RISE summarizes recent regulatory-related news.

Medicare Part D premium will drop slightly in 2023

The average basic monthly premium for standard Medicare Part D coverage for brand-name and generic prescription drugs will likely be $31.50 next year, a decrease of nearly two percent from 2022, according to the Centers for Medicare & Medicaid Services (CMS).

The agency releases the projected average basic monthly Part D premium—calculated based on plan bids submitted to CMS—annually to help Medicare beneficiaries understand overall Part D premium trends before Medicare Open Enrollment, when they can select from plan options for the upcoming benefit year that begins January 1, 2023.

CMS also provided additional information—such as the Part D national average monthly bid amount—to help Part D plan sponsors finalize their premiums and prepare for Medicare Open Enrollment, which runs from October 15 to December 7, 2022. The memo indicates the Part D national average monthly bid amount for 2023 is $34.71.

CMS said in the announcement that it plans to release the 2023 premium and cost-sharing information for 2023 Medicare Advantage and Part D plans in September 2022.

Medicaid: CMS offers guidance on new optional benefit for children with medically complex conditions

The Department of Health and Human Services (HHS), through CMS, has released guidance on a new Medicaid health home benefit for children with medically complex condition. The optional benefit helps state Medicaid programs provide Medicaid-eligible children who have these serious health conditions with person-centered care management, care coordination, and patient and family support. The goal of the hew benefit is to help these children receive the care they need, including across state lines.

Children with medically complex conditions often require tremendous care coordination and highly specialized treatment. Finding needed services often requires families to travel far from their home and often care is only available out-of-state. The new “health home” benefit is expected to give these children and their families help in coordinating and managing care. The benefit gives states new options and a financial incentive to improve care for children with complex medical conditions, HHS Secretary Xavier Becerra said in the announcement.

States will have the option to offer the new benefit beginning Oct. 1. The services provided include access to the full range of pediatric specialty and subspecialty medical services, including services from out-of-state providers, as medically necessary. The guidance offers information about the new benefit, including payment methodologies, provider standards, provider and state reporting, state monitoring, and state assurance requirements. States with approved Medicaid state plan amendments to cover the new health home benefit will receive a 15-percentage point increase in federal matching for their expenditures on health home services during the first two fiscal year quarters that the amendments are in effect.

HHS, DOJ issue guidance to end telehealth discrimination

HHS and the Department of Justice have partnered to publish guidance on the protections in federal nondiscrimination laws, including the Americans with Disabilities Act (ADA) and Section 1557 of the Patient Protection and Affordable Care Act. The laws require that telehealth be accessible to people with disabilities and limited English proficient persons. These laws work in tandem to prohibit discrimination and protect access to health care.

“We have seen important expansions in health care technologies, such as telehealth, that provide great convenience and help for people seeking care. This guidance makes clear that there is a legal obligation to ensure that all people receive full access to needed health care and can connect to telehealth services, free of discriminatory barriers,” Acting Director Melanie Fontes Rainer of HHS’s Office for Civil Rights said in the announcement. “While we celebrate the progress of the ADA, we know how important it remains to uphold the rights of people with disabilities and other protected individuals to make our country accessible and inclusive for all. That work has been a priority of this Administration from day one, and President Biden’s Executive Order on advancing equity explicitly includes people with disabilities in its call for comprehensive action.”

Technological developments and the COVID-19 public health emergency have increased the importance of providing telehealth and expanded its use. Telehealth can take many forms, including communication between a patient and a health care provider via video, phone, or other electronic means. While telehealth has many benefits, including making health care more available and convenient, certain populations may face discrimination or other barriers in accessing care provided via telehealth. For example:

  • A person who is blind or has limited vision may find that the web-based platform their doctor uses for telehealth appointments does not support screen reader software
  • A person who is deaf and communicates with a sign language interpreter may find that the video conferencing program their provider uses does not allow an interpreter to join the appointment from a separate location
  • A limited English proficient person may need instructions in a language other than English about how to set up a telehealth appointment

The guidance provides examples of actions that may be discriminatory and describes steps that providers may need to take to ensure that health care offered via telehealth is accessible. The guidance also provides a list of resources that providers and patients may wish to consult for additional information about telehealth and civil rights protections.

