Below is a special edition of Sirona Strategies’ Policy Update – focused on federal COVID-19 related activity.
For more information, http://coronavirus.gov provides up to date CDC information and https://go.cms.gov/3cYVHzC provides links to CMS’ notifications.
What’s Ahead: This Week
Hearings –
- Wednesday, March 18
- Senate HELP Committee, “An Emerging Disease Threat: How the U.S. is Responding to COVID-19, the Novel Coronavirus – Part 2.”
Wrap-Up of Last Week’s COVID-19 Related Activity
Presidential Actions –
- On March 11, President Trump delivered a speech from the Oval Office regarding the COVID-19 (coronavirus) outbreak announcing that the World Health Organization declared the coronavirus a global pandemic and detailed actions the Administration has taken to address the coronavirus. President Trump Remarks: http://bit.ly/2IE4Tf0 Fact sheet: http://bit.ly/2TKAcLf HHS Secretary Azar Statement: http://bit.ly/2W8Mb7h
- On March 13, President Trump declared the COVID-19 outbreak in the United States a national emergency. This declaration invokes section 1135 of the Social Security Act, 42 U.S.C. 1320b–5, to allow the Secretary of Health and Human Services to exercise the authority under that section to temporarily waive or modify certain requirements of the Medicare, Medicaid, and State Children’s Health Insurance programs and of the Health Insurance Portability and Accountability Act Privacy Rule throughout the duration of the public health emergency declared in response to the COVID-19 outbreak. Statement: http://bit.ly/2IH4Q1U Proclamation: http://bit.ly/2U5j3Lu CMS summary and fact sheet detailing actions in response to the National Emergency: https://go.cms.gov/33njipb and https://go.cms.gov/2vsr7O6
Federal Funding – On March 11, HHS announced that CDC is awarding over $560 million to state and local jurisdictions in support of COVID-19 response. Press release: http://bit.ly/2U1GEMS List of CDC funding actions to jurisdictions: http://bit.ly/2IFfHJO
Prevention, Testing and Treatment –
- On March 9, FDA and FTC issued warning letters to seven companies for selling fraudulent COVID-19 products. Press release with letters: http://bit.ly/38H8wLB
- Also on March 9, HHS announced it will support advanced development of the first high-throughput diagnostic test for the coronavirus disease, designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours. Press release: http://bit.ly/38Bl1Ze
- Also on March 12, HHS Secretary Azar designated HHS Assistant Secretary Giroir to coordinate COVID-19 diagnostic testing efforts among the Public Health Service agencies including CDC and FDA, as well as state and local public health authorities and private or public clinical laboratories. Press release: http://bit.ly/3cWXHIM
- On March 13, HHS announced advanced development support for two diagnostic COVID-19 tests that may detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in approximately one hour. Press release: http://bit.ly/39P1eXI
- Also on March 13, FDA provided an update on COVID-19 actions including giving flexibility to the New York State Department of Health to begin patient testing after validating their tests and issuing the third emergency use authorization diagnostic. Press release: http://bit.ly/38KjkIV
- On March 15, CDC advised Americans to cancel large events and mass gatherings of 50 or more people. Guidance: http://bit.ly/2QeyyzB
Coverage –
- On March 9, CMS issued a press release highlighting telehealth benefits in Medicare. Last week CMS posted a fact sheet with additional guidance for healthcare providers and patients about the telehealth benefits in Medicare. Press release: https://go.cms.gov/2TUcQC1 Fact sheet: https://go.cms.gov/2VP4I8h
- Also on March 10, CMS published a memo to help Medicare Advantage (MA) and Part D health and prescription drug plans respond to COVID-19 such as flexibilities they have to provide healthcare coverage to Medicare beneficiaries for COVID-19 testing, treatment and prevention. Press release: https://go.cms.gov/39J0Z0e Memo: https://go.cms.gov/39GiRJ2
- Also on March 11, the Internal Revenue Service (IRS) announced that high-deductible health plans can pay for the 2019 novel coronavirus-related testing and treatment, without jeopardizing their status. One day before, on March 10, Sen. Daines (R-MT) sent a letter to Department of Treasury Secretary Mnuchin to eliminate monetary barriers to testing for the Coronavirus disease. Sen. Daines (R-MT) Press release: http://bit.ly/2Wbjbfb Letter: http://bit.ly/2Ub5Hxp IRS Press release: http://bit.ly/38H9Nm1 Notice: http://bit.ly/39EbwK5
