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”.
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.
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.
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.
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:
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.
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 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.
- 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.