Vibra Healthcare & Ernest Health Issues Public Comment on Centers for Medicare & Medicaid Services Notice

WASHINGTON, April 8 -- Brad Hollinger, chairman and CEO of Vibra Healthcare and Ernest Health, Mechanicsburg, Pennsylvania, has issued a public comment on the Centers for Medicare and Medicaid Services notice entitled "Review Choice Demonstration for Inpatient Rehabilitation Facility (IRF) Services". The comment was written on Feb. 16, 2021, and posted on April 7, 2021:

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This letter presents the comments and recommendations of Vibra Healthcare and Ernest Health on the above-referenced Notice. Vibra Healthcare and Ernest Health operate networks of inpatient rehabilitation hospitals certified by Medicare as inpatient rehabilitation facilities ("IRFs"). IRFs provide hospital-level care that is significantly different in intensity, capacity, and outcomes from other post-acute care provided in non-hospital facilities. We appreciate the opportunity to provide input on CMS's collection of information associated with the proposed IRF Review Choice Demonstration ("RCD"). We trust that pursuant to CMS's obligations under the Paperwork Reduction Act of 1995 ("PRA"), CMS will carefully consider each of the issues raised in this letter.

CMS INCONSISTENCES

We have identified a number of inconsistences with CMS's proposed collection of information for the new IRF RCD. First, the "Review Choice Demonstration for Inpatient Rehabilitation Facility Services" instrument, for which CMS is seeking approval from the Office of Management and Budget ("OMB"), states that IRFs' resubmissions under the RCD will need to include a post-admission physician evaluation ("PAPE"). However, CMS recently removed the PAPE requirement from the IRF documentation regulation for all IRF discharges on or after October 1, 2020./1

Accordingly, under the PRA, there is no "practical utility" for CMS to collect the information contained in the PAPE./2

Second, we are disappointed that CMS appears to be contemplating an imminent implementation of the IRF RCD. We believe that CMS's sudden implementation of the RCD is inconsistent with CMS's recent actions for other health care programs. For example, CMS recently issued rules containing new pre-authorization requirements for Medicaid, Medicaid managed care, and the Children's Health Insurance Program.

These new authorization requirements would not apply until 2024. Although CMS is not proposing a pre-authorization requirement for IRFs, 100% pre-claim review will have a similar effect on limiting access to the IRF level of care. Yet, CMS is not delaying the start of this claim review, which would offer IRFs the opportunity to take needed actions to meet the significant burden the RCD will impose (e.g., hiring additional staff to complete record requests, upgrading computer systems to track RCD submissions, etc.).

Third, we believe that the process for pre-claim review under the RCD is inconsistent with CMS's requirements for completion of the individualized plan of care. The IRF documentation regulation requires IRFs to complete an individualized plan of care within 4 days of a patient's admission to the IRF./3

However, the IRF RCD instrument requires that IRFs provide the individualized plan of care with all pre-claim submissions. CMS is proposing that the MACs will have 5 business days to make a determination on a preclaim review request. Due to this 5-business day wait, it will essentially become a requirement that IRFs complete the individualized plan of care immediately upon a patient's admission because IRFs will need to know the MAC's determination as soon as possible. Requiring completion of the plan of care in this manner conflicts with the 4day time period in the regulation. Moreover, such quick completion of the plan of care is inconsistent with the intent of the individualized plan of care. This document is supposed to be completed with input from the IRF's interdisciplinary care team.

However, under the IRF RCD, the short timeframe provided by CMS will limit the ability of IRFs to obtain meaningful input from the interdisciplinary care team, to urgently complete this document so that it can be submitted to the MAC.

Finally, we are concerned about the inconsistencies in CMS's justification for the IRF RCD. CMS claims that the IRF RCD is necessary due to the high rates of improper payments to IRFs. However, any references to IRF improper payments or high rates of denials of IRF claims by the MACs and other Medicare contractors fail to account for the successful appeals that IRFs prosecute through the agency's claim review process.

IRFs have significant success in overturning the initial denials when IRFs appeal by submitting redeterminations, reconsiderations, and requests for hearings before ALJs.

Thus, CMS's justification for the IRF RCD is based on data that is overstated and inconsistent with the agency's final decisions regarding IRF claims.

IRF RCD REVIEW AND APPEALS PROCESSES

The PRA requires CMS to consider whether the collection of information for the IRF RCD will have a practical utility and whether the burden can be minimized./4

Based on these requirements, we believe that CMS must consider how it can reduce the burden on IRFs. First, as noted above, we are extremely concerned about the RCD's 5business day review period for the MACs to evaluate pre-claim review submissions.

