Released a proposed rule (not yet final) that would make significant changes to the Medicaid Drug Rebate Program, including
- changing the definition of best price to allow for more commercially negotiated value-based agreements.
- broadening the definition of line extension drugs for purposes of manufacturer Medicaid rebate obligations.
- changing policy around manufacturer coupons/copay cards for patients and calculation of rebates (June 2020).
- Released guidance related to excluding PBM rebates/price concessions from MLR claims calculations for Medicaid MCOs (May 2019).
- Approved state plan amendments from eight states for supplemental rebate agreements for value-based arrangements with manufacturers.
- Issued Advanced Notice of Proposed Rulemaking in October 2018 to limit prices under Medicare for certain drugs administered by physicians, based on international reference prices (but did not issue proposed or final rule) and signed executive order in September 2020 to test “most favored nation” drug pricing model for certain high-cost Medicare Part B and Part D drugs; not yet implemented.
- Issued proposed rule in February 2019 (withdrawn in July 2019) and signed executive order in July 2020 requiring the HHS Secretary to promulgate regulations to ban prescription drug rebates, which is projected to reduce copays for some drugs, but increase total Medicare spending and Part D premiums; not yet implemented.
- Issued final rule in May 2019 to require drug companies to disclose prices in TV ads to give consumers have more knowledge about their potential drug costs (U.S. District Court struck down proposal in July 2019; U.S. Appeals Court upheld ruling in June 2020).
- Issued proposed rule and FDA draft guidance in December 2019, signed executive order in July 2020, and issued final rule and FDA guidance in September 2020 to allow importation of prescription drugs, subject to safeguards
- Signed executive order in July 2020, and issued proposed rule in September 2020 that requires Federally Qualified Health Centers (FQHCs) that participate in the 340B program to make available insulin and injectable epinephrine at 340B price; not yet implemented.
- Signed legislation requiring Part D plans (both stand-alone drug plans and Medicare Advantage drug plans) to provide up to a 90-day (3 month) supply of covered Part D drugs to enrollees who request it during the COVID-19 public health emergency.
- Signed legislation requiring COVID-19 vaccine to be covered under Medicare Part B with no cost-sharing.
- Issued an executive order and final rule that requires hospitals to disclose “standard charges” (negotiated prices) so consumers can shop for lower prices, expected to take effect in 2021 (currently being challenged in federal court)
Sexual and Reproductive Health
The Trump Administration has made efforts to reduce access to contraception by issuing regulations that allow employers to opt out of the ACA’s requirement to offer no-cost contraception in its health plans and that exclude family planning clinics that provide or refer for abortion from the Title X family planning program for low-income people. The Administration has also sought to limit access to abortion coverage and care by appointing judges opposed to abortion rights and issuing restrictive rules and regulations.
- Nearly 200 federal judges have been appointed since Trump took office. Many states have enacted abortion bans and restrictions, hoping these new judges will rule in their favor or that they are on a trajectory to the new conservative majority at the Supreme Court to reconsider the abortion precedents of Roe v. Wade and Planned Parenthood v. Casey.
- The network of clinics receiving federal family planning funding has been reduced. Twenty-six percent of Title X clinics have left the network, including all Planned Parenthood clinics, which may limit low-income women’saccess to low- or no-cost reproductive health care.
- Some federal Title X family planning funding has been redirected to faith-based organizations (“crisis pregnancy centers”) that do not provide contraception, including condoms for STI patients, and may only provide counseling on abstinence and natural family planning methods.
- Workers with health insurance provided by employers with a religious or moral objection to contraception are no longer entitled to that coverage. Female workers and dependents will have to pay for contraception out of pocket.
- Insurers who offer plans that cover non-Hyde abortion services would have to send enrollees two separate bills, one for the portion of the premium attributable to abortion coverage and another for all other health care coverage. Policyholders would be required to make two separate payments.
- Issuers in states that do not require private plans to include abortion coverage may choose to no longer cover it due to administrative burden, resulting in reduced access to abortion coverage for people buying or enrolled in a Marketplace plan.
- It is unclear how these regulations would impact issuers in the 6 states that require most private plans to include coverage for abortion. Litigation brought by these states is pending.
- Providers may discriminate against patients on the basis of termination of pregnancy.
- Patients in need of abortion or other health care services that violate a provider’s religious beliefs could be denied, delayed, or discouraged from seeking care, placing them at risk of serious or life-threatening results in emergencies and other circumstances where the individual’s choice of health care provider is limited.
- Litigation is ongoing.
- See LGTBQ Health section below for details on anti-discrimination regulatory provisions related to protections for LGBTQ patients.
