1 The Privacy Rule standards address the use and disclosure of individuals' health informationcalled "protected health information" by organizations subject t. 235. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3415-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. We have issued PHE waivers for most Medicare- and Medicaid-certified For these reasons and the reasons set forth in section II.A. Specifically, during the last 6 months, April through September 2021, total staff deaths were 202, an average of 34 per month and no clear trend (the last 4 weeks, all in September, 2021 produced fewer than 20 deaths). 38. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $79 for each employee. 254. 173. Oregon Department of Human Services : Electronic Visit Verification https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. New York enacted a State-wide health care worker COVID-19 vaccine mandate and recorded a jump in vaccine compliance in the final days before the requirements took effect on October 1, 2021.[159]. [6], One analysis published in February 2021 found that Black and Latino Americans have experienced a disproportionate burden of COVID-19 morbidity and mortality, reflecting persistent structural inequalities that increase risk of exposure to COVID-19 and mortality risk for those infected. COVID-19 Vaccination of facility staff. For staff, who are generally of working ages in roughly the same proportions as the population at large, the typical rate of death for the full course of two vaccines (or possibly three with a booster) is roughly 1 percent of the older adult rate, and the expected value for each employee receiving the same vaccinations is about $57,500 ($11.5 million .005). As discussed previously, it is possible there may be disruptions in cases where substantial numbers of health care staff refuse vaccination and are not granted exemptions and are terminated, with consequences for employers, employees, and patients. 2006; 333: 1241-1246. In a policy statement dated July 21, 2021, a large long term care association, strongly urges all residents and staff in long-term care to get vaccinated and supports requiring vaccines for current and new staff in long-term care and other healthcare settings. The Federal Medicaid program does not reimburse states for the cost of covered services provided to beneficiaries in institutions for mental diseases (IMDs) except in specific, statutorily-authorized exceptions, including for young people who receive this service, and individuals age 65 or older served in an IMD. We analyze both the costs of the required actions and the payment of those costs. 39. 148. For all 5,556 hospices, the total burden would be 11,112 hours (2 5,556) at an estimated cost of $1,355,664 (5,556 $244). As a result, while similarly comprehensive data are not available for all Medicare- and Medicaid-certified provider and supplier types, we believe the LTC facilities experience may generally be extrapolated to other settings. accessed at . Similarly, several articles published in CDC's Morbidity and Mortality Weekly Reports (MMWRs) regarding nursing home outbreaks have also linked the spread of COVID-19 infection to unvaccinated health care workers and stressed that maintaining a high vaccination rate is important for reducing transmission. . For the IPs in all 1,358 CAHs, the burden would be 10,864 hours (8 hours 1,358) at an estimated cost of $858,256 (632 1,358). Any delay in the implementation of this rule would result in additional deaths and serious illnesses among health care staff and consumers, further exacerbating the newly-arising, and ongoing, strain on the capacity of health care facilities to serve the public. Additionally, adverse events are also monitored through electronic health record- and claims-based systems (through CDC's Vaccine Safety Datalink and FDA's Biologics Effectiveness and Safety System (BEST)). Based upon our experience with CORFs, we believe some facilities have already developed policies and procedures requiring COVID-19 vaccination for staff unless medically contraindicated. Residents of LTC facilities make up less than 1 percent of the U.S. population but accounted for more than 35 percent of all COVID-19 deaths in the first 12 months of the pandemic.[134]. 151. To view the ONC final rule, please visit: https://healthit.gov/curesrule. On September 2, 2020, we issued a third IFC (Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (85 FR 54820 through 54874)) (September 2, 2020 COVID-19 IFC), that included new requirements for hospitals and CAHs to report data in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. The patient must be under the care of a physician. In response to the PHE, organizations experienced a reduction in patients. The data on cumulative COVID-19 cases among health care personnel show 677,000 cases (most of which incapacitated workers at least temporarily), and 2,200 deaths, all of which permanently eliminated those workers as sources of future care.[243]. In addition to the avoided death and human suffering, one of the major benefits of vaccination is that it lowers the cost of treating the disease among those who would might otherwise be infected and have serious morbidity consequences. Moderna Fact Sheet The IP would need to work with the DON and medical director to revise and finalize the policies and procedures. This second IFC contained additional information on changes Medicare made to existing regulations to provide flexibilities for Medicare beneficiaries and providers to respond effectively to the PHE for COVID-19. Start Printed Page 61568 The Rule's Applicability: Providers and Suppliers The Rule requires full COVID-19 vaccination by January 4, 2022, of covered staff at health care facilities that participate in Medicare and Medicaid programs . Assuming that the average rate of death from COVID-19 (SARS-CoV-2 infection) at LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected life-extending value of each resident who would otherwise be infected is $150 thousand at a 3 percent discount rate and $240 thousand at a 7 percent discount rate. Any burden for modifying the PACE organization's policies and procedures for these activities is already accounted for above. In light of our responsibility to protect the health and safety of individuals providing and receiving care and services from for Medicare- and Medicaid-certified providers and suppliers, and CMS's broad statutory authority to establish health and safety regulations, we are compelled to require staff vaccinations for COVID-19 in these settings. In the May 13, 2021 COVID-19 IFC, we included an extensive discussion on the subject of staff in relation to the LTC facility staff and to whom the testing, reporting, and education and offering of COVID-19 vaccine requirements of that rule might apply. 