More Protections for Rx Drug Access Included in Final Medicare Rules

All medically necessary drugs must be available under Medicare drug plans, according to the final rules implementing the massive Rx benefit -- a decision that addresses key concerns by drugmakers and lawmakers that some drugs could have been excluded under the proposed guidelines.

The final rules released by the Centers for Medicare & Medicaid Services (CMS) provided assurances that beneficiaries will be able to obtain the drugs they need, while allowing health plans the flexibility to provide the drugs at the lowest possible cost. A prescription drug plan's formulary must not exclude access to drugs that would discriminate against beneficiaries with certain illnesses, according to the final rules.

CMS also said the final rules significantly shorten the time frames for Medicare drug plans to make coverage determinations and appeal decisions. Under the final rule, enrollees will receive decisions about their required medications in less than 72 hours and in less than 24 hours for expedited requests.

The issue of accommodating all eligible drugs on Medicare formularies was a key concern in the months leading up to the final rule. PhRMA, the Biotechnology Industry Organization and numerous federal lawmakers called on CMS to ensure access to as many medications as possible.

The final regulations and formulary guidance provide a road map for implementing the $534 billion drug benefit in the Medicare Modernization Act, which starts in January 2006.

For more information on the final rules, go to http://www.cms.hhs.gov/medicarereform/pdbma/ (http://www.cms.hhs.gov/medicarereform/pdbma/).