Based on this 5-business day period, the review period will almost always include two additional days--Saturday and Sunday. If the MAC decides to reject the admission after the 5-business days, many IRF patients will have already completed a significant portion of their intensive rehabilitation program by the time the IRF receives the MAC's rejection. Thus, CMS must revise the review period so that MACs are required to provide a response on the same day of the IRF's submission (i.e., within 12 hours of receipt). CMS should also require that the MACs are capable of providing responses to the IRFs 24 hours a day, 7 days a week. This is necessary because if the MAC decides to deny the admission, the IRF will need to immediately begin the referral and transfer process. It is therefore vital that IRFs have as much notice as possible regarding the need to transfer the patient. This is especially true right now during the COVID-19 pandemic as short-term acute care hospitals sometimes become overwhelmed with patients and must divert patients to other facilities.

Second, CMS must include a robust appeal process that is capable of providing rapid reconsiderations of the MAC's initial decision to deny the admission. The appeals process should be completed within 48 hours of the IRF's request. If the MAC does not meet this deadline, we believe that the appeals process should include the ability to seek expedited external review of the MAC's initial decision by an independent review organization ("IRO") or an administrative law judge ("ALJ"). IRFs should also have the option of a peer-to-peer discussion between the MAC's medical director and the IRF's rehabilitation physician regarding the medical necessity of the patient's admission to the IRF.

ACCESS TO IRF SERVICES

We are concerned that the IRF RCD may reduce beneficiary access to IRFs and have a chilling effect on new referrals for IRF services. Specifically, the RCD process may lead to inappropriate discharges of patients based on the MAC's pre-claim review determination. Such determinations may be based an individualized plan of care that was not as fully developed as it would have been prior to the IRF RCD, because the IRF needed to submit the plan of care as soon as possible to the MAC rather than completing the document during the 4-day period allowed by the regulation. Moreover, the MAC's review of the documentation may not always provide the full picture of the patient's functional status as compared to the medical decision making of the rehabilitation physician that has determined the patient's need for IRF services based on the physician's bedside care for the patient. If patients are discharged too early based on the MAC's determination, there could be risks of medical complications and readmissions to short-term acute care hospitals.

FRAUD DETECTION

CMS is proposing to implement the IRF RCD pursuant to its fraud demonstration authority at 42 U.S.C. Sec. 1395b-1(a)(1)(J). We do not believe the IRF RCD is an appropriate use of this fraud authority. There is no indication that the IRF sector as a whole, or even significant segments of the IRF sector, are engaging in widespread Medicare fraud. The improper payment rate percentages cited by CMS are not signs of widespread fraud by IRFs. Rather, many improper payments occur simply due to the difficulty in applying CMS's extensive documentation requirements for IRFs. In other words, IRFs are providing medically necessary services to beneficiaries, but claims may be denied due to differing interpretations of the documentation requirements by MACs and their claim reviewers. Instead of targeting all IRFs through this demonstration, CMS should instead focus on any "bad apples" where CMS has documented evidence of fraudulent Medicare claims. This would ease the burden on IRFs overall, so that patient access is not unnecessarily limited, while still allowing CMS to identify and prevent actual fraud that may exist.

We note that CMS is proposing to implement the IRF RCD based on CMS's experiences with other types of providers, including home health agencies ("HHAs") and durable medical equipment ("DME") suppliers. However, IRFs are very different from those types of providers. IRFs are licensed and accredited inpatient hospitals. IRFs are also subject to the hospital conditions of participation. As a result, IRFs operate according to a sophisticated set of internal controls to meet much higher program standards than HHAs and DME suppliers. It is unreasonable for CMS to expand its fraud demonstration for home health agencies to the IRF setting. Unlike an HHA or DME supplier, not just anyone can decide to open an IRF, obtain a Medicare provider agreement, and provide services to Medicare beneficiaries.

BURDEN ON IRFS

The purpose of the PRA is to reduce the paperwork burden on the public, including small businesses. We are concerned about the significant paperwork and financial burden that the proposed RCD will place on IRFs. As currently proposed, the IRF RCD will threaten IRFs' revenue cycles as IRFs are forced into the lengthy appeals process (i.e., redeterminations, reconsiderations, and ALJ hearings) if the MAC denies the IRF's RCD submission. IRFs will need to spend considerable resources to locate, review, and provide medical records and other documentation to the Medicare contractors, for both the initial documentation submission and any appeals following MAC denials.

