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Welcome (But Last Minute) Relief for Prescription Drug Reporting Originally Due December 27

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules governing prescription drug data collection (RxDC). The rules require group health plans, including plans offered to Federal Employees Health Benefits carriers, and health insurance issuers to report certain information related to prescription drug and other healthcare expenditures to the US Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). Under the statute, the first RxDC reports were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022.

In an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56), the Departments provided relief to group health plans and health insurance issuers who are required to report information relating to prescription drug and healthcare spending.

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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.




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Drug Discount Fights in Limbo Until Biden Restores Review Board

McDermott Will & Emery lawyer Emily J. Cook recently spoke to Bloomberg Law about a drug alternative dispute resolution (ADR) process that’s on hold after the Biden administration removed its Trump administration appointees. This particular process concerns Department of Health and Human Services panelists that will determine the direction of a 340B drug review board.

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IRS Expands Scope of Preventive Care Under Health Savings Account Rules

A new IRS notice will allow many with chronic health conditions who participate in high-deductible health plans (HDHPs) with health savings accounts (HSAs) to receive necessary care that may otherwise be out of financial reach. The notice expands the list of preventive care benefits that can be covered by an HDHP prior to a participant meeting the minimum deductible without disqualifying them from making or receiving HSA contributions.

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American Health Care Act: Considerations for Employers

On Monday March 6, 2017, the House Republican leadership in the Energy and Commerce and Ways and Means Committees unveiled their signature bill to “repeal and replace” the Affordable Care Act (ACA). The “American Health Care Act” (AHCA) is an effort to make good on President Trump’s promise to dismantle the ACA. Democrats are united in their opposition to the AHCA and other stakeholders have also come out against the bill – while the proposed legislation is subject to modification as it is marked up in committee and debated in Congress, certain provisions of the AHCA, if enacted, will be of particular importance to employers and provide the framework for a strategic road map as employers plan and design future health care benefits for their employees.

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Summary of Benefits and Coverage Templates Finalized

On April 6, 2016, the US Department of Labor posted final versions of the updated summary of benefits and coverage (SBC) template and instructions, updated uniform glossary and other associated materials. In previous guidance, the US Departments of Treasury, Labor, and Health and Human Services provided that health plans and issuers who maintain an open enrollment period will be required to start using the new template and associated documents on the first day of the open enrollment period beginning on or after April 1, 2017, with respect to coverage for the plan year or policy year that begins on or after April 1, 2017. Health plans and issuers who do not use an open enrollment period should begin using these documents on the first day of the first plan year or policy year that begins on or after April 1, 2017.

Employers should begin preparations to ensure that the finalized documents are ready for distribution by the required implementation date. Health plans and issuers with calendar year plans and open enrollment periods must be ready to use the new documents during the 2017 open enrollment period for coverage that begins on January 1, 2018. Health plans and issuers with calendar year plans and no open enrollment period should be prepared to use the documents by January 1, 2018.




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HHS Guidance Clarifies that Insurance Companies Must Make Available Health Insurance Coverage for Same-Sex Spouses

On March 14, 2014, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released guidance clarifying the final regulations implementing Section 2702 of the Public Health Service Act (PHSA).  PHSA Section 2702 addresses guaranteed availability of coverage.  Pursuant to that section, health insurance issuers offering non-grandfathered health insurance coverage in the group or individual market, including coverage under a state or federal Marketplace Exchange, must accept every employer and individual in the state that applies for the coverage, subject to limited exceptions.  PHSA Section 2702 and the related regulations prohibit discriminatory marketing practices, including discrimination based on sexual orientation.

The new CMS guidance clarifies that health insurance issuers offering non-grandfathered group or individual health insurance coverage must offer coverage on the same terms and conditions to same-sex spouses that is offered to opposite-sex spouses.  Prior to this guidance, this requirement to extend coverage to same-sex spouses already applied in states that perform and recognize same-sex marriage.  The new CMS guidance clarifies, however, that all insurance companies in all states are required to make such coverage available.

Importantly, the CMS guidance does not require private sector employers to offer coverage to same-sex spouses.  Instead, the guidance requires an insurance company offering non-grandfathered health insurance coverage to offer private employers the option to cover same-sex spouses.

Employers will continue to have discretion—subject to other non-discrimination laws—regarding whether or not to offer coverage to same-sex spouses.  For example, employers with self-insured plans are not subject to the new CMS guidance.  Likewise, employers sponsoring fully-insured plans that are funded by insurance contracts issued in states that do not currently recognize same-sex marriage also are not necessarily required to offer coverage to same-sex spouses; they must simply be offered the opportunity by the insurance company.

Thus, while the CMS guidance ensures that health insurance coverage will always be available to employers that wish to offer coverage to same-sex spouses, it does not ensure that all same-sex spouses will receive coverage under employer plans.  The CMS guidance clarifies that while health insurance issuers are encouraged to offer coverage to same-sex spouses in 2014, all issuers must fully comply for plan or policy years beginning on or after January 1, 2015.

Next Steps for Employers

Employers with insured group health plans should review their policies to determine whether existing spousal coverage is required to be extended to same-sex spouses.  Plans insured under a contract issued in a state where same-sex marriage is legal already must extend existing spousal coverage to same-sex spouses.  Employers with insured plans issued in states where same-sex marriage is not legal must have the option of extending coverage to same-sex spouses beginning on or after January 1, 2015.

Employers offering either insurer or self-insured plans may also wish to consider whether other nondiscrimination laws implicate the decision whether to offer same-sex coverage.




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