May 22, 2023

Compliance Update:
18-Month Review

As we approach the June 1 deadline for the Section 204 reporting requirements, Healthgram looks back on the most impactful regulatory changes from the last 18 months.

Relief	Impact	Resources
	2022
Beginning January 1: No Surprises Act (“NSA”) goes into effect for Calendar Year Plans in accordance with the Consolidated Appropriations Act, 2021	NSA Protections Independent Dispute Resolution (IDR); and,NSA NoticeEffective for non-Calendar Year Plans is the date of their 2022 renewal.	2022 Q2 Update NSA Notice
January 10: FAQ 51	FAQ 51 clarifies that individuals who purchase over-the-counter (“OTC”) COVID-19 diagnostic tests during the public health emergency will be able to seek reimbursement from their plan or issuer.	FAQ 51
January 15: OTC COVID-19 tests	Effective date of OTC Mandate set forth in FAQ 51.
February 4: FAQ 52	FAQ 52 provided additional information regarding the OTC Mandate, including safe harbors.	FAQ 52
March 15 Consolidated Appropriations Act, 2022	Extended allowance for first dollar coverage for telehealth services for HDHP’s without affecting HSA eligibility effective 1 April 2022 through 31 December 2022.	Statute
April 19: FAQ 53	FAQ 53 provided guidance regarding Machine-Readable Files (“MRF”).	FAQ 53
June 24: Dobbs v. Jackson Women’s Health Organization (“Dobbs”)	Overruled Roe v. Wade (“Roe”), which recognized a constitutional right to obtain an abortion. After Dobbs, the issue of abortion is returned to each state.	2022 Q3 Update Opinion
June 29: HIPAA Disclosures of Information Relating to Reproductive Health Care	Clarifies requirements to disclose Protected Health Information (“PHI”) without the individual’s authorization as it relates to reproductive health that are: Required by law For law enforcement purposes; or, To avert a serious threat to health or safety.	News Release
July 1: MRF (Out-of-Network and In-Network)	Deadline for posting MRF.	Healthgram MRF 2022 Q3 Update Federal Register CMS Technical Clarifications
July 8: Executive Order Protecting Access to Reproductive Health Care Services	Order indicated eliminating the right to an abortion recognized in Roe has had and will continue to have devastating implications for women’s health and public health more broadly.	Executive Order News Release
July 11: HHS guidance on the Emergency Medical Treatment and Active Labor Act (“EMTALA”)	Guidance makes clear that EMTALA preempts state law restricting access to abortions in legally-mandated, life- or health-saving abortion services in emergency situations.	Letter to Providers Guidance (Rev’d August 25)
July 13: HHS Guidance to Pharmacies Clarifying Obligations to Ensure Access to Comprehensive Reproductive Health Care Services	Guidance makes clear that as recipients of federal financial assistance, including Medicare and Medicaid payments, pharmacies are prohibited under law from discriminating based on race, color, national origin, sex, age, and disability in their programs and activities. This includes supplying prescribed medications; making determinations regarding the suitability of prescribed medications for a patient; and, advising a patient about prescribed medications and how to take them.	News Release Guidance
July 25: Proposed Rule to Strengthen Nondiscrimination in Healthcare	Proposed rule affirms protections against discrimination on the basis of sex, including sexual orientation and gender identity, and reiterates protections from discrimination for seeking reproductive health care services.	Federal Register News Release
July 31: PCORI Payments due	Due date for annual Patient-Centered Outcomes Research Institute payments assessed on, inter alia, self-insured plans for each person covered.	IRS Notice 2022-59
August 3: Executive Order on Securing Access to Reproductive and Other Healthcare Services	Order announced actions to ensure health care providers comply with federal non-discrimination laws and promote research and data collection on maternal health outcomes.	Executive Order Fact Sheet
August 16: Inflation Reduction Act of 2022	Impacts health plans by, inter alia, allowing HDHP’s to have no deductible for certain insulin products, effective for Plan Years beginning after 31 December 2022.	Statute
August 19: FAQ 55	FAQ 55 answered a number of open questions regarding the specifics of the NSA, Qualifying Payment Amount, and the IDR process.	FAQ 55
August 26: HHS Action to Strengthen Access to Reproductive Health Care, including Abortion Care	CMS Administrator issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. The letter also underscored that current or proposed abortion restriction laws do not negate providers’ responsibilities to comply with federal laws protecting access to emergency health care. HHS also issued a report and plan of action in response to theDobbs.	News Release Letter to Governors Secretary’s Report
October 13: Affordability of Employer Coverage for Family Members of Employees	Regulations changed determination of affordability for purposes of premium tax credit (“PTC”) for a family’s employer-sponsored health insurance, beginning in 2023, from just the cost to cover the employee to the cost to cover the employee plus family members when applicable. This change fixes what was known as the “family glitch”, but does not impact the Affordable Care Act’s employer-mandate, which is triggered only if the employee’s coverage is unaffordable and the employee receives a PTC in the marketplace.	Federal Register
October 15: Medicare Part D Creditable Coverage	Deadline to provide written disclosure notice to all Medicare eligible individually who are covered under its prescription drug plan.	CMS.gov – Creditable Coverage
November 28: HHS Notice of Proposed Rulemaking to Increase Care Coordination and Confidentiality for Patients with Substance Use Challenges	Proposed rule increases coordination among providers in treatment for substance use challenges and increases protections for patients concerning records disclosure to avoid discrimination in treatment.	Federal Register News Release
December 23: FAQ 56	FAQ 56 extended the deadline by which Prescription Drug Data Collection (“RxDC”) data for 2020 and 2021 Plan Years must be submitted from 27 December 2022 to 31 January 2023.	FAQ 56 Federal Register
December 27: RxDC Prescription Drug Data Collection Submission Deadline for Plan Years 2020 / 2021	Original RxDC deadline to submit data for 2020 and 2021 Plan Years; extended to 31 January 2023, per FAQ 56
December 29: Consolidated Appropriations Act, 2023	Included provision that extended allowance for first dollar coverage for telehealth services for HDHP’s without affecting HSA eligibility through Plan Years beginning before 1 January 2025.	Statute
June 1, 2023: Section 204 of Division BB, 2021 (CAA)	Employers must report premium data by employers and members for any periods during the 2022 calendar year.	RxDc