Life Science Compliance Update

April 17, 2018

Nicodemo (Nico) Fiorentino Joins Life Science Compliance Update as Associate Editor


As Life Science Compliance Update enters its fourth year of publication, it is a great pleasure to announce that Nicodemo Fiorentino joins Thomas Sullivan, Publisher and Dr. Seth Whitelaw, Editor as a member of the Update’s editorial staff. 

“Nico brings an outstanding mix of passion, scholarship and pure writing ability that will only enhance quality of the publication,” said Sullivan.  “It is aligned with our goal to create a single resource that allows busy compliance professionals and business executives to read less but become more attuned.”

“It’s a sign that both the topics we cover and the Update itself are growing,” said Whitelaw. “We have so much going on every month that it is a challenge to get the critical information and insights out quickly enough.  Nico, will help us continue to bridge the knowledge gaps between the most experienced practitioners and those with less time in the profession.”

In addition to being a member of the Editorial Board and a frequent contributor on multiple topics, including drug pricing transparency, to the Update, Nicodemo Fiorentino, currently is a member of G&M Health LLC., which provides a wide range of services to the life science industry. A New Jersey native, he received his bachelor’s degree, with honors, in History from Rowan University, Glassboro, New Jersey and his Juris Doctor (J.D.) from Rutgers University School of Law, Camden, New Jersey.

April 16, 2018

House E&C Subcommittee on Health Reviews Dozens of Opioid Bills


Last week, the House Energy and Commerce Subcommittee on Health held a two-day hearing entitled “Combating the Opioid Crisis: Improving the Ability of Medicare and Medicaid to Provide Care for Patients” to discuss a variety of bills aimed at addressing the opioid misuse and overdose crisis. Conversation focused on how to improve Medicare and Medicaid services for patients in need of comprehensive care and mental health and abuse services, and the role these coverage plans play in combatting the opioid crisis.   

Bills discussed during the hearing included requirements for state Medicaid providers to include prescription drug monitoring programs (PDMPs) into their clinical workflow, requirements for physicians to participate in continuing education programs, the benefits of electronic prescribing (e-prescribing), and the potential impact of the Trump administration’s proposal to cut finding to the Medicaid program.  While Republicans on the Committee put a particular emphasis on the need to provide patients with alternative forms of non-pharmacological treatments for pain, while several Democrats criticized the Trump administration’s proposal to cut funding to state Medicaid programs. Members on both sides of the aisle were generally in agreement that the Centers for Medicare & Medicaid Services (CMS) could do more to respond to the crisis.     

Opening Statements

During his opening statement, Subcommittee Chairman Michael Burgess confirmed his commitment to continuing to “ask the hard questions and seek solutions,” while questioning the status quo of Medicaid and Medicare’s role in the opioid crisis. He also voiced his personal support for several pieces of legislation and noted his belief in the importance of educating physicians in how to identify patients who may be vulnerable to opioid use and addiction while not denying access to patients with legitimate chronic pain.

Energy and Commerce Committee Chairman Greg Walden encouraged members of Congress to work with stakeholders and put forth “bold ideas” to combat the opioid crisis that seems to be evolving and changing on a regular basis.

Health Subcommittee Ranking Member Gene Green also mentioned Medicaid and its role in helping individuals suffering from substance use disorder (SUD) and plugged the importance of Medicaid expansion so that comprehensive coverage can continue to be provided to beneficiaries suffering from SUD and close treatment gaps that exist in significant numbers.

Energy and Commerce Committee Ranking Member Frank Pallone stressed his belief that there needs to be legislation that helps the vulnerable populations, including providing strong and consistent access to health care coverage.

Panel Testimony

Each day, members of the Committee heard from different stakeholders and received different perspectives on a variety of topics. Kimberly Brandt from Centers for Medicare and Medicaid Services (CMS) discussed what her agency has been doing to help combat the crisis, including some of the prevention, treatment, and data gathering measures they have enacted. She also highlighted a new requirement that Medicare Part D sponsors limit all opioid prescription refills to no more than a seven-day supply and alert all pharmacists when a patient’s opioid use reaches “high levels.” She also noted that the Agency is hoping to give more flexibility to the states to expand access to treatment for SUD patients.

