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HHS Announces New Guidance on Reproductive Healthcare

On July 8, President Biden signed an executive order for abortion access. In this order, the US Department of Health and Human Services (HHS) pledged to take steps to ensure that all patients have access to the full rights and protections for emergency medical care afforded under the law. Currently, medical providers and hospitals are required by the Emergency Medical Treatment and Labor Act to provide stabilizing treatment for patients with emergency medical conditions. On July 11, the Biden administration reiterated, through new guidance from HHS, that medical providers must offer abortion services if the life of a mother is at risk and that procedures conducted under such circumstances would be protected regardless of state law. The state of Texas has already filed a lawsuit challenging the Biden administration on this new guidance on the grounds that it violates the rights of physicians who oppose providing abortions and violates a state’s right to invoke its own policies.

Additionally, the Office of Civil Rights released guidance for retail pharmacies on access to reproductive healthcare services. The guidance, directed toward the nation’s 60,000 retail pharmacies, directed that pharmacists must provide medications related to reproductive healthcare as directed and prescribed by providers. This includes abortion pills, birth control and other reproductive care treatments. The agency cited reports outlining instances in which women were denied certain medications because the drugs may be linked to abortion or the drugs have ingredients like those used for medication abortion, for example Methotrexate, which is sometimes used to treat certain types of cancer, psoriasis and rheumatoid arthritis, but can also be used off-label to end ectopic pregnancies.

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Biden Administration Foreshadows Impending Nursing Home Quality Reforms

On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s initiatives have not yet been implemented, President Biden reiterated his administration’s focus on nursing home reform during his March 1, 2022, State of the Union address. Accordingly, the efforts described in the Fact Sheet provide stakeholders with a peek into the regulatory crystal ball of the governmental efforts that may be forthcoming, either through new laws, regulatory action, policy changes, enforcement activities or subregulatory guidance.

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COVID-19 Vaccine Exemptions as Easy as Copy and Paste

The federal government’s COVID-19 vaccine mandate has spurred an uptick in religious exemption requests. In this Politico article, McDermott Partner Michelle Strowhiro explains how some workers are copying and pasting exemption documents from anti-vaccine websites.

“The religious exemption is not a tough standard for a worker to submit,” Strowhiro said. “There can be a level of people making things up, unfortunately.”

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COVID-19 Response in Jeopardy amid Congressional Inaction

Congressional inaction may prevent a more robust federal government COVID-19 response, according to this Washington Post article. A $15 billion COVID-19 funding bill recently collapsed in Congress, potentially crippling testing, treatment and vaccine access. McDermott+Consulting’s Rodney Whitlock said not enough “spadework” was done to get compromises across the finish line.

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Biden Administration EO Requires Project Labor Agreements with Unions on Certain Federal Construction Projects

A project labor agreement (PLA) is a collective bargaining agreement between a contractor and the building trade union on a specific construction project. PLAs are negotiated before any workers are hired, and they establish the terms of employment on a project. Executive Order (EO) 14063, issued by the Biden administration on February 2, 2022, requires PLAs on “large-scale construction projects,” defined as Federal construction projects within the United States for which the total estimated cost of the construction contract to the Federal Government is at least $35 million.

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Trump-Era Medicare Program Under Increased Scrutiny

A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.

“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.

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Proposed Rule on MA and Part D Would Reinstate Historical Requirements, Make Changes to Prescription Drug Payment Structure

On January 6, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule regarding Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs, marking the Biden administration’s first proposed rule on these topics. The proposed rule includes proposed changes to the manner in which pharmacy price concessions are accounted for in the Part D benefit, the timing of network adequacy reviews for Medicare Advantage Organization (MAO) applicants, and new rules regarding oversight of third-party marketing organizations. The proposed rule also reverses course on some policy changes that were initiated under the prior administration, including changes related to medical loss ratio (MLR) reporting and past performance evaluations. The proposed rule includes proposed policy updates for Dual Eligible Special Needs Plans (D-SNPs) and a few provisions related to the ongoing COVID-19 public health emergency (PHE).

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Issues Mount as Health Plans Offer At-Home COVID-19 Tests

The Biden administration’s January guidance that group health plans and insurers cover the costs of at-home COVID-19 tests has rattled insurers and employers. According to this SHRM article, insurers’ data processing systems have had difficulty paying for tests purchased by consumers at pharmacies, and self-insured employers have struggled to identify the best way to pay for tests. McDermott’s Jacob Mattinson, Teal Trujillo and Judith Wethall recently advised plan administrators to work with their third-party administrators to develop a process for coverage of over-the-counter COVID-19 tests and to develop procedures to reduce the risk of participant fraud.

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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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Staying Connected: An Update on Medicare Reimbursement for Telehealth Services After the PHE

In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.

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