Congress pushes toward $400 billion Medicare reform package

Bills address pharmacy interests in several areas

Congress focused on Medicare reform in June, with both the House and Senate passing their own versions of a Medicare prescription drug program.

The Senate approved its bill by a 76-to-21 margin, but the House bill passed by just one vote, 216 to 215. Both bills would spend $400 billion, take effect in 2006, and give Medicare enrollees more choices among private health plans. However, Medicare participants would have to pay a monthly premium and annual deductible before the government would help pay for the prescription drugs.

The bills might be similar in some respects, but their differences will be challenging to overcome, says Kristina Lunner, director of federal government affairs for the American Pharmacists Association (APhA) in Washington, DC. "There are some dramatic differences between the two bills."

House conservatives, for example, are against anything that they think will weaken free-market reform of Medicare. Senate Democrats, on the other hand, think that the House reforms will gut the traditional Medicare program. Congressional sources say that an accord may not be reached until early this month or maybe in the fall.

Provisions address pharmacy concerns

Even with the negotiations that lie ahead, pharmacy groups are pleased to see several provisions added to the bills that address pharmacy concerns. "We are very encouraged that both chambers have listened to our concerns and have attempted to address them. Whether they have gone far enough is yet to be seen," Lunner says.

Here are details (most from APhA) about some of the pharmacy-related provisions included in one or both of the bills:

• The Senate adopted an amendment that would close unintended loopholes in the Hatch-Waxman Act. Those loopholes have delayed the approval of generic pharmaceuticals for reasons other than safety and efficacy. The bill, introduced by Sen. Judd Gregg (R-NH), chairman of the Senate Health, Education, Labor, and Pensions Committee, and Sen. Charles Schumer (D-NY), would establish the following:

One 30-month stay. The stay would be triggered if a name-brand company sues to block a generic application for infringing on a patent if the application is filed before a generic application is submitted to the U.S. Food and Drug Administration (FDA). Once a generic application is filed, the name-brand company has 45 days to challenge the generic application in court. If the name brand does not challenge the generic company’s application within 45 days, the generic can seek a declaratory judgment indicating that it does not violate the name-brand drug’s patents.

New enforcement mechanism. To ensure that the name-brand companies do not use frivolous patents to keep generic drugs off the market, the proposal would allow generic companies to file counterclaims if a name-brand company sues them for violating a patent.

180-day exclusivity. Under the bill, a generic drug company would forfeit its rights to this exclusivity if it were found to have made an anticompetitive deal with a brand company or otherwise fails to come to market in a timely manner. If one of the forfeiture provisions outlined in the bill occurs, the exclusivity would be forfeited and the marketplace would open up to any generic company ready to come to market.

Authority for establishing bioequivalence. The bill would clarify that the FDA does have the authority to establish separate tests for determining the bioequivalence of drugs that are not absorbed into the bloodstream — as long as those tests are scientifically valid and meet rigorous standards.

• A Senate amendment would require plan sponsors to disclose discounts, rebates, and other financial incentives and would require plans to authorize pharmacies to dispense 90-day supplies to beneficiaries — although beneficiaries would be responsible for any price differences between providers.

• A Senate amendment allows pharmacists, wholesalers, and individuals to import prescription medications from Canada. The amendment was modified to include several safety provisions, including requiring certification by the Secretary of Health and Human Services that the drugs are safe and that importation would result in "significant" savings before the law can be implemented. The House bill includes a similar provision.

• A Senate amendment instructing the Department of Health and Human Services to develop a Committee on Drug Compounding "to ensure that patients are receiving necessary, safe, and accurate dosages of compounded drugs."

• A Senate amendment for a one-year assessment of payment models for pharmacist-provided medication therapy management services. This is different from the stand-alone legislation that gives pharmacists provider status.

• Provisions for medication therapy management programs. These would be for beneficiaries with chronic conditions and/or on multiple medications. The House bill specifically says "pharmacy providers" would provide the services; the Senate bill doesn’t make that specification.

Provider status legislation introduced in the Senate

Legislation to give pharmacists provider status was introduced in the Senate in June by Sen. Tim Johnson (D-SD) and Sen. Thad Cochran (R-MI).

The Medication Therapy Management Act, S. 1270, would amend the Social Security Act to cover medication therapy management service provided by pharmacists to high-risk Medicare patients. Patients who would have access include those receiving medications for asthma, diabetes, or chronic cardiovascular disease, as well as those on anticoagulation or lipid-reducing medications. The services provided by a number of other health care professionals, including registered dietitians, nurse practitioners, physician assistants, certified nurse midwives, and clinical social workers, also are recognized for payment under Medicare.

Pharmacy groups are strongly voicing their support of this bill. "The involvement of pharmacists is imperative so that Medicare patients with complex medical needs can successfully control their disease and avoid multiple doctor and hospital visits to deal with complications," says Phylliss Moret, acting executive director of the American Society of Consultant Pharmacists, in a statement.