The Centers for Medicare & Medicaid Services (CMS) recently announced in the 2017 Physician Fee Schedule proposed rule that since publication and implementation of the Open Payments Final Rule and the 2015 Physician Fee Schedule, various stakeholders have provided feedback to CMS regarding aspects of the Open Payment program, including identification of certain areas that may benefit from revision. Thus, CMS is soliciting comments to inform future rulemaking, but made it clear that it was not intending to finalize any Open Payments requirements directly as a result of the 2017 Physician Fee Schedule.
To further discuss the topics listed in the 2017 Physician Fee Schedule, CMS held today a Special Open Door Forum for industry stakeholders “to inform future rulemaking and other enhancements” to the Open Payments program. CMS provided a presentation slide deck for the Open Door Forum, which outlined various topics in which it was soliciting stakeholder feedback, including:
We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1. If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we will assume a certain level of familiarity with the Medicaid Drug Rebate Program in our discussion below. However, although the issues addressed in the Final Rule are technical, the business implications are very real, and the Final Rule is significant to all manufacturers with marketed drug products participating in the Medicaid Drug Rebate Program (or who hope to participate someday).
Those of you who have been anxiously awaiting a final AMP rule for years now will be pleased to learn that some long-standing questions raised by CMS’s controversial 2012 proposed AMP rule have been answered (and, of course, some new questions have been raised). Some highlights of the Final Rule, in no particular order:
If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)! The publication of this Final AMP Rule follows the 2012 publication of CMS’s highly controversial proposed policies implementing various changes to the Medicaid Drug Rebate Program enacted under the Affordable Care Act. This rule has significant potential to impact drug manufacturers’ calculations and policies regarding the Medicaid Drug Rebate Program and pricing more generally, and should be carefully reviewed by all interested parties. It is being issued as a final rule with comment period.
We are currently reviewing the 657 pages of material, and plan to provide more substantive commentary in a subsequent post. For those of you playing along at home, the rule is expected to appear in the February 1, 2016, Federal Register, and comments are expected to be due by 5:00 PM Eastern April 1, 2016 (which is also the effective date of the rule). Separately, State Medicaid Agencies must comply with certain rule requirements by submitting a State Plan Amendment (SPA) by June 30, 2017 to be effective no later than April 1, 2017.
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. In addition to summarizing the process and outcome of the 2014 reporting period, the recently released annual report includes a few key takeaways for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs):
- CMS intends to continue making enhancements to the Open Payments website so that all website visitors, including “advanced data users” and the general public, can “discover meaningful information.” This will include providing the data in a dashboard layout and access to additional aggregate views of the data.
- CMS provided statistics demonstrating the significant amount of attention that the Open Payments database received. This included over 13,500 downloads of the database, and nearly 1 million visitors to the Open Payments website. Additionally, during the week of February 8-14, 2015, the Open Payments database received nearly 2.5 million unique page views.
- CMS confirmed that no civil monetary penalties (CMPs) have been imposed to date. The near-term objective of CMS is to focus on applicable manufacturers and GPOs that failed to register and submit data in the Open Payments system. CMS stated in the report that it is “engaged in an effort to increase submission compliance of specific entities that did not submit data.” CMS further confirmed that it “will launch targeted audits to identify applicable manufacturers and GPOs that should have submitted payment information but did not for 2013.”
The Centers for Medicare & Medicaid Services (CMS) released this week 5 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals in connection with the federal Sunshine Act. The FAQs generally relate to the reporting and attestation process. The new FAQs are posted below. Cooley also maintains a CMS Open Payments FAQ tracker that can be accessed under the “Trackers and Presentations” section on the right side of the blog or under the “Resources” section at the top of the blog.
||Do applicable manufacturers and applicable GPOs need to re-certify their Open Payments system registration each program year?
||What happens if I do not re-new a record’s delay in publication status?
||Why am I receiving a “Failed Matching Validation” message for payment records that were accepted last year?
||How do I re-new a record’s delay in publication status?
||How do I remove a delay in publication request for a previously submitted record?
The Centers for Medicare and Medicaid Services (CMS) released today a 20 minute on-demand video tutorial related to the 2014 Open Payments reporting program. The video provides an overview of the registration, reporting and certification processes, as well as CMS resources available related to Open Payments. According the CMS, the current reporting timeline for 2014 is the following:
- Submission of data by Applicable Manufacturers and Applicable Group Purchasing Organizations (GPOs): February – March 31, 2015
- Review and dispute period for Covered Recipients (i.e., physicians and teaching hospitals): April – May 2015
- Review and correction period for Applicable Manufacturers and Applicable GPOs: May – June 2015
- Publication of data by CMS: June 30, 2015
CMS also will be hosting an informal Q&A session on January 15, 2015 from 11:30 AM – 12:30 PM Eastern for anyone interested in the Open Payments reporting program. The teleconference information is 1-877-267-1577, meeting number: 995 248 830 (no password or pre-registration required).
On December 12, 2014, the U.S. Department of Health & Human Services Office of Inspector General (OIG) published a report titled: “States’ Collection of Offset and Supplemental Medicaid Rebates” (OEI-03-12-00520). This report was based on the findings of a 2013 OIG survey of all fifty states and the District of Columbia relating to their collection and reporting of the federal ”offset rebates”. Very basically, the offset rebates are the amounts attributed to the Medicaid drug rebate increase required by the Affordable Care Act (ACA) that must be remitted by the states to the Centers for Medicare & Medicaid Services (CMS). While the report is relatively technical with respect to the state offset rebates (which the OIG finds were accurate), it also includes some interesting background data and recommendations regarding states’ supplemental rebate agreements (SRA) with pharmaceutical manufacturers.