This week in Washington: COVID-19 relief bill negotiations begin in earnest; Congress works on Appropriations bills hoping to have them passed before government funding ends on Dec. 11.

Congress

House

• Pelosi, Schumer Support Bipartisan $908B Pandemic Relief Proposal

Senate

• Cardin, Portman, Thune, Menendez Introduce Legislation to Fund COVID-19 Vaccine Public Advocacy Campaign
• Warner: CMS Must Extend Enrollment Window over APTC Confusion

Administration

• CMS Announces New Model to Advance Regional Value-Based Care in Medicare
• CMS Avoids Deeper 340B Cuts for Now, Future Action Possible
• FDA Streamlines COVID-19 Test EUA Review to Speed Decision-Making
• FDA Launches Pilot Program to Assess Novel Drug Development Tools
• CDC: New Diagnosis Codes for the International Classification of Diseases

Final Regulations/Guidance

• CMS: Outpatient Prospective Payment System and Ambulatory Surgical Center Final Rule with Comment Period
• CMS Delays of Radiation Oncology Model in Outpatient Rule

Reports

• National Academy of Medicine: Advancing Artificial Intelligence in Health Settings Outside the Hospital and Clinic
• The Commonwealth Fund: How Prepared Are States to Vaccinate the Public Against COVID-19? Learning from Influenza and H1N1 Vaccination Programs
• GAO: Military Health Care - Defense Health Agency Processes for Responding to Provider Quality and Safety Concerns
• GAO: COVID-19 - Urgent Actions Needed to Better Ensure an Effective Federal Response
• GAO: Artificial Intelligence in Health Care - Benefits and Challenges of Technologies to Augment Patient Care

House

Pelosi, Schumer Support Bipartisan $908B Pandemic Relief Proposal

On Dec. 2, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer said they are endorsing a new compromise $908 billion pandemic relief bill as a framework for negotiations with Senate Majority Leader Mitch McConnell (R-KY) and House Minority Leader Kevin McCarthy (R-CA). The framework proposed by a bipartisan group of senators and supported by the House Problem Solvers Caucus is over 1 trillion dollars less than Democrats are seeking in the House-passed HEROES Act. It is over $400 billion more than Republicans sought in their most recent proposal. It is unclear when the proposal would be ready for a vote on the House or Senate floor, or if either leader would commit to calling it up to vote. Senate Majority Whip John Thune (R-SD) said he thinks there is a path forward with the current framework.

Find the framework here.

Senate

Cardin, Portman, Thune, Menendez Introduce Legislation to Fund COVID-19 Vaccine Public Advocacy Campaign

On Dec. 3, Sens. Ben Cardin (D-MD), Rob Portman (R-OH), John Thune (R-SD) and Bob Menendez (D-NJ) introduced bipartisan legislation to fund a science-driven public advocacy campaign to ensure that when the Food & Drug Administration (FDA) has authorized an effective COVID-19 vaccine, distribution will properly occur throughout the country. This legislation would authorize necessary funding to fund a public awareness campaign on COVID-19 vaccine information through the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). Grants would go to entities to start developing campaigns that target all Americans, and that would begin no later than 30 days after a vaccine is authorized.

Warner: CMS Must Extend Enrollment Window over APTC Confusion

On Dec. 3, Sen. Mark Warner (D-VA) announced that he wants the Internal Revenue Service (IRS) and the Centers for Medicare and Medicaid Services (CMS) to provide more clarity to consumers, waive any enforcement penalties and create an open enrollment period to ensure enrollees do not go without coverage during the COVID-19 pandemic. CMS announced that Affordable Care Act enrollees who have reconciled their 2019 advanced premium tax credits (APTCs) as required can keep their 2021 subsidies, even if they were notified that they are at risk of losing them, by checking a box on their exchange application. Sen. Warner does not think that is enough to help enrollees, commenting that consumers remain confused about their options and are at risk of losing their health coverage during a pandemic.

