Life Science Compliance Update

December 01, 2017

Trump Nominates Alex Azar to Head HHS 

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A few weeks ago, President Donald Trump nominated Alex Azar to lead the Department of Health and Human Services (HHS), following in the footsteps of Tom Price. The nomination – announced where else other than Twitter – said “Happy to announce, I am nominating Alex Azar to be the next HHS Secretary. He will be a star for better healthcare and lower drug prices!” 

Azar has a history of involvement in the pharmaceutical world, including serving as HHS General Counsel and Deputy HHS Secretary under President George W. Bush. Mike Leavitt, the HHS Secretary when Azar was Deputy had kind words about his former colleague, noting, “He’s precise, highly motivated, he has high standards for performance for himself and for other people. He had full responsibility as deputy secretary for the regulatory processes at HHS.” 

As HHS general counsel, Azar worked on the administration’s response to the 9/11 terrorist attacks and the ensuing anthrax attacks, stem-cell policy and the advent of the Medicare prescription drug benefits. During his tenure as deputy secretary, he pushed for greater disclosure of prices associated with medical services to help foster competition and contain costs. He also backed converting medical records to electronic form. He was confirmed for those previous positions by unanimous voice vote. 

Azar recently spent five years at Eli Lilly, which makes several blockbuster medications, including the antidepressant Cymbalta and several forms of insulin. Insulin prices have drawn widespread ire because they keep spiraling higher, even though insulin has been around almost a century. During his tenure at Lilly, Azar sat on the Board of Directors of the Biotechnology Innovation Organization (BIO).  

"Drug corporations have undue influence over health policy in America, and they use it to make money on the backs of patients and taxpayers," said Ben Wakana, executive director of Patients For Affordable Drugs, an advocacy group. Even still, Wakana supports Azar and believes that he has a good history, "Mr. Azar is well-qualified and has the chance to stand up for patients because he knows exactly how our drug pricing system is broken. If he wants to take meaningful action to lower drug prices, we want to help him." 

Azar currently serves on the board of HMS Holdings, a Texas company that helps health insurance companies cut costs, and runs his own biotech and health insurance consulting company, Seraphim Strategies. 

Congressional Reaction 

Senate Majority Leader Mitch McConnell: “Alex brings a wealth of private and public sector knowledge that will prepare him well for this crucial role. The Secretary of HHS oversees some of the nation's most important programs, including Medicare and Medicaid in addition to safeguarding public health at the Centers for Disease Control, advancing cures at The National Institutes of Health, and working through the Food and Drug Administration to get those cures to patients. I look forward to meeting with him soon to discuss his outlook and vision for the department, particularly the opioid epidemic that has hurt so many Kentuckians and so many Americans across the country.” 

Speaker of the House Paul Ryan: “Alex Azar is an experienced and highly capable leader who knows what it takes to tackle big challenges in health care. The Senate should swiftly confirm him as our next @HHSGov secretary.” 

Advocacy Groups in Support 

There are many advocacy groups and commentators who support Azar’s appointment. A few are sampled below.  

American Hospital Association President and CEO Rick Pollack: “We welcome the nomination of Alex Azar to be Secretary of the Department of Health and Human Services (HHS). We are confident that his extensive background in business, health care and medicine distinguishes him as a uniquely qualified candidate for the vacancy. The expertise garnered from his career in the private sector and prior public service at HHS as Deputy Secretary will prove to be particularly valuable in addressing the serious challenges facing our nation's health care system today. We look forward to working side-by-side with him to achieve our mission of advancing the health of the patients and communities we are privileged to serve.”  

Politico Healthcare Editor Adriel Bettelheim:“Azar built a reputation as a pragmatist during stints as HHS deputy secretary and general counsel in the George W. Bush administration.” 

Doctor Roger Klein:“I applaud President Trump’s nomination of Alex Azar to lead the Department of Health and Human Services. As a former Deputy HHS Secretary and attorney with extensive private sector business experience, he brings the necessary skills and expertise to confront the disruption and dislocation the Affordable Care Act has caused. Alex Azar’s appointment will add stability to HHS, and help improve healthcare for millions of Americans.” 

 What Does the Future Hold 

Republicans predicted that, if confirmed, Azar would pursue Trump’s goals to tilt health-care policies in a more conservative direction through executive action. Leading Democratic health policy experts, while not sharing Azar’s views, said he is well qualified for the post.   

In today’s world, predictability is sparse, but based on past comments and statements, it is possible that Azar will attempt to move authority to the states over Medicaid, turning over the program to the states to make them “better stewards of the money.” He has previously alluded to a path forward by having HHS use its regulatory powers to allow states to customize the rules around Medicaid. Seema Verma, the CMS Administrator, also favors giving states waivers to create their own Medicaid Systems.   

However, where Azar stands on the issue that has just about everyone all riled up – drug prices – is much less clear. While drug prices were a hot topic during the 2016 presidential campaign, President Trump has not made it a priority this year. Interestingly, he did mention drug prices when announcing Azar’s nomination on Twitter.  

The White House believes that Azar’s combination of public and private sector experience will serve him well at a time when the administration is seeking big changes to Obamacare and regulatory agencies like the FDA.  

