Life Science Compliance Update

March 22, 2017

CMS Delays New Bundled Payments Model


In late-February, we reported that CMS had recently finalized new Innovation Center models. However, now, in an interim rule, CMS is delaying the implementation of the mandatory cardiac bundle program and cardiac rehabilitation program from July 1 to Oct. 1.

The rule also postpones the expansion of the mandatory joint replacement bundle program to include other treatments for hip and femur fractures in addition to hip replacement from July 1 to Oct 1. Further delays the effective date of a final rule to implement the joint replacement bundle initiative, the cardiac rehabilitation incentive payment model and the initiative to advance care coordination through episode payment models from March 21 to May 20. CMS is seeking comment on a potential further delay of the programs to January 1, 2018.

Original announcement

As we wrote, in the original announcement from CMS on the proposed program, the agency finalized three significant new policies related to: (1) cardiac care; three new payment models will support clinicians in providing care to patients who receive treatment for heart attacks, heart surgery to bypass blocked coronary arteries, or cardiac rehabilitation following a heart attack or heart surgery; (2) orthopedic care; one payment model to support clinicians in providing care to patients who receive surgery after a hip fracture, other than hip replacement; and (3) CMS finalized updates to the Comprehensive Care for Joint Replacement Model, which began in April 2016.

CMS comments regarding new delay

CMS writes that the delays allow it more time to review the programs. They also state it gives providers time to prepare for the changes in payment under the models. The agency is accepting comments on the delays for 30 days starting on March 21. CMS stressed that it would prefer to line the payment period with the calendar year as well.

Stakeholder response

As reported by the Advisory Board, stakeholders said the decision raises important questions about how President Trump and his HHS will approach value-based care and mandatory (as opposed to voluntary) payment bundles. They cite Ashish Jha, a professor of health policy at the Harvard School of Public Health, who said the delays might suggest CMS will make the programs voluntary, which he said would affect the pool of participants and ultimately drive up costs.

In contrast, Carolyn Magill—CEO of Remedy Partners, a firm that helps hospitals and health systems with bundled payment programs—said, "We have found that voluntary models provide a forum for more engaged participation."

This comes after groups like the American Hospital Association had criticized the payment models for being “too much, too soon.” The Federal of American Hospitals praised the decision to delay the bundles.

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?


Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.

Although adapting to changes in regulatory environment and technology has always been a necessary skill of successful life science compliance officers, few would argue that there has been a more challenging and uncertain environment faced by these professionals as 2017 begins. From rapidly changing communications technology to the uncertain future of the Affordable Care Act, to the unpredictable nature of a Donald J. Trump presidency, several factors will impact the life sciences industry in 2017 and beyond, and sound strategies will be necessary to mitigate the risk to companies in the industry. The following discussion specifically highlights how social media platforms and cyber security pose a significant risk.

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March 21, 2017

Dr. Janet Woodcock on the Opioid Epidemic


The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the director of the FDA Center for Drug Evaluation and Research (CDER). One of the most recent episodes featured an interview with Dr. Janet Woodcock, by Colleen Labbe from the CDER Office of Communications, who discussed the way the FDA has been addressing the opioid epidemic affecting many communities around the United States.

CDER’s Response to FDA Labeling Changes

One of the first questions asked of Dr. Woodcock was what, exactly, CDER did with regard to the various opioid safety labeling changes that were announced in 2016. Dr. Woodcock noted that “part of our effort has been to change the labels – the actual instructions for use and warnings and so forth on opioid labels – to get more information to practitioners.” CDER has actually changed the product labels for hundreds of opioid products with numerous updates, including adding a boxed warning with safety information on all the immediate release opioid products. Dr. Woodcock said that the reason for the boxed warning on immediate release opioid products has to do “with their inherent risks – we strengthened the warnings about their risks.”

CDER also added a warning about using benzodiazepines – also known as “benzos.” Benzos, as well as opioids, have respiratory depression characteristics, and in the event of an overdose, patients can increase their risk of very serious problems, including death.

Additionally, Dr. Woodcock noted, pregnant women should be on treatment for their opioids and not abusing opioids throughout their pregnancy. She continued, “there are medication-assisted treatments, such as methadone and buprenorphine, that the FDA has approved, that are fairly widely used for treatment of opioid addiction. But there can be risks to the newborn from the mother being chronically on these, and that can be managed in the hospital properly and can be dealt with.” However, Dr. Woodcock and CDER wanted to draw more attention to these potential problems, so more information was added to the labels, referring to this as the “NOW Syndrome,” which stands for neonatal opioid withdrawal syndrome.

Decline in Opioid Prescriptions

Labbe asked Dr. Woodcock about the decline in the number of prescriptions written for opioids over the last three years, and what she believes has contributed to the drop. Dr. Woodcock responded, “I think this is a sustained collaborative effort among the federal agencies – including FDA – plus state governments, local agencies, professional societies, and hospitals, to address the epidemic by putting out guidelines, such as CDC did. States and other localities have limited the amount of medicines that can be prescribed at once. FDA upscheduled certain drugs and put them in a schedule where you can’t as easily get prescriptions, like just phone in and get a whole lot of extra refills, and so forth.”

Prescriber Education

Dr. Woodcock stated that the FDA has worked for a long time on prescriber education and referred to the Risk Evaluation Mitigation Strategy (REMS) program, where the FDA required that manufacturers of extended release or long-acting opioids provide funding for independent, continuing medical education groups to develop continuing medical education (CME) on these topics, which had to meet FDA-developed criteria.

The FDA has “long advocated as part of the administration’s initiative that prescribers should be required to get training as part of their DEA registration,” and held a meeting in 2016 focused on the training of prescribers. The FDA continues to review ways to ensure prescribers are properly trained and educated without “making a huge burden on the health care system,” but in the meantime, “medical schools and nursing schools, and other places are making sure there is training for new trainees about opioids. Many states have made pain management training or opioid training mandatory for state licensure.”

What Does the Future Hold?

As far as future CDER efforts to address the opioid epidemic, it will be “considering another recommendation, which is that the immediate release opioids be added to the REMS program that we already have for the extended-release/long acting” opioids. CDER also plans to expand the “blueprint” for the requirements that a practitioner should be trained on to include pain management. CDER wants to ensure that practitioners are trained on pain management and “aren’t just automatically reaching for the prescription pad every time people come in with a complaint of pain.”

CDER also plans to work with stakeholders about mandatory training and how it can be ensured that all practitioners (physicians, nurse practitioners, dentists, etc.) who prescribe opioids are “armed with the correct tools to understand the uses and liabilities of these drugs and the alternatives to them.”


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