The following LPG Weekly Health Care Watch provides a summary update of legislative and regulatory health care activities from March 16 – 22. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
Senate
· On March 16, Sens. Martha McSally (R-AZ) and Doug Jones (D-AL) unveiled the Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2020, which would lower out-of-pocket costs for biosimilars in Medicare Part B.
House
· House Democrats are expected to release an Affordable Care Act expansion bill to coincide with the 10-year anniversary of the law on March 23. The bill is expected to provide moderate Democrats with an alternative to Medicare for All. The plan is rumored to expand subsidies beyond 400% of the federal poverty level while also increasing the value of the existing subsidies.
REGULATORY UPDATE
· On March 16, Oklahoma Gov. Kevin Stint (R) unveiled a draft plan to receive federal funds for the state’s Medicaid expansion population in the form a block grant, becoming the first state to formally request participating in the Centers for Medicare & Medicaid Services’ (CMS) “Healthy Adult Opportunity” demonstration.
· On March 15, the Office of Management & Budget (OMB) received the Substance Abuse & Mental Health Services Administration’s (SAMHSA) “Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders (SUD)” final rule, which pertains to 42 CFR Part 2.
· On March 18, Senate Democrats sent CMS Administrator Seema Verma a letter challenging the recent approval of Texas’ 1115 waiver to a to prohibit providers from receiving Medicaid funding if they offer abortion services. The lawmakers claim the waiver violates congressional intent and federal law.
· On March 18, President Donald Trump officially nominated Russ Vought to serve as the director of White House Office of Management and Budget (OMB). Vought has been the acting director for over one year.
CORONAVIRUS UPDATE
· On March 15, the Centers for Disease Control & Prevention (CDC) issued guidance calling for mass gatherings to be limited to no more than 50 people for eight weeks.
· On March 15, the Washington delegation sent U.S. Department of Health & Human Services (HHS) Secretary Alex Azar a letter requesting access to the Strategic National Stockpile to attain personal protective equipment (PPE) for medical professionals and emergency responders.
· On March 15, former Centers for Medicare & Medicaid Innovation Center (CMMI) head Adam Boehler joined the White House’s coronavirus task force.
· On March 15, it was reported that the Trump administration is attempting to convince CureVac, a German company working on a vaccine, to bring its research to America. The company predicts it will have an experimental vaccine ready for human testing by June or July.
· On March 16, the White House issued guidance to slow the spread over the next 15 days, such as by limiting social gatherings to 10 people or less and avoiding visits to long-term care facilities. In a press briefing, President Trump also clarified that the U.S. would not impose a nationwide lockdown, as Italy and Spain have done.
· On March 16, the National Institute for Allergies & Infectious Diseases (NIAID) announced clinical trials have begun for a potential vaccine developed by Moderna. If successful, the vaccine could be licensed in 12-18 months.
· On March 16, the Food & Drug Administration (FDA) gave state public health departments discretion to authorize laboratories to conduct COVID-19 testing.
· On March 16, the Substance Abuse & Mental Health Services Administration (SAHMSA) announced states may request blanket exceptions for stable patients in an opioid treatment program to receive 28 days of take-home doses of opioid use disorder medication; less stable patients can receive a 14 day supply.
· On March 16, the White House unveiled a plan to deploy a SWAT team to increase access to testing, including setting up drive-through testing areas. The team will be overseen by testing “czar” Admiral Brett Giroir and former CMMI Director Boehler.
· On March 16, the House passed by unanimous consent “technical” corrections to H.R.6201, the “stage two” emergency funding package. However, House Democrats later claimed the 90-pages of corrections, which were negotiated between Speaker Nancy Pelosi (D-CA) and the White House, actually scaled back some of the bill’s major provisions. Specifically, they were frustrated that the corrections narrowed eligibility for family and medical paid leave, expanded language exempting certain small businesses from providing paid leave, and eliminated a provision preventing states from receiving a 6.2% increase in the federal government’s share of Medicaid funding if they checked beneficiaries' eligibility more than once a year (which many states do). On March 17, Speaker Pelosi assured House Democrats that the “stage 3” stimulus bill would strengthen paid leave protections. The measure passed the Senate by a 90-8 vote on March 18 and was signed into law by President Trump that same day.
