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FDA Approves Over-the-Counter Birth Control Pill

• On July 13, the Food and Drug Administration (FDA) approved the first over-the-counter (OTC) birth control pill, Opill, which is expected to become available in the first quarter of 2024. People will be able to purchase it online and at pharmacies, convenience stores, and grocery stores without a prescription. Perrigo, the drugmaker, has not yet released the price of the pill. CMS is also working with the Departments of Labor and Treasury to determine ways that private plans can cover FDA-approved contraceptives when purchased OTC. Additionally, CMS says there are ways that Medicare and Medicaid plans could work around current restrictions to cover OTC birth control. Coverage of the pill is likely to vary depending on the type of coverage. Most private employers commonly cover contraceptive products that are available OTC without cost-sharing if approved by the FDA or prescribed by a health care provider. For Medicaid, states may cover and receive federal matching funds for OTC drugs when prescribed by health care professionals as provided under state laws. Finally, Medicare Part D sponsors may provide OTC drugs in their administrative cost structure with no cost-sharing at the point of sale provided it is as part of general drug utilization management or step-therapy protocol (STAT News, July 13; Inside Health Policy, July 14).

2024 Medicare Physician Fee Schedule

• On July 13, CMS proposed a 1.25% pay cut for doctors under the Medicare physician fee schedule for 2024. The Medicare conversion factor, used in conjunction with relative value units, would be reduced by 3.34% under the proposed rule. Various physician associations such as the American Medical Association have been advocating for payment system reforms as the fee schedule has not kept up with inflation, resulting in an effective decline of 26% in Medicare physician payment from 2001 to 2023. However, advocacy groups are concerned about the impact of the pay cuts to physician practices which are already facing challenges due to inflation and the lingering effects of the COVID-19 pandemic. A separate add-on payment is proposed for healthcare common procedure coding system (HCPCS) code G2211 to recognize resource costs associated with evaluation and management visits for primary care and complex patients. Health and well-being coaching services are proposed to be added to the Medicare Telehealth Services List temporarily for CY 2024 and Social Determinants of Health Risk Assessments permanently. Under the same proposed rule, CMS also aims to revise quality reporting and financial benchmarking requirements under the Medicare Shared Savings Program; increase access to behavioral health services; and expand a model for treating Medicare patients with diabetes in underserved communities. Comments on the proposed rule can be submitted are due by September 11 with the final rule anticipated for the fall (Modern Healthcare, July 14; PoliticoPro, July 13; CMS, July 13).

2024 Medicare Outpatient Fee Schedule

• On July 13, CMS proposed Medicare payment rates for hospital outpatient and Ambulatory Surgery Center (ASC) services along with many other proposed policies to align with the goals of the Biden administration to promote health equity, expand access to behavioral health care, improve transparency in the health system, and address medical product shortages. CMS proposes updating the Outpatient Prospective Payment System (OPPS) payment rates for hospitals meeting quality reporting requirements by 2.8%. The agency also proposes to extend the five-year interim period for applying the productivity-adjusted hospital market basket update to the ASC payment system rates for 2024 and 2025. CMS seeks comments on potential payment adjustments to hospitals for the additional costs of establishing and maintaining a buffer stock of essential medicines to address shortages. Other proposals include establishing the Intensive Outpatient Program (IOP) under Medicare to address gaps in behavioral health coverage, extending this IOP coverage to include Opioid Treatment Programs (OTPs) and establishing a weekly payment adjustment for IOP services furnished by OTPs. The agency also proposes modifications to Community Mental Health Centers (CMHCs) Conditions of Participation (CoPs) to include IOP services and introduces a new Medicare benefit category for Mental Health Counselor (MHC) and Marriage and Family Therapist (MFT) services furnished by CMHCs. The comment period will end on September 11. The final rule is expected to be issued in early November (CMS, July 13).

