Life Science Compliance Update

February 15, 2018

House Holds Hearing on Opioid Crisis


On January 17, 2018, the House Ways and Means Subcommittee on Oversight held a hearing entitled “The Opioid Crisis: The Current Landscape and CMS Actions to Prevent Opioid Misuse.” The hearing focused on efforts by the Centers for Medicare and Medicaid Services (CMS) to utilize data to identify high risk individuals in the Medicare Part D program who are likely to abuse opioids. The hearing also examined the extent of the problem as well as the tools and programs CMS has used to protect individuals with substance abuse issues and to prevent physicians from over-prescribing.

The Committee heard testimony from a three-person panel, all of whom shared progress reports regarding steps the agency has taken to address different aspects of the opioid crisis. Discussion at the hearing largely focused on the desire to pass bipartisan legislation to address the opioid crisis as well as to determine best practices to identify over-prescribers and reduce instances of fraud.

Opening Statements

Chairwoman Lynn Jenkins opened the hearing by highlighting statistics regarding rising opioid related overdose death rates in her home state of Kansas. She went on to state that the “immense cost opioids impose on society” have caused a loss of productivity and put undue burden on the U.S. economic system. To lessen this burden, Jenkins stressed the importance to provide Medicare, specifically private Part D plan sponsors, the tools they need to ensure that opioids are provided only when medically necessary.

Full Committee Ranking Member Richard Neal mainly focused on the effect the opioid epidemic has on Medicare beneficiaries and negative impact on labor participation rates around the country. In the face of a looming expiration of the Administration’s public health emergency declaration, Neal voiced his frustration that there has not been “positive action” taken to find a solution to opioid overuse.

Witness Testimony

Gary L. Cantrell, Deputy Inspector General for Investigations at the Department of Health and Human Services (HHS), highlighted the work at the Office of the Inspector General (OIG) in restricting vulnerable beneficiaries’ access to drugs by identifying and apprehending physicians and pharmacies who inappropriately or unnecessarily prescribe opioids. He explained that opioid related fraud encompasses a broad range of criminal activity that the OIG, in tandem with state and federal law enforcement officials, has focused on recently.

Elizabeth H. Curda, Director of Health Care at the Government Accountability Office (GAO), explained how CMS developed a “misuse” strategy to oversee opioid prescribing in the Medicare program. She explained that CMS relies on private insurers – known as plan sponsors – to be alerted of “high-risk” beneficiaries, or beneficiaries receiving opioid prescriptions from four or more prescribers. After a high-risk beneficiary is identified, she said, plan sponsors are alerted, identify a plan of action, and respond to CMS within thirty days of the alert.

Kimberly Brandt, Principal Deputy Administrator for Operations at CMS, explained how CMS oversees efforts from Medicare Part D sponsors to work with prescribing physicians in an attempt to identify improper opioid utilization. Brandt explained that this is done by using utilization monitoring systems to identify high-risk beneficiaries and then alerting pharmacies of the patient’s status.

Committee Discussion

Tracking High-Risk Beneficiaries

Chairwoman Jenkins voiced her concern that CMS only tracks a small portion of the at-risk population when attempting to determine high-risk beneficiaries. Ms. Curda agreed and noted that beneficiaries who are receiving large doses of opioids should be tracked, regardless how many doctors or pharmacies they have visited. It was suggested that current monitoring by CMS is insufficient, with nearly three-quarters of a million beneficiaries receiving high-level doses of opioids being overlooked and at risk for falling victim to addiction or overdose death.


Fraud in Treatment Programs

Representatives Pat Meehan and Carlos Curbelo expressed interest in the most common health care fraud schemes surrounding the opioid crisis. Mr. Cantrell explained that the most common fraud schemes are seen in “sober houses” where addicts go to receive treatment. Patients are often farmed out to corrupt doctors to receive lab testing and other expensive and unnecessary treatments, he explained. He said there have also been cases of individuals selling expensive medications back to pharmacies or on the black market, and unethical prescribers who receive kickbacks from pharmacies as a reward for prescribing certain addictive drugs. Mr. Cantrell attributed this to a lack of resources for law enforcement officials to address every fraud case that comes through the system.

Potential Legislative Solutions

Throughout the hearing, members on both sides of the aisle promoted bipartisan legislation to address the opioid epidemic. Representative Judy Chu advocated for Ensuring Access to Quality Sober Living Act of 2017 (H.R. 4684), a bill she sponsored in hopes to develop a set of best practices for sober living communities. Chu also highlighted details of the Acupuncture for Heroes and Seniors Act of 2017 (H.R. 2839), a bill she sponsored in an effort to advocate for alternative treatment options, particularly acupuncture, to be covered through Medicare.

Meanwhile, Representative David Schweikert spoke in support of the Comprehensive Opioid Abuse Reduction Act of 2016, which was signed into law in 2016. He claimed the bill would act as a mechanism to standardize the prior authorization process and promote the use of pharmaceuticals with less addictive tendencies.

