Tag Archives: 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 Committee on Ways and Means, Tavenner indicated, that, among other things, CMS does not plan to finalize its proposal to alter its current policy requiring Part D plans to cover “all or substantially all” drugs in the antidepressant, immunosuppressant, and antipsychotic classes.  Tavenner’s letter follows the March 6 introduction of H.R. 4160, the “Keep the Promise to Seniors Act”, by Rep. Renee Ellmers (R-NC), which was intended to block the implementation of “any provision of the proposed regulation…insofar as such regulation relates to the provisions of part D”.

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Filed under Coverage and Reimbursement, Medicare, Part C, Part D, Uncategorized

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 payment data.  Phase I must be completed by March 31, 2014. 

CMS also announced a webinar for Tuesday, February 25th from 1-2 PM ET related to phase I.  Register for the webinar here.

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Filed under Federal Transparency

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 data submission.  Phase I, which will occur from February 18, 2014 – March 31, 2014, will allow for user registration in CMS’ Enterprise Portal, submission of corporate profile information and submission of aggregate 2013 payment data.  The corporate profile and aggregate data submission materials have not been made available on the Open Payments website and are only accessible after CMS registration is completed. 

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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 publishes a Work Plan that summarizes new and ongoing reviews and activities that OIG plans to pursue during the applicable fiscal year.  Among other things, the 2014 Work Plan includes a number of new items (since the 2013 Work Plan) relevant to prescription drugs, including the following proposed audits:

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Filed under Corporate Compliance, DHHS OIG, Government Enforcement, Medicaid, Medicare, OIG Guidance, Part D

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 January 10, 2014.  Public comments are due to CMS by 5 p.m. EST March 7, 2014.  Among other things, the Proposed Rule would “limit ‘protected’ drug classes to those for which access to all drugs in a category or class for a typical individual with a disease or condition treated by the drugs in the class is required within 7 days and more specific formulary requirements would not suffice to meet multitude of specific applications of the drugs within the category or class.”  CMS proposes that the antidepressant class and the immunosuppressant class would no longer be “protected” and that continued protection of the antipsychotic class beyond 2015 would not be certain.

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Filed under Fraud and Abuse, Health Reform, Medicare, Part C, Part D, The Affordable Care Act

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 has not provided firm dates for registration, stating only that it will be available in “early 2014.”  Further, CMS announced that another webinar will be held in January 2014 related to technical aspects of the Open Payments system.  CMS also released today the reporting specification templates that we discussed here

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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:

  1. Submission File Specifications, which list the data elements to be collected for each of the three payment types (i.e., general payments, research payments, ownership/investment interests).  This information is currently available here.
  2. Schema and Sample Files, which will provide the exact format and layout of the files that will be accepted by the Open Payments system.  This information will be available by the end of November and announced via the CMS Open Payments list serve. 

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