In The News

CMS Takes Action to Lower Prescription Drug Costs by Modernizing Medicare

Proposed regulation for Medicare Parts C & D would strengthen negotiations with prescription drug manufacturers to lower costs and increase transparency for patients

Today, the Centers for Medicare & Medicaid Services (CMS) proposed polices for 2020 to strengthen and modernize the Medicare Part C and D programs. The proposal would ensure that Medicare Advantage and Part D plans have more tools to negotiate lower drug prices, and the agency is also considering a policy that would require pharmacy rebates to be passed on to seniors to lower their drug costs at the pharmacy counter.

President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice, said HHS Secretary Alex Azar. By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans. The Part D proposals complement efforts to bring down costs in Medicare Advantage and in Medicare Part B through negotiation, all part of the President’s plan to put American patients first by bringing down prescription-drug prices and out-of-pocket costs.

In the twelve years since the Part D program was launched, many of the tools outlined in today’s proposal have been developed in the commercial health insurance marketplace, and the result has been lower costs for patients. Seniors in Medicare also deserve to benefit from these approaches to reducing costs, so today CMS is proposing to modernize the Medicare Advantage and Part D programs and remove barriers that keep plans from leveraging these tools.

In designing today’s proposal, foremost in the agency’s mind was the impact on patients, and the proposal is yet another action CMS has taken to deliver on President Trump and Secretary Azar’s commitment on drug prices, said CMS Administrator Seema Verma. Today’s changes will provide seniors with more plan options featuring lower costs for prescription drugs, and seniors will remain in the driver’s seat as they can choose the plan that works best for them. The result will be increasing access to the medicines that seniors depend on by lowering their out-of-pocket costs.

Private plan options for receiving Medicare benefits are increasing in popularity, with almost 37 percent of Medicare beneficiaries expected to enroll in Medicare Advantage in 2019, and Part D enrollment increasing year-over-year as well. The programs are driven by market competition; plans compete for beneficiaries’ business, and each enrollee chooses the plan that best meets his or her needs. Consumer choice puts pressure on plans to improve quality and lower costs.  Premiums in both Medicare Advantage and Part D are projected to decline next year.

Today’s proposed changes include:

  • Providing Part D plans with greater flexibility to negotiate discounts for drugs in “protected” therapeutic classes, so beneficiaries who need these drugs will see lower costs;
  • Requiring Part D plans to increase transparency and provide enrollees and their doctors with a patient’s out-of-pocket cost obligations for prescription drugs when a prescription is written;
  • Codifying a policy similar to the one implemented for 2019 to allow “step therapy” in Medicare Advantage for Part B drugs, encouraging access to high-value products including biosimilars; and
  • Implementing a statutory requirement, recently signed by President Trump, that prohibits pharmacy gag clauses in Part D.

CMS is also considering for a future plan year, which may be as early as 2020, a policy that would ensure that enrollees pay the lowest cost for the prescription drugs they pick up at a pharmacy, after taking into account back-end payments from pharmacies to plans.

Medicare Advantage and Part D will continue to protect patient access, as both programs are embedded with robust beneficiary protections. These include CMS’s review of Part D plan formularies, an expedited appeals process, and a requirement for plans to cover two drugs in every therapeutic class.

CMS looks forward to receiving comments on these proposals and other policies under consideration.

For a blog post on the proposed rule by Secretary Azar and Administrator Verma, please visit: https://www.cms.gov/blog/proposed-changes-lower-drug-prices-medicare-advantage-and-part-d.

For a fact sheet on the proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/contract-year-cy-2020-medicare-advantage-and-part-d-drug-pricing-proposed-rule-cms-4180-p.

The proposed rule (CMS-4180-P) can be downloaded from the Federal Register at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-25945.pdf

NIH statement on World COPD Day 2018

NIH-supported studies aim to reduce the burden of COPD.

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2018 Report to Congress

The U.S. Preventive Services Task Force (USPSTF or Task Force) has released its “Eighth Annual Report to Congress on High-Priority Evidence Gaps for Clinical Preventive Services.”

In this annual report, the USPSTF highlights seven recent topics related to cancer prevention and cardiovascular health, the leading causes of death among adults in the United States, for which more research is needed. The report also calls for more research in populations who are disproportionally affected by these conditions, yet often underrepresented in studies.