February 02, 2018

FDA REMS Blueprint on Opioids Finalized


On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (non-opioid analgesic and opioid analgesic).  This REMS represents a major upgrade from the current ER-LA Opioid REMS and includes all Opioid Manufacturers.

Ever since the Opioid Policy Steering Committee was established the FDA has been working to evaluate different policy efforts to combat the emergency. According to FDA Commissioner Dr. Scott Gottlieb, “At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use.”

The Blueprint aims to educate health care providers on safe opioid practices, as well as current Federal and state regulations, national guidelines, and professional organization and medical society guidelines on treating pain and prescribing opioids.

The Blueprint begins with an overview on pain management, including intelligence behind the need for comprehensive pain education, definitions and mechanisms of pain, and how to assess patients in pain.

From there, it goes on to help providers learn how to create a pain treatment plan, customized to the needs of the individual patient and including the types of therapies planned, the goals of treatment, and an explanation of the patient and prescriber roles and responsibilities. It further notes that if HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat patients with pain, attempts should be made to address these barriers. The overall treatment approach and plan should be well documented in the patient record, including written agreements and informed consent/patient provider agreements that reinforce patient-provider responsibilities and avoid punitive tones.

The section about creating a pain treatment plan includes sections that outline: components of an effective treatment plan, general principles of nonpharmacologic approaches, general principles of pharmacologic analgesic therapy, managing patients on opioid analgesics, and a primer on addiction medicine.

FDA is making the FDA Blueprint, which will be approved as part of the Opioid Analgesic REMS, available on the REMS@FDA Website (, where it will remain posted for use by CE providers as they develop the CE materials and activities. A list of the REMS-compliant CE activities supported by unrestricted educational grants from the opioid analgesic companies to accredited CE providers will be made available when the Opioid Analgesics REMS is approved.

Other FDA Actions

On the same day the FDA released the new Blueprint, the Agency also hosted a meeting entitled, “FDA’s Opioid Policy Steering Committee – Prescribing Intervention – Exploring a Strategy for Implementation,” where various stakeholders spoke about the Agency’s Risk Evaluation and Mitigation Strategy (REMS) authority and how to improve safe use of opioid analgesics.

In the Press Announcement that accompanied these moves by the FDA, Commissioner Gottlieb wrote, “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse. If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books. You have a social contract to take voluntary steps to help address public health challenges.”

Gottlieb encouraged stakeholders to participate in this ongoing process by submitting electronic or written comments to the docket until March 16, 2018.

February 01, 2018

State of the Union De-Briefing


President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he mentioned several items of importance to the healthcare space.

Affordable Care Act

First, he noted the repeal of the individual mandate found in the Affordable Care Act, by noting, “We eliminated an especially cruel tax that fell mostly on Americans making less than $50,000 a year -- forcing them to pay tremendous penalties simply because they could not afford government-ordered health plans. We repealed the core of disastrous Obamacare -- the individual mandate is now gone.”

Interestingly to some of his most ardent fans, however, the President did not call for the repeal of the Affordable Care Act in its entirety. Therefore, it seems as though his focus on the ACA will be muted with respect to the rest of the ACA that is still in place, including the Medicaid expansion and other reforms.

Right to Try

President Trump also noted his belief in right to try laws, stating, “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure -- I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”

Vice President Mike Pence has long held Right to Try as a priority of his, and Trump’s call on Congress to pass legislation comes amid stalled House legislation, which easily passed the Senate in August.

More than half of the states have laws that already exist to allow some patients access to experimental treatments and the Food and Drug Administration also hash a pathway that grants expedited access to treatment to patients with terminal illnesses; however, FDA Commissioner Scott Gottlieb has been reluctant to expand much past that.

Opioid Abuse

Many Senators and Congresspeople wore purple ribbons in an attempt to highlight the opioid crisis. President Trump addressed this hot-button issue as well, saying, “In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour. We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge. My Administration is committed to fighting the drug epidemic and helping get treatment for those in need.”

As we have previously written, President Trump has always placed a priority on resolving opioid abuse, including creating a Task Force to review the situation and craft a plan of action. However, he has yet to propose new funding to help states respond (one of the suggestions we often hear from Democrats).

Newly appointed Health and Human Services Alex Azar recently highlighted the administration’s five-point strategy, including (1) encompassing better treatment, prevention, and recovery services; (2) better targeting of overdose-reversing drugs; (3) better data on the epidemic; (4) better research on pain and addiction, and (5) better pain management. Funding for treatment will continue to be central to the debate, and it remains to be seen whether Congress will provide the boost that many public health advocates have been calling for.  

Drug Pricing

Prescription drug prices were a hot topic in the 2016 Presidential election and were, naturally, mentioned during the State of the Union as well. President Trump stated, “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history... One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

Given the political climate, little action has been seen on this front while excessive rhetoric continues to be the modus operandi of the political class.


Overall, there were statements by the President that earned cheers and some jeers from both sides of the political aisle. While lip service can be effective in providing a motivating speech, we will have to wait to see what changes are actually effectuated in the future.



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