Life Science Compliance Update

June 22, 2015

New York Legislature Considers Mandatory Opioid CME

New legislation in New York would require healthcare professionals who prescribe pain medication to complete three hours of Continuing Medical Education (CME) on addiction and pain management every two years. Sponsors say it will be an outgrowth of the state's I-STOP law that cracked down on legal prescriptions of pain medications. I-Stop is an internet database set up to prevent over-prescribing of narcotic medications. The bill's summary states that it authorizes the commissioner of health to establish standards, and review and implement requirements for the performance of continuing medical education on pain management, palliative care and addiction.

The bill does offer some exceptions, as specified under (3)(C)(I) and (II):

THE COMMISSIONER SHALL PROVIDE AN EXEMPTION FROM THIS REQUIREMENT TO ANYONE WHO REQUESTS SUCH AN EXEMPTION AND WHO DEMONSTRATES TO THE COMMISSIONER'S SATISFACTION THAT:

(I) THERE WOULD BE NO NEED FOR HIM OR HER TO COMPLETE SUCH COURSE WORK OR TRAINING BECAUSE OF THE NATURE, AREA OR SPECIALTY OF HIS OR HER PRACTICE; OR

(II) HE OR SHE HAS COMPLETED COURSE WORK OR TRAINING DEEMED BY THE COMMISSIONER TO BE EQUIVALENT TO THE STANDARDS FOR COURSE WORK OR TRAINING APPROVED UNDER THIS SECTION.

The bill also requests further study of the issue:

(D) THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION AND STAKEHOLDERS SHALL REPORT TO THE TEMPORARY PRESIDENT OF THE SENATE, THE SPEAKER OF THE ASSEMBLY AND THE CHAIRS OF THE HEALTH AND HIGHER EDUCATION COMMITTEES NO LATER THAN THREE YEARS AFTER THE EFFECTIVE DATE OF THIS SUBDIVISION ON THE SUCCESS AND IMPACT OF THIS SECTION AND ANY RECOMMENDATIONS.

The law seeks to establish a work group, "composed of experts in the fields of palliative and chronic care pain management and addiction medicine," to determine the appropriate coursework. Specifically:

(A) Report to the commissioner regarding the development of recommendations and model courses for continuing medical education, refresher courses and other training materials for licensed health care professionals on appropriate use of prescription pain medication. Such recommendations, model courses and other training materials shall be submitted to the commissioner, who shall make such information available for the use in medical education, residency programs, fellowship programs, and for use in continuing medication education programs later than January first, two thousand thirteen. Such recommendations also shall include recommendations on: [(A)] (I) educational and continuing medical education requirements for practitioners appropriate to address prescription pain medication awareness among health care professionals; [(B)] (II) continuing education requirements for pharmacists related to prescription pain medication awareness; and [(C)] (III) continuing education in palliative care as it relates to pain management, for which purpose the work group shall consult the New York state palliative care education and training council[.]

And perhaps more broadly, the legislation asks this group to consider: "other issues deemed relevant by the commissioner, including how to protect and promote the access of patients with a legitimate need for controlled substances, particularly medications needed for pain management by oncology patients, and whether and how to encourage or require the use or substitution of opioid drugs that employ tamper-resistance technology as a mechanism for reducing abuse and diversion of opioid drugs."

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Dr. Joshua Cohen, a neurologist at the Headache Institute and the Icahn School of Medicine at Mount Sinai in New York City, wrote in MedPage Today, questioning the premise that mandatory CME is the way to achieve the state's goals. Dr. Cohen describes the essence of CME as physicians identifying "knowledge gaps relevant to their practice and seek courses that will help fill those gaps." His concern is that legislation dictating subject matter and time runs contrary to this goal by limiting the ability of physicians to discern and remedy those knowledge gaps. According to Dr. Cohen, this adds an additional burden on to physicians who are already dealing with added costs to their practice, time away from the office, an "age of exploding medical knowledge" that may be shifted by science every 5 or 10 years, and the risk that mandatory courses may take away from other educational opportunities.

