DaVita Comments on Medicare, Medicaid, and Children's Health Insurance Program

WASHINGTON, Nov. 23 -- LeAnne Zumwalt, group vice president of purchasing and public affairs at the DaVita Inc, Denver, Colorado, has issued a public comment on the Centers for Medicare Medicaid Services's rule entitled "Medicare, Medicaid, and Children's Health Insurance Programs: Program Integrity Enhancements to the Provider Enrollment Process". The comment was written on Nov. 4, 2019, and posted on Nov. 22, 2019:

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DaVita Inc. and its related companies and subsidiaries ("DaVita") appreciate the opportunity to submit comments in response to the final rule for Medicare, Medicaid and CHIP Program Integrity Enhancements (the "Final Rule"). DaVita serves hundreds of thousands of Medicare beneficiaries in the dialysis setting for ESRD patients. We applaud the Centers for Medicare and Medicaid Services ("CMS") efforts to improve program integrity, and decrease fraud, waste and abuse. We have significant concerns, however, that the actions taken by CMS in the Final Rule to effectuate such goals could dramatically increase the burden and costs for legitimate, compliance-focused healthcare providers and suppliers (collectively, "Providers") without achieving the primary goal of preventing "bad actors" from continuing to abuse the Medicare and Medicaid programs. This appears contrary to this Administration's oft-stated focus on putting "patients over paperwork," as the administrative burdens created by this rule will force providers to utilize resources that could be used to care for patients on the paperwork compliance with new reporting requirements will require.

Although we fully understand CMS' need to bolster program integrity, this effort should not come at a severe cost to Providers striving to furnish high-quality, legitimate and necessary care to beneficiaries across the country. It is unreasonable to require Providers to report information that is impossible to accurately collect when CMS already possesses the data in its Provider Enrollment, Chain and Ownership System ("PECOS"). As demonstrated throughout our comments, we believe, through PECOS, CMS has the tools to achieve the stated program integrity goals without significantly increasing the compliance burden on Providers. We do not inherently object to enhanced denial and revocation rights in connection with Provider affiliations that cause undue risk, but we believe there are more efficient and equitable means to protect Medicare, Medicaid and CHIP (collectively, "the Programs").

We urge CMS to reconsider its position and adopt rules which are more consistent with its statutory mandate:

A provider of medical or other items or services or supplier who submits an application for enrollment or re-validation of enrollment in the program under this title, title XIX, or title XXI on or after the date that is 1 year after the date of enactment of this paragraph shall disclose (in a form and manner and at such time as determined by the Secretary) any current or previous affiliation (directly or indirectly) with a provider of medical or other items or services or supplier that has uncollected debt, has been or is subject to a payment suspension under a Federal health care program (as defined in section 1128B(f)), has been excluded from participation under the program under this title, the Medicaid program under title XIX, or the CHIP program under title XXI, or has had its billing privileges denied or revoked./2

This statutory mandate does not require such onerous changes as those in the Final Rule. We ask that CMS reconsider its mandate in light of the tremendous burden imposed on Providers. We also hope CMS considers the negative impact that this Final Rule could have on access to care by encouraging legitimate Providers to exit the Programs or causing denials or revocations for such Providers following inadvertent errors or unknowing failure to report errors of affiliates.

I. DISCLOSURE OF AFFILIATIONS

A. Definitions

We continue to advocate that CMS limit the proposed definition of affiliation/3 ("Affiliation(s)") because it is overly broad and will require Providers to go to extreme lengths to determine whether it, or any of its owning or [managing employees or organizations] has or, within the previous 5 years, has had an Affiliation with a currently or formerly enrolled Medicare, Medicaid or CHIP provider or supplier that has or had a Disclosable Event (as defined herein).

In order to remain compliant with the proposed reporting obligations, Providers must initially catalogue all Affiliations of its owners and managing employees/organizations within the previous 5 years. A Provider would have to identify all of its Affiliations regardless of whether the Affiliation was with an organization/individual who is currently or was formerly enrolled in Medicare, Medicaid or CHIP. Then, after collecting all of the data surrounding Affiliates, the Provider must determine whether any of such Distant Affiliates has or has ever had any of the following "Disclosable Events":

(1) Currently has an uncollected debt to Medicare, Medicaid or CHIP, regardless of the following: (i) The amount of the debt; (ii) Whether the debt is currently being repaid; (iii) Whether the debt is currently being appealed;

(2) Has been or is subject to a payment suspension under a federal health care program (as that term is defined in section 1128B(f) of the Act), regardless of when the payment suspension occurred or was imposed;

(3) Has been or is excluded from participation in Medicare, Medicaid or CHIP, regardless of whether the exclusion is currently being appealed or when the exclusion occurred or was imposed; or

(4) Has had its Medicare, Medicaid or CHIP enrollment denied, revoked or terminated, regardless of the following: (i) The reason for the denial, revocation or termination; (ii) Whether the denial, revocation or termination is currently being appealed; (iii) When the denial, revocation or termination occurred or was imposed.

