Tag: formularies

FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]

OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items: Secretary Price’s Use of Chartered Aircraft for Federal Travel. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel […]

CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.

Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit.  We previously reported on that proposed rule here.  In a Letter to Representative Sander Levin, Ranking Member of the House […]

CMS Proposes Medicare Part D Rule for 2015 Contract Year – Antidepressants and Immunosuppressants Would No Longer Be “Protected Classes”; Antipsychotics May Follow

On January 6, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule: “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (the “Proposed Rule”).  The Proposed Rule is expected to be published in the Federal Register on […]