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HHS should streamline its involvement in the reviewing of medical technology and promote collaboration between the Centers for Medicare & Medicaid Services (CMS) and the FDA to improve the medical product discovery-to-delivery process, according to a recent report released by HHS’ Medical Innovation Task Force.
The full Senate has confirmed Michael Leavitt to become the next secretary of HHS. The voice vote on Jan. 26 came one day after the Senate Finance Committee unanimously recommended Leavitt to the post after he provided written answers to dozens of questions from Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Max Baucus (D-Mont.).
Drug plans under the new Medicare Rx benefit must provide access to all medically necessary drugs, according to the final rules implementing the massive Rx benefit.
HHS secretary-designate Mike Leavitt announced proposed regulations Jan. 27 that would facilitate the use of electronic prescriptions when the Medicare drug benefit takes effect next January.
The Senate Finance Committee yesterday recommended Michael Leavitt to become the next HHS secretary after Leavitt explained in writing his positions on various HHS and FDA issues, including calls for an independent drug safety office and a mandatory clinical trial registry.
The agreement between the FDA and the Centers from Medicare & Medicaid Services (CMS) to conduct parallel reviews of products — which would allow drugmakers to receive both a drug approval and reimbursement coverage simultaneously — could speed some products to market, but it also raises concerns for the pharmaceutical industry, according to experts.
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 Centers for Medicare & Medicaid Services (CMS) plans to issue a guidance in March summarizing its policies on implementing an evidence-based approach to medicine — in which treatments are compared and selected based on effectiveness and value.
The FDA and Centers for Medicare & Medicaid Services (CMS) will increase their postmarket surveillance activities to collect "invaluable information" on the use of medical products in the real world, according to an HHS task force report that examined ways to better coordinate activities across the department and to streamline the way HHS does business.