Finally, after initially gathering this data - some of which will be based on representations from Affiliates, because Providers have no way of independently verifying - the Provider must maintain, regularly update and verify the data - including for Affiliates for which it no longer maintains a relationship with. Obtaining, tracking, and maintaining this information will be very difficult, especially for providers and suppliers with complex ownership structures, such as chain home organizations. As demonstrated in this comment, this tedious reporting scheme, aimed at bad actors defrauding the Programs, will primarily harm legitimate, well-intentioned Providers because even if they dedicate significant resources to this data compilation, due to the enormity and impossibility of the task, they will never be able to report with confidence that they are in compliance.

B. Proposal

While we understand CMS' goals, requiring all Providers to collect data on whether any Affiliates have suffered a Disclosable Event is overly burdensome and often impossible to achieve accuracy, duplicative of existing resources and will not significantly improve CMS' ability to protect program integrity. The proposal also exceeds the statutory mandate described above, which only requires a Provider to report any affiliation with a Provider which has a re-portable event. Rather than requiring Providers to gather data on Affiliates, we recommend CMS focus instead on ensuring the accuracy of the data Providers are already required to enter into PECOS regarding relationships with their Affiliates, and to improving the performance of the PECOS system to accurately capture and compile that data.

All Providers enrolling in the Medicare Program must complete a CMS-855 form containing extensive data on the Provider, its practice locations, owners, officers, managing employees (all of which are Affiliates) and whether any of such individuals or organizations have had a Final Adverse Action, including convictions, exclusions, revocations and suspensions. This information is contained in PECOS and could be referenced by all Medicare Administrative Contractors ("MACs") and CMS. To the extent CMS believes PECOS could benefit from enhancements which allow it to more easily reference and review affiliations (which we strongly agree that it can), we would encourage CMS to make these enhancements, as they could improve program integrity.

In fact, specific Final Adverse Actions reported by an individual or organization are automatically associated with the reporting individual's or organization's Social Security Number or Employer Identification Number. When a Final Adverse Action is reported for such individual/organization either by that individual/organization, a MAC or CMS, it is automatically added to the enrollment record for any Provider who reported that individual/organization as an owner, officer, director or otherwise having control over the Provider. As a result, CMS is immediately able to determine if a Provider has an Affiliate with a Final Adverse Action. There is no reason this same function cannot be used for collection of Disclosable Events.

To illustrate using one of CMS' examples, "suppose a revalidating Medicare provider ["Provider A"] has three owners: A, B, and C. Owner A had an affiliation 30 months ago with a revoked Medicare provider. Owner B had an affiliation 2 years ago with a terminated Medicaid provider. Owner C currently serves as a management company for a CHIP provider with an uncollected debt. Each of these three affiliations would have to be disclosed on the re-validating provider's Form CMS-855 application."/4

Under the contemplated scheme, Provider A would have to report that its Affiliates had affiliations which had a Disclosable Event. The above example seems reasonably easy to report, but is much more complicated in real life. Assume that Owner A only owns 5% of Provider A. It is disclosable as an owner, but clearly does not possess a significant interest in Provider A. If Owner A owns a minority interest in 10 other Providers, Provider A will have to collect data on each Affiliation, confirm none have had a Disclosable Event and regularly monitor this to maintain its own compliance in the Programs. This is all because one of its minority owners has a small ownership in other Providers, with which Provider A has no direct relationship or interest. This reporting scheme of Affiliations and Disclosable Events is well beyond the statutory mandate and creates an impossible compliance standard for Provider A, all for information that CMS already has available through PECOS but to which Provider A has little or no meaningful access. Requesting duplicative information from Providers is unreasonable and unduly burdensome. If it doesn't feel it has all the information it needs on each Provider, CMS can expand the questions asked on the CMS 855 of individuals and organizations with ownership/control in each Provider to include Disclosable Events. This will ensure CMS is able to rely upon such data in making determinations with regard to program integrity.

