Washington Watch for November 9, 2020

Carter L. Alleman, J.D.

Bera, Bucshon Introduce Legislation to Offset Fee Schedule Cuts
Representatives Ami Bera (D-Calif.) and Larry Bucshon (R-Ind.) have introduced legislation (H.R. 8702) that would provide support for physicians scheduled to see cuts to their Medicare reimbursement rates next year. The Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020 would provide relief payments for most Medicare physician services to mitigate the reimbursement cuts resulting from a budget neutrality adjustment under the Medicare Physician Fee Schedule (MPFS). The legislation would keep pay increases to office/outpatient evaluation and management services set to begin in January 2021 in place while ensuring that other services are not reduced in the midst of the coronavirus pandemic.

Pelosi, Mnuchin Continue to Spar Over COVID Relief
House Speaker Nancy Pelosi (D-Calif.) and Treasury Secretary Steven Mnuchin are still at odds over a new coronavirus stimulus bill. In a letter to the administration last week, Pelosi outlined seven areas of continuing disagreements – national virus testing and tracing program, funding for state and local governments, school safety measures, child-care funding, tax credits for working families, unemployment insurance, and workplace protections and liability issues – while Mnuchin faulted Pelosi’s “all or nothing” approach for the stimulus bill hold up. The chances of COVID relief being passed during the forthcoming lame-duck session may depend on the outcome of the election, with some lawmakers arguing that Senate Republicans may not support any additional stimulus if Democratic candidate Joe Biden is elected president.

Amy Coney Barrett Confirmed to Supreme Court
The Senate confirmed Amy Coney Barrett to the Supreme Court last week by a vote of 52-48. Every Senate Democrat voted against the nominee, as did Sen. Susan Collins (R-Maine), who objected to the confirmation coming so close to the presidential election. Barrett took the judicial oath on Tuesday, becoming the 115th justice. She will immediately assume her new responsibilities and in the coming weeks is expected to participate in a case (California v. Texas) that will rule on the constitutionality of the Affordable Care Act (ACA).

Senate Finance Continues Investigation into Organ Transplant System
The Senate Finance Committee is continuing its investigation into the nation’s organ transplantation system, asking the U.S. Department of Health and Human Services (HHS) for details about its oversight of organ procurement organizations (OPOs). A joint letter from Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) expresses concerns about gaps in federal oversight that could result in thousands of life-saving organs going unrecovered every year. The lawmakers cite several inspector general audits and other reports regarding the adequacy of patient safety standards. The Committee also shared the answers it received from the United Network for Organ Sharing in response to a previous inquiry from the panel.

Open Enrollment from Nov. 1 through Dec. 15
This year’s HealthCare.gov open enrollment began on Sunday. While millions of people have been left uninsured as a result of the economic impact of the current public health crisis, outreach efforts to promote enrollment have not been a focus of the current administration, which previously cut funding for Affordable Care Act (ACA) marketplace advertising and navigator efforts. Nevertheless, experts are predicting that enrollment will hold steady with previous years, which has hovered around 11 million people since 2015. Open enrollment for HealthCare.gov ends December 15, though some states will keep their enrollment open for a longer period. Average premiums for the most popular coverage option have decreased two percent, and only four percent of counties will only have one insurer.

HHS Issues Series of Key Rules
On October 29, the U.S. Department of Health and Human Services (HHS) released a series of regulations pertaining to health coverage transparency, compliance with information blocking requirements, the home health prospective payment system (HH PPS), implementation of the SUPPORT Act, and coverage of COVID-19 vaccines and therapeutics.

The Centers for Medicare and Medicaid Services’ (CMS) Transparency in Coverage Final Rule would require insurers in the group and individual markets to disclose price and cost-sharing information. Most health plans, including employer-based group plans and insurance issuers offering group and individual coverage, will be subject to the reporting requirements. Plans must make publicly available standardized and regularly updated cost data files starting on January 1, 2022. Beginning January 1, 2023, health plans will be required to offer an online shopping tool that allows consumers to see the negotiated rate between their provider and their plan, as well as a personalized estimate of their out-of-pocket cost, for 500 of the most shoppable items and services. These tools will be required to show the costs for any remaining procedures, drugs, durable medical equipment, and other items or services available for plan or policy years beginning on or after January 1, 2024.

The 2021 Home Health PPS Final Rule updates HH PPS payment rates and wage index for calendar year (CY) 2021. The final rule implements changes to the home health regulations regarding the use of telecommunications technology in providing services under the Medicare home health benefit, and also implements the permanent home infusion therapy services benefit and supplier enrollment requirements for CY 2021.

The Drug Enforcement Administration’s (DEA) Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment amends certain regulations to make them consistent with the SUPPORT Act. The law expanded the conditions a practitioner must meet to provide medication-assisted treatment as well as the options available for a physician to be considered a qualifying physician. The SUPPORT Act also allows a pharmacy to deliver prescribed controlled substances to a practitioner’s registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner.