Michael Botticelli, the Executive Director of the Grayken Center for Addiction, heaped praise on CMS for the role Medicaid plays in resolving the crisis, while plugging for a requirement that both Medicare and Medicaid cover medications for opioid use disorder, including overdose prevention drugs like Naloxone.

Toby Douglas, the Senior Vice President for Medicaid Solutions at the Centene Corporation, noted that the opioid crisis tends to disproportionately affect Medicaid beneficiaries and Congress should look into that correlation to explore various strategies.

David Guth, the CEO of Centerstone America, put his support behind increasing access and availability to evidence-based treatment for opioid addiction, especially for rural areas.

John Kravitz, CIO of Geisinger Health System, outlined the approach his company has taken to stop the flow of opioids, including investing in innovative health information technology and care delivery models. He also highlighted the “great success” that Electronic Prescriptions for Controlled Substances (EPCS) have brought to the Geisinger health system, noting that it has helped to reduce instances of forgery and diversion in opioid prescribing.

Sam Srivastava, CEO of Magellan Healthcare, focused on allowing a greater access to PDMPs and updating privacy laws to allow providers to share details about a patient’s substance abuse when necessary.


Alternative Pain Management Methods

Several of the Committee members, mostly Republicans, expressed varying degrees of interest in some non-pharmacological alternatives for opioid addiction. Representative John Shimkus asked the panel to discuss cost effectiveness of alternative pain management and what additional steps Congress could take to help CMS and state Medicaid directors make coverage decisions based on those medications. Mr. Kravitz and Mr. Botticelli offered examples, including physical therapy, yoga, and acupuncture, and discussed the success those avenues have had on patients with chronic illnesses and legitimate pain.

Representative Larry Buchson, a physician, told hearing attendees and his fellow members of Congress that it is “critical to have a good evaluation of the causes of pain” and that proper consultation with the patient and the patient’s family needs to be held to discuss alternative methods of treatment.


Several of the panelists praised the PDMP program as a good tool for monitoring fraud and identifying outliers within the prescribing system. However, Representative Buddy Carter cautioned that pharmacists should not be the ones required to “police’ physicians who are over-prescribing based on PDMP data, further noting it is “unfair” to assume that physicians are always going to be able to successfully profile patients with opioid abuse problems.


Representative Joe Barton had asked the panel whether the electronic prescribing of opioids was actually helpful in stemming the tide of opioid abuse at all, to which Mr. Kravitz responded that e-prescribing had proven to be “very valuable” for his health system, and that it also resulted in a greater patient satisfaction than the paper prescribing system.

Budget Cuts to Medicaid

Ranking Member Green was one of several Subcommittee Democrats who expressed concern over the impact of proposed Federal funding cuts to the Medicaid program. Instead he urged the Administration to work with the states to strengthen Medicaid coverage and remove barriers of access to beneficiaries who need treatment. Representative Anna Eshoo also criticized the President’s budget proposal that would slash funding for Medicaid and “diminish the work done” regarding the opioid crisis.


Chairman Burgess indicated that he is still deciding whether to combine numerous opioid-related bills into a single legislative package or try to move the bills through committee individually. Chairman Burgess noted that it is possible to put all of the legislation together in one package, but added that part of him “wants to consider them as individual bills so that, as we go through at least the subcommittee markup and the full committee markup, there will be ample opportunity for people’s ideas to be heard.”

Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept


For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to expand its efforts to use data analytics to detect Medicare fraud. While promising, it remains to be proven that the tool and techniques will be cost-effective in this context.

The fiscal year 2017 was a big year for the Office of Inspector General of the Department of Health and Human Services (“OIG”). Among many important accomplishments, the OIG undertook “the largest healthcare fraud takedown in history,” involving more than 400 defendants and more than $1.3 billion in false billings to Medicare and Medicaid.

This action was notable not just for the number of defendants involved and the amount of money recovered, but for the fact that as characterized by the OIG, it was a “data-driven effort.” Therefore, the case represents a signature moment in the evolution of healthcare fraud enforcement, as we transition from a “pay and catch” approach to using data analytics to support targeted enforcement.

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