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:
The Centers for Medicare & Medicaid Services (CMS) announced today that it had released an improved Open Payments website. The website has been enhanced with a homepage tool for searching by doctor name, a “snapshot” of Open Payment data, and additional sections to explore and download data.
Additionally, CMS updated the Open Payments dataset previously published on June 30, 2015. This updated Open Payments dataset reflects changes made to records, changes to delays in publication flags, changes to disputed records, and records that were deleted since original publication. These changes were submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) to CMS. This data should be carefully reviewed by all covered recipients.
As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion in the Legislation is draft language that would exclude from federal Sunshine law reporting:
- “peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks”;
- indirect payments or transfers of value provided to covered recipients “for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply”; and
- payments or transfers of value made for the “sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.’’
Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. This deadline was delayed until 2017 by recently enacted Public Act 15-4. Additionally, Public Act 15-4 changed the reporting period from quarterly to annually, consistent with other similar federal and state reporting requirements.
Notably, the law also clarifies that the reporting requirements relate only to those APRNs who are “practicing not in collaboration with a physician in the state.” The law requires the Connecticut Department of Public Health to annually publish on its website by December 1st a list of APRNs who are authorized to practice not in collaboration with a physician.
The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP). This includes section 16-29H-8 of the Code, which requires prescription drug manufacturers and labelers to annually report advertising and promotion costs for the prior calendar year by April 1st. Because Senate Bill 267 becomes effective 90 days after enactment, manufacturers and labelers are still expected to file the calendar year 2014 report by April 1, 2015.
Is this a new trend for 2015? Although the CMS Open Payments database is now live and the second round of reporting will be completed by applicable manufacturers and applicable group purchasing organizations this week, Minnesota and Connecticut each recently expanded the list of health care providers for whom payment reporting is required. We will be watching further federal and state transparency developments.
The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company. You can read Cooley’s posts about the first two 2015 enforcement actions here and here.
The Assurance of Discontinuance for Premier Dental Products Company states that it provided allowable expenditures and/or permitted gifts to Vermont health care professionals in fiscal and calendar year 2011, and calendar years 2012 and 2013, and failed to submit required reports with the VT AG for those years in violation of the state’s Prescribed Products Gift Ban and Disclosure Law, 18 V.S.A. §§ 4631a, 4632. Premier agreed to pay the state $35,000 and otherwise comply with the Prescribed Products Law.
Similarly, the Assurance of Discontinuance for Leica Microsystems states that it “may have given” allowable expenditures and/or permitted gifts to Vermont health care professionals in fiscal year 2010, fiscal and calendar year 2011, and calendar years 2012 and 2013, and failed to submit required reports with the VT AG for those years in violation of the state’s Prescribed Products Gift Ban and Disclosure Law, 18 V.S.A. §§ 4631a, 4632. Leica Microsystems agreed to pay the state $50,000 and otherwise comply with the Prescribed Products Law. This Assurance is notable because the “may have given” language suggests that the company was unable to confirm whether allowable expenditures or permitted gifts were provided were provided to health care professionals in the relevant years. Additionally, this is the second largest penalty by the VT AG to date.
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).