- On March 12, CMS posted frequently asked questions (FAQs) to aid state Medicaid and CHIP agencies in their response to the COVID-19 (coronavirus) outbreak such as resources available to states. Press release: https://go.cms.gov/2IHxtvZ FAQ: http://bit.ly/2WeWirf
- On March 13, CMS posted frequently asked questions (FAQs) for individuals, issuers and states on essential health benefits coverage in response to the 2019 COVID-19 outbreak. Press release: https://go.cms.gov/2viQJga FAQs: https://go.cms.gov/38Mvn8D
- Also on March 12, CMS posted a fact sheet to aid Medicare providers with information relating to the pricing of both the CDC and non-CDC tests. Fact sheet: https://go.cms.gov/2TL1nFY
Provider and Health System Guidance –
- Also on March 9, CMS issued guidance for hospice providers and nursing homes about how to address the potential and confirmed COVID-19 cases, including screening, treatment and transfer of patients to higher levels of care when appropriate. Press release: https://go.cms.gov/38KAWnY Hospice providers: https://go.cms.gov/38ITUvp Nursing homes: https://go.cms.gov/2THIu6M
- Also on March 9, CMS published a memo with frequently asked questions (FAQs) to State Survey Agency directors providing guidance to hospitals with emergency departments (EDs) on patient screening, treatment and transfer requirements to prevent the spread of infectious disease and illness, including COVID-19. Press release: https://go.cms.gov/3aN800e Memo: https://go.cms.gov/38LSQql
- On March 10, CMS issued frequently asked questions (FAQs) on guidance to State Survey Agencies suspending non-emergency survey inspections, enabling State Inspectors to address the spread of COVID-19. Press release: https://go.cms.gov/39DZBvM FAQs: https://go.cms.gov/2Q7JCyh
- Also on March 10, CMS issued guidance to State Survey Agencies clarifying CDC and FDA guidance expanding the types of facemasks healthcare workers may use in situations involving COVID-19 and other respiratory infections. Press release: https://go.cms.gov/3cPq3o6 Memo: https://go.cms.gov/2wMtgo8
- Also on March 10, CMS issued guidance to home health providers and dialysis facility providers with specific considerations for when it is safe to treat patients at home, when patients should be considered for hospitalization and advises all Medicare-enrolled dialysis facilities to identify high risk individuals. Press release: https://go.cms.gov/2w0Vc7s Home Health Agencies memo: https://go.cms.gov/2vMpCdP Dialysis facilities memo: https://go.cms.gov/3aNua2s
- Also on March 11, FDA posted a notice to health care providers on surgical mask and gown conservation strategies during the coronavirus outbreak. Notice: http://bit.ly/2TM49eb
- On March 13, CMS announced new measures intended to improve healthy and safety of nursing home residents by restricting visitors and nonessential personnel. Press release: https://go.cms.gov/2wVmFrs Guidance: https://go.cms.gov/2INwPx9
Veterans and Military Health – On March 10, VA announced new safeguards including a “No Visitor” stance aimed at limiting COVID-19 exposure risk for nursing home residents and spinal-cord injury patients. Press release: http://bit.ly/2vXwPrr
State Action – All 50 states and the District of Columbia have declared either a state of emergency or a public health emergency. A chart with links to each state’s declaration and underlying statute and emergency powers is attached.
Legislative Activity –
Committee Actions and Votes – On March 14, the House passed by a 363-40 vote the Families First Coronavirus Response Act (H.R. 6201), which would make emergency supplemental appropriations for the fiscal year ending September 30, 2020. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2QcVjnx Summary: http://bit.ly/2U1XgUI Bill text: http://bit.ly/2xHOF2f
Introduced COVID-19 Legislation –
- On March 9, Rep. Harder (D-CA) and Schrader (D-OR) introduced H.R. 6130, which would require the Secretary of Labor to update the model COBRA continuation coverage general notice and the model COBRA continuation coverage election notice.
