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.  

August 15, 2017

President Trump Declares Opioid Crisis a National Emergency

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Working off of the recent recommendations in the interim report issued by the President’s Commission on Combating Drug Addiction and the Opioid Crisis, President Donald Trump has issued a directive to his administration to use all “appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

Some of the immediate actions the Trump administration could take to address the opioid crisis include: (1) approve state waivers to remove the Medicaid Institutions for Mental Diseases (IMD) exclusion, which prohibits the use of federal Medicaid funds for care provided to most patients in mental health and substance use disorder residential treatment facilities larger than 16 beds; (2) negotiate lower prices for naloxone (the drug that reverses opioid overdoses) as suggested by the Commission; and (3) distributing some of the $45 million in the Public Health Emergency Fund. Earlier this week, President Trump suggested the administration would combat the epidemic by focusing on law enforcement and security on the southern border to stop illegal drugs from entering the country.

The emergency declaration may allow the government to deploy the U.S. Public Health Service, a uniformed service of physicians and other staffers that can target places with little medical care or drug treatment, said Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. He said the DEA might be able to use the emergency to require prescriber education for doctors and others who dispense opioids.

This comes after several states (Arizona, Florida, Maryland and Virginia) have already declared emergencies. And in recent months, the Centers for Disease Control and Prevention, the Food and Drug Administration, Congress, physician groups and the insurance industry have taken institutional steps to address the crisis. At the street level, police, firefighters and paramedics now routinely carry naloxone.

Health and Human Services Secretary Tom Price, M.D. issued the following statement on President Donald Trump’s instruction to his Administration to use all appropriate authority to respond to the nation’s opioid emergency:

President Trump is taking strong, decisive action in directing the Administration to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic. Today’s announcement demonstrates our sense of urgency to fight the scourge of addiction that is affecting all corners of this country.

Traveling the country, we have seen firsthand the devastation this crisis is inflicting on individuals, families, and communities. President Trump’s announcement further punctuates his clear commitment to combating this epidemic and I thank him for his leadership.

Attorney General Jeff Sessions also released a statement,

I applaud President Trump for his leadership in taking this drastic and necessary measure to confront an opioid crisis that is devastating communities around the country and ripping families apart. The death toll of this horrific epidemic reached 60,000 people in 2016, but as horrible as it is to think of that number, it is worse when we look past the staggering statistic and see our children, our moms and dads, sisters and brothers, friends and co-workers. This nation has never seen overdose deaths anywhere close to these numbers, and for each death, many more suffer debilitating addictions.

Just last week the Department of Justice announced its new Opioid Fraud and Abuse Detection Unit and we continue to follow the President’s lead and use every tool we have to combat this deadly crisis.

August 02, 2017

Opioid Commission Interim Report - Calls for Mandatory CME for Opioid Prescribers

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The White House’s Commission on Combating Drug Addiction and the Opioid Crisis (Opioid Commission) has issued an interim report, which offers recommended actions for President Trump to take now, with more recommendations planned for the fall of 2017. The headline-creator of the report was the recommendation to President Trump that he declare the opioid epidemic a national public health emergency and expedite funds and resources to stop the crisis.

The Opioid Commission discussed its outreach to individuals and organizations, including all fifty Governors and bipartisan members of Congress, providers, insurers and medical and treatment societies.  It has received more than 8,000 comments from the public, including comments from at least fifty organizations.

Overprescribing of opioid pain relievers has been widely viewed as the leading cause for the rise in opioid-related substance abuse cases and overdose deaths over the past decade. Opioids accounted for more than 63% of the more than 52,000 drug overdose deaths that occurred in the U.S. in 2015, according to the Centers for Disease Control and Prevention. Among opioid-related deaths, more than 15,000 involved the use of a prescription opioid.

The commission advised Trump to enforce current federal law and to ensure that health plans do not impose less favorable benefits for particular diagnoses, including those surrounding mental health and substance abuse.

"This is simply an issue of equity and medical civil rights so that patients who have an illness not unlike any other chronic illness are not treated differently by their insurers," said former Rep. Patrick Kennedy, a member of the commission. "I believe a lot of the denial we are seeing in insurance coverage stems from the overall denial that our country is living in when it comes to this healthcare crisis."

Recommendations of the Opioid Commission include:

  • Rapidly increase treatment capacity and grant waiver approvals for all 50 states to quickly eliminate barriers to treatment resulting from the federal Institutes for Mental Diseases (IMD) exclusion within the Medicaid program;
  • Mandate prescriber education initiatives by working with medical and dental schools across the country;
  • Mandate medical education training in opioid prescribing and risks of developing an SUD by amending the Controlled Substance Act to require all Drug Enforcement Administration (DEA) registrants to take a course in proper treatment of pain;
  • Establish and fund a federal incentive to enhance access to Medication Assisted Treatment (MAT). Require that all modes of MAT are offered at every licensed MAT facility and that those decisions are based on what is best for the patient. Partner with the National Institutes of Health (NIH) and the industry to facilitate testing and development of new MAT treatments;
  • Provide model legislation for states to allow naloxone dispensing via standing orders, and require the prescribing of naloxone with high-risk opioid prescriptions;
  • Equip all law enforcement in the United States with naloxone to save lives;
  • Prioritize funding and manpower to the Department of Homeland Security’s Customs and Border Protection, the DOJ Federal Bureau of Investigation, and the DEA to quickly develop fentanyl detection sensors and disseminate them to federal, state, local, and tribal law enforcement agencies;
  • Support federal legislation to staunch the flow of deadly synthetic opioids through the U.S. Postal Service;
  • Provide federal funding and technical support to states to enhance interstate data sharing among state-based prescription drug monitoring programs (PDMPs) to better track patient-specific prescription data and support regional law enforcement in cases of controlled substance diversion;
  • Regulate and better align patient privacy laws to ensure that information about SUDs be made available to medical professionals treating and prescribing medication to a patient; and
  • Enforce the Mental Health Parity and Addiction Equity Act (MHPAEA) with a standardized parity compliance tool to ensure health plans cannot impose less favorable benefits for mental health and substance use diagnoses verses physical health diagnoses.

The Opioid Commission notes that in its final report in the fall, it will “provide an additional set of detailed recommendations that, if implemented, will ensure that the Federal Government operates as a strong partner in the fight against addiction and the opioid crisis.”

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