Life Science Compliance Update

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.”

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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