cms final rule 2023 medicare

Missouri, https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. CMS Office of Communications, Department of Health and Human Services, Such requirements include the CoPs for providers, CfCs for suppliers, and requirements for LTC facilities. Health systems and health care employers may continue to require that workers stay up to date on COVID19 vaccinations, consistent with other Federal, State, and local laws. Consistent with the documentation requirements we established for LTC facility staff, we required at 483.80(h)(3)(ii) that the facility document in the resident's medical record that testing was offered, completed (as appropriate to the resident's testing status), and the results of each test. We also show a range (plus or minus 25 percent) for the upper and lower bounds of potential cost savings to emphasize the uncertainty as to several major variables, including changes in voluntary vaccination levels, longer-term effects, and others previously discussed. The Centers for Medicare & Medicaid Services today issued a final rule for the long-term care hospital prospective payment system for fiscal year 2023, which increases aggregate Medicare payments by approximately $71 million relative to FY 2022. Adequate staffing was a concern prior to the pandemic, and we recognize that the COVID19 PHE simultaneously exacerbated and accelerated those trends. It is important to understand, as explained previously in this final rule, that this Comment: [35] Before offering a COVID19 vaccine, all residents, resident representatives, and staff members are provided with education regarding the benefits, risks, and potential side effects associated with the vaccine. 55. Access to adequate testing supplies and arrangements for acquiring testing supplies must have been addressed by the facility's infection prevention and control plan. On May 13, 2021, CMS issued the educate and offer IFC, which revised the health and safety requirements that LTC facilities and ICFsIID must meet to participate in the Medicare and Medicaid programs. CMS implemented the staff vaccination requirements in the IFC to assure health and safety during a PHE declaration. In situations where COVID19 vaccination requires multiple doses, the resident, resident representative, or staff member is provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects associated with the COVID19 vaccine, before requesting consent for administration of any additional doses. Other commenters recommended that CMS recognize the importance of booster shots and consider including boosters in the definition of fully vaccinated once the CDC updates its guidance. We note that these cost (now benefit) estimates apply only to the mandatory nature of the rule addressing staff vaccination. For CY . In September 2021, COVID19 related deaths in the U.S. surpassed the number of deaths from the 1918 influenza pandemic. Industry, civil society groups, and individual commenters sought clarification regarding religious, medical, and administrative exceptions to the vaccination requirements. https://www.hrsa.gov/vaccine-compensation/about. 25. Start Printed Page 36492 Throughout the COVID19 PHE, we implemented and revised regulations to reflect lessons learned and emerging data and knowledge to protect the health and safety of individuals that receive care and services from Medicare- and Medicaid-certified providers and suppliers. https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. It omitted, however, potential increases in recruitment costs and a variety of potential business disruption costs for facilities that may have had difficulties hiring vaccinated workers. 273, 1302, 1320b8, and 1395hh. Until the ACFR grants it official status, the XML legal research should verify their results against an official edition of Response: Additionally, we also considered whether we could or should extend the LTC facility testing requirements that expired with the PHE, and determined that there was no need in the face of current standards of care that call for testing when clinically indicated. Section 494.30 is amended by removing paragraph (b) and redesignating paragraphs (c) and (d) as paragraphs (b) and (c), respectively. In this section, we review the requirements issued in the staff vaccination IFC, the educate and offer IFC, and the LTC facility testing IFC. CMS releases final rule for the Medicare Advantage RADV program 17. https://www.federalregister.gov/documents/2021/06/21/2021-12428/occupational-exposure-to-covid-19-emergency-temporary-standard. 37. [34] LTCHQRP. We recognize that American Indians and Alaska Natives (AI/AN) face unique health care needs and have been disproportionately impacted by COVID19. Relevant information about this document from Regulations.gov provides additional context. [71] 1. Accessed on January 17, 2023. Additionally, CMS continues to host stakeholder engagement calls to address ongoing concerns and questions. Response: 82. We note that the evolution of COVID19 continues to present challenges to the development of both preventative drugs, including vaccines, and therapeutic treatments. coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html 31. After evaluation of public comments on the COVID19 testing requirements for residents and staff of LTC facilities, and in light of their applicability ending with the end of the COVID19 PHE, we are revising the CFR at 483.80(h) to remove the expired text. of this final rule, we discuss the withdrawal of regulations pertaining to COVID19 vaccination of health care staff. CMS Backs Off Severe Cuts, Finalizes 0.7% Increase To 2023 Provider Critical Access Hospitals (CAHs)485.640(f). When the current budget for the vaccines runs out, private and public health insurance will in most cases assume the costs of vaccination, depending on future coverage decisions by these insurance programs. existing emergency preparedness policies and procedures. We thank the staff for their hard work in complying with these requirements. CMS finalized new exceptional condition SEPs under section 1837(m) of the Act in 42 CFR 406.27 and 407.23 for Medicare parts A and B, respectively, in a final rule that was published in the Federal Register on November 3, 2022 . 