March 1) release of the administration's revised initiative, according to an industry source.
Members of the two key pharmacy groups that successfully halted the administration's original card plan are meeting today to discuss continuing their court action. A source with one of the groups says the revised card plan is almost identical to the first proposal and therefore, violates the federal court injunction.
In an unprecedented move, AARP will soon ask Congress to dip into the Medicare Trust Fund to finance a $700 billion Medicare reform bill that would mostly pay for a comprehensive prescription drug benefit, according to an AARP source.
AARP is preparing a letter to both the House and Senate budget committees that will propose taking $350 billion from general revenue and $350 billion from the Medicare Trust Fund, according to the source. The letters will likely be sent this week.
A key Senate player in the Medicare prescription drug debate is pursuing increased usage of generic drugs to help cut the cost of a comprehensive drug benefit. Sen. John Rockefeller (D-WV) is examining the potential savings through generics in a bid to save money and increase the chances of enacting a drug benefit this year.
Legislation that would deal with all aspects of Medicare reform, including a prescription drug benefit as well as numerous other Medicare reform language, has a "good chance" of passing by "early summer," according to a GOP source.
A powerful Senate Democrat last week accused the Bush administration of "cooking the books" on its new Medicare funding request, criticizing Bush's proposed budget for lacking enough money for a prescription drug benefit and provider payment adjustments.
A yet-to-be-released congressional document estimates that the provider payment recommendations recently issued by the Medicare Payment Advisory Commission (MedPAC) would cost $174 billion over 10 years. This high price tag is significant because it will force Congress and the administration to pick and choose which MedPAC recommendations to implement in 2002.
The recently announced breakup of Merck-Medco has caught the attention of top policymakers on Capitol Hill, who say the failed marriage of the pharmaceutical giant and the pharmacy benefit manager (PBM) could be a significant blow to the House's attempt to pass a prescription drug bill this year. Merck-Medco's endorsement of the House drug bill in the 106th Congress was crucial to the measure's success in the chamber, sources note.
Two senators have changed their minds and now will not send letters chastising the head of a major pharmaceutical trade group who speculated the senators were close to endorsing the tripartisan Medicare reform plan.
Last month, Pharmaceutical and Research Manufacturers of America President Alan Holmer told reporters that Sens. Robert Torricelli (D-NJ) and Blanche Lincoln (D-AR) were possibly set to endorse the tripartisan Medicare reform plan that is favored by the White House (Inside CMS, Jan. 31, p1).
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