- The Trump administration approved a waiver from Texas’s Medicaid program to block Medicaid payments to Planned Parenthood and other providers affiliated with an abortion provider for non-abortion family planning services.
- Disregarding Medicaid’s ‘free choice of provider’ provision limits low-income people’s access to affordable, comprehensive reproductive health care.
- Short-term plans allowed by the Administration typically do not cover maternity care, mental health, or prescription drugs, meaning enrollees may have to pay out-of-pocket for these services or forgo them. See ACA section for more details.
- In 2017, the Trump administration notified TPPP grantees nationwide that their funding would end two years early. In 2018, a district court blocked the administration from cutting the grants.
- Federal funding supports abstinence-until-marriage programming that has already been demonstrated to be ineffective in preventing teen pregnancy and STIs and potentially harmful.
- If the ACA is found to be unconstitutional, women could lose access to coverage for no-cost preventive care including mammography screenings, contraception, well woman visits, Pap smears, and other services.
- Insurance reforms that ban gender rating (charging women more than men for the same coverage) and require plans to include services such as contraception and pregnancy care would be eliminated.
- Approximately 700 women die each year in U.S. as a result of pregnancy or delivery complications. The Preventing Maternal Deaths Act of 2018 authorized the CDC to increase support for state and tribal maternal mortality review committees to collect, analyze, and report data related to pregnancy-associated deaths.
- In January 2017, the President reinstated and expanded the Mexico City Policy, now called “Protecting Life in Global Health Assistance.” The policy requires foreign non-governmental organizations to certify that they will not “perform or actively promote abortion as a method of family planning,” even with their own funds, as a condition of receiving most U.S. global health assistance. This marks a significant expansion of the policy from prior Republican administrations.
Mental Health and Substance Use
The Trump Administration has taken steps to address the opioid epidemic and high suicide rates among veterans. The Administration also supports overturning the ACA and increased the duration of short-term health plans, steps that would ultimately reduce coverage of mental health and substance use disorder services and limit the scope of mental health parity rules. President Trump also proposed budget reductions to the Substance Abuse and Mental Health Services Administration (SAMHSA) and Medicaid, key funders for substance use disorder services. Most recently, during the COVID-19 pandemic, President Trump signed legislation providing some additional funding to SAMHSA and to support mental health services for isolated veterans.
- The ACA extended mental health parity requirements to the small group, individual, and Medicaid managed care markets; and required coverage of mental health services as an “essential health benefit” in many private health plans (except large employer plans). Overturning the ACA would reduce coverage for mental health services and substantially limit the scope of mental health parity rules.
- Insurers can now sell short-term health plans that provide coverage for twelve months, as opposed to three months.
- Short-term health plans do not have to comply with ACA requirements, typically do not cover mental health services or substance use treatment, and generally exclude people with pre-existing conditions such as serious mental illnesses.
- Created a commission on opioids in 2017 that released a number of recommendations and proposals. However, very few recommendations were implemented.
- Released a five-point opioid strategy to address prevention and treatment, access to Naloxone, improve data collection and research.
- Signed legislation approving additional grant funds to combat the opioid epidemic, including the SUPPORT for Patients and Community Act in 2018. However, President Trump’s proposed 2021 budget decreased overall funding to SAMHSA and Medicaid, key funders for substance use disorder services. The proposed budget for opioid response programs in rural areas under HRSA shows a decrease from 2019 funds.
- Through the executive order, the PREVENTS task force was created to focus on suicide prevention among veterans.
- Proposed 2021 budget for the Department of Veterans Affairs allocates roughly 30% more in funding for suicide prevention among veterans than the 2020 enacted budget.
- Proposed 2021 budget for SAMHSA includes a small increase in funding for specific grant-based suicide prevention programs.
- The 2021 budget proposal for Health Resources and Services Administration (HRSA) includes an increase in funding (by over 20%) for behavioral health workforce development programs from 2019 to 2020. However, funding would remain flat for 2021.
- Allocated a $425 million appropriation for use by SAMHSA
- Created provisions aimed at expanding coverage for, and availability of, telehealth and other remote care for those covered by Medicare, private insurance, and other federally-funded programs
- Allowed for the Department of Veterans Affairs to arrange expansion of mental health services to isolated veterans via telehealth or other remote care services
- Extended duration of, and expanded, Certified Community Behavioral Health Clinics, which are currently underway as part of efforts to increase care access and quality at community behavioral health clinics.
Immigration and Health
Since taking office, the Trump Administration has taken numerous actions to reshape immigration policy. These efforts have included limiting entry into the country, including restrictions for humanitarian immigrants such as refugees and asylees; enhancing interior enforcement efforts and expanding the scope of individuals targeted for removal; and discouraging legal immigrants from using public programs for which they are eligible, including Medicaid. A number of these actions have particularly significant implications for the health and well-being of immigrant families, including their children, who are primarily U.S.-born citizens.
