- November 17, 2020 - The House passed 10 healthcare bills addressing a variety of topics including health disparities research endowments, food and drug labeling, trauma centers, and responding to the nation’s opioid epidemic. Some of this legislation is likely to wind up on the president’s desk for signature before the end of the year. View the press release here.
- November 12, 2020 - After a campaign generated by patient and provider groups, United HealthCare, one of the nation’s largest health insurers, postponed a plan to implement a co-pay accumulator adjustment program for its medical benefits. A joint letter from patient and provider organizations expressed concern that such a program would negatively impact patients’ ability to access and afford their medications. View the UHC Announcement here.
- November 10, 2020 - The Biomedical Advanced Research Development Authority (BARDA) within the U.S. Department of Health & Human Services (HHS) announced a new type of public-private partnership, BARDA Ventures. This will allow authorities granted by the 21st Century Cures Act to utilize venture capital (VC) methods and practices. This will be the first time HHS has utilized VC practices to make investments. As part of the new program, BARDA is soliciting proposals for an existing nonprofit partner to manage an investment fund that will support breakthrough technologies and create entirely new approaches to enhance U.S. preparedness and response to 21st century health security threats, including COVID-19 and future pandemics.
October 29, 2020 - The Departments of Health and Human Services, Labor, and Treasury issued final rules this week on drug pricing transparency. The rules set forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee, including an estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider. View the CMS Fact Sheet here.
October 28, 2020 - This week the Centers for Medicare and Medicaid Services released a plan to ensure that Medicare and Medicaid beneficiaries, along with those covered by private health insurance plans, receive a COVID-19 vaccine at no cost when it becomes available. View CMS COVID-19 Vaccine Coverage Fact Sheet and Press release.
- October 14, 2020 - the Health Resources and Services Administration (HRSA) released a report on health equity across the United States. According to the Centers for Disease Control and Prevention (CDC), health equity is achieved when no one is disadvantaged from achieving their full health potential because of social position or other socially determined circumstances. Read the press release and full report from HRSA as well as the CDC's information on health equity.
- October 13, 2020 - A coalition of 33 organizations representing millions of people with pre-existing conditions launched an unprecedented effort this week by releasing their top health insurance coverage priorities for the first 100 days of the next administration. The report elevates the collective voices of patients and urges elected officials to ensure all people living in the United States, including those with pre-existing conditions, have access to adequate and affordable health coverage. Read the press release and full document.
October 1, 2020 - The House passed sixteen health bills this week ranging from school-based asthma management and health centers to improved mental/behavioral health and the FDA Pediatric Rare Disease Priority Review Voucher program. The House Energy & Commerce Committee has provided a press release containing summaries of the bills included.
October 1, 2020 - Ranking member of the Senate HELP Committee, Senator Patty Murray (D-WA), and several colleagues introduced the $4.5 billion Public Health Infrastructure Saves Lives Act. This bill is designed to provide grants to states and other jurisdictions to improve public health capabilities. The COVID-19 pandemic has highlighted the vulnerability of the nation’s public health infrastructure, and the Murray bill aims to provide resources to help make necessary improvements. An explanation of the bill, summary, and text are located here.
October 1, 2020 - The Health Resources and Services Administration (HRSA) announced the availability of $20 billion in new funding for healthcare providers on the frontlines of the coronavirus pandemic. Eligible providers may begin applying for funding Monday, October 5, 2020 through Friday, November 6, 2020. Those who already received Provider Relief Fund payments are invited to apply for additional funding. This considers financial losses and changes in operating expenses caused by the coronavirus pandemic. Previously ineligible providers, such as those who began practicing in 2020 will also be invited to apply. More information is available here.
September 24, 2020 - President Trump issued new executive orders (EO) aimed at solidifying his administration’s commitment to coverage for individuals with pre-existing health conditions and preventing surprise medical billing. The president stated, "The historic action I am taking today includes the first-ever executive order to affirm it is the official policy of the United States government to protect patients with pre-existing conditions." Read the executive orders here.
