Life Science Compliance Update

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30 posts from September 2017

September 29, 2017

Senate Passes CHRONIC Care Act


On September 26, the Senate passed the CHRONIC Care Act is also known as the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act.” The law passed with bipartisan support. “This legislation will improve disease management, lower Medicare costs and streamline care coordination services — all without adding to the deficit,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said in a statement.

Bill Specifics

There are several highlights from the bill. First, it extends the Independence at Home Model of Care. Specifically, it would extend the demonstration’s expiration date by two years—until September 30, 2019, increase the cap on the total number of participating beneficiaries from 10,000 to 15,000, and give practices three years to receive a shared savings payment. Currently practices are to be terminated if they do not receive such an incentive payment in two consecutive years.

Furthermore, the bill will expand supplemental benefits to meet the needs of chronically ill Medicare Advantage (MA) enrollees. This would allow an MA plan to offer a wider array of supplemental benefits to chronically ill enrollees beginning in 2020. These supplemental benefits would be required to have a reasonable expectation of improving or maintaining the health or overall function of the chronically-ill enrollee and would not be limited to primarily health related services. The section would allow an MA plan the flexibility to provide targeted supplemental benefits to specific chronically ill enrollees.


Telehealth advocates are especially supportive of this bill. It has language that would allow an MA plan to offer additional, clinically appropriate, telehealth benefits in its annual bid amount beyond the services that currently receive payment under Part B beginning in 2020. The Secretary would be required to solicit comments on what types of telehealth services offered as supplemental benefits should be considered to be additional telehealth benefits. The use of these technologies would not be a substitute for meeting network adequacy requirements, and the beneficiary would have the ability to decide whether or not to receive the service via telehealth.

Additionally, in a win for stroke patients, the legislation expands the ability of patients presenting with stroke symptoms to receive a timely consultation to determine the best course of treatment through telehealth, beginning in 2019. Specifically, it would eliminate the geographic restriction as to permit payment to a physician furnishing the telehealth consultation service in all areas of the country. The hospital at which the patient is present and the telehealth consultation is initiated would not receive a separate, originating site payment.

Other areas

The bill directs the Government Accountability Office (GAO) to submit a report to Congress within eighteen months of the date of enactment to inform the development of a payment code describing the formulation of a comprehensive plan of longitudinal care for a Medicare beneficiary diagnosed with a serious or life- threatening illness. Specifically, GAO would identify the extent to which such a comprehensive longitudinal care planning service is provided to beneficiaries, whether there would be any duplication in payment for such service with billing codes for which Medicare current pays, and barriers to hospitals, skilled nursing facilities, hospice programs, home health agencies, and other providers working with a Medicare beneficiary to engage in the care planning process.

It would also identify any barriers to providers accessing the care plan and options for promoting adherence to it. In addition, GAO would also assess the need to develop quality metrics related to care planning, the characteristics of Medicare beneficiaries who would be most appropriate to receive a longitudinal planning services, and the providers best suited to furnish the service as a part of a multi-disciplinary team.

The GAO is additionally directed to submit a report to Congress providing information on the prevalence and effectiveness of Medicare and other payer medication synchronization programs. Specifically, GAO would identify common characteristics of programs and assess their impact on medication adherence, patient outcomes, and patient satisfaction. GAO would also assess the extent to which Medicare rules support medication synchronization and whether there are barriers to such programs in Medicare.

Finally, GAO is further asked to submit a report on the impact of the use of obesity drugs on patient health and spending. Specifically, GAO would look at obesity drug utilization in Medicare and other payer programs, identify physician prescribing attitudes, assess drug adherence, and maintain weight loss. GAO would also identify the impact of obesity drugs on patient health outcomes, on other services furnished, and health spending.

Webinar: Trump or Trumped – Update on CME and Federal Policy


On October 25, 2017, Andrew Rosenberg at Thorn Run Partners and Thomas Sullivan, our editor and President of Rockpointe Corporation, will present a webinar on CME and federal policy. The webinar will be hosted by the Alliance for Continuing Education in the Health Professions (ACEHP).