Feds provide guidance on birth control coverage under ACA

Contraceptive coverage is guaranteed at no additional cost under the Affordable Care Act (ACA) no matter where someone lives or works, according to HHS and the Departments of Labor and the Treasury. The guidance makes clear that under the ACA, most private health plans must provide birth control and family planning counseling at no additional cost. The departments issued the guidance to remind plans and issuers of the ACA’s contraceptive coverage in the wake of the Supreme Court’s ruling to overturn the constitutional right to abortion.

“Today’s guidance makes clear that the law requires group health plans and health insurance issuers to provide contraceptive coverage—including emergency contraception—at no cost to participants,” Labor Secretary Marty Walsh said in the announcement. “We have heard troubling reports that plans, and issuers are not following the law. We expect them to remove impermissible barriers and ensure individuals have access to the contraceptive coverage they need. If plans and issuers are not complying with the law, we will take enforcement action to ensure that participants receive this coverage, again with no cost sharing.”

The ACA guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling, for all individuals and covered dependents with reproductive capacity. This includes, but is not limited to:

  • Hormonal methods, like birth control pills and vaginal rings
  • Implanted devices, like intrauterine devices (IUDs)
  • Emergency contraception, like Plan B® and ella®
  • Barrier methods, like diaphragms and sponges
  • Patient education and counseling
  • Sterilization procedures
  • Any additional contraceptives approved, granted, or cleared by the Food and Drug Administration (FDA)

HHS secures vaccines for COVID-19, monkey pox

HHS and the Department of Defense have announced an agreement to purchase 66 million doses of Moderna’s bivalent COVID-19 vaccine booster candidate for potential use in the fall and winter. The agreement follows a recommendation by the FDA last month that vaccine manufacturers update their existing COVID-19 vaccines to create a bivalent booster that can target BA.4 and BA.5 Omicron subvariants, the predominant strain in the United States today. The purchase is in addition to the 105 million bivalent COVID-19 vaccine booster doses the U.S. government purchased r from Pfizer for potential use later this year, pending FDA authorization and a recommendation by Centers for Disease Control and Prevention. To pay for the Moderna vaccines, the Biden administration reallocated money from COVID-19 response efforts. Combined, the two agreements with Moderna and Pfizer would make 171 million bivalent vaccine booster doses available but not enough for every American. Both agreements include options for a total of 600 million doses (300 million from each company), but these options would require additional funding from Congress.

HHS also has announced plans to increase the supply of monkeypox vaccine doses. It will allocate an additional 786,000 doses of JYNNEOS vaccine to states and jurisdictions in addition to the 340,000 doses previously delivered.

“Our goal is to stay ahead of this virus and end this outbreak. We have a strategy to deploy these additional vaccine doses in a way that protects those at risk and limits the spread of the virus, while also working with states to ensure equitable and fair distribution,” Becerra said in the announcement. “These vaccines are the result of years of federal investment and planning.”

The plan for allocating the doses takes into account two key factors: the total population of at-risk people and the number of new cases in each jurisdiction. The strategy ensures that jurisdictions have the doses needed to complete the second dose of this two-dose vaccine regimen for those who have been vaccinated over the past month. Beginning Friday, July 29, states and jurisdictions can order additional vaccine doses through HHS.

In addition to vaccines, the White House administration has worked to increase the availability of monkeypox tests nationwide by partnering with five commercial laboratories. Since the start of the current outbreak, testing capacity has increased to 80,000 per week–up from 6,000 per week, according to HHS.  CDC has also taken action to significantly reduce the burden in accessing treatments for monkeypox, such as TPOXX, by decreasing the documentation required to prescribe TPOXX and also allowing providers to prescribe TPOXX prior to completing the documentation.