- September 23, 2020 - Congress heard testimony this week from experts about COVID-19 in two separate hearings. The Senate HELP Committee featured NIAID Director Dr. Anthony Fauci, CDC Director Dr. Robert Redfield, HHS Assistant Secretary for Health Dr. Brett Giroir, and FDA Commissioner Dr. Steven Hahn with an update on the federal response to the pandemic. Much of the hearing was focused on a safe and reliable COVID vaccine. The House Energy and Commerce Committee reviewed the Affordable Care Act and the implications of the COVID-19 pandemic.
- September 13, 2020 - President Trump issued an executive order (EO) on pricing related to reimbursement rates for Medicare Part B drugs and some part D drugs. The EO states that “the Medicare program should not pay more for costly Part B prescription drugs or biological products than the most-favored-nation price. The ‘most-favored-nation price’ shall mean the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organization for Economic Cooperation and Development that has a comparable per-capita gross domestic product.” The EO calls on the HHS secretary to embark on a pilot study and rulemaking process to implement the order. View the EO here.
- September 9, 2020 - The House Energy & Commerce Committee advanced 26 health-related bills focusing on a variety of topics and conditions. View the Energy & Commerce Committee press release, including summaries of each bill here. The bills that were passed through the Committee include:
H.R. 1379 - Ensuring Lasting Smiles Act
H.R. 945 - Mental Health Access Improvement Act of 2019
H.R. 2564 - Medicare Enrollment Protection Act
H.R. 4078 -EARLY Act Reauthorization of 2019
H.R. 7948 - Tribal Health Data Improvement Act of 2020
H.R. 2466 - State Opioid Response Grant Authorization Act
H.R. 3878 - Block, Report, And Suspend Shipments Act of 2019
H.R. 3797 - Medical Marijuana Research Act of 2019
H.R. 1109 - Mental Health Services for Students Act
H.R. 3539 - Behavioral Intervention Guidelines Act of 2019
H.R. 7293 - Suicide Training and Awareness Nationally Delivered for Universal Prevention Act of 2020 or the STANDUP Act of 2020
H.R. 5469 - Pursuing Equity in Mental Health Act of 2019
H.R. 4439 - Creating Hope Reauthorization Act
- August 21, 2020 - HHS released Healthy People 2030 — the fifth iteration of the Healthy People initiative. Building on knowledge gained over the past 4 decades, Healthy People 2030 sets national objectives to address the nation’s most critical public health challenges. New objectives for this decade address emerging health issues — like opioid use disorder and adolescents’ use of e-cigarettes and flavored tobacco.
- August 6, 2020 - The NIH announced the selection of Lindsey Criswell, MD, MPH, DSc to be the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Dr. Criswell currently serves as the vice chancellor of research at the University of California, San Francisco (UCSF). She is a professor of rheumatology in UCSF’s Department of Medicine, as well as a professor of orofacial sciences in its School of Dentistry. Dr. Criswell is expected to begin her new role in early 2021.
- August 3, 2020 - President Trump signed an executive order boosting access to healthcare in rural areas by extending an emergency authority on telehealth benefits, making permanent temporary measures introduced during the coronavirus pandemic. The order announced by Trump in a news conference at the White House, would support wider access to healthcare. View the Executive Order.
- July 31, 2020 - HHS announced that certain Medicare providers would be given another opportunity to receive additional Provider Relief Fund payments. These are providers who previously missed the June 3rd deadline to apply for additional funding equal to 2% of their total patient care revenue, including many Medicaid, Children's Health Insurance Program (CHIP), and dental providers with low Medicare revenues. In addition, certain providers who experienced a change in ownership, making them previously ineligible for Phase 1 COVID-19 funding, will also be given an opportunity to apply for financial relief.
- July 29, 2020 - In response to Section 7 of President Trump’s Executive Order 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients, The U.S. Department of Health and Human Services relaesed the HHS Secretary's Report on Addressing Surprise Medical Billing. This report outlines critical steps needed to implement the Administration’s principles on surprise billing, which includes Congressional Action. HHS aknowledges that sound surprise billing legislation will not only protect patients but will encourage a fairer, more transparent, patient-centered healthcare system that benefits all Americans. For more information read the HHS press release or the full report.
