In Medicare news, let’s start from the beginning. The original 1965 bill signed that created Medicare and Medicaid included two parts to the Medicare program: Part A (Hospital Insurance) and Part B (Medical Insurance). Since then, Congress has made Medicare and Medicaid changes to open eligibility to more people. For example, Medicare was expanded in 1972 to cover the disabled, people over 65, and others. Medicare includes more benefits today, including limitless home health visits and quality standards for Medicare-approved nursing homes. Medicaid has also been expanded to cover a larger group than initially intended. This includes coverage for low-income families, pregnant women, people requiring long-term care, and people with disabilities.
Wide variations in Medicaid programs across the nation occur because individual states have the ability to tailor Medicaid programs to serve the needs of their residents. In 2010, the Affordable Care Act introduced the Health Insurance Marketplace, which has had a direct impact on Medicaid service. Potential consumers can now use the Marketplace website to determine their Medicaid eligibility.
The Future of Medicare and Medicaid
As the baby boomer generation approaches retirement, thus qualifying for Medicare, healthcare spending by federal, state, and local governments is projected to increase. Assuming the government continues to subsidize Marketplace premiums for lower-income populations, this increased government healthcare spending will greatly affect the entire healthcare system in the U.S. Although Medicaid spending growth decelerated in 2016 due to reduced enrollment, spending is expected to accelerate at an average rate of 7.1 percent per year in 2018 and 2019 due to the aging baby boomer generation.
A Shift in Healthcare Providers
Along with policy and technological changes, the people who provide healthcare are also changing. Providers are an important part of the healthcare system and any changes to their education, satisfaction or demographics are likely to affect how patients receive care.
Future healthcare providers are also more likely to focus their education on business than ever before. A large-scale analysis of Harvard Business School’s physician graduates indicates substantial growth in the number of physicians pursuing M.B.A. degrees in the last decade. This growth may result in more private practices and healthcare administrators.
(via The New York Times)
President Biden has announced that healthcare providers who receive federal funding are prohibited from discriminating based on sexual orientation and gender identity. The announcement comes after President Biden pledged commitment to the Equality Act, which expands civil rights to the lesbian, gay, bisexual, transgender, and queer (LGBTQ) community. President Biden’s secretary of Health and Human Services (HHS), Xavier Becerra, says, “Fear of discrimination can lead individuals to forgo care, which can have serious negative health consequences. It is the position of the Department of Health and Human Services that everyone — including LGBTQ people — should be able to access health care, free from discrimination or interference, period.”
This new policy is the first step in reversing the Trump-era HHS policy that said antidiscrimination provisions of the Affordable Care Act do not apply to transgender people. The new interpretation does not fully reverse the former administration’s interpretation but invites people who may have experienced discrimination to file complaints with the federal government. Further plans include more robust civil rights provisions under Section 1557 of the Affordable Care Act, such as specifying the types of institutions and services that are subject to the provisions.
The move is not without critics. Roger Severino, leader of HHS’s Office for Civil Rights under the Trump Administration, says, “Many people of good will who are scientists and doctors believe sex is a biological reality. This action is attempting to impose a contrary view.”
The Biden announcement conflicts with recent state legislative activity, increasing controversy around the medical treatment of transgender adolescents. More than ten states are considering or have already passed bills that prohibit medical providers from offering certain medications, hormones, or surgeries to transgender teens. Medical providers in these states risk criminal penalties if they treat transgender youth, but they risk federal discrimination penalties if they do not.
A new president always brings new policy priorities and objectives, particularly when that president is from a different political party than his predecessor. As we begin 2021, and usher in the Biden era, we should likewise expect a significant shift in the health policy agenda. Following are the top priorities to watch.
COVID Response. In his campaign, Biden focused on the federal response to COVID-19 more than any other issue, so we should expect this to be his number one focus as he assumes office and the virus continues to infect both the population and the economy. In addition to a federal centralization of the response commanded from within the White House, the new administration also will be pushing for more stimulus and relief, including support for health care providers. Notwithstanding the large stimulus and relief bill approved just before the New Year, health care providers will be seeking, among other things, more financial support through the Provider Relief Fund and flexibility and maybe forgiveness from debt obligations associated with the Accelerated and Advance Payment Program, as well as liability protections.
