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Are Out-of-Pocket Costs on Their Way Out? At-Home COVID-19 Testing and Expanded Preventative Healthcare for Women and Children

In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.

In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.

COVID-19 AT-HOME TESTING COVERAGE

On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.

Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.

The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.

Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).

HRSA UPDATES ACA PREVENTIVE HEALTHCARE GUIDELINES

On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.

HRSA accepted the updates recommended by the Women’s Preventative [...]

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Update to Fraud Self-Disclosure Rules for Regulated Healthcare Entities

On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the Provider Self-Disclosure Protocol last updated by OIG in 2013. The changes are mostly procedural in nature and update the SDP based on legislative adjustments to penalty amounts.

Read more here.




Hospitals Push Back Against HHS Slashing of Reimbursement Rates

Hospitals are pushing back after the US Department of Health and Human Services (HHS) cut Medicaid reimbursement rates to participating hospitals under the 340B drug discount program.

According to this article published in The Well News, 340B program supporters have filed a petition with the Supreme Court, arguing that HHS failed to collect sufficient data and that the department overstepped its authority with the cuts. McDermott Partner Emily Jane Cook said that the cuts will mean rural hospitals are “deprived of an important source of support for the services that they provide to their communities.”

Read more here.




Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court announced in July that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely watched, given its potentially far-reaching impacts on reimbursements to most hospitals that participate in the Medicare program, not just those that participate in the 340B Program.

Read more here.




Requirements Related to Surprise Billing: Policy Update

The US Departments of Health and Human Services, Treasury and Labor, and the Office of Personnel Management issued an Interim Final Rule with comment implementing portions of the No Surprises Act, legislation enacted in December 2020 that bars surprise billing beginning January 1, 2022. Under the law, payers and providers (including hospitals, facilities, individual practitioners and air ambulance providers) are prohibited from billing patients more than in-network cost-sharing amounts in emergency and non-emergency circumstances. This IFR establishes regulations defining the payment methodology. The regulation proposes the methodology payers must use to determine cost sharing; the information payers must share with out-of-network providers; the process for submitting and receiving consumer complaints; and the format and details of the notice and consent requirements.

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“Because of Bostock” – Court Delays HHS Rule Re-interpreting Section 1557 Discrimination “Because of Sex”

One day before an updated rule of the US Department of Health and Human Services regarding Section 1557 of the Patient Protection and Affordable Care Act took effect, the US District Court for the Eastern District of New York ordered a stay and issued a preliminary injunction precluding the most recent final rules from becoming operative. Entities subject to Section 1557 should — at least until decisions are issued in cases pending in US district courts — be cautious in their approach to their non-discrimination compliance obligations.

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Use a Checklist to Avoid LGBTQ Discrimination in Your Benefits Programs

The US Supreme Court ruled June 15 in Bostock v. Clayton County, Ga. that the prohibition against sex discrimination in the workplace under Title VII of the Civil Rights Act covers sexual orientation and gender identity. Title VII applies to employers with 15 or more employees, including part-time and temporary workers.

Following the decision, benefits experts advise that employers review their benefits programs to ensure that lesbian, gay, bisexual, transgender and queer (LGBTQ) employees are treated equally. Employers can use a checklist to find and correct discriminatory language and practices, and thereby reduce the likelihood of being sued under Title VII or other statutes that provide employees with sexual-orientation and gender-identity protections.

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HHS Finalizes Anti-Discrimination Revisions to ACA Section 1557

On June 12, 2020, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) finalized a rule under Section 1557 of the Patient Protection and Affordable Care Act (the 2020 Final Rule) that rescinds certain protections afforded to LGBTQ individuals and persons with limited English proficiency. At the same time, the 2020 Final Rule removes burdensome disclosure requirements that may be a welcome relief for entities covered by Section 1557. On June 15, 2020, the Supreme Court of the United States ruled that workplace discrimination based on gender identity and sexual orientation is forbidden under Title VII of the Civil Rights Act of 1964. Although Title VII is not included in the precedential civil rights laws that gave rise to Section 1557, we nevertheless anticipate that the Supreme Court’s holding will lead to legal challenges in a number of areas, including healthcare and health insurance, religious exemptions and the 2020 Final Rule from HHS OCR.

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HHS Proposes Changes to 2016 Regulations for ACA Non-Discrimination Rule

On Friday, March 24, 2019, the US Department of Health and Human Services issued a proposed rule (along with a related fact sheet) under Section 1557 of the Affordable Care Act (ACA) that would make significant changes to the final regulations issued in 2016. Section 1557, in effect since the ACA was enacted in 2010, provides that an individual shall not—on the grounds prohibited under Title VII of the Civil Rights Act of 1964 (race, color, national origin), Title IX of the Education Amendments of 1972 (sex), the Age Discrimination Act of 1975 (age) or Section 504 of the Rehabilitation Act of 1973 (disability)—be excluded from participation in, be denied the benefits of or be subjected to discrimination under any health program or activity, any part of which is receiving federal financial assistance, or under any program or activity that is administered by an agency established under Title I of the ACA.

The proposed rule addresses a broad range of changes to the previously issued rule. These changes would include eliminating the non-discrimination notices and “tagline” translation notices in significant communications and revising prior guidance on sex discrimination to no longer include gender identity and termination of pregnancy, among other changes. Interested parties are invited to submit comments on the proposed rule through the period ending 60 days after publication in the Federal Register.




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