- July 24, 2020 - President Trump issued a series of executive orders that brought attention to surprise medical billing and drug pricing. The orders call for:
- Federally qualified health centers to pass along on discounts on insulin to low-income consumers.
- Establishment of state plans for safe importation of certain drugs and authorization of the re-importation of insulin products made in the United States.
- Prohibition of undisclosed discount deals between drug manufacturers and pharmacy benefit managers and directing discounts to patients.
- Lowering the reimbursement amount for Medicare Part B drugs to the lowest amount paid by other countries with economies comparable to the US. More information available here.
- Bipartisan/bicameral congressional leaders responded to the surprise billing report and its call on Congress to act by urging swift action on comprehensive legislation to end surprise billing. Their statement press release is available here.
- The US Department of Health & Human Services Office of the Inspector General issued a warning alerting the public about fraud schemes related to the novel coronavirus (COVID-19). Scammers are offering COVID-19 tests to Medicare beneficiaries in exchange for personal details, including Medicare information. However, the services are unapproved and illegitimate. Find the official statement here.
- July 16, 2020 - Preserving Patient Savings on Drug Costs Act, HR 7647, would prevent insurance companies from instituting copay accumulator programs until a year after the COVID-19 public health emergency ends. This bipartisan legislation was introduced to limit financial barrier for those affected by chronic illness and COVID-19.
- Senate HELP Committee Chairman Lamar Alexander (R-TN) released “Preparing for the Next Pandemic," a 40-page white paper with five recommendations to address future pandemics based on lessons learned from COVID-19 and the past 20 years of pandemic planning. The HELP Committee is requesting feedback from the public on this white paper and the recommendations. Find the committee request and information on how to provide input here. The five recommendations include:
- Accelerating research and development of tests, treatments, and vaccines.
- Expand the ability to detect, identify, model, and track emerging infectious diseases.
- Rebuild and Maintain Federal and State Stockpiles and Improve Medical Supply Surge Capacity and Distribution
- Improve state and local capacity to respond
- Improve coordination of Federal Agencies during a public health emergency.
- The CDC has released a report regarding the effects of COVID-19 on the health of racial and ethnic minority groups. The data suggests a disproportionate burden of illness and death among these groups. Learn more about the information collected and the CDC's recommendations on how individuals and government, community, and healthcare organizations can work together to combat this issue here.
- On June 22nd, House Democrats introduced the Patient Protection and Affordable Care Enhancement Act (H.R. 1425). This legislation includes provisions intended to bolster the Affordable Care Act and reverse efforts to eliminate the law, enhance affordability for patients with chronic illness, and address drug pricing. H.R. 1425 is supported by the Chairman of the committees of jurisdiction in the House; Congressman Frank Pallone (D-NJ) of the Energy & Commerce Committee, Congressman Richie Neal (D-MA) of the Ways & Means Committee, and Congressman Bobby Scott (D-VA) of the Education & Labor Committee. Notable provisions of H.R. 1425 include:
- Increasing the amount of premium tax credits for purchasing marketplace plans, and expanding eligibility beyond 400% of the federal poverty line.
- Establishing a State Health Insurance Affordability Fund by providing $10 billion to states to provide financial assistance to lower out-of-pocket costs (or implement reinsurance programs).
- Restricting the availability or short-term limited-duration health plans that bypass patient protections and coverage requirements.
- Providing $200 million annually for states to test pilot initiatives that increase enrolmment or otherwise strengthen the healthcare exchanges.
- Enhancing civil and monetary penalties for insurers that engage in unjustified or excessive rate hikes.
- Incentivizing Medicaid expansion on the state level.
- Providing 12-months of continuous eligibility for Medicaid and the Children’s Health Insurance Program, which cannot be jepordized by fluctuations in income.
- Increasing payment rates for primary care providers.
- A variety of provisions designed to facilitate drug price negotiations.
