In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers. Under ...


FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics and more...

FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics


In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.

Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.

On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals.

In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them.

The FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017) lists draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The proposed Blueprint broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The draft also provided context for discussions at the public meeting.

Electronic or written comments to the Blueprint may be submitted by July 10, 2017.

The 2017 public workshop on May 9 and 10 attempted to build on one of the requests outlined in that RFI: the request for suggestions of additional activities HHS and its federal partners can implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.

The workshop had three main goals. First, participants discussed the role that health care provider training plays – within the broader context of ongoing activities – to improve pain management and the safe use of opioids. Second, participants commented the best way to provide health care providers who prescribe or are directly involved in the management or support of patients with pain appropriate training in pain management and the safe use of opioids. Finally, participants discussed various issues and challenges that are associated with possible changes to federal efforts to educate health care providers on pain management and the safe use of opioids.

Opening Session

During the opening session, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the extent of opioid prescribing and considerations in addressing prescriber training. She said that there are 200 million prescriptions for opioids dispensed annually, contributing to a “surge in opioid-related substance abuse disorders.”

Dr. Woodcock said that historically, “the liabilities of prescribing opioids were minimized” for an “entire generation of prescribers.” She cited alternative modalities, such as physical therapy and cognitive and behavioral therapy, and said the selection of a pain treatment modality should be a “sophisticated decision that weighs costs and benefits.” She noted that although opioids will remain a “mainstay in many situations,” including acute trauma, there should be a “renewed understanding that any opioid prescription confers risk.”

Dr. Doug Throckmorton, CDER’s Deputy Director for Regulatory Programs, said the meeting would focus on improving prescriber education while continuing access to appropriate treatment. He said healthcare worker education is a part of the FDA’s Opioid Action Plan. He pointed to a variety of inter-agency efforts, such as the Department of Health and Human Services’ multi-pronged opioid plan, the Surgeon General’s efforts, National Institutes of Health Centers of Excellence in Pain Education, and Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines.

Veterans Affairs Experience

Dr. Bernie Good, Chair of the Medical Advisory Panel for Pharmacy Benefits Management at the VA, provided an overview of the VA’s efforts to ensure appropriate prescribing of opioids and combat opioid abuse. He said that in 2000, the VA mandated pain as fifth vital sign, encouraging veterans’ feedback on their pain severity. Approximately 30,000 VA prescribers had written at least one opioid prescription and the thought was that if veterans have to provide regular feedback on their pain severity, perhaps less prescriptions would be written.

In 2014, the VA started an academic detailing programs on opioid medications involving one-on-one meetings between a clinical pharmacist and prescriber. The VA has 285 academic detailers, and 10,436 clinical staff have been detailed. Dr. Good said that there has been a 58 percent reduction in high-dose opioid prescribing among those receiving detailing compared with 34% reduction among those without detailing.

Dr. Good noted that VA providers have mandatory training on opioids and that as part of the VA’s Opioid Safety Initiative, the VA distributes individualized prescriber and regional reports and identifies high-risk patients.

Risk Evaluation and Mitigation Strategies (REMS) Options and Considerations

Doris Auth, Acting Director of the FDA’s Office of Medication Error Prevention and Risk Management, discussed options and considerations for using FDA REMS authority under Federal Food, Drug, and Cosmetics Act (FFD&CA) to assure prescriber training on opioid medications. She noted that REMS can have elements to assure safe use and can be restrictive or non-restrictive.

She provided examples of how prescriber education could be required under REMS. For instance, the acne drug isotretinoin has a REMS known as the iPLEDGE program to prevent fetal exposure and reduce the risk of birth defects. It requires informing providers and patients about the risk of fetal exposure, initial documentation of a negative pregnancy test, pharmacy authorization from the REMS program, a medication guide with each prescription, a voice or web-based authentication prior to dispensing, patient enrollment and informed consent, an ongoing monthly negative pregnancy test for female patients, and other dimensions.

Ms. Auth reviewed a potential structure for an opioid REMS involving training. She said there could be:

  • No patient enrollment or patient-specific requirements; and
  • Required prescriber training prior to dispensing.

She believes that such a program would be quite a bit larger than any existing REMS and at least double the size of the current extended-release/long-acting opioid REMS. If pursued, it would involve ninety manufacturers, some of which would have multiple products.

Andrew Rosenberg, JD with the CME Coalition, Thomas Sullivan of Rockpointe and others gave comments at the meeting to reinforce that education is a valuable tool in fighting the opioid epidemic.  To encourage clinician's to participate in the Opioid REMS the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program.