C. Reporting of Affiliations

The Final Rule indicates that a Provider must report all current Affiliations or Affiliations within the previous 5 years when initially enrolling or re-validating enrollment with currently or previously enrolled Providers which suffered a Disclosable Event.

CMS' current proposal requiring disclosure of Affiliations within the previous 5 years is overly broad. While we understand CMS' intent to capture prior Affiliations of Providers in order to determine whether the relationship between the enrolling Provider and the Affiliation creates undue risk for the Medicare program, CMS already has tools at its disposal to track, monitor and consider such information; provided, the applicant honestly completes the CMS-855. If the applicant intends to circumvent the system by inaccurately reporting ownership/control information, then it does not matter how many questions are asked as no level of "required" reporting will ensure Medicare is able to prevent undue risk. It will simply make it more difficult for legitimate, compliance-minded actors to comply with disclosure requirements. As such, CMS should limit reporting of prior Affiliations to only those Affiliates for which CMS can show it does not otherwise have the information available. In this way, the rule would follow the statutory requirement for providers to report prior Affiliations, but in a manner that does not unduly burden providers and suppliers to investigate and report information they generally cannot access but that CMS already possesses.

Also, Providers should only be required to disclose Affiliations with other providers who were enrolled or attempted to enroll during the period in which the affiliation occurred ("Affiliation Period") or were enrolled in Medicare or Medicaid prior to the Affiliation Period./5

If the Affiliate was not enrolled during or prior to the Affiliation Period, the Provider would have no reason to believe that it suffered a Disclosable Event, and would not collect or monitor whether such Affiliate suffered a Disclosable Event.

The Final Rule standard sets up Providers for failure.

With respect to past Affiliations, Providers should have to disclose only whether the Provider or an Affiliate had a Disclosable Event during the Affiliation Period. Mandating the disclosure of a prior Affiliate's Disclosable Events which occurred after the Affiliation Period puts Providers in the impossible position of having to obtain information from prior Affiliates to determine if, since after the Affiliation Period, the Affiliate suffered a Disclosable Event. The Affiliate may have no relationship to the Provider (e.g., the Affiliate is the Provider's current managing employee's past employer and the Provider has no means of obtaining or verifying the information). This is an arduous task for even the most sophisticated of organizations and will require significant effort to catalogue data on when specific Affiliations ended and whether the prior Affiliate suffered a Disclosable Event following the Affiliation Period. This impossible collection is only part of the problem--the reporting Provider has no ability to determine the accuracy of the information for reporting purposes and the failure to accurately report creates significant denial and revocation risk, as discussed below. By including this new requirement, CMS sets Providers up to fail even in the most dedicated efforts at compliance, and will likely result in revocation or termination for undeserving, legitimate Providers.

In fact, one of CMS' own examples demonstrates the complications of reporting past Affiliations: "Ambulance Company X had a limited partnership interest in a Medicaid provider (the affiliated provider) between February 2015 and April 2015. The affiliated provider voluntarily terminated its Medicaid enrollment in May 2015. In June 2015, the state notified the affiliated provider that it had a large Medicaid over-payment that must be repaid. In September 2017, Ambulance Company X is enrolling in Medicare for the first time. The affiliated provider's debt is still outstanding. Ambulance Company X must report the affiliation as part of its initial Medicare enrollment because--(1) it had a partnership interest in an affiliated Medicaid provider; (2) the formerly enrolled Medicaid provider has an uncollected debt; and (3) the affiliation occurred within the previous 5 years."/6

Under this example, CMS will require Ambulance Company X to contact an organization that it had a limited partnership interest in to confirm it has not had a Disclosable Event since the Affiliation Period ended. The affiliated provider, which was voluntarily terminated, may no longer exist, and there may be no individual whom the Ambulance Company X may contact to obtain any information. This is an impossible task for CMS to require of Ambulance Company X. By limiting Provider's disclosure burden, CMS does not jeopardize its ability to protect the Programs from undue risk.

As this example demonstrates, the Final Rule requires Providers to seek, maintain and keep current an extremely broad range of information on Affiliations and Disclosable Events that is nearly impossible for the Provider to obtain--yet CMS already has direct access to that information. If the Provider makes a mistake in this reporting, which will assuredly occur, CMS can revoke or deny the Provider's enrollment.

