Senators Urge Revision of Proposed Medicare Prescription Drug Formulary
Proposed guidelines for a prescription drug formulary under the new Medicare drug benefit could limit access to many medications that beneficiaries use, and it should be rewritten, Sens. Max Baucus (D-Mont.) and John Breaux (D-La.) wrote Sept. 30 in a letter to United States Pharmacopeial Convention officials, which are developing the guidelines, CQ HealthBeat News reports (Reichard, CQ HealthBeat News, 10/7).
The draft guidelines, which USP released in August, list 146 classes of medications that should be covered by Medicare drug plans, including categories for antidepressants, HIV/AIDS drugs, cholesterol-lowering medications and anti-inflammatories. USP, which will receive $1.1 million to create the guidelines, began the project in April with the help of four advisory panels representing beneficiaries, care providers, drug companies and companies that will sell prescription drug insurance, including pharmacy benefit managers.
Insurers and PBMs have said that private health plans generally have 50 to 90 separate drug classes, and a Medicare drug formulary with a small number of classes would create more competition among drug makers and give negotiators more leverage to procure lower drug prices. However, the Pharmaceutical Research and Manufacturers of America has said it found the number of drug classes in four private-sector formularies ranged between 157 and 311 classes.
Drug makers have urged that more than 200 drug classes be included to enhance their companies' odds of having products listed on the formulary and to give consumers broader access to drugs (California Healthline, 8/20). Medicare prescription drug plans are not required to comply with the USP guidelines, but "doing so helps assure that they do not run afoul of the law's prohibition of drug formularies that discriminate against Medicare enrollees with costly conditions," CQ Healthbeat reports.
Baucus and Breaux have said that the USP guidelines should "be more in line with the 209 drug classes" included in the Medicare prescription drug discount card program, CQ HealthBeat News reports. The USP draft includes 146 therapeutic classes and 235 subdivisions. The letter from Baucus and Breaux states, "While the recommended subdivisions reflect USP's laudable intention to require plans to cover additional drugs, unfortunately, this will not be the result."
The senators also said that USP "should get the guidelines right in terms of the scope of covered drugs" and not rely on an appeals procedure called for under the law to ensure beneficiaries receive necessary medications, CQ HealthBeat News reports. The USP draft guidelines must be submitted to CMS by mid-November, with the final guidelines to be released by Dec. 31 (CQ HealthBeat News, 10/7).
The Hill on Thursday examined how 6.4 million people dually eligible for Medicare and Medicaid could "face a gap" in prescription drug coverage before the Medicare prescription drug benefit takes effect in 2006. Members of the Medicare Consumer Workers Group, a coalition of beneficiary advocacy groups, said that dual eligibles will be automatically enrolled in the Medicare drug benefit May 15, 2006; however, their Medicaid drug benefits are scheduled to expire Jan. 1, 2006.
The group said that the rules do not ensure that such beneficiaries "do not confront a loss of benefits or a gap in drug coverage, either of which could have disastrous health consequences." A spokesperson for CMS said that the agency "is aware of the gap" and is working with the Social Security Administration to identify and alert affected individuals. According to The Hill, the spokesperson indicated that CMS "intends to ensure that there is no gap in the final rule" (Marre, The Hill, 10/7).