· On March 16, CMS approved the first COVID-19-related 1335 Medicaid waiver request. The approval permits Florida to waive prior authorization requirements, streamline provider enrollment processes to ensure access to care for beneficiaries, allow care to be provided in alternative settings in the event a facility is evacuated to an unlicensed facility, suspend certain nursing home screening requirements, and extend deadlines for appeals. CMS approved a similar waiver for Washington on March 19.
· On March 17, OMB Acting Director Vought sent a letter to congressional leaders requesting nearly $48 billion to fund various federal departments during FY 2020. The request would direct an additional $11.5 billion to HHS, $16.6 billion to the VA, $8.3 billion to the Pentagon, and $3.2 billion to Homeland Security. House appropriators believe request is insufficient; instead, they are considering allocating between $120 billion to $150 billion to federal departments. Some lawmakers have suggests tying such funds to the stage three stimulus package.
· On March 17, CMS leveraged emergency powers to expand coverage of Medicare’s telehealth benefits. Providers are now able to bill Medicare for virtual visits conducted after March 6. Administrator Verma said the decision aims to help hospitals preserve their supplies of PPE and align Medicare with the government's broader social distancing guidelines. Along with the expanded telehealth benefits, the HHS Office for Civil Rights waived potential Health Insurance Portability & Accountability Act (HIPAA) penalties for “good faith use of telehealth” during the public health emergency.
· On March 17, HHS Office of Inspector General (OIG) released a policy statement to notify physicians and other practitioners that they will not be subject to sanctions for reducing or waiving any cost-sharing obligations that federal health care program beneficiaries may owe for telehealth services.
· On March 17, Sens. Patty Murray (D-WA) and Kirsten Gillibrand (D-NY) and Rep. Rosa DeLauro (D-CT) announced plans to introduce the Providing Americans Insured Days (PAID) Leave Act, which would extend emergency paid leave to all U.S. workers.
· On March 17, CMS issued guidance to all Programs of All-Inclusive Care for the Elderly (PACE) Organizations to reduce risk of infection and prevent patients from contracting COVID-19.
· On March 17, it was reported that President Trump told New York Gov. Andrew Cuomo (D) he will authorize the Federal Emergency Management Agency and the U.S. Army Corps of Engineers (USACE) help New York construct temporary hospital facilities to prepare for an expected surge in cases. On March 20, the USACE began converting 10,000 hotel, school, and dormitory rooms into intensive care units and other medical facilities to preserve beds at civilian hospitals.
· On March 17, Defense Secretary Mark Esper announced that the military is releasing medical supplies, including respirator masks, PPE, and deployable ventilators to hospitals. Secretary Esper also said testing will begin in at least 16 military laboratories and that the U.S. Naval Ships Comfort and Mercy are being prepared to help overwhelmed hospitals. Each ship has the capacity to provide 1,000 beds.
· On March 18, the Trump administration sent Congress a high-level outline for a $1 trillion “stage three” stimulus package. The request would direct federal funds to sectors particularly impacted by the pandemic, offer loans to small businesses, and send cash directly to Americans.
- Democrats have argued any federal aid to corporations should be paired with specific conditions, such as a temporary ban on stock buybacks and executive bonuses, limits on carbon emissions, and a requirement that companies will maintain their payrolls. President Trump has indicated his support for restricting stock buybacks.
- Reports suggest HELP Chairman Lamar Alexander (R-TN) and Energy & Commerce Chairman Frank Pallone (D-NJ) are trying to insert their surprise billing deal to the package. However, given the strong opposition expressed by health care providers who are under financial pressure due to the emergency, it is unlikely that such an effort will succeed at this time
- On March 19, Senate Republicans translated the Administration’s outline into a $1.6 trillion emergency rescue package, S. 3548, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, would: 1) freeze a 2% budget sequestration cut through the end of the year; 2) fund a number of so-called health “extenders” through 2021 or through the end of that fiscal year, including funding for community health centers and delay the Medicaid Disproportionate Share Hospital pay cuts until fiscal 2022; 3) allow labs to develop emergency tests; 4) require insurers to cover vaccines and other preventative measures; 5) loosen patient privacy rules for SUD under 42 CFR Part 2; 6) increase Medicare payments by 15% for COVID-19-diagnosed cases; and 6) temporarily allow Medicare patients to use telehealth, even if they do not have a pre-existing relationship with the clinician.
- On March 22, the bill failed to pass a procedural cloture bill, on a 47-47 vote, short of the 60 votes needed to advance the measure. The contentious provisions include corporations receiving federal assistance, including policy on stock buybacks and executive pay, as well as unemployment insurance and worker protections.