5. Amend 418.60 by adding paragraph (d) to read as follows: (d) (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section. https://pubmed.ncbi.nlm.nih.gov/32743613/,, CDC estimates that 45.4 percent of U.S. adults are at increased risk for complications from coronavirus disease because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), 5. For all 337 HIT suppliers, the total burden for the administrator would be 674 hours (2 hours 337) at an estimated cost of $65,378 (337 194). Among those infected, the death rate for older adults age 65 or higher was hundreds of time higher than for those in their 20s during 2020. Contingency plans might also address special precautions to be taken when, for example, there is a regional or local emergency declaration, such as for a hurricane or flooding, which necessitates the temporary utilization of unvaccinated staff, in order to assure the safety of patients. 2021-23831 Filed 11-4-21; 8:45 am]. 205. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following organization staff, who provide any care, treatment, or other services for the organization and/or its patients: (iv) Individuals who provide care, treatment, or other services for the organization and/or its patients, under contract or by other arrangement. [140] Hence, the burden for these documentation requirements for all 357 PRTFs would be 2,499 (0.0833 30,000) hours at an estimated cost of $184,926 (2,499 74). For all 357 PRTFs, the burden would be 2,856 hours (8 hours 357) at an estimated cost of $211,344 (592 357). Based upon these requirements and our experience with organizations, we believe some organizations have already developed policies and procedures requiring COVID-19 vaccination for staff unless medically contraindicated. Now thats becoming a reality, said HHS Secretary Alex M. Azar. 188. (iv) Individuals who provide care, treatment, or other services on behalf of the PACE organization, under contract or by other arrangement. On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. Many ESRD patients are also residents of LTC facilities or other congregate living settings, which is also a risk factor for COVID-19. [197198199]. We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. . https://pubmed.ncbi.nlm.nih.gov/31384750/. For all ESRD facilities, the burden would be 63,144 hours (8 hours 7,893) at an estimated cost of $4,609,512 (7,893 584). Under section 1861(dd)(2)(G) of the Act, the Secretary may impose such requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization. The CoPs found at part 418, subparts C and D apply to a hospice, as well as to the services furnished to each patient under hospice care. Additionally, CMS is requiring states to send enrollee data daily beginning April 1, 2022 for beneficiaries enrolled in both Medicare and Medicaid, improving the coordination of care for this population. We will promptly inform you as to whether we have jurisdiction to investigate your complaint. More information and documentation can be found in our The agency has considered other alternatives (for example, relying entirely on measures such as voluntary vaccination, source control alone, and social distancing) and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the statute. We recognize that newly reported COVID-19 cases, hospitalizations, and deaths have begun to trend downward at a national level; nonetheless, they remain substantially elevated relative to numbers seen in May and June 2021, when the Delta variant became the predominant strain circulating in the U.S.[185] ONCs final rule establishes secure, standards-based application programming interface (API) requirements to support a patients access and control of their electronic health information. We believe these activities would be performed by the RN and an administrator. COVID-19 disease at this time is resulting in much higher morbidity and mortality than seasonal flu. Start Printed Page 61563 Contingency plans for staff who are not fully vaccinated for COVID-19. Similarly, the U.S. experienced a large COVID-19 wave in the winter of 2020. (ii) Staff who provide support services for the organization that are performed exclusively outside of the organization setting and who do not have any direct contact with patients and other staff Staff have had almost a year to consider COVID-19 vaccinations that are in their own interests as well as vital to patient protections and the protection of other workers. See HHS OIG reports OEI-09-21-00140 and OEI-06-20-00300, both accessed September 26, 2021. We estimate this would require 2 hours. The threats that unvaccinated staff pose to patients are not, however, limited to SARS-CoV-2 transmission. Hence, definitions of fully vaccinated are consistent among the requirements in these regulations. 175. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. The U.S. These and some lesser options are presented and discussed in the main preamble. Nonetheless, the Rule clearly articulates a preference for voluntary compliance. center, the home, and inpatient facilities. These delays likely contributed to increased disability or illness. According to Table 3, these organizations have 10,000 employees. or authorized for use in the U.S. were tested in clinical trials involving tens of thousands of people. Every person who receives a COVID-19 vaccine receives a vaccination record card noting which vaccine and the dose that was received.
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