CMS also released its fourth COVID-19 Interim Final Rule with Comment Period (IFC), which largely focuses on coverage of vaccines and therapeutics across Medicare, Medicaid, and group and individual plans. The rule aims to ensure that patients, including Medicare, Medicaid, CHIP, and most privately insured individuals, pay no out of pocket costs for a COVID vaccine, even if it is under an emergency use authorization (EUA).

Fed Eases Terms of Main Street Lending Program
The Federal Reserve has lowered the minimum loan amount under the Main Street Lending Program from $250,000 to $100,000, making the emergency loans available for more small businesses and nonprofits. While as much as $75 billion in relief funding has been set aside by the Treasury Department to cover potential losses from the Main Street loans, only approximately $4 billion in loans have been made under the program since its inception this summer. Many banks have been reluctant to participate because of the necessary underwriting and the risk of loan defaults. Under the Main Street Lending Program, the Federal Reserve purchases 95 percent of a bank loan to a company with fewer than 15,000 employees or less than $5 billion in annual revenue. As a part of the changes announced last week, companies will be allowed to exclude Paycheck Protection Program (PPP) loans of up to $2 million when calculating how much debt they hold while also increasing the maximum amount others can borrow.

Physicians See Slight Decline in Average Income
A new survey reveals that physician pay remained flat this year amidst the coronavirus pandemic. The average pay for physicians increased by 1.5 percent according to a Doximity survey of more than 40,000 of the nation’s doctors. Because of the 2.3 percent inflation rate in 2019, this represents a slight decline in average physician income. The cancellation of appointments and elective procedures resulting from the current public health crisis is likely to blame. Certain specialties have appeared to fare better than others, however, including vascular surgery, geriatrics, and emergency medicine, which saw pay increases of nearly five percent. Doximity also reported on the observed wage gap between male and female doctors, which increased to 28 percent from 25.2 percent last year.

Bipartisan Lawmakers Request Legislative Fix to Medicare Budget Neutrality
A bipartisan group of 229 House members sent a letter urging Speaker Nancy Pelosi (D-Calif.) and Minority Leader Kevin McCarthy (R-Calif.) to pass a fix preventing Medicare physician fee schedule cuts for certain medical specialties from going into effect. The letter expresses support for pay increases for office-based specialties but urges the leaders to waive the budget neutrality requirement that would result in across-the- board pay cuts elsewhere to offset the increases. The lawmakers ask for a fix to be included in any upcoming legislation moving through the House in the absence of regulatory relief from the Centers for Medicare and Medicaid Services (CMS).

Democrats Request Details on Drug Discount Cards
Democratic leadership of several congressional health panels have sent letters to the U.S. Department of Health and Human Services (HHS) and the Government Accountability Office (GAO) requesting details about the Trump administration’s plan to send $200 drug discount cards to Medicare beneficiaries in the weeks leading up to the November presidential elections. The letters were signed by House Energy and Commerce Chairman Frank Pallone (D-N.J.), House Ways and Means Chairman Richard Neal (D-Ma.), and Senate Finance Ranking Member Ron Wyden (D-Ore.). The lawmakers question the motive and legality of the White House plan, expressing concerns about the “propriety of these actions, particularly in light of recent press reports indicating that the timing of this project is being driven by the upcoming presidential election.” They argue that current law does not provide the Administration authority to proceed with the drug card demonstration.

Ways and Means Leadership Continues Work on Health Equity
House Ways and Means Committee Chair Richard Neal (D-Mass.) is following up on his series of inquiries regarding racial health equity, asking the Centers for Medicare and Medicaid Services (CMS) to examine the issue of the misuse of race in clinical decision-making. He urged the agency to take his questions as “an opportunity to immediately evaluate the unintended consequences of clinical decision tools, including algorithms developed by specific professional societies, along with their uses and relevance to CMS initiatives related to quality and safety for Medicare and Medicaid beneficiaries.” He also requests a briefing from CMS on the current use of racial bias in such clinical decision-making tools by October 30.

CMS Expands Codes Eligible for Telehealth Reimbursement
The Centers for Medicare and Medicaid Services (CMS) has announced an additional set of telehealth services that will be eligible for Medicare reimbursement during the COVID-19 public health emergency (PHE). The announcement was in response to the President’s recent Executive Order on Improving Rural Health and Telehealth Access. CMS added 11 new services to the Medicare telehealth services list and will immediately start paying eligible practitioners who provide these services. The new services include certain neurostimulator analysis and programming services as well as cardiac and pulmonary rehabilitation services.

