(Aug. 4, 2023) – FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product
On July 28, the Food and Drug Administration announced the agency approved the second over-the-counter naloxone nasal spray, RiVive, a three-milligram naloxone hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose. Per the FDA, approval of RiVive nasal spray for nonprescription use was supported by data from a study submitted by the manufacturer showing similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug has been demonstrated to be safe and effective for use as directed in its labeling. The manufacturer also provided data showing consumers can understand how to use the drug safely and effectively without the supervision of a health care professional.
FDA and DEA Issue Joint Letter on Prescription Stimulant Medication Availability
The Food and Drug Administration and Drug Enforcement Administration issued a joint letter to the public on Aug. 1 regarding the availability of prescription stimulant medications. The medications, used to treat conditions such as attention deficit hyperactivity disorder, binge eating disorder and narcolepsy, have been in short supply for many months. The intent of the joint letter was to provide the public with an update on FDA and DEA actions to resolve the shortages. The agencies reported they have been working with pharmaceutical manufacturers, and others, to prevent and reduce the shortages. According to the letter, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States between 2012-2021.
Stimulants are controlled substances that have a high potential for abuse, so the DEA set manufacturing quotas on these products. However, according to the DEA, manufacturers of these products only produced 70 percent of their allowed quota for 2022, and are showing a similar trend for 2023 to date. The FDA and DEA have called on manufacturers to increase production to meet their allotted quota amounts or relinquish their remaining 2023 quota so the DEA may redistribute to manufacturers who will increase production.
The FDA called on health care professionals to accelerate efforts to support appropriate diagnosis and treatment of ADHD, including further development of additional clinical guidelines for ADHD in adults. The FDA also described efforts to approve alternative treatments for ADHD, such as a game-based digital therapeutic approved in 2020 and non-stimulant medications. In May, the FDA issued a safety communication regarding updating warnings to improve the safe use of prescription stimulants.
CMS Releases Final FY 2024 Medicare IPPS and LTCH PPS Payment and Policy Updates
The Centers for Medicare & Medicaid Services released the federal fiscal year 2024 Medicare acute Inpatient Prospective Payment System and long-term care hospital prospective payment system payment and policy updates. CMS finalized a market basket update for IPPS services of 3.1 percent including the 0.2 percent productivity adjustment. After accounting for the payment updates, CMS estimates overall payments will increase by 6.6 percent or $2.2 billion as compared to FY 2023.
CMS finalized a market basket update for LTCH PPS services of 3.1 percent, including the 0.2 percent productivity adjustment. The overall LTCH PPS update includes a projected 2.9 percent decrease in high-cost outlier payments, reducing the overall market basket to 0.2 percent increase.
CMS Releases Final FY 2024 Medicare SNF PPS Payment and Policy Updates
The Centers for Medicare & Medicaid Services released the federal fiscal year 2024 Medicare skilled nursing facility prospective payment system payment and policy updates. CMS finalized a market basket update of 2.8 percent, including the 0.2 percent productivity adjustment. CMS increased payments by an additional 3.6 percent because of a forecast error adjustment, bringing the total market basket update to 6.4 percent. After accounting for the market basket forecast error and the second phase of the Patient-Driven Payment Model parity adjustment recalibration, CMS estimates overall payments will increase by 4.0 percent or $1.4 billion as compared to FY 2023 and increase 0.3 percent, or $200 million, as compared to the proposed FY 2024 rule. Other updates include changes to the PDPM ICD-10 code mappings, labor-share, wage index, SNF value-based purchasing program and SNF quality reporting program.
CMS Extends Deadline for IPFQR FY 2024 Data Submissions
The Centers for Medicare & Medicaid Services extended the submission deadline for the fiscal year 2024 Inpatient Psychiatric Facility Quality Reporting requirements from Tuesday, Aug. 15 to Friday, Sept. 1. All eligible IPFQR program providers must complete all requirements by Sept. 1 to qualify for the full IPF PPS annual payment update. Submission resources are available on the QualityNet and Quality Reporting Center websites.
The extension does not apply to reporting of 1Q2023 COVID-19 HCP measure data. IPFs must submit this data to the National Healthcare Safety Network by Tuesday, Aug. 15.
CMS Releases Final FY 2024 Medicare Hospice Payment and Policy Updates
The Centers for Medicare & Medicaid Services released the federal fiscal year 2024 Medicare hospice payment and policy updates. CMS finalized a market basket update of 3.1 percent. CMS estimates overall payments will increase by $780 million as compared to FY 2023 and increase by $60 million as compared to the proposed FY 2024 rule. Other updates include changes to the labor-share, wage index, the hospice cap amount and hospice quality reporting program.
CMS Releases Final FY 2024 Medicare Inpatient Psychiatric Facility PPS Payment and Policy Updates
The Centers for Medicare & Medicaid Services released the federal fiscal year 2024 Medicare Inpatient Psychiatric Facilities Prospective Payment System payment and policy updates. CMS finalized a market basket update of 3.3 percent. CMS estimates overall payments will increase by 2.3 percent, or $70 million, as compared to FY 2023 and increase 0.4 percent, or $15 million, as compared to the proposed FY 2024 rule. Other updates include changes to the labor-share, wage index, high-cost outlier threshold and IPF quality reporting program.
CMS Announces Medicare Dementia Care Model
The Centers for Medicare & Medicaid Services released information about the Guiding an Improved Dementia Experience Model. The model is intended to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers and help people remain in their homes and communities through a package of care coordination and management, caregiver education and support and respite services. The GUIDE model will test alternative payment for participants who provide support services to people with dementia. Applications for the GUIDE model will open in the fall, and the model will last for eight years beginning July 1, 2024.
CMS Releases October 2023 Public Reporting Hospital Data for Preview
The preview period now is open for hospitals participating in the Inpatient Psychiatric Facility Quality Reporting Program, Inpatient Quality Reporting Program, Outpatient Quality Reporting Program, Prospective Payment System-Exempt Cancer Hospital Quality Reporting Program and Medicare Promoting Interoperability program to review data that will be publicly reported in October 2023. Additional information is available.
CMS Expires Staff Vaccination Guidance
The Centers for Medicare & Medicaid Services issued revised guidance expiring all staff vaccination requirements effective Monday, June 5. The agency published a final rule that took effect Saturday, Aug. 5. The revised guidance reinforces the elimination of the staff vaccination requirements found in the final rule.
CMS Releases Final FY 2024 Medicare Inpatient Rehabilitation Facility Payment and Policy Updates
The Centers for Medicare & Medicaid Services released the federal fiscal year 2024 Medicare Inpatient Rehabilitation Facility Prospective Payment Systems payment and policy updates. CMS finalized a market basket update of 3.4 percent, which is slightly higher than proposed. CMS estimates overall payments will increase by 4 percent, or $355 million, as compared to FY 2023 and increase 0.3 percent, or $20 million, as compared to the proposed FY 2024 rule. Other updates include changes to the labor-share, case-mix group relative weights, updates to the standard payment conversion factor, high-cost outlier threshold and IRF quality reporting program.
MLN Connects Provider eNews Available
The Centers for Medicare & Medicaid Services issued the following updates to MLN Connects Provider eNews:
Before You Go...
The Centers for Medicare & Medicaid Services completed the July 2023 data refresh for the Care Compare and Provider Data Catalog websites. Additional information is available.