The webinar will focus on the various health reform plans that continue to swirl around Washington, D.C., and what they may mean for continuing medical education (CME). Some of the topics to be discussed during the webinar include: the Affordable Care Act (ACA) versus current Republican proposals; reviewing the Open Payment policy and CME changes, including where they may be leading; and evaluating the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the role CME will play in its success.

The webinar will take place from 2:00 pm – 3:00 pm EST on October 25, 2017. If you are interested, please register here. If you have any questions, you can contact

September 28, 2017

Gottlieb Speaks to RAPS Regulatory Conference


United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently spoke with attendees of the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference about the steps the FDA is taking to make the clinical end of drug development more efficient and effective.

Gottlieb started by speaking and providing an overview of the history of medicine, all the way back to the “germ theory,” first proposed by Girolamo Fracastoro in 1546 through the late 1850s when Louis Pasteur and Robert Koch offered convincing evidence that germs caused disease and the 1870s, when sanitation was finally used in the medical field.

Gottlieb goes on to note that there is always a period between when the discovery of “a central principle of biological science” is discovered, to its eventual translation into the tools of clinical medicine. He notes that as science continues to evolve, that time period in shrinking and that primary ideas are more quickly reshaping the way we approach illnesses.

Gottlieb stated that the cost of drug development is on “an unsustainable path, where the cost of drug development is growing enormously, as well as the costs of the new medicines.” He also noted his belief that something needs to be done now, to make the whole process less costly – and more efficient – recognizing that if nothing is done, “we won’t continue to realize the practical benefits of advances in science, and in the form of new and better medicines.”

He noted that:

At FDA, we’ll continue to take steps to bring more competition to the drug market, as one way to reduce costs and improve access. All of the efforts I’m going to discuss today are not just about advancing science that can treat illness. That’s a key part of our mission. But it’s also about making sure patients can have access to these opportunities.

He noted some of the actions that the FDA has already announced that are aimed at addressing the cost of medicine and access to drugs, including: taking steps to boost generic competition and target firms that “game [FDA] rules” to extend drug monopolies past the point Congress intended for.

He focused on the idea that the FDA needs to focus on holding down high costs where they start: “with the high and rising expense of developing a novel drug.”

He did not place the blame at the feet of the pharmaceutical industry, instead noting:

Even while some drug development programs move quickly, most take many years. The costs are also high, and growing. There’s been criticism of the various estimates of how much it costs to develop a new drug. But we know some drug programs can easily top $1 billion, just in direct outlays.

We also know that the average cost of developing a single new drug continues to increase at a pace that often dwarfs even the rate of increases in other healthcare costs. Take just one time period, between 2003 and 2013, and one estimate of these costs. Over that time period, the cost of developing a drug rose by 145 percent after correcting for inflation, according to the Tufts Center for the Study of Drug Development.

Gottlieb stated that the FDA has taken steps to modernize its approach to the way it collects clinical information needed to make decisions about the safety and effectiveness of new drugs, including seeing wider use of adaptive approaches, which allow scientists to enrich trials for patient characteristics that correlate with benefits, or that help to predict which patients are less likely to suffer a particular side effect.

Other concepts the FDA is seeking to better adapt to clinical development include common control studies and the wider use of large simple trials. FDA is also advancing the use of ‘Master Protocols’ to enable more coordinated ways to use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient.

The Agency also needs to engage in more communication between sponsors, investigators, IRBs, and other stakeholders involved in the development program. This is not a “business as usual” approach. It may require a much more iterative process, with greater communication between all of the stakeholders involved in the clinical trial processes.

To better delineate how the FDA approaches the overall development and evaluation of drugs targeted to certain unmet medical needs, it plans to begin work on at least ten new disease-specific guidance documents over the next year. Some of these documents are already underway. Among the diseases targeted are areas of significant unmet need like Amyotrophic Lateral Sclerosis (ALS).

Interestingly, in response to a question on commercial speech and FDA regulations, he made clear that while the FDA has lost recent court cases related to the First Amendment, "Our regulations cannot be in conflict with the courts," noting that the agency is currently "in a period of ambiguity."


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