HealthCare Roundtable e-News – July 5, 2022

 

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2022 Federal Policy and Advocacy Forum Scheduled for July 14th

The Public Sector HealthCare Roundtable will present a virtual Federal Policy and Advocacy Forum. The Roundtable’s Annual Congressional Forum has been rebranded to reflect a broader focus on Federal issues of interest to public sector health care purchasers. The agenda will be presented in two segments – a morning program and an afternoon program – for the convenience of participants.

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Top News – Roundtable Joins Advocacy Efforts

HealthCare Roundtable Joins Joint Letter to the Tri-Agencies in Support of No Surprises Act

Sixty-eight organizations – including the Public Sector HealthCare Roundtable – representing patients, consumers, unions, and employers sent a joint letter to the Departments of Health and Human Services (HHS), Labor, and the Treasury to urge the Biden Administration to stand firm in defending the No Surprises Act. The letter describes the legislation as “a notable example of broad, bipartisan health care reform legislation.” A poll from Morning Consult found that 79% of voters are concerned lawsuits from physician and hospital organizations could delay or overturn the patient protections included in the No Surprises Act. According to a survey from AHIP and the Blue Cross Blue Shields Association, the legislation prevented over two million claims from resulting in surprise medical bills.

 

Roundtable Joins Effort to Rally Support for Seniors’ Medicare Advantage Coverage

Better Medicare Alliance sent a letter to the Centers for Medicare & Medicaid Services (CMS) to ensure continued support for Medicare Advantage beneficiaries. Nearly 70 consumer groups, provider associations, health systems, community-based non-profits, and other health leaders co-signed the letter. In addition to the Public Sector HealthCare Roundtable, notable co-signers include Meals on Wheels America, National Hispanic Medical Association, AMGA, Asian & Pacific Islander American Health Forum, Home Care Association of America, ChenMed, Arizona Nurses Association, America’s Physician Groups, VillageMD, National Adult Day Services Association, Healthcare Leadership Council, and others. The letter encourages CMS to “protect this coverage lifeline and safeguard important benefits in Medicare Advantage,” while also expressing the organizations’ commitment to “ensuring that the more than 28 million Americans who rely on Medicare Advantage can count on stability in the years ahead and continued respect and support for their Medicare coverage choices.”

Administrative Action

  • CMS issued surveyor guidance which clarifies specific regulatory requirements and provides information on how compliance will be assessed to ensure nursing home resident health and safety. The new guidance will support the implementation of the Long-Term Care (LTC) Facilities Requirements for Participation, which were published in 2016. The update provides greater clarity on topics including abuse and neglect, pharmacy, mental health, nurse staffing, and infection control. CMS is also undertaking other initiatives to protect seniors by improving safety and quality of the nation’s nursing homes, a key part of President Joe Biden’s health policy plan.
  • The Biden Administration, through the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), announced new Enhancing Oncology Model (EOM) aimed at improving cancer care for Medicare patients and lowering costs. EOM is a voluntary model where the participating providers will provide enhanced services (such as patient navigation, care planning, etc.), and screening for social needs that may affect treatment. EOM is also designed to encourage other payers to align with its core concepts to promote consistency across payers and populations. In an effort to increase and improve communications, patients will have an opportunity to share feedback on their cancer care experience and outcomes.

     

    EOM will help drive CMS’ commitment to advancing health equity by offering an additional payment to participating oncology practices that provide enhanced services, requiring participating providers to report patient demographic data, and requiring participating providers to develop plans showing how they will address gaps in health equity.

  • The U.S. Department of Health and Human Services (HHS) is seeking public comment on the development of the Initiative to Strengthen Primary Health Care. The initiative is intended to create a foundation for the provision of primary health care in an effort to support health through sustained partnerships, equitably provide first contact access to comprehensive care, and coordinate care across systems. The Office of the Assistant Secretary for Health is specifically requesting information on successful models or innovations that improve primary health care, barriers to implementing successful models, successful strategies to engage communities, and proposed HHS actions. The public comment period will be open for 36 days starting on June 27, 2022, through August 1.
  • Department of Health and Human Services Secretary Xavier Becerra, Labor Secretary Marty Walsh, and Treasury Secretary Janet Yellen (the “Departments”) issued a letter to group health plans and insurance issuers reminding them of their obligations under the Affordable Care Act (ACA) to provide full coverage for contraceptive services. The ACA requires plans and issuers to cover the full cost of at least one form of contraceptive from each of the FDA’s identified contraceptive categories, along with the full cost of associated clinical services like patient education and counseling. The Departments expect plans and issuers to immediately take steps to ensure their compliance and may take further action as appropriate. The full text of the letter can be read here.