Overall the value of continuing education in the REMS program is perhaps the most valuable tool that the government and others can engage to help reduce opioid deaths.


California Senate Passes Ban on "Gifts" to Physicians


Late last week, California passed legislation in the state senate that restricts pharmaceutical companies from giving gifts and incentives to medical professionals. The legislation restricts pharmaceutical companies from providing flights, travel, speaking fees, entertainment, consulting payments, or other financial benefits to healthcare providers.

The sponsor of the bill, Senator Mike McGuire, stated, “I’ll be the first to say that the vast majority of physicians and medical professionals put the needs of their patients first. There’s a reason why doctors answer the call to practice medicine – to help people in their time of need. But growing evidence reveals that financial relationships between some physicians and pharmaceutical companies confirm what has been suspected – financial incentives change minds.”

According to Senator McGuire, data shows that in 2014 California physicians received the highest number of gifts and payments from pharmaceutical companies of any state.

“The facts are clear. Current voluntary efforts are not enough. California physicians and medical professionals lead the nation in the number of gifts taken, over $1.4 billion in 2014.  SB 790 will curb financial payments, gifts and incentives to medical professionals and help drive down the skyrocketing costs of prescription drugs for millions in California.”

Senator Ted Gaines, an opponent of the bill, believes its passage will affect patients, noting that, “Successful products provide the funding for the research, for cures. Why would we do anything to diminish the ability of pharma companies to be successful in providing these new products?”

Senate Minority leader Patricia Gates, also pointed out that gifts from pharmaceutical companies to doctors are already regulated. She also believes that doctors may now be deterred from participating in clinical trials and limit Californians’ access to experimental drugs.

As drafted, this bill looks like it would only apply to drug manufacturers and prescribed medications, not device manufacturers and any products that have a medical device as part of the combination. Interestingly, it also included a provision toward the end that says if the Sunshine Act is repealed, the state would enact a similar provision to disclose payments.

The Bill is drafted as a hybrid between VT’s and MN’s gift ban law. It explains what allowable expenditures are, and then carves out certain exceptions from the “gift” definition (e.g., samples, reprints, scholarships, rebates, etc.)

Under the legislation as currently drafted, “Gift” means either of the following:

(1) Anything of value provided for free to a health care provider.

(2) A payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided to a health care provider, unless it is an allowable expenditure as defined in subdivision (a) or the health care provider reimburses the cost at fair market value.

For example, companies are permitted to pay for meals for doctors as long as the costs are below $250 per year per individual doctor and educational events but not all education.

They did give some allowable expenditures including:

Payment by a manufacturer of a prescribed product to the sponsor of a significant educational, medical, scientific, or policymaking conference or seminar, provided that all of the following conditions are satisfied:

(A) The payment is not made directly to a health care professional or pharmacist.

(B) Funding is used solely for bona fide educational purposes, except that the sponsor may, in the sponsor’s discretion, apply some or all of the funding to provide meals and other food for all conference participants.

(C) All program content is objective, free from industry control, and does not promote specific products.

(2) Honoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide educational, medical, scientific, or policymaking conference or seminar, provided that all of the following conditions are satisfied:

(A) The honoraria or payment is governed by an explicit contract with specific deliverables which are restricted to medical issues, not marketing activities.

(B) Consistent with federal law, the content of the presentation, including slides and written materials, is determined by the health care professional.

(3) For a bona fide clinical trial, the annual direct salary support for principal investigators and other health care professionals.

(4) For a research project that constitutes a systematic investigation, is designed to develop or contribute to general knowledge, and reasonably can be considered to be of significant interest or value to scientists or health care professionals working in the particular field of inquiry, all of the following:

(A) Gross compensation.

(B) Direct salary support per health care professional.

(C) Expenses paid on behalf of each health care professional.

Royalties and licensing fees paid to health care providers in return for contractual rights to use or purchase a patented or otherwise legally recognized discovery for which the health care provider holds an ownership right.

 The payment of reasonable expenses of an individual related to the interview of the individual by a manufacturer of prescribed products in connection with a bona fide employment opportunity or for health care services on behalf of an employee of the manufacturer.

Provision of meals for a health care provider that do not exceed two hundred fifty dollars ($250) per person, per year in value.

(5) Voluntary provision of care

 The bill, passed by a 23-13 vote, now heads to the California Assembly and if it passes there, then it heads to the governor’s desk for a signature.    This bill could put a huge chill on the biotech industry in California.  With little to no evidence that payments for services or meals lead to more prescribing the myth of "gifts" is still promoted throughout legislatures.


