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Senate Approves Resolution to End COVID-19 National Emergency Declaration

On November 15, the Senate approved a resolution to end the national emergency concerning COVID-19 declared by the president on March 13, 2020. The resolution was approved by a bipartisan vote of 62–36, with 13 Democrats joining all present Republicans in voting for the resolution.

While ending the national emergency is different than ending the public health emergency (PHE), which is declared by the US Department of Health and Human Services (HHS), the two are related, as the PHE must be tied to another declaration. Should the national emergency declaration end (as intended in this Senate resolution), most current waivers would terminate. There are notable exceptions, however, where other pieces of legislation have enacted additional flexibility (including telehealth waivers), and where policy changes in HHS rulemakings specified that policy changes are tied to the PHE. Should the national declaration end but the PHE stand, such policies would continue until the end of the PHE. Should both the national emergency declaration and the PHE end, all waiver authority would cease. Please see this +Insight for additional information.

The COVID-19 PHE, which is extended in 90-day increments, was most recently extended in mid-October, until mid-January 2023. The Biden administration has maintained a commitment to provide 60 days’ advance notice of any plans to end the PHE, and that 60-day mark recently passed with no indication that the PHE will end in mid-January. This indicates that the PHE is likely to be extended at least once more, through mid-April 2023.

Senate passage of this resolution will not have a tangible impact, as it is unlikely to be taken up by the Democratic-controlled House this year, and the president has threatened to veto it. However, the vote in the Senate demonstrates “pandemic fatigue” as well as significant bipartisan support for ending COVID-19 declarations, which suggests that the next presumed PHE extension through mid-April 2023 could be the last.




GAO Releases Report on Telehealth

On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).

GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:

  • CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
  • CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
  • CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
  • OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.

Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.

The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.

This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.




Texas Abortion-related Litigation ‘just getting started’

It was a busy end of August for abortion-related litigation in Texas. Multiple pro-reproductive justice nonprofit groups sued Texas Attorney General Ken Paxton and other prosecutors to protect the ability of pregnant Texans to obtain abortions in outside states, and Texas’ new trigger ban law went into effect. In this MedCity News article, McDermott Partner Caroline Reignley notes how the US Supreme Court’s landmark Dobbs decision “did not end the debate over abortion or limit court intervention.”

Access the article.




HHS Issues Proposed Rule Under Section 1557 of the Affordable Care Act: Nondiscrimination in Health Programs and Activities

On August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM or proposed rule) to reinterpret section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age or disability in a health program or activity, any part of which is receiving federal financial assistance. The proposed rule restores and strengthens certain civil rights protections under federally funded health programs and HHS programs which were limited following the 2020 Trump-era version of the rule, specifically regarding discrimination on the basis of sex, including sexual orientation and gender identity, and returns certain protections for individuals with limited English proficiency (LEP). Additionally, the proposed rule bolsters protections against discrimination in healthcare by clarifying that funds received under several federal healthcare programs, including Medicare Part B, are included in the definition of federal financial assistance under the law. As such, under the proposed rule, the list of entities expected to comply with the nondiscrimination measures outlined in Section 1557 of the ACA is significantly expanded, in many ways aligning with the 2016 Obama-era version of the rule. The NPRM also proposes to expand the applicability of the post-Bostock interpretation of “on the basis of sex” to Medicaid, Children’s Health Insurance Programs (CHIP) and Programs of All-Inclusive Care for the Elderly (PACE). For now, portions of the 2020 Final Rule not discordant with Bostock continue to apply.

Read more here.




Monkeypox Declared a National Public Health Emergency

On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited vaccine distribution and expanded testing.

The PHE declaration follows the recent appointment of federal officials to head up the monkeypox response team, including Robert Fenton of the Federal Emergency Management Agency as White House national monkeypox response coordinator, and Dr. Demetre Daskalakis of the US Centers for Disease Control and Prevention as White House national monkeypox response deputy coordinator.

The administration also began holding what will be a recurring weekly briefing with congressional staff on August 4. A press release from the US Department of Health and Human Services (HHS) on the PHE declaration can be found here.

Read more here.




Navigating Data Privacy Questions Post-Dobbs

The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and other service providers to detect the performance of a possibly unlawful abortion. For example, data collected by period-tracking apps, patients’ self-reported symptoms, or diagnostic-testing results might be used to establish the timeframe in which an individual became pregnant, and then demonstrate that a pregnancy was terminated, as part of investigative or enforcement efforts against individuals or organizations allegedly involved in such termination.

On June 29, 2022, the office within the US Department of Health and Human Services (HHS) that is responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA), the Office for Civil Rights (OCR), issued guidance addressing how HIPAA limits disclosures by covered entities and business associates to law enforcement agencies in the absence of a court order or other legal mandate. The guidance provides helpful insight on how OCR may use HIPAA enforcement to discourage unauthorized disclosures of protected health information (PHI) to law enforcement officials in the wake of new state laws outlawing abortion. The guidance also implicitly confirms, however, that HIPAA does not provide a complete shield against law enforcement and litigation-driven requests for abortion-related information.

Read more here.




Hospitals Shouldn’t Expect Quick Pay Despite 340B Win

340B hospitals should not expect to receive withheld program funds anytime soon despite a recent US Supreme Court ruling. According to this Becker’s Hospital Review article, the Court reversed a 2020 federal appeals court ruling that found that the US Department of Health and Human Services (HHS) had the authority to make a $1.6 billion annual reimbursement cut to the program under its Medicare Outpatient Prospective Payment System (OPPS). McDermott Partner Emily J. Cook said that the ruling will not result in any immediate changes to Medicare payments for 340B drugs nor require that HHS restore the full payment rates for the drugs.

Access the article.




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.

Read more here.




See What’s Next with McDermott+Consulting’s 340B Ligitation Tracking Tool

The 340B program landscape is constantly shifting. Wednesday’s US Supreme Court American Hospital Association v. Becerra decision is of critical importance to hospitals that participate in the 340B program. The Court held that the US Department of Health and Human Services (HHS) improperly imposed a payment cut of almost 30% on 340B drugs paid by Medicare. Yet, while this decision is significant, it is not the end of the litigation surrounding the payment cut. The case has been remanded for further deliberation, which will include a determination of the remedies.

McDermott+Consulting has launched the 340B Litigation Tracking Tool, an up-to-date resource following the 30+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for updates on important case developments. This tracker, available 24/7 and routinely monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape.

View the 340B litigation tracking tool here.




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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