48. 61. and they rely on facility staff to provide for their daily needs, including access to health care services such as vaccination. The authority citation for part 460 continues to read as follows: Authority: 81. Some commenters suggested additional educational outreach, especially among communities with lower trust in the health care system, as well as an understanding of the logistical issues preventing prompt implementation of the requirements in the staff vaccination IFC at certain facilities. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/past-reports/033123.html#:~:text=COVID%2D19%20Community%20Levels*,with%20a%20low%20Community%20Level. Some commenters stated that communicating the pros, cons, and side effects of vaccination in a meaningful way to LTC facility residents was challenging and recommended that CMS provide additional guidance and standardized education materials for use. Only a handful of weeks have reached or exceeded 3,500 deaths since May 2022 as shown in this table, at of this final rule. At the time the IFC was issued, the CDC did not include boosters in their definition of fully vaccinated. Instead, a person was considered to be fully vaccinated 2 weeks after receiving the last dose of a primary vaccine series. That is exactly what we are doing today. The authority citation for part 441 continues to read as follows: Authority: These revisions established a sunset date for most COVID19 reporting requirements for LTC facilities. We believe that all LTC Facility residents, ICFIID clients, and the staff who care for them, should be provided with ongoing education about, and access to, vaccination against COVID19. In some instances, an individual may test when the viral load is not high enough to be found on a test and the test result is negative. 64. Most of these comments emphasize that the frequent testing takes away valuable time from resident care and socialization, which is critical at a time when residents are not able to see their families. Many commenters requested clarification as to which facility types the rule applies. Given that the educate and offer provisions are existing requirements for LTC facilities and ICFsIID, the requirements will remain effective after the publication date of this final rule. With all these unknown variables, we cannot predict with confidence future COVID19 morbidity or mortality levels either with or without better vaccination compliance. This is true, of course, for workers as well. Our intention in issuing the staff vaccination IFC was to establish a set of requirements for all applicable facility types consistent with CDC recommendations in place at the time to assure patient health and safety. The central consideration in our evaluation and determination is helping to protect the health and safety of individuals that receive care and services from Medicare- and Medicaid-certified providers and suppliers. v. This means that they do have COVID19, but their viral load is too low to result in a positive antigen test. Share sensitive information only on official, secure websites. 5. We also thank LTC facility staff and health care workers for their continued commitment to providing care for residents. Currently available data do not show that Ivermectin is effective against COVID19 and taking large doses of Ivermectin is dangerous. (accessed May 1, 2023). A summary of the major themes addressed by commenters and our responses follow. In comparison, roughly 200 healthcare worker deaths occurred from COVID19, much and perhaps most contracted outside the workplace. We note that on April 18, 2023, FDA revised the Emergency Use Authorizations (EUAs) for the Pfizer and Moderna mRNA vaccines to make several changes to the authorized dosing regimen and schedule. [19] Becerra, This final rule was not preceded by a general notice of proposed rulemaking and the RFA requirement for a final regulatory flexibility analysis does not apply to final rules not preceded by a proposed rule. Sections 1861(m), 1861(o), and 1891 of the Act. The dollar estimates were based on an estimated labor requirement of 2 minutes per test and hourly wage date from the Bureau of Labor Statistics for 2019. These commenters also expressed concerns that Emergency Use Authorizations (EUAs) issued by the Food and Drug Administration (FDA) do not assure safety, because of the minimal length of development time. [32] 41. Section 485.725 is amended by removing paragraph (f). to the courts under 44 U.S.C. It is important for data to be measured and reported in a standardized manner. 