Last week, U.S. Senators Tammy Baldwin (D-WI), Maggie Hassan (D-NH), and Angus King (I-ME) and Representatives Carolyn B. Maloney (D-NY) and Brian Fitzpatrick (R-PA), led a bicameral, bipartisan group of colleagues in sending letters to seven major manufacturers of naloxone, the opioid overdose reversal medication, urging them to apply for over-the-counter (OTC) status for their products to help increase access. Despite the effectiveness of naloxone to reverse active opioid overdoses and the FDA’s support for making the product available OTC, the medication is currently not available OTC because drug manufacturers have resisted applying for OTC status. If manufacturers made progress towards applying for OTC status, it is widely expected to lower the cost of the medication and increase access both at the pharmacy counter and for community organizations working to distribute the medication.
Health and Human Services Secretary Xavier Becerra extended
the public health emergency for another 90 days in response to cases of Omicron subvariant BA.2 continuing to rise. This extension will be effective April 16, 2022. On average, the US has approximately 30,000 new COVID-19 cases per day. Thankfully, death and hospitalization rates continue to decline. The renewal will allow for pandemic flexibilities to continue, as advocates continue work to make these provisions permanent after the pandemic.
that restores certain minimum standards of compliance for skilled nursing facilities/nursing facilities (SNFs/NFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end-stage renal disease (ESRD) facilities. During the pandemic, certain waivers were in place to provide these facilities with flexibilities needed to respond to COVID-19. CMS is ending specific waivers in two groups: one group of waivers will terminate 30 days from the issuance of this new guidance, and the other group will terminate 60 days from issuance. Waivers ending within 30 days include reinstituted requirements to ensure residents can participate as part of in-person groups, prohibiting physicians from delegating certain tasks, and requirements for certain in-person physician visits. Requirements for long-term care facilities to maintain a Quality Assurance and Performance Improvement program, share information on discharge planning, and handling clinical record requests when requested by residents within 2 days will also be back in effect within 30 days. Waivers ending within 60 days include certain staff training requirements for paid feeding assistants, training requirements for nurse aides, fire drill requirements, making sure inpatient hospices have outside window or door in every sleeping room, construct permits, inspection of medical equipment, maintenance on dialysis machines, and allowance for temporary isolation rooms for COVID-19. CMS notes that it will maintain flexibility for certain requirements, such as making temporary waivers available for nurse aides’ certification if there are documented capacity issues in training or testing programs, and CMS will retain the ability until the expiration or termination of the national COVID-19 PHE to issue individual state-based, county-based, or facility-based waivers as needed.
The Food and Drug Administration (FDA) released its long-awaited draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry
. The purpose of this draft guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States. In this draft guidance document, FDA has a number of recommendations to improve clinical trial diversity. These recommendations address a range of topics, including the collection and analysis of racial and ethnic data; measures that enhance diversity in clinical trials; and the broadening of eligibility criteria when scientifically appropriate to improve clinical trial participation. FDA is also seeking comment on the draft guidance. If interested in submitting comments on the draft guidance document, please click here
. The deadline to submit comments is June 13, 2022.
The Health Resources and Services Administration (HRSA) announced
that providers can now submit a Request to Report Late Due to Extenuating Circumstances for Reporting Period 1 by Friday, April 22, 2022. The request must be based on one of six extenuating circumstances: 1. Severe illness or death; 2. Impacted by natural disaster; 3. Lack of receipt of reporting communications; 4. Failure to click “Submit”; 5. Internal miscommunication or error; and 6. Incomplete Targeted Distribution The announcement comes after HRSA announced in March 2022 that thousands of Provider Relief Fund recipients had to return their funds due to being non-compliant. In response to this, provider organizations had requested additional reporting time in a March 31, 2022 letter to HRSA
, highlighting extenuating circumstances that had prevented providers from reporting, including medical and administrative staff being impacted by COVID-19.
CMS published their FY 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule (full rule
, fact sheet
). CMS is proposing a 3.9%, or $1.4 billion, update to the payment rates for nursing homes, which is based on a 2.8% SNF market basket update plus a 1.5 percentage point market basket forecast error adjustment and a 0.4 percentage point productivity adjustment. The proposed rule also contains a proposed adjustment to payment rates as the result of the transition to the SNF payment case-mix classification model ̶ the Patient-Driven Payment Model (PDPM) that went into effect on October 1, 2019. Since PDPM implementation, CMS’ data analysis has shown an unintended increase in payments. Therefore, CMS is proposing to adjust SNF payment rates downward by 4.6%, or $1.7 billion, in FY 2023 to achieve budget neutrality with the previous payment system. As a result, the estimated aggregate impact of the payment policies in this proposed rule would be a decrease of approximately $320 million in Medicare Part A payments to SNFs in FY 2023 compared to FY 2022. The proposed rule also solicits feedback from stakeholders on how staffing in nursing homes and health equity improvements could lead to better health outcomes. This input will be used in conjunction with a new research study being conducted by CMS to determine the optimal level and type of nursing home staffing needs. The agency intends to issue proposed rules on a minimum staffing level requirement for nursing homes within one year. Comments must be submitted by June 10, 2022.
