CMS Proposed Changes; More News
CMS Proposes Changes to Open Payments
At 5:30pm on July 3, CMS released the CY 2015 Physician Fee Schedule proposed rule. The 609-page document included a number of proposed changes to the Physician Payments Sunshine Act – Open Payments rule.
CMS Proposes Removing CME Exemption, Some Speaker Pay May Still Fall Under "Indirect Payment" Exclusion
The evening before the Fourth of July weekend, the CMS released the CY 2015 Physician Fee Schedule proposed rule. The 609-page document proposes to delete the specific exemption for payments made to speakers at accredited CME events.
CMS Proposed Physician Fee Schedule 2014
The CMS proposed rule would update payment policies and payment rates for services furnished under the Physician Fee Schedule (MPFS) on or after Jan. 1, 2015. In addition to the previously reported changes to Open Payments, the proposed rule also proposes changes to several of the quality reporting initiatives that are associated with PFS payments, including the Physician Quality Reporting System (PQRS), the (EHR) Incentive Program, and the Shared Savings Program, as well as changes to the Physician Compare tool.
CMS Guides Physicians and Teaching Hospitals on “How To Prepare For Phase 2” Come Mid-July
CMS has released information for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. Currently, there is no set date besides "mid-July" for when physicians and teaching hospitals can begin registration in the Open Payments system. Given it is July 8th, we aren't quite sure whether mid-July means this week, next week, or the week after.
EFPIA Launches “Pharma Disclosure” Website; Provides Template Disclosure Form
Starting in 2016, EFPIA member companies will make public the details of payments and transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs). The first disclosures will be made in 2016 and will convey information about payments made in 2015.
CMS Will Not Enforce Penalties for Submissions Done By July 7
According to an official email companies from CMS, it will not enforce penalties for reporting non-compliance until after July 7th. We had previously reported that CMS help desk had sent an email to one company stating that CMS extended the deadline to July 7. The deadline remains at June 30th but companies will not be penalized for reporting before July 7, 2014. Companies should not delay reporting as this is a very detailed process in which your data may be rejected due to mistakes in submission of the data.
With Just One Week Left for Data Submission, CMS Releases 27 New FAQs
CMS just released a reminder for manufacturers to complete 2013 data submission and attestation by June 30th. They also released 27 new Frequently Asked Questions (FAQs) regarding the Phase 2 Submission process, registration, attestation and other nuances of the Sunshine Act.
Understand Physician Expectations and Effective Communications
Jeremy Lazarus, past president of the American Medical Association (AMA), spoke first about how important it is for companies to appreciate and manage physician expectations as we near closer to the public release of Sunshine data on September 30, 2014. Lazarus' presentation focused on AMA's efforts to embrace transparency, while also working to maintain protection and create a meaningful, accurate picture of physician relationships with industry.
PhRMA Urges CMS To Push Back June 30 Deadline For Phase 2 Data Submission
PhRMA notes that foreign manufacturers and foreign affiliates of US-based manufacturers have had an especially tough time. "Registration glitches appear particularly acute" for foreign entities, PhRMA notes, "and they are compounded by the fact that Open Payments helpdesk hours do not accommodate European or Asian time zones."
AMA House of Delegates Passes Resolution to Increase Minimum Reporting Requirements to $100 Payments and Exempt All Informational Materials
Meeting this week in Chicago, the American Medical Association (AMA) House of Delegates overwhelmingly passed two crucial proposed changes to the Physician Payments Sunshine Act. The first recommendation is for the Sunshine Act to include a reporting exclusion for informational items including medical textbooks and peer-reviewed journals. The second is to limit the Sunshine Act reporting requirements to reporting payments and transfers of value over $100.
CMS Pushes Dispute Resolution to August/September; Still Plans to Post Public Database in September
During the presentation, CMS noted that their auditing process of manufacturer reports would begin after publication of the data, and would include an appeals process. Furthermore, they stated that they had no intention of expanding the covered recipient list to include physician assistants, which would have to come from new legislation.
Comments Regarding Dispute Resolution Process
CMS issued a call for comments on the Dispute Resolution process for Open Payments, the program to implement the Physician Payments Sunshine Act. CMS received 38 responses, many of which revealed the tension inherent in the Act between physicians and medicine/device manufacturers.
Massachusetts Pharmaceutical and Device Conduct: Companies Won’t Have to Report Payments Covered by Federal Sunshine Act; Gift Ban Still In Place
In 2009, the State of Massachusetts enacted the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct (PCOC), which requires companies to report payments of more than $50 made to any healthcare provider. The law has provided a foreshadowing of the Federal Physician Payments Sunshine Act, which came into effect August of 2013. We have covered the release of Massachusetts' data from 2010, 2011, and, most recently, in 2012.
Minnesota Expands Reporting Definition To Physician Assistants, APRNs, and Therapists
The Minnesota legislature passed HF 2402, in which one section requires medicine manufacturers to report payments to physician assistants, APRNs, and therapists. These entities are excluded from the Federal Physician Payments Sunshine reporting obligations.