67. Skilled Nursing Facility Quality Reporting Program (SNFQRP). CMS is also providing important protections regarding utilization management policies and coverage criteria that ensure that Medicare Advantage enrollees receive the same access to medically necessary care that they would receive in Traditional Medicare. We subsequently finalized provisions addressing the hospital and CAH COVID19 reporting requirements in the final rule Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation on August 10, 2022 (87 FR 48780) (FY 2023 Hospital Inpatient Prospective Payment System final rule). These drugs have also undergone rigorous testing. Currently, CMS considers LTC facility and ICFIID staff (regardless of whether there is a so-called W2 relationship) to be those who work in the facility on a regular basis (that is, at least once a week). Comment: Including patients served as hospital emergency cases or as outpatient cases, the total number of patients served is more than 300 million based on number of encounters, but likely to be much lowerabout 250 millionbased on number of different individuals. Many of these As discussed in section H. of the staff vaccination IFC, many health care workers must already comply with employer or State government vaccination requirements (influenza, hepatitis B) or OSHA guidelines and are also required to complete screening procedures, such as tuberculosis screening. CMS is figuring to pay about $570 million more in Medicare payments to . Ending the staff vaccination IFC could arguably reduce vaccination levels among health care staff. Vaccine education allows for residents, clients, and their caregivers to be informed participants in their care and allows them to make the most appropriate decisions for themselves. As described in further detail in the previous sections of this rule, this final rule relates to three separate IFCs: This final rule (1) withdraws requirements of the November 2021 IFC regarding staff vaccination; (2) deletes expired requirements of the September 2020 IFC regarding COVID19 testing in LTC Facilities, and (3) finalizes requirements of the May 2021 IFC requiring facilities to provide education about COVID19 vaccines and to offer COVID19 vaccines to residents, clients, and staff. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) of E.O. of this final rule, we address the public comments submitted to CMS regarding the educate and offer provisions. The Centers for Medicare & Medicaid Services April 5 released a final rule that would increase oversight of Medicare Advantage plans and better align them with Traditional Medicare, address access gaps in behavioral health services and further streamline prior authorization processes. At the same time, the advent of a more contagious and severe variant (Delta)and the recognition that additional variants were likely to emerge and, together with seasonal respiratory illnesses, increased the pressure on the health care systemindicated a need for CMS to take additional action. Section 483.430(f) requires that each ICFIID maintain documentation related to its staff that includes, at a minimum, documentation that the staff were provided education regarding the benefits and risks and potential side effects associated with the COVID19 vaccine and were offered a COVID19 vaccine or information on obtaining the COVID19 vaccine. If you are using public inspection listings for legal research, you 27. https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources. and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. Therefore, for PRTFs at 441.151(c)(3)(iii), HIT suppliers at 486.525(c)(3)(iii), and RHCs/FQHCs at 491.8(d)(3)(iii), we required a process for ensuring adherence to nationally recognized infection prevention and control guidelines intended to mitigate the transmission and spread of COVID19. We also note that the staff vaccination IFC permitted individual exemptions consistent with applicable Federal laws. 2:22CV149 DAKDBP (D. Utah Oct. 13, 2022). The original regulatory provisions as issued by the educate and offer IFC also permitted staff members to refuse vaccination. SUMMARY: This final rule will revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance . https://www.hrsa.gov/cicp. https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home. [63] In 7. Learn more here. As previously discussed, many of the residents and clients of LTC facilities and ICFIIDs are not able to independently travel offsite in order to receive a vaccine due to several factors including but not limited to disability, cognitive impairment, low health literacy, and/or functional reasons. In our latest effort to strengthen Medicare and hold insurance companies accountable, we are putting protections in place so that Medicare Advantage works for beneficiaries and they get the quality care they deserve. We thank commenters and health care workers for their continued dedication throughout the COVID19 pandemic. For purposes of estimating benefits from eliminating the implementation costs of the staff vaccination IFC, we therefore estimate that the second- and third-year costs of the November 2021 staff vaccination IFC (if continued unchanged) would have been $691 million (0.5 * 1,382). On November 5, 2021, we published the staff vaccination IFC, which revised the health and safety requirements that most providers and suppliers must meet to participate in the Medicare and Medicaid programs. The quality, utility, and clarity of the information to be collected. https://www.cdc.gov/nchs/covid19/faq.htm. The IFC established requirements that these facilities provide COVID19 vaccination education to residents, clients, and staff, and to offer COVID19 vaccines to these populations, referred to as the educate and offer provisions. Section 485.640 is amended by removing and reserving paragraph (f). As the COVID19 pandemic has continued to evolve and circumstances have normalized, we have continued to evaluate the evolving clinical and epidemiological circumstances of the COVID19 pandemic and the requirements issued in the IFCs, particularly those requirements that have not been finalized to date, for the purpose of determining the appropriate disposition of those requirements. As noted in the IFC, the regulation applied only to those Medicare- and Medicaid-certified providers and suppliers listed. 