- Also on March 9, Rep. Scott (D-VA) and twenty cosponsors introduced the COVID-19 Worker Protection Act of 2020 (H.R. 6139), which would direct the Secretary of Labor to issue an emergency temporary standard that requires certain employers to develop and implement a comprehensive infectious disease exposure control plan to protect employees in the health care sectors and other employees at elevated risk from exposure to SARS-CoV-2. Sen. Duckworth (D-IL) and nine cosponsors introduced companion legislation in the Senate (S. 3475). Press release: http://bit.ly/39DSpzW Bill text: http://bit.ly/2TFU4iY
- Also on March 9, Rep. Scott (D-VA) and twenty cosponsors introduced the COVID-19 Worker Protection Act of 2020 (H.R. 6139), which would direct the Secretary of Labor to issue an emergency temporary standard that requires certain employers to develop and implement a comprehensive infectious disease exposure control plan to protect employees in the health care sectors and other employees at elevated risk from exposure to SARS-CoV-2. Sen. Duckworth (D-IL) and nine cosponsors introduced companion legislation in the Senate (S. 3475). Press release: http://bit.ly/39DSpzW Bill text: http://bit.ly/2TFU4iY
- Also on March 9, Rep. DeLauro (D-CT) and fifty-one cosponsors introduced the Paid Sick Days for Public Health Emergencies and Personal Family Care Act (H.R. 6150), which would allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families. Press release: http://bit.ly/2vVfNdH
- Also on March 10, Rep. DeGette (D-CO) and Shalala (D-FL) introduced the Covering Coronavirus Test Act of 2020 (H.R. 6173), which would require group health plans and health insurance issuers offering group or individual health insurance coverage to cover COVID-19 testing without cost sharing. Press release: http://bit.ly/3cMWqnw Bill text: http://bit.ly/2wLbqBQ
- On March 11, Rep. Omar (D-MN) and seventeen cosponsors introduced the Maintaining Essential Access to Lunch for Students (MEALS) Act (H.R. 6187), which would allow the Secretary of Agriculture to grant certain waivers under the Richard B. Russell National School Lunch Act to address school closures due to COVID-19. Press release: http://bit.ly/2TLoRdX Bill text: http://bit.ly/2Wac3zl
- Also on March 11, Rep. Roe (R-TN) introduced H.R. 6194, which would authorize the Secretary of Veterans Affairs to treat certain programs of education converted to distance learning by reason of emergencies and health-related situations in the same manner as programs of education pursued at educational institutions. Press release: http://bit.ly/2xytoId
- Also on March 11, Reps. Murphy (D-FL), Cunningham (D-SC) Horn (D-OK) and Torres Small (D-NM) introduced the Emergency Paid Leave Act (H.R. 6198), which would provide emergency paid leave benefits to certain individuals affected by COVID-19. Press release: http://bit.ly/2xw08lf Bill text: http://bit.ly/2Q6I5IQ One-page summary: http://bit.ly/38Nd4A4
- Also on March 11, Rep. Fudge (D-OH) and Scott (D-VA) introduced the Pandemic EBT Act (H.R. 6200), which would authorize the Secretary of Agriculture to provide certain food assistance for eligible children during periods when their schools are closed due to a public health emergency. Press release: http://bit.ly/2W3Zrdj
- Also on March 11, Rep. Lowey (D-NY) and six cosponsors introduced the Families First Coronavirus Response Act (H.R. 6201), which would make emergency supplemental appropriations for the fiscal year ending September 30, 2020. Press release: http://bit.ly/3aWSvCH Summary: http://bit.ly/2TOh4wg Bill text: http://bit.ly/2TIilVk
- Also on March 11, Rep. Bonamici (D-OR) and Comer (R-KY) introduced the COVID-19 Child Nutrition Response Act (H.R. 6203), which would provide for certain waivers of program requirements under the Richard B. Russell National School Lunch Act to appropriately address safety measures with respect to COVID-19. Press release: http://bit.ly/2ITOjbf Bill text: http://bit.ly/2IDEkqa
