The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Uncategorized

Updates on Third Party Involvement in Litigation Funding for FCA Cases

By David Pivnick, Brett Barnett and Sarah Ahmed

On January 27, 2020, Deputy Associate Attorney General, Stephan Cox, provided key note remarks at the 2020 Advanced Forum on False Claims and Qui Tam Enforcement. In his remarks, Mr. Cox noted that the Department of Justice (“DOJ”) recovered over $3 billion from False Claims Act (“FCA”) qui tam actions in the past fiscal year.

In his speech, Mr. Cox stated that the DOJ was “considering what, if any, interests the United States has with respect to third-party litigation financing in qui tam litigation,” also noting if it is worth seeking disclosure of qui tam litigation arrangements. Specifically, Mr. Cox was referring to the status of funding from third-parties in relation to qui tam complaints.  Later this year, on June 30, 2020, Ethan Davis, the principal deputy assistant attorney general, delivered remarks on the FCA, mirroring some of the sentiments Mr. Cox had previously alluded to. A few key takeaways are as follows:

New Questions for DOJ Attorneys to ask Relators. Davis noted that since qui tam FCA cases are brought in the name of the United States, the United States has an interest in knowing who is behind those cases. For that reason, DOJ attorneys have been instructed to ask the following questions at each relator interview:

    1. Whether the relator or his or her counsel has any agreement with a third-party funder. If yes, then the following questions will also be asked:
    2. Identity of the funder;
    3. Whether the relator has shared information relating to the qui tam allegations with the funder;
    4. Whether a written agreement exists; and
    5. Whether the agreement entitles the funder to exercise any direct or indirect control over the relator’s litigation or settlement decisions

The DOJ will also ask the relator to inform them if answers to the questions highlighted above changes at any point over the course of litigation.

DOJ May Dismiss Increased Numbers of Cases. The DOJ may move to dismiss qui tam actions brought by relators who have entered into agreements with third-party funders. Although the DOJ did not dismiss many qui tam actions in the past, since the publication of the January 2018 Granston Memorandum, the DOJ has been aggressive in dismissing qui tam cases if dismissal were to advance government interests, preserve government resources, and avoid adverse precedent.

OIG, Stark Law

HHS Extends Timeline to finalize Stark Law Changes and CMP Inflation Rule

By Timothy Fry and Gretchen Townshend

In the last two weeks, the U.S. Department of Health and Human Services (HHS) published two notices in the Federal Register delaying the publication of certain final fraud and abuse rule reforms for up to a full year. First, in the Aug. 27 Federal Register, the Centers for Medicare & Medicaid Services (CMS) delayed the issuance of a final rule on eagerly anticipated reforms to the federal physician self‑referral law (the Stark Law) regulations. This rule has been expected to provide key clarifications to the strict liability Stark Law statue that prohibits physicians from referring certain healthcare services to an entity with which the physician has a financial relationship unless that financial relationship meets technical exceptions to the law. That delay was followed by a second notification in the Sept. 8 Federal Register continuing and extending a current interim rule for the Civil Monetary Penalties (CMP) inflation adjustment. Here are four key things for healthcare providers to know from these two HHS deadline extensions:

1. Providers will want CMS to finalize the Stark Law rule as soon as possible. CMS extended the date for publication of its Stark Law final rule until August 31, 2021, due to “the complexity of the issues raised by comments received on the proposed rule.” Healthcare providers supported many of these proposed changes as the CMS proposed changes, on balance, eased the regulatory burden on providers by revising or adopting new definitions for key terms used throughout various Stark Law exceptions, and proposing new exceptions to the law including for EHR donations, value-based arrangements and certain short-term financial relationships, as discussed in McGuireWoods Alerts dated 1, 2019, Nov. 7, 2019 and Nov. 22, 2019. It is, however, important for providers to note that certain other proposed reforms, such as finalizing changes to the group practice definition profit sharing rules, could require some providers to restructure their financial relationships upon the implementation of the new rules. As such, it is hoped that CMS can finalize the rule sooner than its new deadline. While CMS found it necessary to announce a delay from their previously announced Aug. 2020 release timeframe, the notice did not state that the agency would actually take the full additional year to finalize the reforms. The federal Office of Management and Budget (OMB) has been reviewing a draft of the final rule since July (according to its regulatory dashboard), which may mean the rule is close to release notwithstanding this announcement.

It is hoped that CMS can finalize the rule sooner than its new deadline.