- Meanwhile, House Democrats are working on a counter proposal that would boost unemployment insurance payments, expand Medicaid coverage, increase food security measures, and send cash directly to Americans.
- Majority Leader Mitch McConnell (R-KY) has said that the Senate will remain in session until they pass the stage three deal.
· On March 18, the Taxpayers Protection Alliance sent congressional leaders a letter urging them not to include the HELP-E&C surprise billing legislation in any COVID-19 legislation, arguing a benchmark payment resolution would further strain providers when their resources are needed to respond to the pandemic.
· On March 18, President Trump signed an executive order (EO) invoking the Cold War-era Defense Production Act. The EO directs expanded production of ventilators, masks, and other emergency medical supplies.
· On March 18, CMS issued guidance to hospitals on limiting non-essential adult elective surgeries to help providers preserve medical resources.
· On March 18, Reps. Mario Diaz-Balart (R-FL) and Ben McAdams (D-UT) announced they have contracted COVID-19, becoming the first members of Congress to do so. Rep. McAdams has since been hospitalized. On March 22, Sen. Rand Paul (R-KY) announced he had become the first senator to test positive for the virus and would be isolating himself. Soon after, Sens. Mike Lee (R-UT) and Mitt Romney (R-UT) said they would be self-quarantining after recently spending time with Sen. Paul.
· On March 18, HHS authorized clinicians to practice across state lines.
· On March 18, FDA suspended all routine inspections of domestic faciliites. Commissioner Stephen Hahn also noted that all eligible FDA employees have shifted to teleworking.
· On March 18, the FDA approved Abbott’s new diagnostic test, which is already available in 175 U.S. labs. The company is continuing to produce tests and aims to manufacturer one million tests per week by month’s ends.
· On March 18, the Milken Institute launched a COVID-19 vaccine and treatment tracker.
· On March 18, CMS issued Frequently Asked Questions to clarify coverage for diagnosis and treatment by catastrophic health plans.
· On March 18, Sens. Bill Cassidy, Doug Jones, Steve Daines, and Tina Smith introduced legislation to require commercial health plans to cover COVID-19 vaccines and treatments and at no cost to the patient.
· On March 19, Democratic House leaders announced the chamber will not return to Washington until the stage three stimulus package is ready for a vote.
· On March 18, Connecticut and Nevada opened a special enrollment period (SEP) for their health insurance exchanges to provide additional coverage ahead of an expected COVID-19 surge. Maryland, Massachusetts, New York, Rhode Island, Washington, California, and the District of Columbia have already reopened their exchanges.
· On March 19, America’s Health Insurance Plans (AHIP) and Blue Cross Blue Shield Association sent a letter to congressional leaders expressing support for allowing a one-time special enrollment period (SEP) for the federal exchange, paired with enhanced premium subsidies for those in the individual market. They also asked for establishing a temporary, emergency risk mitigation program to offset potential losses to insurers.
· On March 19, the White House informed Congress that senior administration officials handling COVID-19 response efforts will not be available for congressional testimony until next April 1.
· On March 19, President Trump held a briefing where he promised to “slash red tape like nobody has ever done it before" in order to get unapproved treatments to patients faster and identify effective drugs. Specifically, the President directed the FDA to build on right-to-try and "eliminate out-of-date rules and bureaucracy so this can go forward fast."
· On March 19, the Department of Homeland Security outlined "critical" industries that should maintain their usual work schedules to support the nation's COVID-19, in accordance with guidance issued by the President on March 16.
· On March 19, California Gov. Gavin Newsom (D) signed an EO directing all California residents to only leave their home for essentials; the mandate will remain in effective indefinitely. Gov. Newsom claimed that without aggressive action, 56% of state residents could contract COVID-19 over the next two months. Later that day, New York and Illinois also ordered ordered all nonessential workers to stay home.
· On March 19, 16 Senate Democrats asked large health insurance companies to "suspend all cost-sharing requirements connected with treatments for COVID-19 and associated health complications.
· On March 19, the American Hospital Association, American Medical Association, and American Nurses Association asked congressional leaders for $100 billion to offset the expenses related to COVID-19 testing and treatment.