Topics highlighted in the report include:

Cancer Prevention

  • Screening for Cervical Cancer, Especially Among Diverse Populations
  • Screening for Prostate Cancer, Especially Among African American Men and Men With a Family History
  • Screening and Behavioral Counseling for Skin Cancer

Cardiovascular Health

  • Screening for Atrial Fibrillation With Electrocardiography
  • Screening for Cardiovascular Disease Risk With Electrocardiography
  • Risk Assessment for Cardiovascular Disease With Nontraditional Risk Factors
  • Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index

Future research in these areas can help fill these gaps and could result in important new recommendations that will help to improve the health of Americans.

Please click here to read the complete USPSTF report.

Standardized Library of Atrial Fibrillation Outcome Measures

Introduction

Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation reduces the utility of registries, making it difficult to compare, link, and aggregate data across the spectrum of clinical care and reporting. To address these limitations, the Agency for Healthcare Research and Quality (AHRQ) developed the Outcome Measures Framework (OMF), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas.a

AHRQ is assessing the feasibility of using the OMF to develop standardized libraries of outcome measures in five clinical areas, including (1) Atrial fibrillation, (2) Asthma, (3) Depression, (4) Lung cancer, and (5) Lumbar spondylolisthesis.b These clinical areas represent diverse populations and care settings, different treatment modalities, and varying levels of harmonization. For each clinical area, the relevant registries and observational studies are identified, and registry sponsors, informaticists, and clinical subject matter experts are invited to participate in a registry group that focuses on harmonizing outcome measures through a series of in-person and web-based meetings. A stakeholder group, including payers, patient representatives, Federal partners and health system leaders, is also assembled to discuss challenges and provide feedback on the harmonization effort.

A key goal of this effort is to standardize the definitions of the components that make up the outcome measures, so users can understand the level of comparability between measures across different systems and studies. As a final step in the harmonization process, clinical informaticists map the narrative definitions (generated by the workgroups) to standardized terminologies to produce a library of common data definitions.

This document describes the technical approach used to prepare the Standardized Library of Atrial Fibrillation Outcome Measures workbook. For reference, the narrative definitions for the minimum set of outcome measures produced by the Atrial Fibrillation Workgroup are included in Appendix A. The harmonization methodology and rationale for the measure definitions are discussed in a related publication.

A key goal of this effort is to standardize the definitions of the components that make up the outcome measures, so users can understand the level of comparability between measures across different systems and studies. As a final step in the harmonization process, clinical informaticists map the narrative definitions (generated by the workgroups) to standardized terminologies to produce a library of common data definitions.

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HHS Releases Physical Activity Guidelines for Americans, 2nd edition

Federal physical activity guidance updated for the first time since 2008

(Chicago) – Today, Adm. Brett P. Giroir, M.D., assistant secretary for health, announced the release of the U.S. Department of Health and Human Services’ second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s Scientific Sessions meeting. The second edition provides evidence-based recommendations for youth ages 3 through 17 and adults to safely get the physical activity they need to stay healthy. There are new key guidelines for children ages 3 through 5 and updated guidelines for youth ages 6 through 17, adults, older adults, women during pregnancy and the postpartum period, adults with chronic health conditions, and adults with disabilities.

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11 Drugs to Seriously Consider Deprescribing

You might consider "giving the axe" to these 11 drug classes, particularly in older patients, to increase safety and reduce pill burden.

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Primary Care Practices Invited to Join Initiative Aimed at Improving Opioid Management

Get resources and guidance on how to implement effective team-based opioid management strategies in primary care by participating in the AHRQ-funded “Six Building Blocks” project. Selected practices will implement the Six Building Blocks toolkit to improve opioid prescribing and collect metrics to monitor progress. An anticipated 15 participating practices will each receive technical assistance and a $2,500 honorarium to offset costs of producing metrics required for program evaluation The estimated start date for practices is January 2019.

Learn more about the project, including how to participate.

Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update

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AHRQ Views Blog: Fresh Data Show Patient Safety Improving, But Advances Still Needed in Many Areas

Jeff Brady, M.D., M.P.H., director of AHRQ’s Center for Quality Improvement and Patient Safety, and Karen Chaves, M.H.S, Director of AHRQ’s National Healthcare Quality and Disparities Report Program, highlight data in the  newly released Chartbook on Patient Safety. The Chartbook, based on AHRQ’s recently released 2017 National Healthcare Quality and Disparities Report, shows that the nation’s efforts to improve the safety of health care resulted in some encouraging overall gains between 2000 and 2016. However, there is much room for improvement, particularly for people of color and people in poor households. The Chartbook findings also identify ongoing safety concerns. Quantifying these challenges provides essential information to inform future quality improvement efforts.

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