- Also on March 11, Reps. Delgado (D-NY), Herrera Beutler (R-WA) and Titus (D-NV) introduced the Pandemic Response and Emergency Preparedness (PREP) Act (H.R. 6206), which would provide that the President may provide additional Federal assistance for an emergency related to a public health emergency, including a pandemic or virus threat. Press release: http://bit.ly/2TZkVoZ
- Also on March 11, Reps. Kilmer (D-WA), Herrera Beutler (R-WA) and Rutherford (R-FL) introduced the Coronavirus Worker Relief Act (H.R. 6207), which would provide for unemployment benefits to workers affected by the 2019 Novel Coronavirus. Sen. Peters (D-MI) and six bipartisan cosponsors introduced companion legislation in the Senate (S. 3476). Press release: http://bit.ly/39HbnFL
- Also on March 11, Rep. Wilson (D-FL) and seventeen cosponsors introduced the No Cost for COVID-19 Testing Act (H.R. 6213), which would provide for coverage (without cost sharing or utilization management requirements) under group health plans and individual and group health insurance coverage of testing for COVID-19. Press release: http://bit.ly/2w5kd1l Bill text: http://bit.ly/2ILPFV6
- Also on March 11, Sen. Booker (D-NJ) and Menendez (D-NJ) introduced the Care for COVID-10 Act (S. 3442), which would require private health insurers to cover related to COVID-19 without cost-sharing and to provide for special enrollment periods for individuals diagnosed with COVID-19. Press release: http://bit.ly/2Qaf1Ah Bill text: http://bit.ly/2vfItNW
- On March 12, Reps. Kind (D-WI), Trahan (D-MA) and Barragan (D-CA) introduced H.R. 6214, which would provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program. Press release: http://bit.ly/2W8UG1V
- Also on March 12, Reps. Scott (D-VA), Adams (D-NC), Takano (D-CA) and Lee (D-NV) introduced the Emergency Family and Medical Leave Expansion Act (H.R. 6220), which would amend the Family and Medical Leave Act of 1993 to provide for leave with respect to a public health emergency. Press release: http://bit.ly/3cUaeg1 Bill text: http://bit.ly/33eO5ol
- Also on March 12, Rep. Schakowsky (D-IL) and Bucshon (R-IN) introduced the Ensuring Access to COVID-19 Preventative Care Act of 2020 (H.R. 6222), which would provide for coverage of items, services, and immunizations relating to the diagnosis or treatment of COVID-19 under group health plans and health insurance coverage within 15 days of the issuance of a recommendation from the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices. Press release: http://bit.ly/2TNNneA
- Also on March 12, Rep. Bucshon (R-IN) and Schakowsky (D-IL) introduced the Ensuring Affordable COVID-19 Preventative Care Act of 2020 (H.R. 6231), which would ensure affordable coverage of certain vaccines and testing services under group health plans and group and individual health insurance coverage during the COVID-19 public health emergency. Press release: http://bit.ly/2TNNneA
- Also on March 12, Reps. Cardenas (D-CA), Sanchez (D-CA) and Castro (D-TX) introduced H.R. 6232, which would require the Secretary of Health and Human Services, through the National Disaster Medical System, to provide for certain laboratory reimbursement for diagnostic testing for COVID-19 in uninsured individuals. Press release: http://bit.ly/2xyzTut
- Also on March 12, Reps. Kelly (D-IL), Sewell (D-AL) and DeSaulnier (D-CA) introduced H.R. 6244, which would provide for coverage at no cost sharing of COVID-19 testing under the Medicaid program and Children’s Health Insurance Program. Press release: http://bit.ly/2TNcA93
- Also on March 12, Sen. Scott (R-FL) introduced the Coronavirus Mobile Collection Site Act (S. 3498), which would require the Secretary of Health and Human Services to reimburse States for the cost of operating drive-through sites for COVID-19 testing. Press release: http://bit.ly/2xvWcRr
- Also on March 12, Sen. Smith (D-MN) and thirty-two cosponsors introduced the Free COVID-19 Testing Act (S. 3499), which would amend coverage requirements to ensure that no person incurs cost-sharing when receiving a test to confirm a COVID-19 infection. Press release: http://bit.ly/2W9FCkJ
Congressional Correspondence –