1302, 1395, 1395eee(f), and 1396u4(f). Changes in Patient Lives Saved or Lost. For example, commenters found it unreasonable for a staff member that works in the billing officewho has no face-to-face contact with residents or with staff who provide direct care to residentsto be tested weekly. Since ICFIID staff may be required to take a COVID19 vaccine in some States, or by some employers, we believe it is inappropriate to include explicit permission to refuse in the regulations. AHA Summary of Physician Fee Schedule Final Rule for CY 2023 483.460(a)(4) for LTC facilities and ICFIIDs. Only official editions of the In this section we provide a summary of the public comments received and responses to them, and the policies we are finalizing. On November 01, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that includes updates and policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues, effective on or after January 1, 2023. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: This rule contains no new requirements and would sunset those promulgated by the staff vaccination IFC and the LTC testing IFC. On May 13, 2021, we issued an IFC titled Medicare and Medicaid Programs; COVID19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFsIID) Residents, Clients, and Staff (86 FR 26306), otherwise known as the educate and offer IFC. This IFC revised the requirements for LTC facilities and CoPs for ICFsIID to require the provision of COVID19 vaccination education and to offer vaccines to residents, clients, and staff. Comment: Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. [69] 73. Some comments highlighted that PCR tests cost about $130 and that testing costs accumulate quickly. Omnibus COVID19 Health Care Staff Vaccination, C. COVID19 Vaccine Educate and Offer Requirements for LTC Facilities and ICFsIID, D. COVID19 Testing Requirement for LTC Facilities, F. Requirements for Issuance of Regulations, G. Enforcement of Staff Vaccination Provisions, II. The pre-rulemaking process requires that HHS make publicly available, not later than December 1 annually, a list of quality and efficiency measures HHS is considering to adopt, through the rulemaking process, for use in certain Medicare quality programs and for use in publicly reported performance information in any Medicare program. We recognize that the COVID19 pandemic has strained the economy and created many challenges. End-Stage Renal Disease Quality Incentive Program (ESRD QIP). Hospital-Acquired Condition Reduction Program (HACRP). Comprehensive Outpatient Rehabilitation Facilities (CORFs)485.70(n). The educate and offer requirements support our responsibility to protect and ensure the health and safety of residents and clients by enforcing the standards required to help each resident and client attain or maintain their highest level of well-being. importance of practicing preventative measures in order to mitigate the risk of transmission and control the spread of COVID19 among residents and staff of LTC facilities. In this section, CMS discusses the public comments received for the COVID19 testing requirement for LTC facilities, the staff vaccination IFC, and the educate and offer provisions of the COVID19 Vaccine Requirements for LTC Facilities and ICFsIID Residents, Clients, and Staff IFC (educate and offer IFC), published September 2, 2020, November 5, 2021, and May 21, 2021, respectively. Like the SARSCOV2 virus itself, the science of preventing and treating COVID19 and the tools available to prevent and treat it continue to evolve. PDF Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease This feature is not available for this document. https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staff-vaccinations-boosters-and-shortages-after-vaccination-deadlines-passed/. [7] Response: We discuss these educate and offer provisions of the IFC in section II.B. In the final rule, CMS clarifies its interpretation of the statute and permits Medicare to make payment for dental services under Medicare Part A and B "that are inextricably linked to,. 78. The rule streamlines prior authorization requirements and reduces disruption for enrollees by requiring that a granted prior authorization approval remains valid for as long as medically necessary to avoid disruptions in care, requiring Medicare Advantage plans to annually review utilization management policies, and requiring denials of coverage based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued. While the number of health care staff (whether called employees, workers, or staff) dying from COVID19 infections was already decreasing when the staff vaccination IFC was issued, it has for the last year decreased to very low levels, often zero, for weeks at a time. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations). Federal Register We refer readers to the Department of Labor for issues regarding workplace injury and compensation. 21. Contact us. We recognize and acknowledge the important role of new treatment therapies that have recently become available, as previously discussed in this rule. However, this does not mean infection-induced immunity can or should be substituted for vaccination. We have no basis for changing the overall estimated total future year compliance costs from the estimates made at that time.
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