2. CMS’ delay likely also applies to the Anti-Kickback Statue (AKS) final rule. As discussed in an 10 client alert, HHS’s Office of Inspector General (OIG) announced its significant reforms to the AKS and CMP regulations on the same day CMS announced its amendments to the Stark Law regulations. HHS intended the proposed rules to both AKS and Stark Law to work together to incentivize value based arrangements and patient care coordination by expressly permitting certain activities that could be deemed problematic under the current laws. OIG’s proposed changes to the AKS and CMP regulations generally tracked those in the CMS proposed rule, particularly with respect to value-based arrangements, deviating only to reflect differences in the scope of the three laws. OIG and CMS have joined to discuss the proposed rules collectively with stakeholders, such as during an Oct. 24, 2019, AHLA webinar. OMB received final rules from both CMS and OIG on July 21, 2020. Therefore, while OIG has not announced an extension on its final rulemaking as discussed in 1 above, CMS’s announcement will likely mean a similar delay for the OIG final rule addressing the AKS and CMP regulations. We anticipate both final rules stemming from HHS’s Regulatory Sprint to Coordinated Care to be issued on the same day, and OMB is unlikely to approve the AKS changes to value-based arrangements without also signing off on the Stark Law changes.

3. CMP inflation extension likely will not have a substantive effect for providers. HHS and CMS also announced a one-year continuation through Sept. 6, 2021, of its interim final rule with respect to annual CMP inflation adjustments, after a similar 6-month extension earlier this year. The interim final rule was first published Sept. 6, 2016, to adjust CMP civil penalties annually for inflation as required in the Federal Civil Penalties Inflation Adjustment Act and Improvement Acts of 2015. We most recently discussed these annual inflation adjustments to the CMP civil penalties in a 18, 2019 FCA Insider post, particularly how the fines apply to various fraud and abuse conduct, such as violations of the Stark Law and AKS, beneficiary inducement violations, submission of false claims, and other prohibited conduct. HHS explained that this second continuation was necessary due to the extenuating circumstances of the 2019 novel corona virus (COVID-19) pandemic. This further extension also comes after CMS discovered that it had “inadvertently missed setting a target date for the final rule to make permanent the changes to the Medicare regulations” for CMP inflation adjustments after its 2016 interim final rule necessitating the earlier extension. Until the interim final rule is finalized, we expect CMS to announce its annual inflation adjustment in Nov. 2020 under the interim final rule. In addition, providers should remember that while such CMP civil penalties exist for government enforcement, whistleblowers continue to begin most enforcement actions under these regulations through the federal False Claims Act.

4. These extensions likely suggest continued workload burdens. Earlier this summer, we discussed how the announced Stark Law 2019 settlements continued a downward trend. In that FCA Insider post, we speculated that federal fraud and abuse regulatory staff workload may lead to a decline in Stark Law self-disclosure settlements despite a potential increase in filings, and noted, how if that was the case, COVID-19 would likely further reduce settlements in 2020. In our discussion, we noted that the reduction in announced settlements is likely due to staff shifting their focus and efforts on the Stark Law proposed reforms discussed above, a new Stark Law advisory opinion process (as detailed by McGuireWoods), as well as certain COVID-19 Stark Law waivers discussed on FCA Insider on May 2, 2020 and April 4, 2020. It is possible that the need to extend the time period for finalizing these rules suggest similar workload burdens as staff focus on necessary emergency needs with respect to COVID-19 rather than finalizing these reforms. On the other hand, as noted above, CMS and OIG have sent their reform suggestions to OMB and OMB is currently reviewing, which may suggest the rules are ready. We will continue to monitor these rulemaking processes to see if this could be part of a wider trend based on the current federal workload as regulators look to adjust fraud and abuse rules.

McGuireWoods will continue to monitor HHS and CMS rulemaking to assist clients in navigating these critical fraud and abuse rules, and will provide additional guidance as they are finalized.

OIG, Regulatory

OIG Responds to Free/Discounted Lodging and Free Antibody COVID-19 Test Inquiries

By Timothy Fry, Jon Steinberg and Brett Barnett

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory flexibility to ensure necessary care responding to COVID-19, particularly with respect to the federal anti-kickback statute (AKS) and civil monetary penalty (CMP) beneficiary inducement prohibition provisions. OIG responses are publicly available through a frequently asked questions (FAQ) posting on the OIG COVID-19 portal. OIG has continued to update this FAQ since its initial publication, including those inquiries discussed in a May 13 post and a May 17 post, most recently providing guidance approving certain discounted lodging and free antibody testing arrangements:

