American Health Care Association Issues Public Comment on Centers for Medicare & Medicaid Services Rule
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The
The COVID-19 pandemic has created and continues to create unprecedented challenges for our entire health care and public health system and
The following are responses to specific questions or solicitations for comments posed by CMS in the IFC and comments on specific provisions of the rule including, when appropriate, recommended modifications. Thank you in advance for your consideration of the issues we raise and our associated recommendations.
Sincerely,
Senior Manager, Quality Improvement
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Responses to Specific Questions Posed by CMS or Solicitation for Comments in the Preamble
On page 54852 it states, "We recognize that there may be additional factors that may be useful in developing parameters for COVID-19 testing. As a result, we are soliciting comments on other factors the Secretary should consider for LTC facility resident and staff testing for COVID-19."
AHCA Comment:
AHCA Recommendation: We would encourage CMS to take the following factors into consideration as the test frequency criteria continues to evolve.
* Evaluate efficacy of/need for twice weekly routine test frequency: As of
From this recommendation, it seems that a twice weekly testing strategy may not be necessary when not dealing with an active outbreak. A facility managing an outbreak may actually test less than a facility without COVID-19 in the community but under a twice weekly test strategy.
* Provide flexible pathways for testing contractors, consultants, etc.: The test frequency guidance requires routine testing of staff, which includes "employees, consultants, contractors, volunteers, and caregivers who provide care and services to residents on behalf of the facility, and students in the facility's nurse aide training programs or from affiliated academic institutions." CMS further indicates that facilities should prioritize individuals at the facility on a regular basis and with contact with residents and staff. The rationale behind this is sound; COVID-19 does not discriminate based on job title. However, this puts a disproportionate burden on SNF providers when testing requirements for other provider/employer types would be more effective especially in light of the requirement for a physician order which is almost impossible to obtain for vendors and consultants entering the building. A more effective strategy of requiring their employers to provide testing should be implemented. Nursing facilities commonly rely on external staff to provide care and services to residents, and residents commonly have external professionals supporting their care. From a practical standpoint, requiring providers to enforce test requirements on non-staff poses a significant challenge. Especially challenging for providers when they must test twice weekly, there is a hardship on the provider to ensure "contracted staff" are tested. We would strongly encourage CMS to impress testing requirements upon other professional groups under their jurisdiction, such as EMS, laboratory services, transportation, hospice and state employees. We also encourage CMS to exercise flexibility in their approach to enforcement of this policy, recognizing that providers may not be able to test or match the frequency required for testing non-staff.
* Understand the impact of race and ethnicity: The secretary may want to consider the demographics of residents in the nursing home, or in the county where the nursing home resides, as there have been large disparities in COVID-19 rates by different races and ethnicities. Race and ethnicity have been shown to be a stronger predictor of COVID-19 cases in nursing homes.
* Develop guidance for outbreak testing: CMS' testing strategy requires frequent testing (every 3-7 days) in response to an outbreak. There continues to be confusion on what prompts outbreak testing. For example, it is not clear whether a staff person with a family member who has a confirmed case of COVID-19 would be a cause for outbreak testing in a facility. We recommend that CMS with the
We also recommend testing of Ombudsmen and Surveyors as a critical component to preventing outbreaks. It is unclear why ombudsman and state and federal survey inspectors are not subject to the same testing frequency. All the reasons supporting testing of contractors, consultants, volunteers, etc. apply to these two categories of individuals as well. Individuals are at risk of contracting COVID-19 in the community in which they live and work. The job duties of these individuals require traveling from building to building and other health care settings, increasing their potential exposure to COVID-19. The argument that ombudsman and surveyors wear PPE and follow transmission-based precautions does not eliminate the need for their testing to prevent the spread of COVID-19. This is posing a serious risk to residents that can be easily mitigated by requiring these individuals to be tested on a regular basis.
On page 54863 it requests, "We solicit comments on our cost estimates, as well as any additional costs associated with acquiring reagents, test kits, or anything else we may not have considered. Best practices for catching and eliminating these outbreaks, as well as availability of the tools necessary to do so, is a quickly changing landscape."
AHCA Comment:
However, the cost of complying with this regulation goes well beyond the direct cost of the test charged by the commercial labs or the cost of test kits for rapid antigen point of care (POC). There are also increased direct costs in PPE as
CMS and HHS have been extremely supportive in providing rapid antigen POC test devices to nursing homes, along with a new initiative to provide Abbott test kits. This has been incredibly helpful and important in our fight against COVID-19. Unfortunately, these testing requirements are so extensive that most nursing homes will exhaust those supplies after just a few weeks of testing. This is already happening for nursing homes in counties with high test frequency. We would recommend CMS continue to prioritize and distribute test supplies to nursing homes across the country. We also recommend that CMS continue to recognize providers good faith efforts to meet the intent and purpose of these requirements.
CMS also requested, "... public comments regarding our policy to revise the FY 2022 SNF VBP Program performance period to
AHCA Comment:
However,
General Comments
A. New Enforcement Requirement for LTC Facilities
In the IFC, CMS states "We will determine if noncompliance exists through a retrospective review each week to identify the facilities that failed to take the necessary and timely actions to report to
AHCA Comment:
On page 54824, CMS writes "We are enforcing the new reporting requirements through the imposition of CMPs for each time a facility fails to report the required data to the
AHCA Recommendation: CMS should utilize a warning letter to providers who fail to report before issuing a citation. This warning letter should permit facilities to submit any missing data in a timely manner for the sake of obtaining the most accurate surveillance data. This approach is supportive to providers during this demanding time and aligns with the goal of effective disease surveillance and transparency. Citations and penalties for failure to report to NHSN as required should be reserved for providers that continually fail to report and have not made a good faith effort to do so.