· On March 22, the FDA issued new temporary guidance allowing hospitals to re-purpose existing products such as CPAP devices as ventilators. The guidance also allows ventilators normally used in other environments, such as ambulances, to be used for long-term care. It also allows non-medical device companies, such as auto manufacturers, to start making ventilator parts.
· On March 22, the Senate failed to secure the needed votes to proceed on a $1.6 trillion GOP-led bill constituting a third round of COVID-19-related funding and relief. Senate Democrats and Speaker Pelosi have expressed concerns about $500 billion in funding for businesses impacted by the health emergency and have expressed more money for hospitals and unemployment insurance. On March 23, Senate Democrats blocked a floor vote on the bill, forcing negotiations to continue. Summaries of the legislation and the bill itself can be found here.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments (CMS-3337-P); Proposed Rule; Received 6/6/2019
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/2019
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Strengthening the Program Integrity of the Medicaid Eligibility Determination Process (CMS-2421-P); Proposed Rule; Received 12/20/2019
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482-P); Proposed Rule; Received 12/27/19
Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2021 Rates (CMS-1735); Proposed Rule; Received 1/30/20
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
FY 2021 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1737); Proposed Rule; Received 2/24/20
FY 2021 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1729); Proposed Rule; 2/24/20
FY2021 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1733); Proposed Rule; Received 3/3/20
FY 2021 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1731); Proposed Rule: Received 3/4/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/11/20
Amendments to the HHS-operated Risk Adjustment Data Validation under the Patient Protection and Affordable Care Act's (ACA) HHS-operated Risk Adjustment Program (CMS-9913); Proposed Rule; Received 3/11/20
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage (CMS-1739); Proposed Rule; Received 3/12/20
HHS-IHS
CY 2020 Reimbursement Rates; Notice; Received 3/2/20
HHS-OIG
Civil Monetary Penalties Law Notice of Proposed Rulemaking; Proposed Rule; Received 1/23/20
HHS-HRSA
Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program Eligibility Guidelines; Notice; Received 11/8/2019
HHS-SAMHSA
Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders; Final Rule; Received 3/16/20
REPORTS
Congressional Budget Office (CBO)
· On March 19, CBO released their spring baseline budget projections. The estimate accounts for legislation enacted through March 6, which excludes changes to the nation’s economic outlook resulting from COVID-19.
HHS OIG
· On March 17, OIG posted a report entitled Missouri Should Improve Its Oversight of Selected Nursing Homes' Compliance with Federal Requirements for Life Safety and Emergency Preparedness. OIG concludes that Missouri did not ensure that selected nursing homes in the state that participated in the Medicare or Medicaid programs complied with the CMS requirements for life safety and emergency preparedness. OIG identified deficiencies in areas related to life safety and emergency preparedness at all 20 nursing homes that had an onsite inspection.
· On March 18, OIG released a report entitled States' Use of Grant Funding for a Targeted Response to the Opioid Crisis. The 21st Century Cures Act awarded nearly $1 billion in grants to states over a two-year grant period (May 2017 through April 2019) under the State Targeted Response (STR) program. OIG founds that More than $300 million of such funding total grant funding for the STR grant program remained unspent after the two-year period.
· On March 19, OIG posted a report entitled CMS Could Take Actions To Help States Comply With Federal Requirements Prohibiting Medicaid Payments for Inpatient Hospital Services Related to Provider-Preventable Conditions (PPC). To help states comply with federal PCC requirements, OIG claims that CMS could take actions to (1) verify that all state plans fully comply with federal requirements prohibiting Medicaid payments for inpatient hospital services related to treating PPCs, and (2) issue clarifying guidance to address specific areas in which states did not comply with those requirements.
UPCOMING HEARINGS
Senate
· None of note
House
· None of note
OTHER HEALTH POLICY NEWS
· On March 13, the Medicare Payment Advisory Commission (MedPAC) released its March report to Congress, outlining the Commission’s recommendations on provider payment updates. A summary of the report can be found here.
· On March 16, U.S. District Court for the District of Columbia upheld CMS' decision to reverse its previous calculation of the average manufacturer price used to determine Medicaid rebates; Mallinckrodt alleged that CMS failed to give fair notice and a clear, legal basis for retroactively changing how it determined rebates amounts. The district court ruled that the Mallinckrodt knowingly underpaid Medicaid rebates for its drug Achar Gel and ordered them to pay back $650 million in rebate payments. The drug company will request for the ruling to be halted while it continues to challenge the decision in court.