Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to cover payments and other transfers of value made to advance practice nurses and physician assistants. As indicated in Senator Grassley’s announcement of the bill, the Senators are tying the expansion of the Sunshine Act to addressing the opioid epidemic.  Applicable manufacturers who are required to report Sunshine Act data through the Open Payments system should follow this bill.  As Congress continues to consider opioid issues, this bill could be included in a broader package of legislation. Continue Reading New Bill Would Expand the Sunshine Act to Cover Physician Assistants and Advance Practice Nurses

As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs. The Globe article relates to a ProPublica analysis of physician prescribing patterns and payments from the pharmaceutical industry. To perform the analysis, ProPublica researchers tapped into two important sources of information about prescribers collected nationwide: information on payments received by physicians from pharmaceutical and device manufacturers (available through the Open Payments website) and Medicare Part D prescribing data. The analysis was limited to data from both sources for 2013 and 2014 (with only limited data available from Open Payments for 2013). Continue Reading Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier

Written by:  Brian P. Dunphy

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”).  When CMS proposed several of these changes in July, my colleague discussed them in detail in an earlier post.  The changes will become effective for the 2016 reporting year (pharmaceutical and medical device manufacturers (“Manufacturers”) will submit reports to CMS covering 2016 in 2017).

The Final Rule includes four changes.  First, CMS eliminated a separate reporting exclusion for payments to physicians for speaking at accredited or certified continuing medical education (“CME”) programs.  Even though CMS eliminated this CME-specific exclusion, most of these CME payments will still not have to be reported.  CMS decided that, where a Manufacturer provides funding to a third-party CME provider for physicians to attend or to speak at a CME program, these payments are not reportable “indirect payments” if the Manufacturer does not “require, instruct, direct, or otherwise cause” the CME provider to direct the payment to a specific physician.  CMS further explained that a CME payment does not become reportable if the Manufacturer later learns the physician’s identity “because the payment or other transfer of value did not meet the definition of an indirect payment.”  With respect to tuition fees for physician attendees, CMS will issue “sub-regulatory guidance specifying [that] tuition fees provided to physician attendees that have been generally subsidized at continuing education events by manufacturers are not expected to be reported.”

Second, Manufacturers must report the marketed name and therapeutic area or product category of the covered drug, device, biological, or medical supply to which the payment or transfer of value was related (previously, Manufacturers of drug or biologicals had to report marketed names, and Manufacturers of devices or medical supplies had to report either the marketed name, product category, or therapeutic area).  For payments related to non-covered products, reporting the marketed name will remain optional.

Third, Manufacturers must report payments in the form of stocks, stock options, or any other ownership interest as distinct forms of payment under 42 C.F.R. § 403.904(d).  Previously, these distinct forms of payment were grouped together in a single “form of payment” category.

Finally, CMS eliminated the definition of “covered device” because it is duplicative of the definition of “covered drug, device, biological or medical supply.”

Although most of these four changes are not contentious, the proposed elimination of the reporting exclusion for certain CME payments proved controversial when the proposed Sunshine Act changes were announced in July 2014.  But with the interpretation that CMS adopted in the Final Rule, which will keep many CME payments from being reported, CME coalitions largely applauded the change.

Written by: Kate Stewart

On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was previously excluded from reporting in the Open Payments system due to data errors.  Applicable manufacturers and GPOs will have until the end of the 2014 data submission and attestation period (expected to be March 31, 2015) to submit the corrected reports for the 2013 reporting year. 

Applicable manufacturers and GPOs were initially required to report payments made to physicians and teaching hospitals and ownership interests held by physicians for the period running from August 1, 2013, to December 31, 2013, by June 30, 2014.  As previously reported, after the initial reporting of 2013 data, CMS temporarily shut down the Open Payments system to address problems with data submissions.  After the shutdown, approximately one-third of the submitted records were flagged as having errors related to the identity of the recipient of the payment.  These payments were not included in the data that was publicly released on September 30, 2014. 

Applicable manufacturers and GPOs can now download a Removed Records Report from the Open Payments system showing the records that were removed.  A guide for correcting records is also available.  CMS will host a webinar on November 13, 2014 at 1:00pm EST to address the re-submission of data.

Written by: Thomas S. Crane and Kimberly J. Gold

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).

Mandated by the Affordable Care Act, the Sunshine Act creates a regulatory scheme requiring drug and device manufacturers and group purchasing organizations (GPOs) to report a variety of information about payments and other transfers of value to physicians and academic medical centers.  The first data reporting period was for August 2013 through December 2013, and this data is now available on the Open Payments website.