- For additional information, please see congress.gov here.
- The HHS Office of Minority Health this week announced a $40 million award to Morehouse School of Medicine to fight COVID-19 in racial and ethnic minority, rural and socially vulnerable communities. Morehouse will enter into a cooperative agreement with OMH to lead the initiative to coordinate a strategic network of national, state, territorial, tribal and local organizations to deliver COVID-19-related information to communities hardest hit by the pandemic. More information is available here.
- The U.S. Food and Drug Administration (FDA) is seeking input from the public and stakeholders on the establishment of a rare disease clinical trial network. Docket No. FDA-2020-N-0837 was announced on May 29th. The FDA is interested in learning practical steps and successful approaches relating to start-up, implementation, and sustainment of clinical trial networks for rare diseases. With less than 10 percent of the approximately 7,000 known rare diseases having an FDA-approved treatment available, the FDA is seeking ways to overcome the challenges of rare disease drug development. Learn more about this request for information here.
- The Medical Nutrition Therapy Act (H.R. 6971) was introduced on May 22nd by Congressmen Eliot Engel (D-NY-16) and Peter King (R-NY-2). This legislation seeks to provide Medicare coverage and access to medical nutrition therapy services. The bill will allow for Medicare coverage of physician requested medical nutrition therapy for conditions that cause involuntary weight loss. While H.R. 6971 lists specific conditions, the Secretary is granted discretion to acknowledge additional conditions. The US Preventative Services Taskforce is also acknowledged for its role in identifying necessary prevention, treatment, and management protocols for various conditions. There is no Senate companion bill at this time. Find more information about this legislation here.
The Dietary Guidelines states that "in the U.S., more than half of all adults have one or more preventable chronic diseases, many of which are related to poor diets and not enough physical activity. Additionally, poor diets, tobacco use and not enough physical activity, among other risk factors, are leading causes of deaths in the U.S. Providing up-to-date nutrition advice through the Dietary Guidelines can help to improve the health of Americans by encouraging healthy food and beverage choices that are enjoyable, promote health, and help prevent chronic disease."
These Guidelines are intended to provide guidance for building and maintaining a healthy diet that focuses on preventing diet-related chronic diseases. It is important to understand that the focus is to prevent disease, not to use it as a treatment. The intent of these recommendations is to help individuals improve and preserve
overall health to reduce the risk of chronic conditions.
The 2020 Dietary Guidelines Advisory Committee’s final systematic review protocols are available online. These protocols take into consideration input from the Committee during its public meetings and public comments received. Included is the scientific articles cited, and those excluded, including the reasons for exclusion.
The 2020 Dietary Guidelines Advisory Committee’s schedule has been extended by one month, as a result, the Committee will now present its draft report via webcast on June 8, 2020. The 2020-2025 Dietary Guidelines document can be found here.
- While the Removing Barriers to Colorectal Cancer Screening Act of 2019, H.R. 1570, is still seeking more cosponsors, the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020, H.R. 2339, passed the House of Representative on February 28th. In addition to stricter regulations on tobacco products and e-cigarettes, this language includes similar language to waive Medicare coinsurance for colorectal cancer screening tests, otherwise known as the "polyp penalty".
- A letter was sent from Democratic leads to the Center for Medicaid and Medicare Services (CMS) Administrator regarding the proposed discontinuation of advanced premium tax credits (APTC). Read the letter here.
The comprehensive spending package for Fiscal Year (FY) 2020 includes the following health policy and program reauthorizations.
- Reauthorization of the Patient-Centered Outcomes Research Institute (PCORI) for 10 years.
- A nationwide increase in the age for the sale of tobacco products to 21 years
- Increases generic drug competition to lower the price of drugs
- Repeal of the Affordable Care Act’s (ACA) Medical Device Tax, Health Insurance Tax, and Cadillac Tax
- Rare Disease Legislative Advocates (RDLA) visited the nation’s capital the week of February 24th yo educate legislators about the need to support research, improve patient care, and awareness about rare diseases.