News

• Last week the CDC announced that millions of uninsured and underinsured adults will have access to free COVID-19 vaccinations beginning fall 2023 and ending December 2024. The access to free vaccinations will be funded through the CDC’s new Bridge Access Program. As the program rolls out, HHS continues to put pressure on drug manufacturers to have FDA applications ready for the fall campaign. Additionally, HHS wrote a letter to vaccine manufacturers emphasizing that COVID-19 vaccines entering the market should be priced at a reasonable rate and that drug maker’s support and provision of vaccines is a critical piece for the success of the Bridge Access Program (Inside Health Policy, July 14).
• A study published in Health Affairs found that Medicaid beneficiaries with advanced-stage cancer living in expansion states may have improved access to palliative care compared to those in non-expansion states. Researchers analyzed data from the National Cancer Database for patients aged 18-64 and diagnosed with stage IV cancer between 2010 and 2019. Non-expansion state participants were more likely to be non-Hispanic Black, low income, rural, and uninsured. Patients from expansion states were more likely to receive palliative care compared to those from non-expansion states. Over time, the share of advanced-stage cancer patients receiving palliative care increased in both groups. Younger, Hispanic, and high-income individuals were less likely to receive palliative care. Despite an increase in rates of palliative care, only around one in five advanced-stage patients received palliative care. The study suggests that expanding Medicaid coverage could improve access to palliative care for these patients (Health Payer Intelligence, July 13; Health Affairs, July 5).
• On July 12, HHS issued a notice of proposed rulemaking (NPRM) that will clarify certain prohibitions on sex discrimination, specifically based on sexual orientation and gender identity, in federal grants and other programs. However, the rationale HHS is relying on for the NPRM is based on HHS interpretation of the U.S. Supreme Court’s decision in Bostock v. Clayton County which is currently facing a legal challenge in a lawsuit known as Neese v. Becerra. If the rule is finalized based on the Bostock case, the NPRM could be invalidated in the Fifth Circuit or nationwide if the courts rule against HHS in the Neese case (Inside Health Policy, July 12).

Waivers

• 1915(c) Appendix K
  • Colorado
    • Effective December 1, 2022, the State Medicaid Agency will implement longevity and retention bonuses for case managers for all 10 HCBS waivers to promote, encourage, support, and retain case management workers during the public health emergency (PHE) using Section 9817 American Rescue Plan (ARP) funds.
  • Colorado
    • Effective July 1, 2023, the State Medicaid Agency will implement a 3% Across the Board (ATB) rate increase through the end of the Appendix K waiver for certain services. The State Medicaid Agency will also implement Targeted Rate Increases (TRI) for Non-Medical Transportation (DD and SLS waivers) and Residential Habitation (DD waiver) using Section 9817 ARP funds. The State Medicaid Agency also intends to amend the base waivers in July 2023 to keep rates effective beyond the Appendix K approval period.

SPAs

• COVID-19 SPAs
  • Alaska (AK-23-0006, effective May 12, 2023): Extends the PHE flexibility to waive provider first aid and CPR requirements as originally approved in .
  • Alaska (AK-23-0008, effective May 12, 2023): Extends pharmacy dispensing fee rates (with time period modifications) through May 11, 2024 as originally approved in AK-23-0003.
  • Georgia (GA-23-0003, effective March 11, 2021): Authorizes coverage of COVID-19 treatment, including specialized equipment and therapies and ensures compliance with the provisions of the HHS COVID-19 Prep Act.
  • Georgia (GA-23-0005, effective March 11, 2021): Authorizes coverage of COVID-19 vaccines and vaccine administration and ensures compliance with the provisions of the HHS COVID-19 Prep Act.
  • Louisiana (LA-23-0001, effective April 1, 2021): Increases bonus payments to personal care services and targeted case management providers in accordance with the state’s approved HCBS services spending plan authorized under Section 9817 of the ARP.
  • Michigan (MI-23-0019, effective May 12, 2023): Extends supplemental payments for in-person direct care services provided in Skilled Nursing Facilities, Adult Foster Care Homes, and Homes for the Aged as originally authorized in MI-21-0016.
• Payment SPAs
  • Georgia (GA-22-0008, effective July 1, 2022): Eliminates attestation requirements and increases rates for certain Obstetrics/Gynecology services to the 2020 Medicare reimbursement rate.
  • Louisiana (LA-23-0021, effective May 12, 2023): Increases the amount paid to private (non-state) owned Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) for increased costs related to retaining and hiring direct care staff through June 30, 2024.
  • Louisiana (LA-23-0006, effective May 1, 2023): Authorizes an additional add-on rate for comprehensive dental care provided to Medicaid beneficiaries age 21 or older who reside in ICFs/IID.
• Services SPAs
  • Minnesota (MN-23-0005, effective May 12, 2023): Updates requirements for Targeted Case Management (TCM) for individuals placed outside the home and those receiving services for child protection.
• Eligibility SPAs
  • California (CA-23-0012, effective January 1, 2024): Authorizes the state to disregard, under the authority of Section 1902(r)(2) of the Social Security Act, all countable resources for all eligibility groups covered under the state plan for which a resource standard applies.
  • Guam (GU-23-0004, effective April 1, 2023): Establishes compliance with the mandatory coverage and reimbursement of routine patient costs associated with participation in qualifying clinical trials under Sections 1905(a)(30) and 1905(gg) of the Social Security Act.
  • Michigan (MI-23-0110, effective July 1, 2023): Authorizes access to family planning services for Michiganders who do not qualify under the income eligibility for Healthy Michigan or traditional Medicaid but have incomes below 200% of the federal poverty level (195% of the federal poverty level with a 5% income disregard).

News