Coverage Expansion. President-elect Biden’s hope of expanding coverage to more Americans by offering a public option alternative to commercial health insurance in the exchange marketplaces is likely to run into opposition from Senate Republicans, as well as moderate Democrats. Instead, the new President will likely seek to expand access to health insurance by undoing a number of Affordable Care Act (ACA)-related administrative actions advanced by the Trump administration, reinvigorating enrollment promotional activity, and enticing states to expand Medicaid, perhaps through new flexibilities and federal cost sharing.
Congress may yet have to deal with the ACA, if the Supreme Court strikes down or severely weakens the law when it rules on California v. Texas, the case challenging the constitutionality of the individual mandate. There are relatively easy paths for Congress to avoid a wholesale undoing of the ACA, but there will have to be the political will to forge bipartisan compromise.
Prescription Drug Pricing. While not a major campaign priority for Biden, he likely will seek to find compromise with Congress as a means for reducing health care costs for individuals. There are a number of policy proposals that enjoy bipartisan support and could advance in this divided government environment, including capping out-of-pocket costs for seniors, capping price increases or rebates for increases greater than inflation, and possibly some use of international pricing indices.
Surprise Billing. Congress approved surprise billing legislation late in the 2020 lame duck session, but this legislation now needs to be implemented. Health care providers and payers may seek further revisions and delays as implementing regulations are developed. Additionally, Congress may scrutinize the role of private equity investment in health care interests. Champions of surprise billing legislation have blamed profit motives by private equity investors as a major driver for the out-of-network dynamics that cause surprise medical bills, and cast aspersions on private equity investors in the process. Health care interests with private equity investment may find themselves on the wrong end of a bad public relations narrative as a result.
Value-Based Care. Value-based care has been a rare area of bipartisan agreement, and so expect the move to value-based care to continue regardless of the change in party control at the Centers for Medicare & Medicaid Services (CMS). What might change is the tone and details of the models. The Trump administration supported pre-paid and capitated models, like the Direct Contracting Model, which required participating entities to take some amount of capitated payment for services. The Obama administration previously offered increasingly advanced forms of payment as options, but not requirements. The Biden administration likely will revert closer to an Obama-era approach, favoring flexibility and inducements for providers to begin the journey to risk and capitation.
Medicare Solvency. The 2020 Annual Report on the Medicare Trust Fund projected that the Medicare program would become insolvent in 2026. This estimate was based on data gathered prior to the pandemic. Since the report was released, more than 36 million people have lost their jobs, and the federal government has lost significant tax contributions to the Trust Fund. At the same time, significant dollars are being spent on COVID-19 care in both direct medical expenditures and additional financial relief for providers. Trust Fund solvency likely will become a major concern for both parties, but action may be postponed until after the public health emergency (PHE). A focus on Trust Fund solvency typically leads to expenditure reduction measures, which often mean slower payment growth and lower reimbursements for providers.
Telehealth Flexibilities. During the COVID-19 pandemic, the administration implemented waivers that allowed the delivery system to flex to meet the needs of the pandemic. While many of these flexibilities are likely to be extended temporarily, many stakeholders are seeking more enduring extensions. The genie may be out of the bottle on this one. Expect Congress to enact a series of short-term extensions while it gathers data to address concerns about quality, effectiveness, cost, and fraud.
Stark and Anti-Kickback Reform. CMS and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) in November 2020 finalized eagerly awaited changes to the Stark Law and Anti-Kickback Statute regulations, which were proposed in October of 2019. The final rules represent a significant overhaul of the Stark Law and Anti-Kickback Statute regulations. Notably, CMS and OIG have adopted new exceptions and safe harbors intended to accelerate health care’s transition to value-based reimbursement and coordinated care. The Stark final rule also clarifies key requirements for compliance, notably Stark’s “Big 3” standards of fair market value, commercial reasonableness, and the prohibition on “taking into account” the volume or value of a physician’s referrals. Many of the interpretations and positions in the final rules likely will impact future enforcement trends and ongoing False Claims Act whistleblower actions.
