On May 3, 2023, the Centers for Medicare & Medicaid Services (CMS) published the proposed rule Medicaid Program; Ensuring Access to Medicaid Services. The aim of the proposed rule is to enhance transparency in payment rates, establish uniformity in data and monitoring and provide states with fresh avenues to encourage the active involvement of beneficiaries in their Medicaid programs. These efforts are aimed at enhancing access to care. The rule places a special emphasis on home and community-based services (HCBS), encompassing mandates for direct care worker compensation, the development of grievance processes, defining critical incident reporting and implementing HCBS quality reporting measures.
CMS Ups Hospital Price Transparency Enforcement, Seeks More Authority from Congress
The Centers for Medicare & Medicaid Services recently unveiled plans to toughen its hospital price transparency enforcement. According to this InsideHealthPolicy article, these proposals include earlier and automatic civil penalties, eliminating warning notices for hospitals that have not attempted to comply with price transparency requirements and giving hospitals no more than 45 days to implement a corrective action plan.
Federal Government to Wind Down Vaccination Mandates
The Biden administration has announced that the federal government will wind down its remaining COVID-19 vaccination mandates (including those for federal workers, contractors and international air travelers) effective May 11, 2023. This action coincides with the conclusion of the COVID-19 public health emergency (PHE). Additionally, the US Department of Health and Human Services (HHS) will initiate steps to terminate the vaccination prerequisites for healthcare facilities that are certified by the Centers for Medicare & Medicaid Services (CMS).
CMS Seeks Provider and Stakeholder Feedback on First National Directory of Healthcare Providers and Services
CMS is soliciting feedback on the creation of the first national directory of healthcare providers and services (NDH), which would contain information on healthcare providers and services across the country. CMS states that the NDH would improve and support interoperability throughout the healthcare sector for payers and providers while making it easier for patients to identify, compare and locate providers who meet their specific needs and preferences, such as those related to office accessibility, languages spoken or other data. CMS proposes that consolidating provider data into a single source would ultimately reduce the unnecessary burden placed on providers to maintain dozens of separate directories while improving access to care. The new system would be used in place of commercial payor directories and allow payers to update their own directories seamlessly from a single directory. CMS is proposing integrating the NDH with current CMS-maintained systems (i.e., NPPES, PECOS and Care Compare).
New California Law Requires Open Payments Notice to Patients
On September 29, 2022, California Governor Gavin Newsom signed Assembly Bill 1278, which requires physicians and their employers to provide patients with notices about the Open Payments database starting January 1, 2023.
The federal Open Payments program is designed to promote transparency by requiring applicable manufacturers of drugs, devices, and biological or medical supplies to annually report to the Centers for Medicare & Medicaid Services certain payments and other transfers of value made to physicians, certain advanced practice providers (e.g., nurse practitioners) and teaching hospitals. Currently, pharmaceutical companies in California must disclose their compliance program, including information related to the annual dollar limits on gifts, promotional materials or incentives provided to medical or health professionals (California Health & Safety Code § 119402). The enactment of this new legislation will impose new disclosure requirements specifically onto physicians and their employers regarding physicians’ financial relationships with pharmaceutical and medical device manufacturers.
CMS Downshifts on Expectations for Covered Healthcare Provider Staff COVID-19 Vaccination
The Centers for Medicare & Medicaid Services (CMS) released guidance for surveyors that provides leeway in surveying for compliance with the November 2021 interim final rule with comment that imposed a vaccination mandate for most staff at certain covered provider types.
Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:
- Drug Price Negotiations: Allows the federal government to negotiate for a select number of vaccines and/or drugs
- Inflation-Based Rebates: Mandates that manufacturers pay a rebate to the federal government when the list prices of Part B or Part D drugs grow at a faster rate than the inflation rate
- Part D Benefit Redesign: Implements an out-of-pocket maximum for beneficiaries at $2,000 and redistributes liability among manufacturers, health plans, patients and the federal government across phases of the Part D benefit starting in 2024.
Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.
This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.
This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.
GAO Releases Report on Telehealth
On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).
GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:
- CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
- CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
- CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
- OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.
Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.
The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.
This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.
CMS Announces 2023 Medicare Premiums and Deductibles
On September 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released 2023 premiums, deductibles and coinsurance amounts for Medicare Parts A and B, and the Medicare Part D income-related monthly adjustment amounts.
In 2023, the standard monthly premium for Medicare Part B enrollees will be $164.90, a decrease of $5.20 (from $170.10) in 2022, and the deductible for all Medicare Part B beneficiaries will be $226, a decrease of $7 (from $233) in 2022. The decreases stem from a decline in the price of an Alzheimer’s drug and limitations on its usage, as the Alzheimer’s drug was the main factor for the spike in monthly Part B premiums in 2022, according to CMS.
For Part A, the inpatient hospital deductible (which beneficiaries pay if admitted to the hospital) will be $1,600 in 2023, an increase of $44 from $1,556 in 2022.
For Part D, where higher income beneficiaries’ monthly premiums are adjusted based on income, CMS set forth the 2023 monthly adjustment amounts, beginning with beneficiaries with less than $97,000 in modified adjusted gross income (no monthly Part D adjustment) and incrementally increasing to a $76.40 monthly premium adjustment for those whose modified adjusted gross income is greater than $500,000.
Medicare open enrollment for 2023 begins on October 15 and ends on December 7.
CMS Recommends Cost Savings Be Passed Along to Medicare Part B Beneficiaries
The US Centers for Medicare & Medicaid Services (CMS) recently released a report recommending that cost savings from lower-than-expected Medicare Part B spending be passed along to individuals with Medicare Part B coverage in the calculation of the 2023 Part B premium.
CMS’s recommendations are based upon the development of the Part B premium and the potential effects of factors that have changed since a premium was announced on a drug used for the treatment of Alzheimer’s disease. CMS builds in a reserve to ensure the Medicare Supplementary Medical Insurance (SMI) Trust Fund remains adequately financed for the year. In 2021, CMS built in a reserve to ensure the SMI Trust Fund could cover the potential costs of the Alzheimer’s disease drug and similar drugs.
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