Life Science Compliance Update

October 16, 2017

Florida Governor Proposes Limit on Prescribed Opioids

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At the end of September, Florida Governor Rick Scott announced that during the upcoming legislative session, he will propose new legislation – including more than $50 million to next year’s budget – to combat opioid abuse in Florida.

The proposed legislation will include:

  • Placing a three-day limit on prescribed opioids, unless strict conditions are met for a seven-day supply;
  • Requiring all healthcare professionals that prescribe or dispense medication to participate in the Florida Prescription Drug Monitoring Program, a statewide database that monitors controlled substance prescriptions; and 
  • Additional reforms to fight unlicensed pain management clinics, require continuing education courses on responsibly prescribing opioids, and create new opportunities for federal grant funding.

The proposed investment of more than $50 million will include funding for:

  • Substance abuse treatment
  • Counseling and recovery services
  • The Florida Violent Crime and Drug Control Council

In announcing the proposal, Governor Scott released the following statement,

We made a commitment here in Florida to do everything possible to support our communities and fight the national opioid epidemic, and while we have taken major steps to fight this crisis, more must be done. Today, I am proud to announce that I will propose major legislation during the upcoming legislative session and more than $50 million in my recommended budget to combat opioid abuse in our state.

As I travel the state, I have met many families who are dealing with the heartache of drug addiction. Growing up, my own family dealt with the struggle of substance abuse and I know firsthand how this painful issue causes families to worry and pray for help and healing. As states across the country continue to fight this national epidemic, we must make sure Florida is doing our part to help vulnerable individuals and keep our families safe. 

These proposals will make a major impact on limiting the chance of drug addiction, reducing the ability for dangerous drugs to spread in our communities, giving vulnerable Floridians the support they need, and ensuring our hardworking law enforcement officers have the resources to protect Floridians. I look forward to working with President Negron, Speaker Corcoran and the entire Legislature to pass this impactful legislation and major investment. I would also like to thank Attorney General Pam Bondi for her focus on this issue and her commitment to keeping our families safe. We will continue to work closely with our federal, state and local partners throughout this fight.

Attorney General of Florida Pam Bondi stated, “We are in the midst of a national opioid crisis claiming lives in Florida, and we must do everything we can to stop drug abuse and save lives. I want to thank Governor Scott for proposing these legislative initiatives that will help stop addiction before it begins. It will take an all-hands-on-deck strategy, not only in Florida, but nationwide to address this crisis destroying American families.”

Florida Senate President Joe Negron said, “The Senate is committed to working with our partners across the state to combat opioid abuse, and I appreciate Governor Scott’s leadership on this serious issue. The Senate looks forward to working with Governor Scott and our colleagues in the Florida House as we continue to do all we can to protect Florida communities from this national epidemic.”

Florida House of Representatives Speaker Richard Corcoran said, “The State of Florida is fully dedicated to protecting our families and communities from the national opioid epidemic. I look forward to continuing to work together with Governor Scott and my fellow Legislators to ensure our families, healthcare professionals and law enforcement officers have all the resources they need in this fight.”

Florida is the most recent state to discuss the possibility of entering the arena of regulating opioids in response to the opioid epidemic. It is likely that this proposed legislation will become a hot topic during the next legislative session, and we will continue to keep an eye out for state and local legislation that will have an impact on industry

September 06, 2017

New Jersey Governor Christie Introduces Regulation to Cap Physician-Pharma Relationships

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In the last days of his administration, New Jersey Governor Chris Christie has introduced a regulation to cap the amount physicians can earn from drug companies – an already rule-laden area – to $10,000 per year.

The Regulation

In addition to the $10,000 per year cap on any earnings from pharma to physicians, prescription writers are prohibited from accepting certain gifts, such as entertainment and lavish meals (an exception is carved out for four meals a year under $15). The $10,000 cap excludes compensation for speaking at continuing education events.

The new regulations detail the different kinds of services – such as speaking at promotional events and consulting arrangements – physicians and other prescription writers can perform for drug companies. According to Christie’s office, all such agreements and payments would have to be in writing.

According to the press release, summarized by Nicodemo Fiorentino, G&M Health LLC the bill proposes to do the following:

  • Prohibit prescribers from accepting (1) cash, (2) gift cards, (3) entertainment, (4) recreational items, (5) items for the prescriber’s personal use, and (6) payments supporting non-faculty attendance at promotional activities and continuing education events;
  • Establish exemptions if the items of value (includes the prohibitions) are for the benefit of patients or prescriber education (e.g., educational materials);
  • Set standards for agreements for “bona fide services” (i.e., (1) speaking at promotional activities and continuing education events, (2) participation in advisory boards, and (3) consulting arrangements);
  • To require “bona fide service” agreements to be in writing, with dollar amounts and an “articulation” of the prescriber’s expertise;
  • To cap compensation for “bona fide service” arrangements from all manufacturers at $10,000 every calendar year; and
  • To allow and define the value (not to exceed $15 for each provider) and frequency (4 times each from each manufacturer) of “modest” meals.

The regulation follows a 2016 Centers for Medicare and Medicaid Services (CMS) open payments report in NJ.com that showed pharmaceutical companies paid out $69 million to physicians in New Jersey – with two-thirds of that cash going to 300 physicians alone. Thirty-nine physicians received at least $200,000 in New Jersey according to the press release.  The report outlines how Insys the manufacturer of Subsys a Fentanyl spray spent the most money over 3 years of all the opioid manufacturers, but that payments by opioid manufacturers dropped significantly between 2015 and 2016.

Presidential Commission on Opioids

It’s also important to remember that Governor Christie is the Chair of President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis, which recently persuaded President Trump to declare the opioid crisis a national emergency.