The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion


The purpose of this article is to give manufacturers some initial background on the topics and some tools that could be considered.The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.

Over the last few years, the 340B Program has experienced rapid expansion as the result of participation by new covered entities under the Affordable Care Act (“ACA”) and from covered entities contracting with multiple contract pharmacies. As it has grown, the 340B Program has come under significant scrutiny from the Government Accountability Office (“GAO”), the U.S. Department of Health and Human Services (“HHS”), and Congress, primarily to address what is perceived as an inadequate level of oversight by the Health Resources and Services Administration (“HRSA”) as well as a lack of specificity around the program’s requirements. HRSA was attempting to issue final regulations around the program but even those were frozen earlier this year with the Trump adminstrations regulatory freeze.

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Medicare Cuts in the Future of HACRP Hospitals


As has been noted, CMS named 769 hospitals that will face Medicare payment cuts in fiscal year (FY) 2017 under the Hospital-Acquired Condition Reduction Program (HACRP), which for the first time considered rates of infection from antibiotic-resistant bacteria in its calculations. The HAC Reduction Program requires the Secretary of the Department of Health and Human Services to adjust payments to applicable hospitals that rank in the worst-performing quartile of all subsection (d) hospitals with respect to risk-adjusted HAC quality measures. These hospitals will have their payments reduced to 99 percent of what would otherwise have been paid for such discharges. In the FY 2017, HAC Reduction Program, hospitals with a Total HAC Score greater than 6.5700 are subject to a payment reduction.


From Modern Healthcare: “Our goal is for all hospitals to improve,” and roughly half did improve enough to escape the bottom quartile, said Dr. Patrick Conway, the CMS' deputy administrator and chief medical officer. Federal data on quality measures released earlier this month by the Agency for Healthcare Research and Quality also showed that between 2010 and 2013, progress was made in reducing patient harm and preventing avoidable deaths, he said.


The Advisory Board collected reaction from stakeholders. Some noted that hospitals cannot fully control antibiotic-resistant infections that occur in their facilities. Louise Dembry, a professor at the Yale School of Medicine and president of the Society for Healthcare Epidemiology of America, said, "The reality is we don't know how to prevent all these infections."

Moreover, some critics take issue with the way HACRP assesses penalties. Because the program penalizes the 25 percent of hospitals that perform worst overall, in some cases a hospital is penalized even though it has reduced its rate of avoidable complications. Nancy Foster, vice president for quality and patient safety at the American Hospital Association, said, "The HAC penalty payment program is regarded as rather arbitrary, so other than people getting upset when they incur a penalty, it is not in and of itself changing behavior"

Example from Emory

Three Emory-affiliated hospitals were fined for high rates of hospital-acquired conditions for fiscal year 2017. Emory University Hospital Midtown (EUHM) is being fined for the third consecutive fiscal year, and Emory Johns Creek Hospital (EJCH) for the second consecutive fiscal year. Emory University Hospital (EUH) is being fined for a second fiscal year, the first instance occurring in 2015.

But Emory’s response is worth considering. Director of Media Relations of Emory Healthcare Janet Christenbury wrote in a statement that the ratings inaccurately compared hospitals because they are “based on methodologies that often do not sufficiently take into account the differences in patient populations and the complexity of conditions that certain hospitals treat.”

Teaching hospitals, such as Emory’s Midtown facility, are unique because they conduct various common and complex procedures and provide clinical education and training to current and future medical providers, Christenbury said. Consequently, there is more data to report to CMS in comparison to other facilities that treat patients with limited specializations or more common conditions, Christenbury added.


Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support


Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing to adhere to the new principles for third-party educational support set forth by the MedTech Europe Code.

MedTech Europe Code of Ethical Business (“Code”) will become effective on January 1, 2018. Now with only seven months left in the Transition Period, it is a good time to examine how medical device and in-vitro diagnostic companies have been preparing. While most the standards and requirements are not new to Member Companies (“Companies”), the Code introduces several updates, which include:

  • a ‘fifth principle’ of holding image and perception of the industry in high regard,
  • new chapters with consolidated definition of events and demonstration products, and
  • changes around the support of third-party educational conferences, which will be the focus of this article.

Although the constant need to adapt to regulatory change is nothing new to those operating within the compliance space, many would agree that transitioning everyday business operations to comply with new requirements is easier said than done. This article will summarize the key changes the Code requires around educational conference support and provide some insights and considerations for in-house ethics and compliance functions.

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