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:
Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of 21st Century Cures, a significant report from the Federal Trade Commission (FTC) on the Internet of Things (IoT) and several pieces of guidance from the Food and Drug Administration (FDA) aimed at reducing regulatory burden for digital health. This is on top of the perennial debate over eliminating the medical device tax (there is an increasing likelihood of this actually happening!). This increased visibility for medtech in Washington bears close attention from company executives and counsel because it will shape the future for regulating medtech at the federal level. Presently, policymakers seem focused on protecting medtech companies’ ability to innovate in general, but that climate can change quickly with pressure from consumer groups and other interests. Click here for an overview of some of the more significant issues being discussed in Washington that could impact medtech growth and innovation.
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).
The Centers for Medicare and Medicaid Services (CMS) held a webinar today to address the process for correcting and resubmitting records that were removed from the Open Payments system in August 2014 by CMS due to data integrity issues. CMS started the webinar by stating that of the 4.4 million records disclosed to the public on September 30, 2014, 1.7 million records ($2.2 billion) were “deidentified” due to these data integrity issues. CMS also disclosed that another 199,000 records ($1.1 billion) were not published because (i) the payments were under dispute at the time of publication; (ii) applicable manufacturers had requested delayed publication of the research payment; (iii) the payment was a research payment related to a non-covered recipient; or (iv) records that were submitted or attested to on July 7th, the last day of data submission and attestation, were excluded due to a technical issue by CMS when it pulled the data for publication.
Interested parties can register for an upcoming webinar hosted by the Centers for Medicare & Medicaid Services (CMS) related to the data that was excluded from public disclosure in August 2014 due to data errors. The webinar is scheduled for Thursday, November 13th from 1-3 PM Eastern. As of late last week, applicable manufacturers and group purchasing organizations (GPOs) can log into the Open Payments system to download a Removed Records Report to see which reported items were excluded from reporting and the reason for such exclusion. Applicable manufacturers and GPOs have until the end of the 2014 data submission and attestation period to address these items so that they may be subject to the covered recipient review and dispute process and made public during the next data release cycle, projected for June 30, 2015. In addition to the webinar, CMS also released a quick reference guide and a downloadable Validated Physician List (via the CMS Enterprise Portal) in an effort to avoid further reporting inconsistencies.