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.
Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49 billion from applicable manufacturers to physicians and teaching hospitals. One key takeaway from the infographic is applicable manufacturers are spending significant resources to track and report de minimis payments and transfers of value to covered recipients. For example:
- 9 million food and beverage interactions were reported at an average of $23.80 per instance
- Gifts accounted for 0.45% of the reported spend
- 49% of physicians in the database received less than $100 total
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.”
On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their own genetic history. This furthers 23andMe’s plan to become a repository for human genetic makeup and to turn data gathered from its $99 saliva tests sold to consumers into a large information sharing deals with drug companies. However, the creation and use of this database raises potential privacy concerns.
The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug, device, biological, or medical supply that provides a payment or transfer of value to an advanced practice registered nurse (APRN) practicing in the state to submit the information required by the Department on a quarterly basis. The first report covering the period January 1, 2015 to March 31, 2015 is due July 1, 2015. All reports must be submitted via email to DCP.DrugManufacturers@ct.gov.
Significantly, payments and transfers of value will not be reported to the Department in a consolidated form. Rather, an Expenditure Disclosure Form must be completed and submitted for each APRN to whom the manufacturer provides a reportable payment or transfer of value, potentially creating a significant administrative burden for manufacturers and the Department each quarter. The following information must be provided on the form: name of manufacturer; first and last name of recipient; medical license number of recipient; Connecticut controlled substance registration (if applicable); date the expenditure was incurred; value/amount of expenditure; nature of the expenditure; purpose of the expenditure; FMV payment description; up to 5 prescribed products to which the expenditure relates, including product type (e.g., pharmaceutical, biologic, medical device, combination product) and product name; name and email address of person completing the form.
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).