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27 posts from January 2018

January 31, 2018

Transparency Bill Reintroduced in Oregon


During the 2017 Oregon Legislature session, Senator Steiner Hayward and Representative Rob Nosse introduced legislation on prescription drug advertising that would have required manufacturers to disclose prices in any advertisement for prescription drugs in Oregon. The bill was introduced on February 14, 2017 and was referred to the Health Care Committee. On March 9, 2017, the Health Care Committee held a public hearing, but when the legislature adjourned on July 7, 2017, the bill remained in Committee, and therefore, it died on the vine.

On January 22, 2018, Representative Nosse introduced HB 4005, “Prescription Drug Price Transparency Act,” a supposedly simplified version of the 2017 price transparency bill. The bill, which is expected to be officially introduced on February 5, 2018, requires prescription drug manufacturers to annually report information to the Department of Consumer and Business Services regarding the prices of prescription drugs and the costs associated with developing and marketing prescription drugs. It also authorizes the Department to impose civil penalties on manufacturers that fail to comply with reporting requirements.

Under the language of the bill, manufacturers would have to justify the price of any prescription drug that goes up ten percent or more over a calendar year if the monthly cost is over $100.

The proposal would also require manufacturers to report on new specialty drugs that have price tags of $600 or more per month/dosage and to give detailed information on patient assistance programs.

Health insurers would need to report to the Department of Consumer and Business Services the 25 most frequently prescribed drugs, 25 most costly drugs and 25 drugs with highest year-over-year increases and impact of prescription drug prices on premiums.

Some required reporting items in the bill are:

  • The drug’s price history
  • Factors and justification that contributed to the increase
  • The name of any generic version
  • The research and development costs paid with public funds
  • Costs associated with manufacturing, advertising, distributing and ongoing safety-effectiveness research of the drug
  • The ten highest prices paid for the drug in other countries
  • Total sales and profits from the drug in the previous year

Interestingly, there is bipartisan support for the bill; Representative Ron Noble, a Republican, plans to co-sponsor it in the House and Senator Dennis Linthicum, a Republican, plans to co-sponsor the legislation in the Senate with Senator Lee Beyer, a Democrat.

"This is more of a first step, instead of a very aggressive, comprehensive approach," Nosse said. "We're trying to move in a fashion where members of the other party are also comfortable."

This bill resembles the California bill that California Governor Jerry Brown signed into law in October 2017. The California bill is considered to be the most comprehensive bill centered around pharmaceutical pricing in the nation.

Unfortunately, we are continuing to see more of these transparency bills that are more focused on shaming the market on drug pricing than actually helping to resolve any pricing issues.  

January 30, 2018

CME Continues to Evolve for Providers and Practitioners


Several articles about continuing medical education (CME) were recently published in the Journal of the American Medical Association (JAMA). One article discussed the importance of regulatory alignment with the boards while the other discussed the proposed CME pyramid.

CME Pyramid

Medical education is an evolving field and as of late, there has been an increased focus on addressing professional practice gaps – the gaps between what physicians are doing and what they should be doing. Therefore, an outcomes framework has been proposed in the form of a pyramid that provides perspective on how addressing these practice gaps may be accomplished.


According to the article, “[t]he pyramid is based on 7 levels of outcomes that are associated with the decisions of a clinician to participate in learning, to engage in learning, to use what he or she learned, and, at the summit, the effects of learning on patients and community. CME has traditionally been focused on learning (level 3) and in some cases on competence (level 4), which is similar to the “shows how” level of the pyramid in which a learner demonstrates to a teacher that he or she can do what has been learned.”

The article further notes, “It could be argued that if CME contributes to improving patient health on a broad front, such that many patients and many diseases are affected, then community health, that is, population health, must necessarily improve,” which is the impetus behind the push for all physicians and health care providers to be current on their education and continue learning for the benefit of their patients.

Cultural differences also plays a role in practice gaps and an analysis of health care in different countries shows how evident cultural differences are and that gaps in knowledge happen in developed countries like the United States and the United Kingdom.

The article also notes, however, that improvement cannot be achieved by CME alone, but will require the involvement of many different organizations. For example, this year the Centers for Medicare & Medicaid Services is proposing completion of an accredited CME program directed at performance or quality improvement. This Clinical Practice Improvement Activity must address a quality or safety gap that is supported by a needs assessment. The proposal has been endorsed by the Accreditation Council for Continuing Medical Education, which is now collaborating with the American Board of Medical Specialties to facilitate the integration of CME and maintenance of certification.

The CME pyramid works to bring each of the individual groups together to create a comprehensive solution to physician and provider education.  