  1. Oncology practice may provide free or discounted lodging to certain patients. Oncology practices often attract patients from a wide catchment area—with patients traveling for chemotherapy or radiation treatment. To assist such treatment, nonprofits have developed free or discounted lodging programs near some of the largest cancer treatment facilities to assist financially needy patients, including federal health care program beneficiaries. An oncology practice questioned whether it could provide such free or discounted lodging to these beneficiaries in lieu of a nonprofit, in instances where the nonprofit has closed due to the COVID-19 public health emergency, or where the beneficiaries must travel due to treatment site closures because of the COVID-19 public health emergency. OIG opined that the oncology practice providing free or discounted lodging to financially needy Federal health care program beneficiaries posed a low risk of fraud and abuse so long as the following conditions are met:
    1. The patient resides at least 50 miles from the treatment site.
    2. The patient is an established patient of the oncology practice who had already scheduled treatment prior to the offer of free or discounted lodging.
    3. The patient’s physician determines that provision of free or discounted lodging would facilitate access to care while the patient is receiving treatment.
    4. The practice reasonably believes that the patient would have qualified for such free or discounted lodging from a nonprofit that is closed due to the COVID-19 public health emergency.
    5. Payment is in-kind, made directly to a hotel or motel and only for number of nights required for treatment.
    6. The hotel or motel is located in close proximity to the treatment site.
    7. The practice does not advertise or otherwise use the offer of free or discounted lodging for patient recruitment.
    8. The lodging is provided during the COVID-19 public health emergency.

Such limitations effectively only provides protection under the AKS and CMP to providers that are located near a pre-existing but closed nonprofit that was assisting patients with such lodging in the past. If a provider wanted to add such service during the COVID-19 public health emergency where there was not such a nonprofit, the provider would not have protection from this FAQ response. That said, such providers might have another option to structure such an arrangement. OIG noted that free or reduced-cost lodging could meet the Promotes Access to Care exception to the beneficiary inducement CMP, specifically pointing to their past guidance in OIG Advisory Opinion 17-01. Providers would still need to consider the AKS, but depending on the factual circumstances, additional flexibility max exist, particularly for oncology providers, to establish lodging programs during the COVID-19 public health emergency.

  1. Clinical laboratories may provide free COVID-19 antibody testing to patients who are undergoing other blood tests.

A clinical laboratory asked OIG whether it could provide free antibody testing to federal health care program beneficiaries (and other payor patients) in conjunction with other medically necessary blood tests performed by the laboratory. I.e., as part of a paid for blood test panel for other necessary care, could the laboratory also screen for COVID-19 antibodies. The laboratory told OIG that it would encourage those with positive antibodies to donate blood plasma containing COVID-19 antibodies. The laboratory would also make the results available to both patients and physicians, as well as report it to the Centers for Disease Control and Prevention (CDC) and state public health agencies. OIG opined that providing free COVID-19 antibody testing to patients already undergoing other medically necessary blood tests poses sufficiently low risk of fraud and abuse so long as the following safeguards are employed:

  1. The physicians ordering the tests do not receive remuneration from the clinical laboratory in connection with the free antibody-testing program.
  2. The patients receiving the tests do not receive remuneration from the clinical laboratory in connection with the free antibody-testing program.
  3. The tests are only offered to patients receiving other medically necessary blood tests.
  4. No payor, including the patient, a commercial insurance company, or a federal health care program, is billed for the antibody tests.
  5. The antibody tests are approved by the U.S. Food and Drug Administration (FDA) or are subject to an FDA-issued Emergency Use Authorization.

OIG further clarified that it views the provision of the free antibody testing as a sufficiently low risk of fraud and abuse because of the corresponding benefit to public health. The antibody testing would identify patients whose blood plasma contains COVID-19 antibodies, which may be donated and used for experimental treatments. Further, the reporting to the CDC and state public health agencies aids those entities in tracking the spread of COVID-19. This position suggests that OIG could negatively view a similar arrangement where the tests were not used to promote blood plasma donation or reported to the CDC or state public health agencies, even if the other safeguards are employed. In such a situation, OIG could view the antibody testing to violate the CMP as a free or discounted service to a federal health care program beneficiary.

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McGuireWoods will continue to monitor OIG’s release of further FAQs as additional providers utilize this inquiry mechanism. Providers may welcome the flexibility provided by OIG exercising enforcement discretion during the COVID-19 pandemic, recognizing the statements do not bind all investigative bodies who could take a different view. OIG will likely continue to require such arrangements to end at the end of the COVID-19 public health emergency declaration, and therefore, providers should plan for the post-pandemic period depending on the arrangement when utilizing these statements.

McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.

Defense Arguments, FCA Litigation

Sixth Circuit Holds Qui Tam Plaintiff a Government “Agent” for Public-Disclosure Bar

By David Pivnick, Brett Barnett and Timothy Fry

A recent Sixth Circuit opinion continues to “snuff [ ] out parasitic suits” brought under the False Claims Act (“FCA”) through the public-disclosure bar.  In U.S. ex rel. Holloway v. Heartland Hospice, Inc. (June 3, 2020 opinion), the court affirmed the lower court’s entry of summary judgment in favor of a hospice provider on grounds that the relator’s claims were barred in light of prior public disclosures of the underlying allegations contained in the complaint.  The Holloway court’s holding is significant in that it found that relators can be the Government’s “agent” for purposes of the public-disclosure analysis, even when the Government declines to intervene.

