US Department of Health and Human Services Archives

HHS OIG Develops Toolkit to Analyze Telehealth Claims to Assess Program Integrity Risks

by James A. Cannatti III, Amanda Enyeart, Marshall E. Jackson, Jr., Tony Maida, Lisa Schmitz Mazur and Dexter Golinghorst | Jun 13, 2023 | Employee Benefits, Health and Welfare Plans

The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.

Read more here.

Medicare Advantage Plan Requirements Post-PHE: Ensuring a Smooth Transition

by Brian Stimson and Fabiola Díaz Vera | Jun 6, 2023 | Employee Benefits, Health and Welfare Plans

Medicare Advantage (MA) plans are facing both regulatory and business risks following the conclusion of the COVID-19 Public Health Emergency (PHE). What are the major MA flexibilities and requirements related to the pandemic, and have they ended along with the PHE?

Read more here.

Federal Government to Wind Down Vaccination Mandates

by Sandra M. DiVarco, Kristen O'Brien and Rachel Stauffer | May 9, 2023 | Employee Benefits, Health and Welfare Plans

The Biden administration has announced that the federal government will wind down its remaining COVID-19 vaccination mandates (including those for federal workers, contractors and international air travelers) effective May 11, 2023. This action coincides with the conclusion of the COVID-19 public health emergency (PHE). Additionally, the US Department of Health and Human Services (HHS) will initiate steps to terminate the vaccination prerequisites for healthcare facilities that are certified by the Centers for Medicare & Medicaid Services (CMS).

Read more here.

OCR Issues Proposed Rule to Modify HIPAA Privacy Rule to Include Explicit Protections for Reproductive Healthcare

by Stacey Callaghan, Jiayan Chen, Caroline Reignley, Scott Weinstein and Dexter Golinghorst | Apr 20, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The Proposed Rule comes as a part of the Biden administration’s response to the US Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization.

The Proposed Rule would provide special protections for protected health information (PHI) related to reproductive healthcare. Following the Dobbs decision, many healthcare providers expressed concerns that PHI related to reproductive healthcare may be sought by state and local governments for use in criminal, civil or administrative investigations or proceedings. OCR noted that such compelled uses and disclosures of PHI could have a chilling effect on lawfully obtained healthcare and erode trust in confidential communications between a patient and provider. Additionally, providers could elect to leave out critical details from a patient’s medical record if they fear the information could later be used by a state or local government actor against the patient.

Stakeholders may submit comments on the proposed rule on or before June 16, 2023.

Read more here.

Preparing for the End of the COVID-19 Emergency: Tri-Agencies Issue FAQs to Assist Plans and Issuers

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | Apr 5, 2023 | Employee Benefits, Health and Welfare Plans

The Biden administration has announced its intention to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our series introduction for more information).

On March 29, 2023, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued a set of Frequently Asked Questions (available here), which answered questions from stakeholders relating to the various laws, regulations and other guidance enacted or adopted in connection with the NE and PHE. The FAQs include eight questions related to the anticipated end of the “Outbreak Period” on July 10, 2023, which is 60 days after the end of the NE and PHE on May 11 (rules regarding the Outbreak Period are set forth in our earlier articles here and here). Below are the highlights:

Following the end of the PHE, plans and issuers can impose cost-sharing, prior authorization or other medical management requirements for COVID-19 diagnostic tests, although the Departments encourage plans not to do so.
Plans and issuers are encouraged to notify plan participants of changes regarding COVID-19 diagnosis, testing and treatment. Special rules apply under which Summaries of Benefits and Coverage (SBCs) need not be amended mid-year.
While plans and issuers will no longer be required to post prices for diagnostic tests furnished after May 11, they are nevertheless encouraged to do so.
Plans must continue to cover vaccines that qualify as preventive services, without cost-sharing, when provided in-network.
The FAQs provide examples relating to the application and termination of extended time periods for elections under the Consolidated Omnibus Budget Reconciliation Act (COBRA) and the Health Insurance Portability and Accountability Act (HIPAA).
In what is a welcome surprise, the FAQs confirm that individuals covered by a High-Deductible Health Plan (HDHP) will remain Health Savings Account (HSA)-eligible until further notice even if the HDHP in which they are enrolled provides medical care services and items purchased related to testing for and treatment of COVID-19 prior to the satisfaction of the HDHP’s applicable minimum deductible.

To keep employers apprised of the rules and to assist with providing notice to plan participants of the changes that will accompany the end of the NE and PHE, the Department of Labor has issued two blog posts, which are available here and here.

Action Items: We urge plan sponsors to pay particular attention to notifying employees of the upcoming changes that will accompany the end of the PHE and NE and to ensure that participants covered under an HDHP understand that they may continue to contribute to their HSAs. Employers should consider communicating these changes to their employees.

For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.

HHS Nondiscrimination Proposal on Gender Procedures, Abortions Meets Resistance

by McDermott Will & Emery | Dec 21, 2022 | Employee Benefits, Health and Welfare Plans

Multiple Republican lawmakers are opposing a US Department of Health and Human Services (HHS) proposed rule that would expand the Affordable Care Act’s Section 1557 requirement preventing most health plans from discriminating on the basis of sex. According to this SHRM article, the rule applies to health insurers or plans that receive federal funds or that contract with the government. McDermott lawyers previously wrote about this proposed rule, noting that the definition of a covered entity is “similar in many ways to the 2016 Final Rule” but “does not explicitly include employee benefit group health plans as covered entities subject to Section 1557.”

Access the article.

GAO Releases Report on Telehealth

by McDermott Will & Emery | Oct 25, 2022 | Digital Health, Employee Benefits, Health and Welfare Plans

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’

by Caroline Reignley | Sep 2, 2022 | Benefit Controversies, Employee Benefits, Health and Welfare Plans

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

by Gregory Fosheim, Jacob Mattinson, Todd Solomon and Moyosore Koya | Aug 18, 2022 | Benefit Controversies, Employee Benefits, Health and Welfare Plans

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

by McDermott Will & Emery | Aug 12, 2022 | Employee Benefits, Health and Welfare Plans

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.

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