Innovation through Regulatory Alignment

The President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), Graham McMahon, MD, MMSc, and the Vice President for Medical Education at the American Medical Association (AMA), Susan Skochelak, MD, co-authored a piece published in JAMA on how to promote innovation through the regulatory framework. The article discussed the collaboration between the ACCME and the AMA to establish and credit CME activities in an attempt to support clinicians and developing learning opportunities.

The authors discussed the way the two groups collaborated on a strategy “to more closely align the 2 organizations’ requirements, simplify the system, and eliminate any barriers (perceived or real) that would constrain innovation in educational delivery. To develop their approach, the organizations convened listening sessions with various groups (including staff, volunteers, and leadership from accredited organizations and state medical societies), gathering feedback from physicians and educators about how to reconstruct the system to better support the evolution of CME.” It was through this process that a joint construct was formed.

“As part of the alignment, the AMA simplified and reduced its learning format requirements. There were previously specific requirements for 7 formats; now, there are specific requirements for only 3 formats: enduring materials, journal-based CME, and performance improvement CME. In addition, the requirements for these 3 format types were simplified, so that learning is prioritized. For example, the familiar posttests can be replaced with a self-reflective statement about what has been learned and how the learner plans to change; the outcome measure for a quality improvement effort can be locally determined.”

This flexibility will help physicians and CME providers alike learn more and be able to achieve more through CME.

To that end, the ACCME, in collaboration with the Accreditation Council for Pharmacy Education and the American Nurses Credentialing Center, created the first joint accreditation system to facilitate interprofessional continuing education. This program can serve as a model for accreditors in the health professions for developing systems that promote and facilitate team-based education by removing barriers between professions and expanding the delivery of interprofessional continuing education to facilitate measurable improvements in team performance.

McMahon and Skochelak noted that the success of this construct and the continuing success of CME is going to mean continuing evolution – including identifying needs and gaps in CME and adopting approaches that reflect “the same innovative spirit and nimbleness” expected of educational providers.

January 29, 2018

MedPAC Proposes Changes to Medicare Part D for Biosimilars


In mid-January 2018, the Medicare Payment Advisory Commission (MedPAC) met to discuss Medicare payment adequacy and vote on 2019 Medicare payment update recommendations. The recommendations approved during this meeting will appear in the 2018 Report to Congress by the Commission.

One of the recommendations finalized by the Commission involved Medicare Part D, stating that Congress should change Part D’s coverage-gap discount program to require manufacturers of biosimilar products to pay the coverage-gap discount by including biosimilars in the definition of “applicable drugs” and exclude biosimilar manufacturers’ discounts in the coverage gap from enrollees’ true out-of-pocket spending.

Principle Policy Analysts Rachel Schmidt and Shinobu Suzuki reported that of the 58.6 million Medicare beneficiaries in 2017, 42.5 million were enrolled in Part D plans, and the program spent nearly $80 billion last year. They noted the coverage gap for Part D beneficiaries will continue to close over the next few years, but the brand manufacturer discount will remain. The analysts stated that key trends since the start of Part D included enrollment growth of six percent, although that number was higher for non-LIS (Low Income Subsidy) enrollees than LIS, and average monthly premiums were stable at around $31 per month. It was also reported that per capita Medicare reinsurance payments to plans have grown much faster than enrollee premiums at 13 percent since 2010.

Schmidt and Suzuki also stated that altering formulary designs to incorporate trends toward moderate tightening, the use of “price protection” rebates for manufacturers, the use of preferred cost-sharing pharmacies, pharmacy fees, and restrictions against specialty pharmacies were all strategies being used to manage Part D premiums. They said that the growth in brand prices more than offset the impact of generic use by beneficiaries, and nearly all the growth in spending for high-cost enrollees is due to higher prices. Ultimately, they said that the trend of growth of high-cost enrollees and rapid growth in Medicare’s payments for reinsurance will continue due to increasing focus on specialty drugs and biologics in the pipeline. They suggested removing the financial disincentive to use biosimilars to encourage price competition.

MedPAC staff suggested the policy change would remove distortion against biosimilars from plan incentives, and Medicare would pay more of its 74.5 percent subsidy through capitated payments rather than reinsurance. The savings from this policy change would be small initially, but has the potential to generate potentially larger savings over the long-run. The recommended policy is likely to encourage plans to place biosimilars on formularies, and fewer enrollees would reach the out-of-pocket threshold.

Commissioner Jack Hoadley stated that it was important that Congress enact the entire recommendation, as using only pieces of the suggested policy change could do more harm than good. He also suggested going further in future discussions to address pricing strategies of companies where plans are left with little to no leverage as well as rebate games and the overuse of the orphan drug class. Several commissioners agreed that more would need to be done to examine the “food chain” of pharmaceutical development to market, so that the commission could better understand how to tackle ever-rising drug costs.


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