The Drug Enforcement Administration (DEA) and Dept. of Health and Human Services (HHS) have issued proposed rules that would ban with only limited exceptions the prescription of controlled substances like opioids and ADD medication via telehealth, unless in-person visits are not possible due to certain circumstances. The agencies hope the new rules will allow for better monitoring and abuse prevention. The public has 30 days to review and comment on the proposals.

The Departments of Labor, Health and Human Services, and the Treasury (Agencies) have issued FAQ guidance under the Consolidated Appropriations Act, 2021 (CAA) requiring group health plans and insurers to annually attest that they have not included any “gag clauses” in their contracts with healthcare providers, TPAs and other plan service providers. Gag clauses prevent providers from sharing certain cost, quality and claims information with plan participants. This certification is made through a “Gag Clause Prohibition Compliance Attestation” (GCPA) form submitted by December 31 each year (beginning December 31, 2023). Plan sponsors should review their contracts with plan service providers and ensure that gag clause provisions have been removed.

The No Surprises Act (NSA) requires group health plans and health insurers to report certain information on plans’ air ambulance services to federal agencies. Proposed regulations under the NSA issued in September, 2021, had indicated that the first reporting deadline would be March 31, 2023 for 2022 calendar-year reporting. However, since final regulations have not yet been issued, no reporting is required in 2023.

The President’s State of the Union address highlighted multiple healthcare, workplace and employee benefits initiatives. The President outlined steps to strengthen Medicare, Medicaid, and the Affordable Care Act, including controlling prescription drug prices and capping costs for Medicare Part D participants. Mental health was also emphasized, with the President outlining a strategy for creating greater access to care. Further, the speech called on Congress to restore rights to abortion access and codify Roe v. Wade, and to strengthen responses to the opioid crisis and the 2022 “Cancer Moonshot” initiatives. The President also discussed a ban on non-compete agreements, protecting employees’ right to organize, sick days, paid family and medical leave, affordable childcare and restoration of the full child tax credits.

The Department of Health and Human Services, the Department of Labor and Treasury released proposed rules eliminating the moral exemption to the ACA’s contraceptive mandate that was set forth in final rules issued in 2018. The rules also propose a new option which allows individuals whose plans are sponsored by objecting entities to access contraceptive care at no cost through a willing contraceptive provider. The objecting entity is not required to take any action to facilitate this coverage, and the contraceptive provider may seek reimbursement for these costs.

Both emergency periods are to end on May 11 giving 60-days’ notice prior to termination of the PHE. Recently, the Department of Health and Human Services (HHS) declared a twelfth extension of the PHE until April 11, 2023. The end of these emergency periods will result in the end of several different types of relief available for health plan sponsors and participants, including, among others, the end of the “Outbreak Period” rules (see our E-Alerts here and here), and rules impacting cost sharing for COVID-19 testing and vaccines (a summary by KFF is available here).

Amazon’s launch of RxPass reflects its continued expansion into the healthcare marketplace. Available only as a subscription service for Prime members, consumers can fill as many prescriptions as they require from a list of generic medications for five dollars per month, delivered free of charge. This fee will be in addition to the cost of the monthly Prime membership. Amazon Pharmacy accepts a range of health insurance plans and also allows for the use of health savings accounts and healthcare flexible spending accounts.

The Biden Administration issued a Memorandum addressing efforts to protect access to reproductive healthcare. Among other topics, the Memorandum addresses: FDA guidance protecting patients’ access to mifepristone (a drug used in medication abortions); continued access to telehealth for mifepristone prescriptions; mail-order options; the permanent removal of an in-person dispensing requirement for the prescriptions; and certification of pharmacies to dispense the medication.

The penalty increases, published in the Federal Register, are effective for any civil penalties assessed after January 15, 2023 by the Employee Benefits Security Administration (EBSA). Per-day penalty increases include: failure to file a Form 5500 to $2,586; failure to file an M-1 to $1,881; failure to provide requested documentation to $184, not to exceed $1,846 per request; failure to provide required CHIP notices to $137; and failure to provide a SBC to participants to $1,362.

Beginning January 1, 2023, the standard mileage rate for business travel will be 65.5 cents ($0.655) per mile, and the rate for deductible medical or moving expenses (for active military members) will remain unchanged from the 2022 mid-year rate of 22 cents ($0.22) per mile. The rate for miles driven in service of charitable organizations, which is set by statute, remains unchanged from the 2022 rate of 14 cents ($0.14) per mile.

President Biden signed into law the Respect for Marriage Act, which mandates federal recognition of same-sex marriages. The law also prohibits states from refusing to recognize out-of-state marriages on the basis of sex, race, ethnicity or national origin. In addition, the statute officially repeals the Defense of Marriage Act, which defined marriage as only between a man and a woman.