- Vice President Pence is to lead the coordination of the US response to the coronavirus. Pence has appointed Debbie Birx, an ambassador-at-large for the State Department who currently focuses on HIV and AIDS, to serve as the "White House Coronavirus Response Coordinator" responsible for leading the administration's strategy on fighting the outbreak. Birx and three new members of the White House's coronavirus task force - Treasury Secretary Steven Mnuchin, Surgeon General Jerome Adams, and National Economic Council Director Larry Kudlow - will report to Pence and Health and Human Services Secretary Alex Azar.
- The House Committee of Ways and Means voiced unanimous, bipartisan support of the Consumer Protections Against Suprise Medical Bills Act of 2020 (H.R. 5826). This legislation has thirty-eight cosponsors and was introduced by Representative Richard Neal, Chairman of the Ways and Means Committee. Find the press release here.
- On February 11th, the House Committee on Education and Labor advanced the Ban Surprise Billing Act (H.R. 5800), which was introduced on February 7, 2020. This legislation is intended to build on solutions to protect patients from surprise medical bills. Find the press release here.
- During the State of the Union Address on February 6th, President Trump remarked that his major priorities include; lowering the cost of healthcare and prescription drugs, and protecting patients with preexisting conditions. Find President Trump's entire remarks here.
- On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance allowing states to apply for capped block grants through Medicaid demonstration waivers, particularly in order to cover services for the Medicaid expansion population (i.e., adults under the age of 65). The guidance also allows states that receive such block grants to make other changes to their programs (e.g., formularies for prescription drugs). Two resolutions in the House of Representatives were created. H. Res. 826 created on February 3rd, expressed the opinion that the House of Representatives feels CMS should withdraw this guidance. On February 5th the House then created H. Res. 833, officially disapproving of the guidance permitting block grants under Medicaid demonstration waivers. Both resolutions were passed on February 6th, the Senate is not expected to act on a similar resolution.
- The Supreme Court declined a motion to fast-track a challenge to the Affordable Care Act (ACA). This is in response to a lower court ruling declaring the individual mandate of the ACA unconstitutional. Further action by the lower court or the Supreme Court is not likely in the near future. Read the Docket information here.
- Legislation addressing drug pricing and surprise medical billing appears to be stalled at this time. The ongoing tension between the House Energy & Commerce Committee and the House Ways & Means Committee has stifled progress on surprise medical billing. The House-passed drug pricing legislation, H.R. 3, is pending in the Senate, a bipartisan proposal (S.2543), is having difficulty finding traction. Proponents of addressing these key topics are hoping that progress can be made between now and May when Congress must act on several expiring health authorities.
- The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF), an independent body of experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. The deadline to submit a nomination is March 15th.
- The Patient-Centered Outcomes Research Institute (PCORI), fresh from a 10-year reauthorization, announced the appointment of Dr. Nakela Cook as its new executive director on January, 15th. Most recently, Dr. Cook served as chief of staff at the National Heart, Lung, and Blood Institute at NIH. Read the announcement here.
- Senate Finance Committee Chairman Charles Grassley (R-IA) continues to push for action on his drug pricing legislation, the Prescription Drug Pricing Reduction Act of 2019 (S.2543). Grassley has made appeals to both Senate Majority Leader McConnell, and House Speaker Pelosi to proceed with his bipartisan plan. Grassley’s Senate bill is less comprehensive than the House-passed bill, the Elijah E. Cummings Lower Drug Costs Now Act (H.R.3), but does have support on both sides of the aisle.
- Progress on surprise medical billing legislation continues to be stalled because of a dispute between House committees. Follow the link to find more information on the End Surprise Billing Act of 2019 (H.R.861).
- Senate HELP Committee Chairman Lamar Alexander (R-TN) released “Preparing for the Next Pandemic” — a white paper with five recommendations to address future pandemics based on lessons learned from COVID-19 and the past 20 years of pandemic planning. The HELP Committee is requesting feedback from the public on this white paper and the recommendations. HELP Committee Request
would prevent insurance companies from instituting copay accumulator programs until a year after the COVID-19 public health emergency ends.