Life Science Compliance Update

April 24, 2017

ACR Announces Health Policy Priorities

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On March 31, 2017, the American College of Rheumatology announced its 2017 health policy priorities, providing detailed policy recommendations to improve access to care and treatments for the millions of Americans living with arthritis and other rheumatologic diseases. 

The policy prescriptions come in the wake of a new Centers for Disease Control and Prevention report showing arthritis prevalence is at an all-time high. According to the report, roughly fifty-four million Americans – one in four people – now live with arthritis, and they estimate that approximately seventy-nine million Americans will have arthritis by the year 2040.

“As the alarming CDC data indicates, now more than ever we need policies that ensure the one-quarter of Americans living with arthritis can access and afford specialized care,” said Sharad Lakhanpal, MD, MBBS, President of the American College of Rheumatology.

While the demand for arthritis care is growing, the pool of U.S. rheumatologists – doctors who provide specialized care to Americans living with arthritis and other rheumatologic diseases – is shrinking as more rheumatologists retire from the profession and fewer new doctors enter the rheumatology subspecialty. According to the ACR’s 2015 workforce study, the demand for rheumatology care exceeded the supply by 36 percent for adult rheumatologists and 33 percent for pediatric rheumatologists in 2015 – a gap that is projected to widen to 138 percent and 61 percent respectively by 2030.

The ACR’s policy priorities for 2017 include actions that Congressional and Administration leaders can take to ensure a thriving rheumatology workforce, as well as to address current healthcare access and affordability issues.

The ACR’s policy priorities for 2017 include:

  • Healthcare reform legislation that prioritizes affordable coverage for chronically ill patients, including coverage for Americans with pre-existing conditions, limits on out-of-pocket costs, and tax credits based on income. 
  • Repeal of the Independent Payment Advisory Board, an agency created under the Affordable Care Act (ACA) that has the power to impose arbitrary payment cuts on medical providers. These cuts would disproportionately impact small and rural rheumatology practices already struggling to stay financially viable.
  • Appropriate MACRA implementation, including optimizing the Merit-Based Incentive Payment System for rheumatology care and supporting a rheumatology-inclusive Alternative Payment Model.
  • Proper valuing of cognitive specialty care, including new ICD-10 service codes that more adequately reflect rheumatology care in reimbursement.
  • Adequate funding for FDA biosimilars review, to ensure the introduction of additional safe and effective therapies and lower biologic drug costs. 
  • Limits on overly restrictive insurance practices, including step therapy, prior authorization and specialty drug tiers.
  • Adequate insurance coverage for biologic therapies, including coverage of administration for complex drugs, and Medicare coverage of reimbursement at true ASP+6%.
  • Increased medical research funding for rheumatic diseases, including arthritis medical research funded by the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense.
  • Interventions to address the rheumatology workforce shortage, including Medicare funding for general Medical Education, funding for additional rheumatology fellowship positions, and support for the Pediatric Subspecialty Loan Repayment Program.

“We look forward to working with Congressional leaders and the Administration to advance policies that ensure access to high-quality, specialized care for the 54 million Americans living with chronic and debilitating rheumatologic diseases,” concluded Lakhanpal.

You can find the full text of the ACR 2017 Health Policy Statements here.

TEVA - Using Legitimate Distributor Payments to Conceal Bribes

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On December 22, 2016, the Securities and Exchange Commission (SEC) announced that Teva Pharmaceutical Industries Limited had agreed to pay more than $519 million to settle parallel civil and criminal charges that it violated the Foreign Corrupt Practices Act (FCPA) by paying bribes to foreign government officials in Russia, Ukraine, and Mexico. The interesting aspect of this settlement is as the government alleges, the bribes were concealed in the form of legitimate payments to distributors.

It has been a long time coming. The U.S. Department of Justice (“DOJ”) and the Securities and Exchange Commission (“SEC”) have been investigating the Israeli drug giant, Teva Pharmaceutical Industries Limited (“Teva”) for alleged Foreign Corrupt Practices Act (“FCPA”) violations since 2012. Four years later and right before Obama left office, the SEC finally announced a settlement with Teva.

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Eighth Aggregate Spend and Sunshine Act Conference

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On June 15th and 16th, 2017, the Eighth Aggregate Spend and Sunshine Act Conference will be held at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA. The conference has proven to be industry’s leading educational event where compliance and reporting professionals convene to discuss past submissions and upcoming changes in order to better prepare for the future.

The conference focuses on the Physician Payments Sunshine Act, which was intended to advance the life sciences industry standard of transparency, but the ambiguity of current regulatory principles continues to puzzle compliance and reporting professionals, leaving them with more questions than solutions. In addition to those issues, the actual collection of aggregate data is challenging for departments across organizations, further complicating even the most effortless tasks. Through interactive discussions and expert presentations, the conference will provide attendees with the tools needed to leverage data analytics and elevate daily operations.

Some of the conference’s featured speakers include:

  • Amie Phillips Pablo, Novo Nordisk Inc;
  • Michael O’Connor, Alexion Pharmaceuticals, Inc.;
  • Richard Velardi, Sun Pharma;
  • Michael Hunn, Draeger Medical;
  • Ishita Arora, Horizon Pharma, LLC; and
  • Gretchen Reyes Cseplo, Convatec.

According to ExL Events, the top five reasons to attend are: you will learn how to (1) uncover ways to optimize your organization’s daily operations using aggregate spend data required by the Sunshine Act; (2) comply with new CMS documentation guidelines surrounding aggregate spend reporting; (3) effectively communicate with healthcare providers across national and global data reporting landscapes; (4) consider frameworks for conducting internal audits designed to measure success; and (5) discuss best practices for leveraging your data analytics to assess compliance risk.

If you are interested in attending, you can register here.

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