- Implemented a zero-tolerance policy in 2018 that resulted in the separation of thousands of children from their parents when they were taken into criminal custody for entering the country without authorization. Family separations were largely halted in June 2018 following an executive order and a preliminary injunction, although some separations are ongoing due to broader criteria for separating children from parents deemed to be unfit or a danger to the child.
- Implemented Migrant Protection Protocols, under which families with children are sent to Mexico to await their U.S. asylum cases, and other policies that limit avenues to claim asylum in the U.S.
- Through a 2017 executive order, expanded the scope of individuals targeted for removal, which has contributed to growing fear and uncertainty and negative health and financial effects among immigrant families.
- Also sought to withhold federal funding from jurisdictions that limit cooperation with federal enforcement agencies (i.e., sanctuary cities); this action has been blocked by the courts.
- In September 2017, rescinded the DACA program, which had granted permission to certain undocumented youth who came to the U.S. as children to stay in the U.S. and work for temporary renewable periods.
- On June 18, 2020, the Supreme Court ruled that the termination of DACA violated federal law. However, in July 2020, the administration issued a memorandum to limit the program, including eliminating eligibility for new applicants and reducing the renewal period from two years to one.
- In August 2019, issued regulatory changes to public charge inadmissibility policies. (In addition, the State Department made parallel changes for individuals seeking visas or adjustment to LPR status from outside the U.S.).
- Under the changes, the federal government will newly consider potential future use of certain health, nutrition, and housing programs, including non-emergency Medicaid for non-pregnant adults, when determining whether someone is likely to become a public charge and denied entry or LPR status. It also will consider age, income, health insurance coverage, and health status, among other factors. Implementation remains subject to ongoing litigation.
- The changes to public charge policy will make it more difficult for individuals with lower incomes and health needs to obtain LPR status or immigrate to the U.S. Further, prior to implementation, it was already contributing to decreased enrollment in public programs and decreased use of health care among immigrant families beyond those directly affected by the rule.
- On October 4, 2019, issued a proclamation suspending entry of immigrants into the United States unless they provide proof of health insurance within 30 days of entry or have financial resources to pay for reasonably foreseeable health insurance costs. Court action has blocked implementation of this requirement.
- After abandoning efforts to add a question on citizenship status to the 2020 Census, in July 2019, issued an executive order directing every federal agency to share records on citizenship status in connection with the Census data collection. In July 2020, issued a memorandum ordering the exclusion of undocumented immigrants from the Census count. Key questions remain about the legality and feasibility of this action.
- Continued broad enforcement actions, curtailing of the Census period for follow-up response, and the emphasis on excluding undocumented immigrants from the Census count may result in lower response rates among immigrant households. Lower responses would affect the apportionment of Congressional representation and may also result in resources being shifted away from areas with higher shares of immigrants because the data are used to determine distribution of federal funds to the states.
Long-term Care
The Trump Administration has proposed changes to Medicaid financing that would have affected the program’s ability to pay for long-term services and supports. In addition, the Administration supported repeal of the ACA which would eliminate some options for states to expand access to Medicaid home and community-based services. Prior the onset of COVID-19, the Administration proposed changes to relax certain requirements for nursing homes, and subsequently relaxed additional requirements at the onset of the pandemic while imposing new ones to prevent the spread of the virus. Since March, as the number of COVID-19 deaths in long-term care facilities increased substantially, the Trump Administration issued new guidance and waivers, established a new commission to make recommendations, required nursing facilities to report cases, deaths and shortages, distributed tests to facilities and made additional funds available to nursing facilities and assisted living facilities.
- Caps on Medicaid funding would limit federal funding for long-term care. Medicaid is the primary payer for long-term care, financing over half of these services nationally.
- ACA repeal would eliminate some state options to expand access to Medicaid home and community-based services.
- Proposed changes to relax requirement for infection preventionist, psychotropic drug use, grievance process, staffing data retention, and quality assurance and performance improvement program.
- In March 2020, CMS suspended state inspections of nursing homes, except for those related to infection control and immediate jeopardy. CMS also required facilities to restrict all visitors except for compassionate care circumstances and cancel all communal dining and group activities.
- In April 2020, CMS issued guidance directing facilities to screen all staff, residents, and visitors for symptoms, ensure staff use PPE “to the extent available,” and designate separate staff and facilities or units for COVID-19 patients. CMS also announced the formation of an independent commission to conduct a comprehensive assessment of facility response to COVID-19.
- New interim final regulations require nursing homes to report COVID-19 cases and deaths weekly to the CDC, beginning in May 2020. CMS also issued nursing home reopening recommendations and an informational toolkit with best practices for states to mitigate COVID-19 in nursing homes.