Watch for the End of the COVID-19 Flexibilities. Health care leaders have had to navigate a changing fraud and abuse regulatory environment due to COVID-19, but many of these changes are temporary. For example, on March 30, 2020, CMS issued blanket waivers of several Stark Law requirements related to COVID-19 physician arrangements. Soon after, on April 3, 2020, OIG also issued guidance stating that it would not impose administrative sanctions under the Anti-Kickback Statute for certain arrangements covered by the Stark blanket waivers. The waivers have provided needed flexibility to hospitals and health systems as they tackled challenging physician contracting, compensation, and staffing issues during the pandemic. Finally, CMS issued a number of Section 1135 waivers to provide relief from a variety of reimbursement and other regulatory requirements.
During the PHE, providers have entered into arrangements and set up care delivery systems that depend on these flexibilities. Some of these changes have specific conditions. For example, providers that intend to rely on the Stark Law waivers must do so for one of the six identified proper COVID-19 purposes. The waiver guidance also provides 18 distinct waivers and more than 20 examples of specific arrangements that could fall within the scope of one of the waivers. Providers should maintain separate documentation supporting their proper purpose and good faith reliance on the waivers. Providers are reminded that the waivers are only temporary and can be relied upon until the end of the declared PHE. While the pandemic does not appear to be ending soon, hopefully during 2021 it will. At this point, changes may need to be made to arrangements and activities that depend on these actions.
New Enforcement Efforts and Targets. The health care industry should expect COVID-19 to become a significant part of the government’s fraud enforcement efforts into 2021 and beyond. The main reason for this shift is the tremendous amount of new federal spending to address the pandemic, including the Provider Relief Fund program in the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act. As many funding recipients know, the HHS, through the Health Resources and Services Administration (HRSA) has issued, and continues to change, a growing body of sub-regulatory guidance in the form of “frequently asked questions” and position statements on many facets of the program, such as the permitted uses for the funds. In addition, HRSA has created reporting obligations for any recipient who has received more than $10,000 from the program, with the first report due February 15, 2021. HHS has said many times that it expects to engage in significant audit activity of funding recipients, and we should also expect scrutiny from the Department of Justice (DOJ) and whistleblowers as time goes on.
Another reason for expecting a COVID-19 shift in fraud enforcement activity is the expansion of telehealth and the other ways in which HHS waived many federal health program requirements to allow greater flexibility in addressing the pandemic. When the dust settles, actions taken under loosened restrictions will likely come under increased scrutiny. We already have started to see an increase in telehealth enforcement in 2020. Notably, telehealth was the focus of the record-setting Health Care Strike Force Taskforce takedown that was linked to $4.5 billion in allegedly false and fraudulent claims. This takedown also involved other high priority areas, including opioids, durable medical equipment, and genetic and other diagnostic testing. The government’s likely continued focus on telehealth, combined with the ongoing expansion of coverage for telehealth services, provides an important opportunity for organizations to evaluate their telehealth service offerings and arrangements and to further enhance their related compliance activities in this evolving area.
39th Annual Conference on LGBTQ Health
Health Professionals Advancing LGBTQ Equality (previously known as the Gay & Lesbian Medical Association, or GLMA) will host its 39th annual conference virtually on September 22–25. The conference theme, Closing the Gaps, focuses on strategies to reduce and eliminate LGBTQ health inequities through expanding access to care and developing leadership of LGBTQ community members and professionals who belong to multiple minority groups. Register for the conference
Call for Abstracts
The Society for Public Health Education (SOPHE) is accepting proposals for virtual oral presentations or skill-building workshops for their 23rd virtual Annual Advocacy Summit, Health Education: Advancing Health Equity at Every Level. The Summit will take place on October 13–14. Abstracts must be submitted by June 25. Learn More
2021 Public Health Law Conference Registration Open
The 2021 Public Health Law Conference is scheduled to be held in Baltimore on September 21– 23. The conference, hosted by the Network for Public Health Law, will provide an opportunity to learn how the strategic use of legal and policy tools can address fundamental drivers of inequity, promote health and well-being, and save lives. (Current cancellation policy allows for a full refund if pandemic conditions do not improve by fall.) Learn more and register
Public Health Law Academy Certificate
CDC and ChangeLab Solutions created the Public Health Law Academy to bridge the learning gap between formal public health and legal training and practice. The Academy now offers a certificate track for its free on-demand trainings. To earn the certificate, you must complete seven trainings in core competencies that all public health practitioners need. Get started