Congressional Action

  • A group of bicameral lawmakers sent a letter to Department of Health and Human Services (DHHS) Secretary Xavier Becerra, urging him to take action that will lower prescription drug prices. Spearheaded by Sen. Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX-35), the letter implores Secretary Becerra to utilize administrative authorities including government patent use compulsory licensing under 28 U.S.C. 1498 and march-in and royalty-free rights under the Bayh-Dole Act. The letter notes that American drug prices cost an average of 2.5 times more than in other countries, leaving many Americans struggling to afford their medication. The members of Congress attribute the rise in prices to corporations’ monopoly on the market and the lack of government negotiation power on pharmaceutical pricing. The members thank Secretary Becerra and President Biden for calling on Congress to allow Medicare to negotiate drug prices for a selection of high-priced, brand-name drugs and to prevent prices for all drugs from rising faster than inflation. However, the members urge Secretary Becerra to take additional action, including to ensure the patent system does not unjustifiably delay generic and drug and biosimilar competition. Such measures will promote competition and destroy longstanding monopoles in the industry.
  • The House Energy & Commerce Subcommittee on Health, Chaired by Representative Anna Eshoo [D-CA-18], hosted a hearing titled “Investing in Public Health: Legislation to Support Patients, Workers, and Research.” The committee discussed several items of pending legislation related to the National Institute of Health (NIH), including population diversity in clinical research trials and security/nondisclosure of federally funded research initiatives. Other bills discussed focused on mobile health care delivery, pediatric care research, and uterine fibroid research and education. The committee’s witnesses included Professor of Epidemiology and Biostatistics, Dr. Kirsten Bibbins-Domingo, CEO of North Memorial Health, Dr. Kevin Croston, Founder of the White Dress Project, Tanika Gray Valbrun, President of Government Solutions at IPTalons, Michael Shannon, CEO of NEW Health, Desiree Sweeney, and Senior Vice President of Seattle Children’s Hospital, Dr. Leslie Walker-Harding. A longer summary of this hearing can be found here.
  • The House Energy & Commerce Committee held an oversight hearing on the Medicare Advantage program. Members of the committee and other witnesses discussed ways in which the federal government is protecting consumers in the MA program as well as areas that Congress can work the federal government and health plans to enhance the program and protect its beneficiaries. To read Healthsperien’s in-depth summary of the hearing, click here. To read a transcript of the hearing, click here.

Regulatory Action

  • The Food and Drug Administration (FDA) released a proposed rule which aims to broaden the selection of nonprescription drugs available to consumers, empowering them to self-treat certain common conditions. If finalized, the proposed rule would expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use (ACNU). The goal of the proposal is to improve public health by broadening the types of safe and effective nonprescription drugs on the market. FDA is inviting the public to comment on this proposed rule for 120 days after publication on the Federal Register. Full text of the proposal can be found here.
  • The Office of Civil Rights (OCR) in the Department of Health and Human Security (HHS) released two guidance documents related to medical privacy and data security.

    The first guidance is meant to inform and aid citizens in protecting the privacy and security of their health information while using personal cell phone or tablet devices. The Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules protects your protected health information (PHI) when transported or maintained by covered entities, including health plans, providers, and the businesses that provide services for those entities. HIPAA generally does not protect your PHI when accessed on personal tablets and cell phones. Information collected by your device and apps, including internet search history, geographic location, and information shared voluntarily online, may be collected by other entities and sold for marketing or other purposes. The guidance provides specific steps to increase privacy of your digital footprint.

    The second guidance clarifies HIPAA’s Privacy Rule procedure for abortion and sexual/reproductive health services in the wake of the Supreme Court’s Dobbs v Jackson Women’s Health Organization ruling late last week. The OCR-administered Privacy Rule regulates when covered entities may use or disclose PHI without an individual’s signed authorization. Disclosure of PHI without consent for purposes unrelated to health care, including disclosure to law enforcement, are narrowly tailored to protect the individual’s privacy and support access to health services. The guidance provides detailed information on permitted disclosures and their limitations.

  • The Centers for Medicare & Medicaid Services released updates to rule CMS-3419-P standardizing Conditions of Participation (CoPs) for Rural Emergency Hospitals (REHs). REHs are a new provider type established under the Consolidated Appropriations Act of 2021. The goal of the REH designation is to avert potential closures for rural hospitals, provide emergency care, and promote health equity for those in rural communities.

Medicare

CMS is reconsidering Medicare coverage restrictions on positron emission tomography (PET) imaging for amyloid beta plaques in response to public comments it received on the national coverage policy for the Alzheimer’s drug Aduhelm. Currently, NCD 220.6.20 covers one PET amyloid-beta scan per patient in CMS approved studies under coverage with evidence development (CED). However, clinical trial protocols for Aduhelm may require more than one scan, promoting CMS to reconsider current coverage restrictions. The national coverage policy for PET scans for beta amyloid plaques is related to the coverage policy for Aduhelm. The drug is meant to be prescribed after the confirmed existence of beta amyloid plaques using PET scans or cerebrospinal fluid tests. Medicare only covers Aduhelm for patients in clinical trials when the FDA grants accelerate approvals. The FDA granted accelerated approval for the drug based on the surrogate outcome of reducing beta amyloid plaques in the brain. This national coverage determination also applies to other prospective monoclonal antibodies against amyloid that are indicated for Alzheimer’s disease.

Other News

The United States Supreme Court limited the Environmental Protection Agency’s (EPA) power to regulate carbon emissions that contribute to climate change. In a 6-3 ruling, the Court determined that new regulations from executive agencies are presumptively invalid, unless Congress specifically authorizes such regulations. Chief Justice John Roberts wrote the majority opinion in the case, known as West Virginia v. EPA. All six conservative members of the Court joined together in the majority opinion. The Court’s ruling may have future implications for other federal regulators, including agencies related to health care.

Roundtable Reminders

SAVE THE DATE – November 9-11, 2022
Annual Conference Returns to Alexandria, VA
After two years of virtual meetings, the Roundtable is planning an in-person Annual Conference for this November. We will return to The Alexandrian Hotel in Old Town Alexandria, Virginia for our annual policy conference from Wednesday, November 9 to Friday, November 11, 2022.
Details will be released later this year. For now, save the dates!