- On March 6, Senate Special Committee on Aging Chair Collins (R-ME) and Ranking Member Casey (D-PA) along with ten bipartisan cosponsors in the Senate Special Committee on Aging sent a letter to HHS Secretary Azar highlighting that older adults in the United States are at much higher risk of deadly complications related to COVID-19. Press release: http://bit.ly/2Qc2XhQ Letter: http://bit.ly/39RhgjA
- On March 9, Senate HELP Committee Ranking Member Murray (D-WA) and Sens. Menendez (D-NJ), Baldwin (D-WI), Brown (D-OH), Duckworth (D-IL), Booker (D-NJ) and Warren (D-MA) sent a letter to Department of Labor Secretary Scalia to direct the Occupational Safety and Health Administration (OSHA) to issue a comprehensive Emergency Temporary Standard (ETS) to protect American workers against the coronavirus (COVID-19) outbreak. Press release: http://bit.ly/38NMmHT Letter: http://bit.ly/337PDAu
- Also on March 9, House Energy & Commerce Committee Chair Pallone (D-NJ) Ranking Member Walden (R-OR), Health Subcommittee Chair Eshoo (D-CA), Ranking Burgess (R-TX), Oversight & Investigations Subcommittee Chair DeGette (D-CO) and Ranking Member Guthrie (R-KY) sent a letter to FDA Commissioner Hahn requesting a briefing on the potential impact the novel coronavirus (COVID-19) could have on the supply of safe drugs and other medical products in the United States. Press release: http://bit.ly/2wNWu5U Press release: http://bit.ly/2TICueb Letter: http://bit.ly/2TICBGD
- Also on March 9, House Education & Labor Committee Chair Scott (D-VA) and Workforce Protections Subcommittee Chair Adams (D-NC) sent a letter to HHS Secretary Azar raising concerns over protections for health care workers and emergency responders for patients with suspected or confirmed COVID-19. Press release: http://bit.ly/39I1ibL Letter: http://bit.ly/2vXN0F9
- Also on March 9, Sen. Warren (D-MA) and Markey (D-MA) sent a letter to Vice President Pence expressing concern about President Trump’s coronavirus press conference at CDC on Friday, March 6. Press release: http://bit.ly/2wPFjRk Letter: http://bit.ly/33bARsz
- On March 10, Senate HELP Committee Ranking Member Murray (D-WA), Senate Minority Leader Schumer (D-NY) and Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to Vice President Pence regarding the mass confusion and lack of clarity around the availability of coronavirus testing and out-of-pocket costs associated with getting tests and treatment. Press release: http://bit.ly/38K0Iss Letter: http://bit.ly/3aQQRm3
- Also on March 10, Senate HELP Committee Ranking Member Murray (D-WA) and thirty-two Democratic senators sent a letter to Department of Education Secretary DeVos to provide clarity and guidance for school districts and institutions of higher education, as well as families and students, following widespread school closures across the country due to the spread of the coronavirus. Press release: http://bit.ly/39DZJvj Letter: http://bit.ly/3cPHIw6
- Also on March 10, Senate HELP Committee Ranking Member Murray (D-WA) and thirty Democratic senators sent a letter to Department of Labor Secretary Scalia regarding the Department of Labor’s role in the federal government’s response to the coronavirus. Press release: http://bit.ly/2TQxeni Letter: http://bit.ly/2Qa8dCO
- Also on March 10, Senate HELP Committee Ranking Member Murray (D-WA) and Sen. Warren (D-MA) sent a letter to FDA Commissioner Hahn and National Institutes of Health Director Collins to consider the needs of pregnant people and other underrepresented populations as they work with pharmaceutical companies to develop a pipeline for COVID-19 vaccines and therapeutics. Press release: http://bit.ly/2Q5UPzy Letter: http://bit.ly/33bAcXY
- Also on March 10, House Ways & Means Committee Chair Neal (D-MA), Worker and Family Support Subcommittee Chair Davis (D-IL), Oversight Subcommittee Chair Lewis (D-GA), Health Subcommittee Chair Doggett (D-TX), and Rep. Jimmy Gomez (D-CA) sent a letter to HHS Secretary Azar to provide additional information regarding a recent whistleblower allegation concerning the alleged improper deployment of Administration for Children & Families employees in response to the coronavirus. Press release: http://bit.ly/2THeUOB Letter: http://bit.ly/2W5iT9i
