Tag: Center for Medicare and Medicaid Services

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 Open Payments Registration Open; Webinar Announced

As posted here, the first of two phases to register and submit payments to the Centers for Medicare & Medicaid Services (CMS) in connection with the federal Sunshine law has now begun.  Applicable manufacturers and group purchasing organizations (GPOs) may now register in CMS’ Enterprise Portal, complete the corporate profile information and submit aggregate 2013 […]

CMS Releases Additional Information Regarding Sunshine Registration and Submissions

The Centers for Medicare & Medicaid Services (CMS) issued additional information today for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) that must register and submit data to the Open Payments system in connection with federal Sunshine reporting requirements.  Specifically, CMS announced that it has decided to implement a two-step process for registration and […]

HHS Office of Inspector General Releases 2014 Work Plan: New Items Relevant to Prescription Drugs

On February 6, 2014, the U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) released its annual 2014 Work Plan.  In addition, the OIG has posted a 25-minute video vignette featuring senior OIG executives discussing the OIG’s top priorities for fiscal year 2014.  The OIG annually […]

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 […]

CMS Sunshine Updates – Webinar Slides, Reporting Specifications, Letter from Congress

There have been several recent and noteworthy developments related to Centers for Medicare & Medicaid Services (CMS) Open Payments.  As we told you here and here, CMS held a follow-up webinar this week to address additional questions related to Sunshine registration and reporting.  The slides from this webinar are available on the CMS Open Payments website.  Notably, […]

CMS Webinar #2 Regarding Sunshine Data Submission

The Centers for Medicare & Medicaid Services (CMS) held two webinars today for applicable manufacturers and applicable group purchasing organizations (GPOs) related to the Open Payments registration and data submission processes.  With regard to data submission, CMS announced that there are two resources that will be available: Submission File Specifications, which list the […]