- In June 2020, CMS issued additional guidance to states on COVID-19 survey activities and enhanced enforcement for infection control deficiencies.
- In late July 2020, CMS began requiring, rather than recommending, that all staff be tested weekly in nursing homes in states with a 5% or greater positivity rate. HHS distributed rapid diagnostic tests to nursing homes in COVID-19 hotspots through a one-time procurement to facilitate on-site testing of residents and staff.
- In August 2020, CMS issued an interim final rule requiring long-term care facilities to test residents and staff for COVID-19.
- The Administration also issued an emergency Section 1135 blanket waiver to allow nursing homes to employ nurse aides who do not meet federal training and certification requirements longer than four months to address potential staffing shortages due to COVID-19.
- HHS announced two targeted distributions of the Provider Relief Fund for skilled nursing facilities: in May 2020, nearly $4.9 billion or skilled nursing facilities and in August, 2020, an additional $2.5 billion was made available for skilled nursing facilities and other qualified nursing homes. In September 2020, HHS announced that assisted living facilities are eligible to apply for funds.
HIV/AIDS Policy
President Trump has taken steps to address the domestic HIV epidemic. In 2019, he launched a new effort, the Ending the HIV Epidemic (EHE): A Plan for America, which aims to drive down new HIV infections, especially in hard hit areas, and includes new funding for domestic HIV programs. It has helped to focus new attention and resources on HIV in the United States. At the same time, other actions of the Administration, such as ongoing attempts to overturn the ACA, which has helped to expand insurance coverage for people with HIV, and the removal of protections for LGBTQ people in health care, threaten to undermine the reach of the EHE. On the global front, the President has publicly supported PEPFAR, but called for significant budget cuts to PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria each year.
- The Administration did not appoint a director of the White House Office of National AIDS Policy, an executive office role that has been filed under both Democratic and Republican administrations since its inception in the early 1990s. HHS leads the EHE.
- The Ending the HIV Epidemic (EHE): A Plan for America was announced during the 2019 State of the Union address and is a targeted federal approach to address HIV in the U.S., aiming to reduce new HIV infections by 75% in five years and by 90% in ten years by focusing first on the hardest hit areas of the country.
- The initiative was funded at $270 million in FY20 and the Administration nearly tripled that figure with their FY21 request. It marks the first significant funding increases for CDC HIV prevention and the Ryan White HIV/AIDS Program in over a decade.
- A cornerstone of the initiative expands access to pre-exposure prophylaxis (PrEP) to prevent HIV acquisition among those at higher risk.
- STLDs plans are exempt from ACA requirements prohibiting medical underwriting, pre-existing condition exclusions, and other protections and generally will not cover individuals with HIV.
- Trump Administration removed regulatory health care protections based on gender identity and sexual orientation put in place by Obama Administration (though a recent Supreme Court decision calls these actions into question and pending litigation is challenging this action).
- Requires service members who have been “non-deployable” for 12 months to be processed for separation from military, allegedly used to discharge members with HIV. A suit challenging these discharges is pending and discharges are currently blocked.
- The CARES Act, the third major legislative initiative to address COVID-19, included $90 million for the Ryan White HIV/AIDS Program to prevent, prepare for and respond to coronavirus and $65 million for HOPWA to maintain operations and for rental assistance, supportive services, and other necessary actions, in order to prevent, prepare for, and respond to coronavirus.
- The President has publicly supported PEPFAR and signed bipartisan reauthorization legislation for the program in 2018. However, he has requested significant budget cuts to PEPFAR and the Global Fund each year (which have been rejected by Congress).
LGBTQ Health
The Trump Administration has implemented or supported several policies that remove or reduce protections for LGBTQ people in in health care. Many of these actions have occurred against the backdrop of protections for “provider conscience.” In some cases, these policies have been halted or are still being considered by the courts.
- The Trump Administration issued final regulations regarding Section 1557 of the ACA removing health care protections based on gender identity and, through conforming amendments to ten other regulations, sexual orientation. Without these protections, providers could, for example, potentially refuse to serve individuals who are transgender or who do not conform to traditional sex stereotypes or could deny services to transgender people based on their gender identity. A recent Supreme Court decision and subsequent federal district court ruling calls these actions into question and other litigation is pending.
- Issued executive order directing federal agencies to expand religious protections, potentially laying groundwork for denying care to LGBTQ individuals, couples, and families.
- Created the Division of Conscience and Religious Freedom in the OCR at HHS and issued final regulation on “Conscience Rights in Health Care” which aims to protect health care entities from discrimination on the basis of conscience, potentially allowing for discrimination based on LGBTQ status.