- Also on March 11, Senate Minority Leader Schumer (D-NY), Senate Judiciary Committee Ranking Member Feinstein (D-CA), Senate HELP Committee Ranking Member Murray (D-WA), Sen. Peters (D-MI) and 32 Democratic senators sent a letter to President Trump to use disaster declaration requests so states can utilize the $42.6 billion available in the Disaster Relief Fund in their efforts to mitigate the spread of COVID-19. Press release: http://bit.ly/38IUwRK Letter: http://bit.ly/33egril
- Also on March 11, Sen. Warner (D-VA) sent a letter to Vice President Pence to combat online misinformation and correct mixed messages from the Trump Administration related to the coronavirus outbreak. Press release: http://bit.ly/3cW0TUP Letter: http://bit.ly/2W7GrKT
- Also on March 11, Senate HELP Committee Ranking Member Murray (D-WA), Sens. Warner (D-VA) and Kaine (D-VA) and 29 Democratic senators sent a letter to Department of Education Secretary DeVos to provide guidance for school districts and institutions of higher education, as well as families and students, following widespread school closures across the country due to the spread of the coronavirus. Press release: http://bit.ly/2TLK2wt Letter: http://bit.ly/3cPHIw6
- Also on March 11, Rep. Kuster (D-NH) and Smith (R-NE) introduced the Reducing Unnecessary Senior Hospitalizations (RUSH) Act of 2020 (H.R. 6209) to facilitate greater use of telehealth in skilled nursing facilities. The legislation would establish a program to allow qualified group practices to furnish certain items and services at qualified skilled nursing facilities to individuals entitled to benefits under part A and enrolled under part B of the Medicare program to reduce unnecessary hospitalizations. Sen. Thune (R-SD) and Cardin (D-MD) introduced companion legislation in the Senate (S. 3447). House Press release: http://bit.ly/2w4LnW6 Senate Press release: http://bit.ly/33eMHlA
- On March 12, Homeland Security Committee Chair Thompson (D-MS) sent a letter to Homeland Security Acting Secretary Wolf, HHS Secretary Azar, and CDC Director Redfield seeking documents and information regarding the ban on travel from certain European countries and additional policy changes announced by President Trump. Press release: http://bit.ly/3aTNniK Letter: http://bit.ly/39KjIbI
- Also on March 12, Sen. Warner (D-VA) and seventeen senators sent a letter to the CEOs of eight major internet service providers to accommodate the likely increased reliance on telepresence services including telework, online education, telehealth, and remote support services during the coronavirus outbreak. Press release: http://bit.ly/2U529fR Letter: http://bit.ly/2W9uKTQ
- On March 13, Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to CMS Administrator Verma to provide guidance on exercising the waiver authority to waive certain restrictions on the use of telehealth in Medicare provided in the Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) passed last week. Press release: http://bit.ly/2TLORGe Letter: http://bit.ly/3aUvqkm
- Also on March 13, Sen. Reed (D-RI) and 24 senators sent a letter to HHS Secretary Azar and CMS Administrator Verma urging them to open a special enrollment period for healthcare.gov to allow uninsured individuals to gain coverage. Press release with text of letter: http://bit.ly/38RioCv
- Also on March 13, Rep. Doggett (D-TX) led 108 representatives in a letter to HHS Secretary Azar urging him to establish a special enrollment period on healthcare.gov. Press release: http://bit.ly/2xCF7W4 Letter: http://bit.ly/3b0V476
- On March 14, House Energy & Commerce Committee Chair Pallone (D-NJ), Oversight & Investigations Subcommittee Chair DeGette (D-CO), and Consumer Protection & Commerce Subcommittee Chair Schakowski (D-IL) sent a letter to the Federal Trade Commission Chair Simons urging him to take immediate action to prevent deceptive advertising and dangerous misinformation related to the coronavirus epidemic. Press release: http://bit.ly/2x2rmj2 Letter: http://bit.ly/39Tm8VD