In the IFR, it is explained that "After each CMP is imposed, CMS will place the facility back into compliance, without requiring a Plan of Correction (POC) in accordance with Sec. 488.408(f). A facility may still submit a POC if it chooses to do so; however, because compliance will be imposed each week and facilities will be assessed an increased CMP amount for each subsequent failure to report, a POC will not be necessary. Facilities are offered an opportunity for Independent Informal Dispute Resolution under Sec. 488.431." AHCA Comment:
D. Quality Reporting: Updates to the Extraordinary Circumstances Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in Response to the PHE for COVID-19, and Update to the Performance Period for the FY 2022 SNF VBP Program
As part of the CMS response to the COVID-19 pandemic, on
In this IFC, CMS is updating the performance period for the FY 2022 SNF VBP Program because the Agency is concerned that using qualifying claims from the two quarters that are not excepted under the ECE for COVID-19 (
CMS also announced that they reserve the right to not score facilities or make associated payment adjustments for the FY 2022 Program if due to ongoing COVID-19 issues, there are additional ECEs or a significant number of individual facility ECEs submitted that the Agency does not have sufficient SNF VBP program data to reliability measure national performance. In the interest of time and transparency, CMS may provide sub regulatory advance notice of an intent to suspend proactive application of SNF VBP program penalties or payment adjustments for FY 2022 if unable to do so under the SNF PPS proposed rulemaking process.
AHCA Comment:
However,
While we recognize the well-intended rationale of seeking more stable data given the earlier projections of the course of COVID-19 infection rates diminishing during the third quarter of CY 2020, the reality is that the spread of COVID-19 has instead grown nationally through Q3 of CY 2020 and that new hot spots have developed in many parts of the country not significantly impacted during the first six months of CY 2020, and the impact is expected to extend into CY 2021. This means that the Q3 2020 hospital readmission data will also be extremely unstable so that the only plausible useful data from FY 2020 would be from Q1.
In addition, we do not believe that retroactively including two quarters of claims data from FY 2019 as a substitute for performance during Q2-3 of FY 2020 is appropriate for several reasons.
* First, we do not believe in general that it is appropriate to make prospective performance payment adjustments (positive or negative) based on overlapping time periods because a provider has already been subject to payment adjustments for the prior reporting periods and should not continue to be penalized for rewarded for prior performance already accounted for.
* Second, the use of CY 2019 Q3-4 data as a substitute for FY 2020 Q2-3 performance penalizes providers that have improved performance in FY 2020 and will result in payment adjustments in FY 2022 based on performance that occurred more than two years earlier.
* Third, while CMS cites an example of historically using overlapping data in the SNF VBP program for the FY 2020 SNF VBP Program when the reporting period was changed from CY to FY, we do not accept that that situation is applicable here because the intent of the measure is to capture the most recent 12-month performance data available that would be reflective of the performance year, and the cited historical precedent was a result of a permanent change in the measure itself. In this case, CMS is not permanently changing the measure performance period like in the FY 2020 SNF VBP Program but is instead attempting to apply a 6-month data proxy to substitute for FY 2020 performance even though CMS has acknowledged concern that most if not all of the CY 2020 performance data is likely to be unstable and not useable. It does not make sense to base the FY 22 SNF VBP Program payment adjustments on 6 months of data that is not from the specified performance period, combined with 6 months of unstable FY 2020 data.
Due to the fact that it now clearly unrealistic that CMS will be able to obtain any reliable hospital readmission data that satisfies the rigorous measure requirements for at least three of the four reporting quarters for the SNF VBP hospital readmission measure, we instead strongly recommend that CMS not score facilities for FY 2020 performance or make associated payment adjustments for the FY 2022 SNF VBP program, and resume the program in subsequent years once reliable performance data consistent with measure specifications is available.
F. Limits on COVID-19 and Related Testing without an Order and Expansion of
This rule proposes to allow one COVID-19 test to be reimbursed without a clinician's order, but subsequent tests require a physician's order for reimbursement. "The order of a physician or other practitioner is not required for one otherwise covered diagnostic laboratory test for COVID-19 and for one otherwise covered diagnostic laboratory test each for influenza virus or similar respiratory condition needed to obtain a final COVID-19 diagnosis, when performed in conjunction with a COVID-19 diagnostic laboratory test in order to discount influenza virus or related diagnosis." AHCA Comment: We support this change and would encourage CMS to accept standing orders in the nursing home setting since other CMS regulations require testing of all residents when they develop any symptoms consistent with COVID-19 or during an outbreak, defined as any one positive test in a resident or staff member. In an outbreak investigation CMS is requiring repeat testing of all residents until no tests are positive for all residents and staff over a 14-day period. Requiring individual orders for each repeat test will slow down the outbreak investigation and jeopardize compliance with CMS and
In addition,
J. Requirement for
We know from experience that testing in nursing homes is extremely burdensome and expensive, and building an effective, systematic testing process is a complex task. Many important questions have arisen from CMS' and
AHCA Recommendation:
At Sec. 483.80, CMS directs providers "When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results."
AHCA Recommendation:
We continue to reinforce that ombudsman, state and federal survey inspectors should be subject to the same testing frequency. COVID-19 does not discriminate based on job title. All the reasons supporting testing of contractors, consultants, volunteers, etc. apply to these two categories of individuals. They are at risk of contracting COVID-19 in the community they live and work and are traveling from building to building and other health care settings with exposure to COVID-19.
AHCA Recommendation: For the safety of residents, the testing requirements should apply to state and federal surveyors. This is posing a risk to residents that can be easily mitigated by requiring these individuals to be tested on a regular basis.
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Footnotes:
1/
2/ Clinical Questions about COVID-19: Questions and Answers. (n.d.) from https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html
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The rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0097-0001
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