The Daily Scan

August 10, 2018

Last Updated: 8:50 AM EST 

Private Sector 

  • Blue365®, an exclusive health and wellness program for Blue Cross and Blue Shield (BCBS) members, is now partnering with Fitbit® to help consumers create and maintain healthy habits. Mark Talluto, vice president of strategy and analytics for Blue Cross Blue Shield Association (BCBSA) commented, “there is no question that increasing activity and moving more is a tremendous benefit that can improve health, and I’m excited Blue365 members will have even more incentives to get and remain healthy by exercising at a pace that’s right for them, this strategic partnership will bring personalized health and wellbeing to the next level, allowing members to put their health first.” (BCBS.com

  • Rite Aid Corporation announced yesterday, that it has mutually agreed with Albertsons Companies Inc. to terminate their previously announced merger agreement. Rite Aid Chairman and Chief Executive Officer John Standley commented, "while we believed in the merits of the combination with Albertsons, we have heard the views expressed by our stockholders and are committed to moving forward and executing our strategic plan as a standalone company." (RiteAid.com)

Litigation

  • The Centers for Medicare and Medicaid services released a fact sheet that discusses the proposed pathways to success for Medicare Shared Savings Program. The fact sheet wrote, "referred to as “Pathways to Success,” this proposed new direction for the Shared Savings Program would redesign the participation options available under the program to encourage Accountable Care Organizations (ACOs) to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses), increase savings for the Trust Funds and mitigate losses, reduce gaming opportunity and increase program integrity, and promote regulatory flexibility and free-market principles." The fact sheet summaries the major proposed changes and select issues CMS is seeking comment on. (CMS.gov

  • A readout of Health and Human Services Secretary Alex Azar's ALEC speech and Louisiana Healthcare leaders roundtable was released. A key excerpt from his speech was noted as, “from administering Medicaid programs to providing mental health services, retiree healthcare, and public health programs, states have a major role to play in running America’s healthcare system. But we don’t just want you administering our system as it stands today. This administration believes states should play a vital role in driving American healthcare forward.” (HHS.gov

Regulation 

  • The OIG conducted a study on questionable billing for compound topical drugs in Medicare Part D. Medicare Part D spending for compounded topical drugs was 24 times higher in 2016 than it was in 2010. This explosive growth raises concerns about fraud and abuse. About 550 pharmacies had questionable Part D billing for compounded topical drugs in 2016. They each billed extremely high amounts for at least one of five measures that OIG has developed as indicators of possible fraud, waste, or abuse. The OIG recommends that CMS clarify Part D policies for coverage of compounded topical drugs and use of utilization management tools. (OIG.HHS.gov

  • The OIG conducted a study on the impact of price substitituions based on 2016 average sales prices of Medicare Part B drug payments. They conducted this study because based on the results of the comparisons in the past, the annual report quantifies the savings to Medicare and its beneficaries that are a direct result of the CMS's price substitituion policy. A major find in the study was that Medicare and its beneficiaries could have saved up to an additional $2.7 million over 1 year if CMS implemented a more expansive price substitution policy that, for example, allowed substitution for drugs that exceeded the 5 percent threshold in a single quarter. The OIG recommends that CMS expand the price-substitiuion policy because of the potential for savings to Medicare beneficiaries and the program. (OIG.HHS.gov

  • The U.S. Food & Drug Administration released a letter reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. Health care providers using rupture of membranes (ROM) tests should be aware of test limitations listed within manufacturer instructions. The FDA is concerned about misuse, over-reliance, and inaccurate interpretation of lab test results from ROM tests used to detect rupture of membranes in pregnant women. The FDA is instructing the reporting of events to help the FDA identify and better understand the risks associated with these tests. (FDA.gov, Letter

  • The U.S. Food and Drug Administration approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. FDA Commissioner Scott Gottlieb, M.D. commented, “today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition, the quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo.” (FDA.gov)

  • The U.S. Food and Drug Administration approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence commented, “mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients, we are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.” (FDA.gov

 

 

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