October 31, 2017

United States Senate Focuses on Opioids

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Senate Finance Committee Chairman Orrin Hatch, along with 10 of his Republican Committee colleagues, recently called on the Department of Health and Human Services (HHS) to increase safeguards against opioid fraud. In the letter, the senators request information about HHS’ measures to prevent opioid abuse among Medicare Part D providers and beneficiaries.

The letter requests details regarding the HHS Office of Inspector General’s (OIG) report issued last July, which found that one in three Medicare Part D beneficiaries received a prescription opioid in 2016 – as many as 500,000 of those beneficiaries were receiving high amounts of opioids and nearly 90,000 beneficiaries were deemed to be at serious risk. The report also identified roughly 400 prescribers with questionable opioid prescription patterns for those beneficiaries at serious risk.

The senators requested additional information of HHS regarding the OIG’s findings, including information on the most prevalent opioid related fraud schemes identified in the report; prevention efforts HHS intends to undertake in the wake of these findings; along with a request for specific congressional recommendations as to additional authority that may be needed to protect beneficiaries and prevent fraud and abuse of opioids. The senators also request further detail regarding the 400 prescribers with questionable opioid prescription patterns and the subsequent actions HHS intends to take to follow-up with these prescribers.

Finally, the lawmakers request increased engagement of HHS with the Committee to address the epidemic, including a discussion of potential regulatory and/or legislative actions in this vein. Specifically, the letter request that “HHS officials engage with the Committee on policy options including, but not limited to, review of Medicare and Medicaid payment incentives related to treatment of pain and addiction.”

The Committee’s letter came in conjunction with the recent Senate Health, Education, Labor and Pensions (HELP) hearing on the opioid epidemic at which a number of HHS officials testified, including Scott Gottlieb, MD, Commissioner of the FDA.

During the hearing, the HHS members noted that five-point Opioid Strategy the Agency has implemented, which provides the overarching framework to leverage the expertise and resources of HHS agencies in a strategic and coordinated manner. The comprehensive Opioid Strategy aims to:

  • Improve access to prevention, treatment, and recovery support services to prevent the health, social, and economic consequences associated with opioid addiction and to enable individuals to achieve long-term recovery;
  • Target the availability and distribution of overdose-reversing drugs to ensure the broad provision of these drugs to people likely to experience or respond to an overdose, with a particular focus on targeting high-risk populations;
  • Strengthen public health data reporting and collection to improve the timeliness and specificity of data and to inform a real-time public health response as the epidemic evolves;
  • Support cutting-edge research that advances our understanding of pain and addiction, leads to the development of new treatments, and identifies effective public health interventions to reduce opioid-related health harms; and
  • Advance the practice of pain management to enable access to high-quality, evidence based pain care that reduces the burden of pain for individuals, families, and society while also reducing the inappropriate use of opioids and opioid-related harms.

July 12, 2017

Prices Testifies On Proposed Budget Cuts

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We continue to follow the President’s budgets with potential cuts to the NIH and possible legislation to address drug prices. With that in mind, HHS Secretary Tom Price’s testimony in front of a House appropriations subcommittee is particularly relevant. The head of HHS reiterated his support for the President’s cuts to NIH and noted that he is working on a plan to lower the cost of drugs in the United States. Chairman Tom Cole’s (R-Okla.) remarks before Price’s testimony can be found here.

Price’s testimony

The Secretary faced a number of questions regarding the promotion of Obamacare plans along with drug prices and NIH funding. On the funding of the NIH, Price argued the agency could be trimmed by cutting “inefficiencies,” such as overhead payments. As has been reported, “About 30% of the grant money that goes out is used for indirect expenses, which as you know means that money goes for something other than the research that's being done,” Price said. The Trump budget, he explained, is “trying to … be the first step in this process” of getting “a bigger bang for our buck.”

In 2016, NIH paid $6.4 billion in overhead costs on top of the $16.9 billion in extramural funds to support the direct costs of research projects and other awards. Price’s comments were echoed by Representative Andy Harris (R–MD), who noted that many private foundations limit overhead payments to grantees to 10%, whereas others, such as the American Lung Association, pay nothing. “It’s very interesting that the private sector doesn’t hold these indirect costs to be so valuable as to pay them,” Harris said.

Rep. Tom Cole, who chairs the appropriations subcommittee that oversees HHS, told Price that current levels of proposed cuts to the NIH and CDC are highly unlikely to be supported by Congress. He said NIH and the Centers for Disease Control and Prevention are every bit as important as national defense. "Frankly, you're much more likely to die in a pandemic than you are in a terrorist attack," said Cole, adding: "I'd rather fight Ebola (the deadly virus) in West Africa than in West Dallas."

Regarding drug prices, Regulatory Focus described Price’s reference to President Trump’s planned “bidding” system, although he did not elaborate on Trump’s call to double user feeds in an effort to offset budget cuts to the FDA.

Price also critiqued the structure of the current Medicaid program during the hearing, calling the system "broken" because it focuses too much on funding and not enough on ensuring beneficiaries achieve better health outcomes. It has been previously noted that Price has expressed support in the past for requiring Medicaid beneficiaries to pay premiums in exchange for program participation and lowering those premiums depending on beneficiaries meeting healthy behavior requirements, such as getting physicals.

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