CMS Administrator Verma Previews Vaccine Regulations
The Centers for Medicare and Medicaid Services (CMS) is in the process of drafting regulations to ensure speedy access to an eventual COVID-19 vaccine. According to CMS Administrator Seema Verma, the agency plans to ensure full payment of COVID vaccines and treatments for Medicare beneficiaries. During the Health Care Payment Learning and Action Network (HCPLAN) Virtual Summit last week, Verma stated that CMS expects to release more details on its plans within the month.

Providers Call for Fix to MPFS Budget Neutrality
A coalition representing 47 organizations and 1.4 million physician and non-physician providers have sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma expressing concerns about the proposed budget neutrality reduction proffered by the agency in its 2021 Medicare Physician Fee Schedule (PFS) proposed rule. The organizations warn that the change could jeopardize the financial viability of providers, reduce access to medically necessary specialty services, and decrease lifesaving cancer screening services. The letter argues that CMS has significant administrative discretion in administering the budget neutrality provision, and that the administration could mitigate the impact of budget neutrality by utilizing funds outside of the PFS under the unique circumstances of the current public health emergency (PHE).

FDA Releases Vaccine Guidance
The Food and Drug Administration (FDA) has released the standards it will use in the emergency use authorization (EUA) of an eventual COVID-19 vaccine. The guidance will require manufacturers to monitor clinical trial participants for a median of two months after administering the last shot, a time frame which could be shortened depending on the data. The White House temporarily blocked the agency from publishing the guidance last week, following insistence from President Trump that a vaccine could be available before the November 3 election. While administration officials claimed that the pharmaceutical industry had expressed opposition to the FDA benchmarks, the FDA stated that it had heard no such complaints and the industry has publicly supported the agency’s expectations for demonstrating safety and efficacy. The guidance decreases the likelihood that any vaccine will receive an EUA before the election.

HHS Announces Release of an Additional $20 B in Provider Relief Funds
On October 1, the U.S. Department of Health and Human Services (HHS) announced the intended distribution of an additional $20 billion in funds from the CARES Act Provider Relief Fund “that considers financial losses and changes in operating expenses caused by the coronavirus.” Providers will be eligible to apply for the funding starting October 5, with an application deadline of November 6, 2020. If a provider has already received the two percent allocation based on patient revenue from the General Distribution, then the provider would be eligible for an equitable add-on payment that considers: (1) a provider’s change in operating revenues from patient care; (2) a provider’s change in operating expenses from patient care, including expenses incurred related to coronavirus; and (3) payments already received through prior Provider Relief Fund distributions. This round of funding is also open to providers that began practicing January 1, 2020 through March 31, 2020 and those who previously received, rejected or accepted a General Distribution payment to ensure that those providers receive their allocation of two percent of patient revenue in addition to any add-on payment. According to HHS, approximately $106 billion of the approximately $175 billion initially appropriated to the Provider Relief Fund has gone out to providers as of September 23.

Congress Passes CR to Fund Government Through Dec. 11
Congress has cleared a $1.4 trillion stopgap spending measure to avert a government shutdown and fund the federal government at current levels through December 11. The bill, which had previously been advanced by the House of Representatives, passed the Senate on Wednesday by a vote of 84-10. Lawmakers were able to reach an agreement on the inclusion of nutrition assistance and trade relief payments for farmers in the final deal. The bill extends the Medicare geographic practice cost index (GPCI) floor and a number of health care programs, including the National Quality Forum, Money Follows the Person (MFP) Medicaid demonstration, Medicaid spousal impoverishment protections, community health centers, community behavioral health clinics, the National Health Services Corps, Teaching Health Centers, and the Special Diabetes Program, that were set to expire on November 30, and averts a $50 increase in 2021 Medicare Part B premiums. It would instead limit any increase in Medicare premiums to around $4 a month. It would extend the time in which health care providers must repay Medicare Accelerated and Advance Payment Program loans and reduce the interest rate of those loans to four percent until the current public health emergency ends. The bill would also delay cuts to disproportionate share hospitals (DSH) until December 11. The bill authorizes the Food and Drug Administration (FDA) to collect user fees to support its reviews of over-the-counter drugs and its regulation of production facilities. The new deadline creates the possibility of a vehicle to which a surprise medical billing fix could be attached after the election but before the end of the year. Lawmakers will now attempt to complete work on the 12 annual appropriations bills for fiscal year (FY) 2021 during the lame duck session of Congress following the November 3 elections.

Lawmakers Probe Private Equity Receipt of COVID Funds
Representatives Katie Porter (D-Calif.), Bill Pascrell (D-N.J.), and Rosa DeLauro (D-Conn.) sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar requesting information regarding coronavirus relief payments made to private equity-backed health care companies. The lawmakers ask for details on how the relief loans have been allocated and which providers have been denied aid. They also seek a breakdown of funding by provider type and ownership. The letter expresses concern that smaller hospitals may be at a disadvantage, arguing that “it is egregious that HHS has prioritized money for private equity-owned hospitals with no transparency and seemingly no regard for hospitals that do not have financial support from Wall Street.”