CMS has also severely underestimated the amount of time (30 minutes) that it will take IRF staff to complete a single IRF RCD submission. Staff will have to review lengthy medical records and consult with clinical staff at the IRF to identify the facts and documentation that best support the medical necessity of the admission. This is essentially the same process that IRFs undertake to develop an appeal following a denied Medicare claim, except it will need to happen under the highly abbreviated timeframe of the IRF RCD. As currently proposed, IRFs will need to complete this process for each and every claim. Over the last 13 months, our IRFs admitted nearly 25,000 patients. Not only is the additional financial burden from the RCD's collection of information plainly unreasonable, it will sap resources from clinical staff who should instead be providing patient care.

Importantly, this additional burden will come at a time that IRFs are already strained from the COVID-19 pandemic. IRFs have supported their communities by partnering with short term acute care hospitals to respond to surges of COVID-19 patients. When surges occur, IRFs are capable of providing a much higher level of care than other provider types that have assisted with the COVID-19 response (e.g., SNFs and nursing homes) because IRFs are Medicare-certified hospitals. It is not rational for CMS to choose the COVID-19 pandemic as the time to implement a 100% pre-claim or post-claim review of all IRFs admissions under this new demonstration. Congress and CMS waived many of the IRF coverage and documentation requirements for the duration of the COVID-19 Public Health Emergency. Therefore the IRF RCD will not review typical IRF patients. CMS simply will not capture an accurate assessment of IRF performance during this time.

MAC EXPERTISE TO MAKE IRF COVERAGE DECISIONS

We are concerned that the MACs do not have the capabilities and expertise needed to make the medical determinations regarding IRF admissions on the wide scale contemplated by the IRF RCD. The RCD will require the MACs to conduct a medical review on every single IRF claim in the demonstration area. CMS should not implement the IRF RCD unless it first requires and publicly confirms that the MACs have nurse reviewers who possess the same level of expertise and qualifications as the IRF nurses who assist with completion of the IRF pre-admission assessment and screening. MAC reviewers must have expertise in the intensive rehabilitation programs provided by IRFs. In addition, the IRF RCD should not be implemented unless CMS requires MACs to have medical directors with experience that is equivalent to the IRF director of rehabilitation--two years of training or experience in the medical-management of inpatients requiring rehabilitation services./5

CONCLUSION

For the reasons discussed above, we are deeply concerned that the proposed IRF RCD, including its collection of information, will cause a significant burden on IRFs without any meaningful practical utility for CMS. Accordingly, CMS should discontinue implementation of this new demonstration. At the very minimum, CMS must wait until IRFs have recovered from the COVID-19 pandemic and returned to more normal operations with typical IRF patients (i.e., at least 2 years after the conclusion of the Public Health Emergency) before CMS considers implementing the IRF RCD. Rather than implementing this sweeping demonstration that will significantly burden all IRFs in the demonstration areas, we recommend that CMS partner with IRFs and associations representing IRFs (e.g., the American Hospital Association and the American Medical Rehabilitation Providers Association) to better educate IRFs on Medicare admission requirements and identify any "bad apples" that are actually engaged in submitting fraudulent claims for payment to the Medicare program.

We appreciate the opportunity to express our comments and concerns regarding CMS's proposed collection of information for the IRF RCD. We look forward to working with CMS on improving the IRF payment system in accordance with these comments.

Sincerely,

Brad Hollinger

Chairman and Chief Executive Officer

Vibra Healthcare and Ernest Health

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Footnotes:

1/ FY 2021 IRF PPS Final Rule, 85 Fed. Reg 48,424, 48,446 (Aug. 10, 2020) ("After consideration of the comments we received, we are finalizing our proposal to remove the post-admission physician evaluation documentation requirement at Sec. 412.622(a)(4)(ii) beginning with FY 2021, that is, for all IRF discharges beginning on or after October 1, 2020.").

2/ 44 U.S.C. Sec. 3506(c)(2)(A)(i).

3/ 42 C.F.R. Sec. 412.622(a)(4)(ii)(A).

4/ 44 U.S.C. Sec. 3506(c)(2)(A).

5/ See 42 C.F.R. Sec. 412.29(g)(4).

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The notice can be viewed at: https://www.regulations.gov/document/CMS-2020-0159-0001

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