Dr. Cohen argues that mandatory CME creates a slippery slope, whereby a legislator can determine "their personal priorities need to be the educational priorities for physicians," and it then "opens the door to mandated CME on whatever is the hot topic of the day." He cites Massachusetts, a state where there are 8 hours of mandated CME on risk management, end-of-life-care, and electronic health records, constituting nearly 20% of the yearly total CME requirement. Dr. Cohen notes, "Absorbing 20% of a physicians' educational time outside of their area of specialty reduces the likelihood that a physician will get sufficient specialty-specific education, much to the detriment of patients."

There is also a lack of empirical evidence to justify mandatory CME. According to IMS Health, there is no evidence that states which have adopted mandatory CME on opioid use or pain management have seen any reduction in use or diversion of controlled substances. In another study looking at state-mandated CME for the management of acute myocardial infarction (AMI) in over 130,000 patients found no difference in AMI outcomes or 1-year mortality compared with control states without the mandate.

Discussion

There are voices on both sides of this issue, extensive resources have been exhausted for voluntary CME for Opioid risk programs under the ER-LA REMS program with limited physician participation.  Both sides deserve a fair hearing, and states will continue to take up education/certification programs for opioids as long as there is a serious addiction problem.  There is enough evidence that opioid risk education is beneficial and should not be discounted as part of the solution to addiction prevention.

 

June 17, 2015

Over 100 Physician Organizations Back H.R. 293 To Exempt from Sunshine Reporting Education Materials and Independent CME

H.R. 293

Over 100 physician organizations have written to Rep. Michael Burgess (R-TX) and Rep. Peter DeFazio (D-OR) expressing their “strong support” for H.R. 293, a bill that would clarify that certain applicable manufacturer transfers of value to support independent medical educational programs and materials are exempt from reporting under the Physician Payments Sunshine Act.

Download the letter to Rep. Burgess here

“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by the Centers for Medicare and Medicaid Services (CMS) that have already chilled the dissemination of medical textbooks, peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent certified and/or accredited continuing medical education (CME),” the letter states. “H.R. 293 would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive through timely dissemination of medical knowledge.”

Congressmen Burgess, Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, and Peter DeFazio (D-OR) introduced the Protect Continuing Physician Education and Patient Care Act, H.R. 293, earlier this year. The bill is in response to the Physician Payment Sunshine Act’s “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain,” according to the accompanying Press Release. This bipartisan legislation "would allow physicians full access to the most up-to-date educational materials like textbooks and journals so they may deliver the best care.”

Rep. DeFazio actually introduced the Physician Payments Sunshine Act way back on March 13, 2008, which became a provision in the Affordable Care Act in 2010. Upon release of the Open Payments data in October 2014, DeFazio stated: “Every year, pharmaceutical companies and medical device manufacturers spend billions of dollars promoting their products…However, there’s a difference between educating doctors on the uses and effects of new drugs and devices, versus enticing healthcare professionals with lavish gifts.”

In his statement supporting this amendment to the Sunshine Act, Rep. Defrazio reiterates this difference: 

While the Sunshine Act that Congress passed in 2010 is an absolutely essential tool to shine the light on the relationship between the pharmaceutical companies and physicians, our bill ensures the Sunshine Act won’t restrict a physician’s access to the latest medical research and training. This common sense fix is a win for America’s doctors and continuing medical education, but most importantly, for patients.

H.R. 293 (View the language here) would make the Sunshine Act consistent with these goals. Currently there are 12 exclusions from Sunshine reporting, including de minimis payments (under $10) and product samples. Congress also excluded “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, however, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. “This conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge,” the letter to Rep. Burgess states. 

The societies write:

The importance of up-to-date, peer reviewed scientific medical information as the foundation for good medical care is well documented. Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care. Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients.

The Coalition for Healthcare Communication issued a statement on the letter, which acknowledges the broad physician-support H.R. 293 has received. “In stating that peer-reviewed educational materials ‘represent the gold standard in evidence-based medical knowledge,’ these well-known medical organizations, including the American Medical Association, focus on the fact that better informed physicians lead to better treatment for patients,” said CHC Executive Director John Kamp. “Doctors know that access to evidence-based medicine is the key to ensuring that patients have access to the best care. H.R. 293 will restore the intent of Congress,” he said.

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