Unlike last year’s launch of the federal health insurance exchange website, the Open Payments website appears to be working smoothly.  CMS reported that the payment information includes over 4.4 million payments valued at nearly $3.5 billion.  More than 26,000 physicians and 400 teaching hospitals registered through the Open Payments data system.

Continue Reading A Brave New World of Transparency Reporting: CMS Launches Open Payments Website

Written by Kate Stewart

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and teaching hospitals. On Friday, August 15, CMS notified users and the Open Payments systems had re-opened.

CMS noted that the errors that led to the temporary shutdown were related to data errors that linked physicians with the same first and last name and intermingled their data in the reporting system. Though the initial CMS email announcing the re-opening of the Open Payments system did not address the volume of records flagged as incorrect during the shutdown, a CMS spokesperson noted that one-third of records submitted to Open Payments were being returned to manufacturers due to errors. Payments flagged as incorrect by CMS have been removed from the current data set and will not be published in this cycle of payment data.

Despite the temporary shutdown, CMS still plans to launch the Open Payments data publicly on September 30, 2014. Physicians and teaching hospitals now have until September 8, 2014 to review and dispute data reported about them. The correction period for disputed data, originally slated to end on September 11, 2014, will now run until September 23, 2014.

Written by:  Brian P. Dunphy

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act. The Open Payments system has encountered data issues and has been the subject of growing criticism from physician organizations and industry groups. The Centers for Medicare & Medicaid Services (“CMS”) recently announced that the Open Payments website went offline “temporarily to investigate a reported issue” involving incorrect data. The shutdown raises questions about CMS’s ability to make Sunshine Act data publicly available by its September 30, 2014 deadline and the accuracy of the reported data.

CMS has implemented a multi-step process for data reporting and validation under the Sunshine Act. During the first step, completed around June 30, 2014, Manufacturers covered by the Sunshine Act reported to CMS payments and transfers of value to physicians and teaching hospitals. Now that Manufacturers have submitted payment data, physicians and teaching hospitals (the payment recipients) are in the midst of a 45-day period during which they may register through Open Payments and review and dispute the data that Manufacturers have reported about them. Lastly, once the review and dispute process has ended, CMS will publicly release payment data by September 30, 2014.

Continue Reading CMS Temporarily Closes the Open Payments System

Written by: Kate Stewart

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine Act regulations.  On July 3, 2014 the Centers for Medicare & Medicaid Services (“CMS”) released its proposed rule on the 2015 Medicare Physician Fee Schedule (the “Proposed Rule”).  The Proposed Rule includes four proposed changes to the Sunshine Act’s reporting requirements based on feedback and experience from the first annual reporting period (covering August 1, 2013 to December 31, 2013).  If finalized, these four proposed changes would become effective on January 1, 2015 and would not apply to 2014 reports.

Continue Reading CMS Proposes Changes to Sunshine Act Reporting

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for Medicare and Medicaid Services (“CMS”) has issued additional guidance on Phase 2 reports. As is well known, the Sunshine Act (the “Act”) requires Applicable Manufacturers and GPOs to report certain financial relationships with physicians and teaching hospitals. The new guidance includes both technical guidance for preparing and uploading data submissions and an updated User Guide.

Continue Reading As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

Written by: Thomas S. Crane, Kimberly J. Gold and Ellyn L. Sternfield

The U.S. Department of Health and Human Services (HHS) announced on April 9th  a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and how much they are paid.”  The Centers for Medicare and Medicaid Services (CMS) declared its intent to make such data available in an April 2ndletter to the American Medical Association.  CMS stated on its blog that “[p]roviding consumers with this information will help them make more informed choices about the care they receive.”  The new data set covers more than 880,000 health care providers in all 50 states, the District of Columbia, and Puerto Rico, who collectively received $77 billion in Medicare payments in 2012 under the Medicare Part B Fee-For-Service program.

The data set includes information on the provision of services by physicians and how much they are paid for those services and is organized by provider (National Provider Identifier or NPI), type of service (Healthcare Common Procedure Coding System, or HCPCS, code), and place of service (either facility or non-facility). The data set also includes the number of services, average submitted charges, average allowed amount, average Medicare payment, and the number of unique beneficiaries treated.

To protect the privacy of Medicare beneficiaries, any aggregated records which are derived from 10 or fewer Medicare beneficiaries are excluded from the data set.

Continue Reading CMS Releases Physician Medicare Billing Data