Last month, CMS released a memo
noting that will not take enforcement action against certain non-grandfathered health insurance coverage in the individual and small group market (i.e., grandmother plans) for certain Affordable Care Act requirements. The non-enforcement policy has been extended every year since 2014 and was first put into place in 2013 to ensure individuals could stay enrolled in health plans that did not otherwise adhere to ACA requirements. In the memo, CMS states that the non-enforcement policy will remain in effect until CMS announces otherwise.
Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) and Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) unveiled new bipartisan-bicameral policy priorities to lower insulin costs. Senators Collins and Shaheen also invited their colleagues to provide input as they finalize their bipartisan legislation. The four lawmakers are specifically prioritizing the following policies in their proposal:
Encourage insulin manufacturers to reduce list prices by:
- Ensuring insurance plans and pharmacy benefit managers cannot collect rebates which drive up costs at the point of sale, on insulins that roll prices back to 2006 or equivalent levels;
- Making such insulins eligible for cost-sharing protections, including a waiver on any applicable deductible and limiting copays or coinsurance to no more than $35 per month; and
- Supporting patient access to such insulins by ensuring coverage and that prior authorization or other medical management requirements cannot be imposed to limit beneficiary use.
Limit out-of-pocket costs for patients with diabetes by:
- Ensuring that group and individual market health plans must waive any deductible and limit cost-sharing to no more than $35 per month, for at least one insulin of each type and dosage form.
The Medicare Payment and Advisory Commission (MedPac) held its April policy meeting. The Commissioners discussed a number of issues related to Medicare payment policy. Specifically, the Commission held hearings on: 1. Addressing high prices of drugs covered under Medicare Part B; 2. Discussing the initial findings from MedPac’s analysis of Part D data on drug rebates and discounts; 3. Leveraging Medicare policies to address social determinants of health; 4. An approach to streamline and harmonize Medicare’s portfolio of alternative payment models; and 5. Aligning fee-for-service payment rates across ambulatory settings. Healthsperien was there to cover the April MedPac meetings. Click here to access Healthsperien’s comprehensive summary. Click here for a copy of the transcript.
Last week, the Medicaid and CHIP Payment Advisory Commission (MacPac) held its April policy meeting. The Commissioners discussed a number of topcis related to Medicaid and CHIP payment policy. Specific the Commission held hearings on: 1. A New Medicaid Access Monitoring System; 2. A Review of CMS Access RFI; 3. Medicaid’s Role in Advancing Health Equity: Review of Draft Chapter for June Report; 4. Oversight of Managed Care Directed Payments; 5. Encouraging Health IT Adoption in Behavioral Health; 6. Updated Analyses of Churn and Coverage Transitions; 7. Vote on Recommendations for June Report; 8. Understanding Medicaid Managed Care Procurement Practices Across States; and 9. Review of HHS Reports to Congress: (1) Managed Care and the Institutions for Mental Disease Exclusion; and (2) Best Practices for Prescription Drug Monitoring Programs. Healthsperien was there to cover the April MacPac meetings. Click here to access Healthsperien’s comprehensive summary.
The Urban Institute and Robert Wood Johnson Foundation released a research report examining trends in insurance premiums and insurer participation in the Affordable Care Act (ACA) Marketplace between 2019-2022. In general, national benchmark insurance premiums were lowered by approximately 2 percent. The report attributes the lower insurance premiums to increased competition and the end of federal payments for cost-sharing reductions. Overall the number of insurers who competed in the Marketplace increased, with a total of 288 insurers in 2022, up from 198 insurers in 2020. Across US regions and states there is wide variation in premiums. This report focused on 58 regions and 25 states for its trend analysis. Several factors contributing to the variation were highlighted, including: the types of participating insurers, the number of insurers, unemployment rates, and public health emergency flexibilities allowing continuous Medicaid coverage. The pandemic’s future effect on premium rates is still uncertain. Despite this, Marketplace premiums decreased in most states for the third year in a row, while employer-sponsored insurance premiums increased.