Administration

CMS Announces New Model to Advance Regional Value-Based Care in Medicare

On Dec. 3, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary payment model, the Geographic Direct Contracting Model that will test whether a geographic-based approach to value-based care can improve quality of care and reduce costs for Medicare beneficiaries across an entire geographic region. Leveraging information learned in the Innovation Center models, this new model will enable Direct Contracting Entities (DCEs) to integrate coordinate care and address clinical and social needs of Medicare beneficiaries.

Beneficiaries in the model will maintain all of their existing Original Medicare benefits, including the ability to see any provider they choose. Beneficiaries may also receive enhanced benefits, including additional telehealth services, easier access to home care, access to skilled nursing care without having to stay in a hospital for three days, and concurrent hospice and curative care. Participants will also have the ability to reduce beneficiary cost sharing for Medicare Part A and Part B services as well as offer beneficiaries a Part B premium subsidy.

Find more information here.

CMS Avoids Deeper 340B Cuts for Now, Future Action Possible

On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) stopped its proposal to increase cuts to Part B pay for 340B drugs by an additional 6 percent in 2021, citing the COVID-19 public health emergency, and instead finalized its alternative proposal to continue paying hospitals for those drugs at the Average Sales Price minus 22.5 percent as part of the final 2021 hospital outpatient pay rule. CMS says it could still move forward with the larger cuts, which are based on survey data, at a later date.

FDA Streamlines COVID-19 Test EUA Review to Speed Decision-Making

On Dec. 3, the Food and Drug Administration (FDA) limited its feedback on emergency use authorization (EUA) requests for COVID-19 diagnostic tests to just one round of questions in order to quickly move through submissions and make decisions on the applications. FDA is still receiving large numbers of EUA and pre-EUA applications for COVID-19 diagnostics, and has had to bring in reviewers from other areas of the FDA to help look over the submissions and reduce the list of open submissions. Now, the FDA needs to go further to get through pending applications, so it will close the applications after one round of questions with sponsors.

FDA Launches Pilot Program to Assess Novel Drug Development Tools

On Nov. 30, the Food and Drug Administration (FDA) launched a pilot program that creates a regulatory pathway for novel drug development tools such as biomarkers, clinical outcome assessments and animal models for use under the Animal Rule. The new program, the Innovative Science and Technology Approaches for New Drugs (ISTAND), will allow developers to receive feedback from the agency in early stages of drug development and create new platforms that enable FDA and other stakeholders, including international regulatory agencies, to share information and expedite approval of the new products. Through ISTAND, drug developers may qualify their products using FDA’s DDT qualification process.

CDC: New Diagnosis Codes for the International Classification of Diseases

On Nov. 30, the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) announced it would implement new diagnosis codes into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), effective Jan. 1, 2021. In addition, the Centers for Medicare and Medicaid Services (CMS) is implementing 21 new procedure codes to describe the introduction or infusion of therapeutics, including monoclonal antibodies and vaccines for COVID-19 treatment, into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS), also effective Jan. 1, 2021.

Find more information here.

Final Regulations/Guidance

CMS: Outpatient Prospective Payment System and Ambulatory Surgical Center Final Rule with Comment Period

On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) finalized a rule that will begin eliminating the Inpatient Only (IPO) list of 1,700 procedures for which Medicare will only pay when performed in the hospital inpatient setting over a three-year transitional period, beginning with some 300 primarily musculoskeletal-related services. The IPO list will be completely phased out by CY 2024. This will make these procedures eligible to be paid by Medicare when furnished in the hospital outpatient setting when outpatient care is appropriate, as well as continuing to be payable when furnished in the hospital inpatient setting when inpatient care is appropriate, as determined by the physician.

Find the final rule here.

