Tag Archives: Open Payments

OIG Issues 2017 Work Plan – PAMA, Open Payments, Drug Manufacturer Rebates Among Areas of New Focus

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various HHS programs. For example:

  • There are at least three new areas of review related to each skilled nursing facilities and hospice.
  • OIG will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).
  • OIG will conduct a review of the data reported to Open Payments under the Physician Payments Sunshine Act. Among other things, OIG intends to determine the volume and total dollar amount for drugs, devices and medical equipment ordered by physicians under Medicare Parts B and D who are contained in the Open Payments reports.
  • OIG will conduct an analysis to determine the amount the federal government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B. This analysis builds on prior OIG analyses.
  • OIG also will conduct an analysis to determine the amount the federal government could potentially save if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.

Pharmaceutical and medical device companies, clinical laboratories and other health care entities should carefully review the OIG 2017 Work Plan to determine areas of government focus. The Work Plan often serves as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring. Additionally, reports issued by the OIG after a review are a valuable resource regarding the OIG’s current analysis of industry activities.

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Open Payments Changes On the Horizon?

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:

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CMS Releases Improved Open Payments Website, Refreshed Open Payments Data

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.

Open Payments snapshot

 

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CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and transfers of value related to continuing medical education (CME). As we previously discussed, there has been confusion in the industry regarding CMS’ changes to reporting requirements for CME beginning in January 1, 2016, which were implemented as part of the 2015 Medicare Physician Fee Schedule. In sum, CMS reiterated that it expects applicable manufacturers to report payments and other transfers of value related to CME if the payment or transfer of value meets the definition of “indirect payment” and the manufacturer “knows or finds out the identity” of the physician speakers and/or attendees within the reporting year or by the end of the second quarter of the following reporting year. “Indirect payment” is defined as “a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.”

There remains some concern among industry regarding its obligation to identify physician speakers and attendees. Although CMS uses in several instances the “knows or finds out the identity of” language, one FAQ uses slightly different and potentially more problematic language – “knows or can determine the identity of the covered recipient.”

CMS also released last week another round of Open Payment FAQs primarily related to its June 30, 2015 release of data. The new FAQs are the following:

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2014 Open Payments Infographic

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

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Minimal Media Interest to Date in Recently-Released Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released last week the 2014 Open Payments data, the first release of data reported by applicable manufacturers and group purchasing organizations (GPO) for a full calendar year. Notably, the media response has been minimal to date:

  • Large media outlets, including the Wall Street JournalNew York Times, Washington Post, the Associated Press and Reuters, released articles on the same day as the data was published, which focused on the $6.5 billion in payments and transfers of value to physicians and teaching hospitals reported by applicable manufacturers and GPOs. This information also has been republished by smaller news outlets.
  • ProPublica and NPR each published a more detailed analysis of the data, focusing on which companies reported the highest level of spend, the payment categories with the highest level of reported payments, physicians who received an extraordinary number of payments or transfers of value over the course of the year, and other data outliers.
  • ProPublica and NPR also each released articles discussing payments and transfers of value that are noticeably lacking from the Open Payments database – payments to nurse practitioners and physician assistants.
  • Bloomberg published an article regarding a physician that failed to disclose $138,000 in payments from a pharmaceutical company in connection with a scientific journal publication.

 

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Key Takeaways from Government Enforcement Panel at ACI Sunshine Conference

Today, representatives from the United States Attorney’s Office for the Northern District of Georgia, United States Attorney’s Office for the District of New Jersey, and Medicaid Fraud Control Unit (MFCU) for the Office of the Attorney General of New York spoke to industry participants at the ACI 7th Advanced Forum on Sunshine Act, Open Payments, and Aggregate Spend Compliance. The robust dialogue included several key takeaways that health care entities should note:

Data Mining. As we previously discussed here, the government uses data mining and other analytics to assist in evaluating and developing cases, such as matters brought to the government’s attention by a qui tam relator or in connection with the review of a particular industry. Although the MFCU teams are prohibited from proactive data mining not associated with a particular matter or investigation plan, federal investigators are encouraged to use the data to proactively identify potential fraud and abuse. According to the panelists, the government has used claims data for data mining and analytics for some time, which will play “an even greater role” in investigations moving forward. Similarly, use of the Open Payments data will continue to increase as the offices become more skilled at working with this data.

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