This "gotcha" result is both unfair and wholly unnecessary for legitimate Providers trying to achieve compliance and irrelevant to bad actors whose current and future reporting will remain intentionally false without regard to current rules or the Final Rule.

D. Method of Collecting Information on Affiliations

The Final Rule requests comments on how CMS should collect the information - which it admits will be burdensome - from Providers. We propose that CMS should mine the data it already has in PECOS from Providers and use that to trigger additional information requests based on risk presented in information on file. This is what CMS proposes to do for the first year, and we think it is the most efficient and least redundant permanent path to accomplish the stated goals.

CMS could also go further and publish information it already has on Providers' Disclosable Events (most of which Providers don't have access to, like uncollected debt) to put Providers on notice of the potential risks of associating with those Providers. To not be transparent with the information it already has on file to help Providers avoid Affiliations that could increase risk seems counter to CMS' mandate to reduce fraud & abuse.

If CMS must require affirmative reporting on Affiliates, it should stagger the requests, starting with the Providers it has already identified as being high risk - whether that is an individual Provider determination of "High" or "Highest" Risk on the OIG's Fraud Risk Indicator, or its determination that a certain provider-type is high risk. Those Providers should be targeted with the new information requests at their next Re-validation, but given advance notice and significant time to compile the data and respond. CMS can fulfill its statutory mandate by acting on the information provided by that tranche of Providers, which will inevitably lead it to take action on risky Providers connected through Affiliation. Once that cycle is complete, CMS should use the learnings of that data collection - including actual burden, Provider resources required to comply, CMS resources required to process, and impact on ability to target fraud, waste and abuse - to refine its proposal for a broader data collection process, through Initial Enrollments or Re-validations, thus limiting the burden on the more compliance-focused Providers.

II. ACCESS TO CARE CONSIDERATIONS

As a conclusion to our more specific comments, we ask CMS to consider the potential impact the Final Rule will have on access to care. Increasing reporting obligations, compliance costs and penalties for failing to comply with these requirements will inevitably lead to increased revocations and denials of well-intentioned Providers simply due to inadvertent errors. Providers must ultimately rely on people to assist in monitoring compliance, and unintentional human errors frequently occur. If these errors lead to revocations and denials, it will result in reduced access to care for communities which need care the most.

It will also cause more organizations to not participate in the Programs because the costs and risks are not worth ever decreasing reimbursement margins. This will harm some of the most at risk populations: the elderly, poor, disabled and children. While we recognize CMS must implement reasonable mechanisms to protect program integrity, this should not come at the detriment of the Programs as a whole.

Sincerely,

LeAnne Zumwalt

Group Vice President

Purchasing and Public Affairs

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Footnotes:

1/ 84 Fed. Reg. 47794 (Sept. 10, 2019).

2/ 42 U.S.C. Sec. 1395cc(j)(5)(A).

3/ Affiliation includes: (1) A 5 percent or greater direct or indirect ownership interest that an individual or entity has in another organization; (2) A general or limited partnership interest (regardless of the percentage) that an individual or entity has in another organization; (3) An interest in which an individual or entity exercises operational or managerial control over or directly or indirectly conducts the day-to-day operations of another organization (including, for purposes of this provision, sole proprietorships), either under contract or through some other arrangement, regardless of whether or not the managing individual or entity is a W-2 employee of the organization; (4) An interest in which an individual is acting as an officer or director of a corporation; and (5) Any reassignment relationship under Sec. 424.80.

4/ 81 Fed. Reg. 10720, 10725 (March 1, 2016).

5/ One of CMS' own examples demonstrates the difficulty of tracking affiliations with non-enrolled organizations. Provider A in the example would have no reason to believe the Affiliated provider would ever enroll in Medicare. "To illustrate, assume Provider A sold its 30 percent interest in an affiliated provider in January 2016. In March 2016, the affiliated provider enrolled in Medicare yet had its enrollment revoked in September 2016. In April 2017, Provider A applied for Medicare enrollment. If we limited the reporting of affiliations to periods when the affiliated provider was enrolled in Medicare, Medicaid or CHIP, Provider A would not have to report--and we would perhaps not learn of--its relationship with a provider that was revoked only 8 months after the affiliation ended. We believe that such information would be valuable in helping us determine whether the affiliation poses an undue risk of fraud, waste or abuse."

6/ 81 Fed. Reg. 10727

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The rule can be viewed at: https://www.regulations.gov/document?D=CMS-2016-0031-0059

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