This is the First of its Kind

While many other states have started to implement regulations with respect to the way physicians and medical and device companies interact, New Jersey is the first state to propose capping physician incomes and applying the regulations not to pharmaceutical companies but to the physicians themselves. Other states, such as Massachusetts, Maine, Vermont, and Minnesota, all have varying restrictions on practitioner relationships with industry, but none of them restrict income. Instead, Massachusetts established a code of conduct that prohibits certain types of payments and interactions between pharmaceutical and medical device companies and Massachusetts health care practitioners, as well as a disclosure requirement. Maine also restricts pharmaceutical and medical device manufacturers and wholesalers from providing gifts to practitioners.

Vermont bans most gifts and requires manufacturers of prescribed products to register with the Attorney General’s Office and disclose the allowable expenditures made and permitted gifts given to Vermont Health Care Providers and other recipients. The law also requires manufacturers to disclose the distribution of samples to Vermont providers, including starter packs, coupons, and vouchers that allow an individual to receive a prescribed product for free or at a discounted price.

Minnesota, one of the earliest states to prohibit certain payments, limits the amount of gifts manufacturers and wholesalers can give to practitioners, but the gifts must not exceed an annual limit of $50 in retail value. There are several items carved out and not considered gifts, including samples, sponsorship for medical conferences or professional meetings, honoraria and other reasonable expenses for practitioners who serve as faculty at professional or educational conference/meeting, consulting services, educational materials, and salaries or other benefits paid to employees.

Other states have recently implemented similar laws, summaries of which can be found here.

Statements by New Jersey Officials

Christie said the rule addresses concerns about whether treatment is being influenced by industry, “While the vast majority of doctors care for their patients honorably and professionally, their education about many of the drugs they are prescribing comes too often from pharmaceutical sales people, who may not always provide an objective analysis of the human and social impacts the drugs may have,” said Christie in a statement. “This rule will help us address any concerns about whether treatment decisions of prescribers are being improperly influenced.”

“Doctors who prescribe medicine should be motivated only by what is best for their patients, and never by financial incentives heaped on them by the pharmaceutical industry,” Attorney General Chris Porrino said. "The rule will prohibit doctors from forming unsavory financial relationships with drug companies that manufacture highly addictive opioids. It also gives our professional boards enforceable standards to hold doctors accountable if they violate that rule."

State Sen. Joseph Vitale, D-Middlesex, said the proposal was a step in the right direction, but said $10,000 was still too high. "$10,000 is still a lot of money," Vitale said. "Why not limit it to $100 or $200?"

However, Vitale noted that he would like to see the proposal pass through the legislature for debate – something that many in Christie’s political party harped on about the Obama Administration’s implementation of the Affordable Care Act. As we have seen time and time again, many politicians can argue either side of the coin, depending on who is in charge.

Public Hearing

The new regulation which was submitted last week to the Office of Administrative law and will be published on October 2, 2017,  in the New Jersey Register must undergo a public hearing before it is implemented, but that doesn’t necessarily mean that changes will be made. The public hearing is expected to be held on October 19, 2017, in the Monmouth Room at the Division of Consumer Affairs in Newark.

August 24, 2017

VA OIG Releases Report on Opioid Prescribing Habits

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Recently, the Department of Veterans Affairs (VA) Office of Inspector General (OIG) released its Healthcare Inspection report, Opioid Prescribing to High-Risk Veterans Receiving VA Purchased Care, in an attempt to identify the need for improved care coordination between VA and non-VA healthcare providers prescribing opioids to veterans.

The report reviewed opioid prescribing to high-risk veterans, such as those with chronic pain and co-occurring mental health illnesses, receiving VA-purchased care from the Veterans Choice and other non-VA community provider programs. According to the report, fragmented care coordination between VA and non-VA providers, as well as differing clinical standards for managing pain, places veterans at an increased risk for overdose or complications associated with prolonged opioid use.

In creating the report, the VA OIG conducted interviews with VA leadership and staff, reviewed the VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain, as well as VA’s Opioid Safety Initiative, current medical literature, and the VA-purchased care Choice contract.

Report Findings and Recommendations

The report notes that while the ability to query PDMP databases is now available, VA providers would not likely access the PDMP when they are not prescribing controlled substances to a specific patient. Timely notification of veteran patients receiving non-VA opioid prescriptions would allow more immediate VA provider awareness and action, if any action were required. For example, if all routine non-VA opioid prescriptions were submitted directly to VA pharmacies, VA pharmacy staff could alert the VA provider of record that a non-VA opioid prescription was being dispensed. This would also allow the same level of pain management committee oversight by VA of opioid prescriptions prescribed by VA and non-VA providers.

While the VA’s Opioid Safety Initiative provides VA healthcare providers a framework to evaluate, treat, and manage patients with chronic pain or long-term opioid therapy, community providers are not obligated to adhere to these guidelines. This can present significant patient safety and care management challenges when community care providers’ prescribing and monitoring practices conflict with the VA’s evidence-based guidelines.

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The OIG report recommends that non-VA providers be required to submit prescriptions for opioids directly to VA pharmacies so that these prescriptions can be tracked and coordinated with medications prescribed by VA care providers; to review evidence-based guidelines for prescribing opioids; and to include in care consults an updated list of the patient’s medications. The VA concurred with the recommendations and submitted action plans to implement them.

Conclusion

“Veterans receiving opioid prescriptions from VA-referred clinical settings may be at greater risk for overdose and other harm because medication information is not being consistently shared,” said Michael J. Missal, Inspector General, U.S. Department of Veterans Affairs. “That has to change. Healthcare providers serving veterans should be following consistent guidelines for prescribing opioids and sharing information that ensures quality care for high-risk veterans.”

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