Life Science Compliance Update

June 29, 2015

Majority of House of Representatives Support 21st Century Cures

The Energy and Commerce Committee has announced that two hundred and thirty bipartisan members of Congress have added their names as co-sponsors of H.R. 6, the 21st Century Cures Act, signaling the continued support for the bill.

On May 21, 2015, the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act—a 300 page bill reflecting a year-long legislative process to bring drug and device regulations up-to-date with current medical innovation. Co-sponsored by House Commerce Committee Chair Fred Upton (R-Texas) and Rep. Diana DeGette (D-Colo.), the bill focuses on the life-cycle of getting new treatments and cures to patients—from discovery, to development, to delivery.

Among the dozens of provisions, H.R. 6 provides significant funding to both the Food and Drug Administration and the National Institutes of Health, seeks to streamline clinical trials and accelerate the approval of safe and effective treatments, aims to incorporate the patient perspective into medical developments, and seeks to advance personalized, or precision medicine. Precision medicine allows doctors to use a patient’s DNA to fight diseases, by customizing gene therapy to each individual patient. The bill also seeks to modernize the regulations surrounding communication from manufacturers to healthcare providers and payers. 

The legislation has received letters of support from hundreds of organizations, including patient groups, the Association of American Medical Colleges, sixty-seven cancer institutes, and seventy-five research, life sciences, and patient advocacy organizations.

We will continue to follow the developments of the Cures Act as it makes its way through the legislative process. 

June 17, 2015

E&C Committee Requests Government Accountability Office Look Into CMS's Fraud Prevention System


Bipartisan leaders of the House Energy and Commerce and House Ways and Means Committees on Monday sent a letter to the Government Accountability Office (GAO) requesting a review of the Fraud Prevention System (FPS) at the Centers for Medicare and Medicaid Services. The FPS was implemented in July 2011 in an effort to more proactively prevent fraud in the Medicare program, as opposed to a “pay and chase” approach that still provides the bulk of the enforcement activities.

The leaders explain, “GAO has previously identified key practices for using predictive analysis systems, including leveraging the results of predictive analysis to address service- or system-specific weaknesses that can lead to payment errors, such as gaps in prepayment edits. It is unclear whether CMS is using FPS to identify these broader program vulnerabilities in Medicare and taking action based on these vulnerabilities throughout the program.”

The letter requests GAO study the following questions:

  • What types of potentially fraudulent payments have been denied by FPS prepayment edits, and how do the FPS prepayment edits differ from those implemented by the Medicare Administrative Contractors?
  • How many administrative actions has CMS taken against providers since 2010, what types of actions were taken, and how many of these actions were a direct result of FPS? How do these actions compare with non-FPS-initiated actions?
  • How has the FPS led CMS to identify program vulnerabilities that could lead to payment errors, and what steps has CMS taken to address any identified vulnerabilities.
  • What percentage of savings attributable to FPS are also attributable to prepayment  denials compared to post-payment recoveries? How do these savings compare with other traditional program integrity efforts?
  • What are CMS’s plans for using FPS with Medicaid and the Children’s Health Insurance Program (CHIP) as directed under federal statute? If this is unworkable due to the nature of Medicaid and CHIP claims, what is a recommended alternate approach?
  • How do the program outlays for FPS compare with the actual and projected savings attributable to FPS-initiated actions?

The letter was signed by:

  • Energy and Commerce Committee Chairman Fred Upton (R-MI)
  • Ways and Means Committee Chairman Paul Ryan (R-WI)
  • Energy and Commerce Subcommittee on Oversight and Investigations Chairman Tim Murphy (R-PA)
  • Ways and Means Subcommittee on Oversight Chairman Peter Roskam (R-IL)
  • Energy and Commerce Subcommittee on Health Chairman Joe Pitts (R-PA)
  • Ways and Means Subcommittee on Health Chairman Kevin Brady (R-TX)
  • Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ)
  • Ways and Means Committee Ranking Member Sander Levin (D-MI)
  • Energy and Commerce Subcommittee on Oversight and Investigations Ranking Member Diana DeGette (D-CO)
  • Ways and Means Subcommittee on Oversight Ranking Member John Lewis (D-GA)
  • Energy and Commerce Subcommittee on Health Ranking Member Gene Green (D-TX)
  • Ways and Means Subcommittee on Health Ranking Member Jim McDermott (D-WA)

The Energy and Commerce Subcommittee on Oversight and Investigations held a hearing in early June to discuss a report from GAO on fraud in the Medicaid program, entitled, “Additional Actions Needed to Help Improve Provider and Beneficiary Fraud Controls.” 

GAO’s report “found thousands of Medicaid beneficiaries and hundreds of providers involved in potential improper or fraudulent payments during fiscal year 2011 – the most-recent year for which reliable data were available in four selected states: Arizona, Florida, Michigan, and New Jersey. These states had about 9.2 million beneficiaries and accounted for 13 percent of all fiscal year 2011 Medicaid payments.”


  • About 8,600 beneficiaries had payments made on their behalf concurrently by two or more of GAO's selected states totaling at least $18.3 million, even though federal regulations do not permit beneficiaries to have payments made on their behalf by two or more states concurrently
  • The identities of about 200 deceased beneficiaries received about $9.6 million in Medicaid benefits subsequent to the beneficiary's death.
  • About 50 providers were excluded from federal health-care programs, including Medicaid, for a variety of reasons that include patient abuse or neglect, fraud, theft, bribery, or tax evasion.

House Energy and Commerce Subcommittee on Oversight and Investigations chair Rep. Tim Murphy (R-PA) noted, “Last year the Medicaid program provided medical services for approximately 60 million people at a cost of $310 billion. But during that same year, the Centers for Medicare and Medicaid Services estimated that the improper-payment rate was 6.7 percent or $17.5 billion. This is an increase of almost 1 percent or over $3 billion from the previous year.

This is a troubling trend, especially as the program continues to expand.” Full committee Chairman Fred Upton (R-MI) said, “Medicaid is supposed to provide our most vulnerable with vital medical services, but continued waste and fraud undermines this important goal.” Dr. Shantanu Agrawal, Deputy Administrator and Director of the Center for Program Integrity at CMS, testified about steps currently being taken by CMS to reduce waste, fraud and abuse, but agreed that continued oversight is essential. Dr. Agrawal told Rep. Joseph Kennedy (D-MA), “Holding our feet to the fire is appropriate.”




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