CMS Delays of Radiation Oncology Model in Outpatient Rule

On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) officially delayed the radiation oncology model demonstration until July 1, 2021, with a clause in the final hospital outpatient prospective payment system rule, giving oncologists another 6 months to comply with the mandatory program.

Courts

Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Reports

National Academy of Medicine: Advancing Artificial Intelligence in Health Settings Outside the Hospital and Clinic

On Nov. 30, the National Academy of Medicine released a report on how the health care ecosystem is witnessing a surge of artificial intelligence (AI)-driven technologies and products that can potentially augment care delivery outside of hospital and clinic settings. These tools can be used to conduct remote monitoring, support telehealth visits or target high-risk populations for more intensive health care interventions. With much of patients’ time spent outside of a hospital or a provider’s office, these tools can offer benefits in facilitating patients’ access to their provider teams in convenient ways, facilitating providers’ understanding of their patients’ daily habits, extending care access to underserved communities, and delivering personalized, real-time care in the patient’s home environment.

Find the full report here.

The Commonwealth Fund: How Prepared Are States to Vaccinate the Public Against COVID-19? Learning from Influenza and H1N1 Vaccination Programs

On Dec. 3, the Commonwealth Fund released a report on the preparedness level by states to vaccinate the public with the COVID-19 vaccines. According to the report, the success of a future COVID-19 vaccination program rests on achieving high rates of uptake, especially in states with higher case counts and states with larger Black, Latino and American Indian populations. The report suggests that the federal government’s strategy should aim for higher COVID-19 vaccine adherence than is typically achieved for influenza and ensure equitable availability across states. Experience to date suggests it may be difficult to predict which states will be at highest risk during the next year. Nearly all states have reported significant racial and ethnic disparities in vaccination, suggesting the need for special efforts to reach communities at higher risk from COVID-19.

Find the full report here.

GAO: Military Health Care - Defense Health Agency Processes for Responding to Provider Quality and Safety Concerns

On Dec. 1, the Government Accountability Office (GAO) released a report on care given by physicians, dentists and other practitioners who want to provide care at military hospitals and clinics must receive permission from the Department of Defense (DOD) to do so. DOD routinely monitors providers at military facilities to make sure they provide safe, high-quality care. The report covers scenarios where the care a provider gives is questioned, and how DOD reviews such concerns and determines whether to limit or revoke a provider’s permission to provide care for the military. If a provider’s permission is revoked, DOD must report it to a national database that tracks disciplinary actions taken against providers, and to the states where the provider is licensed. GAO reviewed documentation that contains policy and guidance for these processes, including DHA’s August 2019 procedure manual for managing clinical quality management in the Military Health System. GAO also interviewed officials from DHA and each of the military services. DOD concurred with GAO’s report and provided technical comments, which GAO deemed appropriate.

Find the full report here.

GAO: COVID-19 - Urgent Actions Needed to Better Ensure an Effective Federal Response

On Nov. 30, the Government Accountability Office (GAO) released a report on its continued oversight of the federal COVID-19. In GAO’s national survey, states and territories were concerned about ongoing shortages of some testing-related and other medical supplies (e.g., nitrile gloves). As vaccines and therapeutics are approved for use, more transparency around the Food and Drug Administration’s (FDA) scientific reviews of safety and effectiveness is needed to strengthen public confidence in them. The Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) have provided little scientific explanation for changing key testing guidelines during the pandemic. GAO made 11 recommendations and one suggestion for Congress to consider.

Find GAO’s recommendations here and the full report here.

GAO: Artificial Intelligence in Health Care - Benefits and Challenges of Technologies to Augment Patient Care

On Nov. 30, the Government Accountability Office (GAO) released a report on how artificial intelligence (AI) tools show promise for improving health care. AI tools can help predict health trajectories, recommend treatments and automate administrative tasks. Challenges associated with these tools include transparency, bias and a need for high-quality data. GAO’s report offers policy options, such as improving data access and establishing best practices, to address these and other challenges that were found in the report.

Find the full report here.