The relator in this action, Holloway, was a former hospice employee who sued Heartland Hospice and related entities (“Heartland”) under the FCA alleging that Heartland engaged in a fraudulent scheme wherein patients were recruited and kept in hospice care, despite the fact that many of these patients were not terminally ill.  According to Holloway, clinicians were trained to document patient care using language specifically designed to ensure hospice eligibility (e.g., “new episodes of chest pain”; “shortness of breath”; “refusing meals”). Holloway also accused Heartland of misleading Medicare auditors by simply failing to respond to audit requests, resulting in a minor penalty, rather than answering audits honestly and risking the discovery of the entire scheme.

Heartland moved for summary judgment arguing that the relator was not a “genuine whistleblower” as her claims were drawn from prior allegations against Heartland in a different portion of the country.  Those cases, brought in South Carolina, alleged similar conduct involving different hospices owned by the same parent company.  As many readers will know, the FCA’s public disclosure bar precludes FCA suits that “merely feed off prior public disclosure of fraud.” Such cases include “substantially the same allegations” as those previously disclosed in public sources, including hearings in which “the Government or its agent” is a party.

Here, Heartland argued the Holloway’s allegations merely added “new, slightly different, or more detailed allegations” to what had already been disclosed in prior complaints.  In response, Holloway argued that because the Government did not intervene in the prior cases, such cases could not be considered public sources “in which the Government or its agent is a party.” The court declined to adopt this interpretation and ruled in favor of the defendants, dismissing the suit.

The court joined what it believed was the majority of district courts, holding that even when the Government declines to intervene in a qui tam suit, the relator is the Government’s agent for purposes of the public disclosure bar.  The court reasoned that even where the Government declines to intervene, it remains the real party in interest and exerts a fair amount of control over any qui tam litigation.  Accordingly, the prior FCA suits brought by other relators in South Carolina were considered “public disclosures” under the FCA, and therefore, barred under the public-disclosure bar standard.

The Sixth Circuit reasoned that its decision was guided by the statutory purpose of “encouraging genuine whistleblower actions while snuffing out parasitic suits.”  This decision may impact larger providers who often have similar conduct across their platform.  As other relators and defendants analyze claims under the public disclosure bar, they will need to consider similar claims against other parts of the platform, some of which may be under seal.

If you have any questions about the FCA, the public disclosure bar, or the contents of this post, please contact any member of our healthcare department, including the authors of this post.

CMS Guidance, Stark Law

Stark Law 2019 Settlements Continue Downward Trend

By Gretchen Townshend, Timothy Fry and Brett Barnett

The number and value of announced settlements with the Centers for Medicare & Medicaid Services (CMS) concerning the physician self-referral law (the Stark Law) continued a downward trend in 2019. This marks the third straight year of such aggregate settlement declines since reaching a peak in 2016. Indeed, as shown on the first chart below, CMS announced the lowest aggregate settlement dollars collected since the Stark Law disclosure first year in 2011. Similarly, as shown on the second chart, CMS announced the lowest number of settlements since the second year of the disclosure protocol in 2012.

Aggregate Amount of Settlements

Number of Disclosures Settled

These announced settlements stem from filings to CMS through its voluntary disclosure protocol to resolve liabilities arising from the strict liability Stark Law. These liabilities arise frequently as a physician is prohibited from referring designated health services (e.g., hospital services, laboratory, prescription drugs, radiology or other imaging, or DMEPOS) to an entity, including his or her medical practice, where he, she or his/her family have a compensation or ownership relationship, unless the referral and/or the  relationship is protected by meeting each element of an enumerated Stark Law exception. Due to the frequency of such conduct, and the, often, inadvertent and technical failure to comply fully with an exception, many in the industry believe voluntary disclosures are rising although we are not aware of CMS confirming this expectation. This raises the question, however, of how to reconcile the increased number of voluntary disclosures with the decreases in the trends revealed in the charts above.

One possible answer has to do with CMS workload for those subject matter experts focused on the Stark Law. Similar CMS staff are responsible both for reviewing the voluntary disclosures and for promulgating Stark Law regulatory policy. In that vein, CMS released proposed reforms to the Stark Law last fall, as discussed in McGuireWoods’ alerts dated Oct. 10, 2019, Nov. 1, 2019, Nov. 7, 2019 and Nov. 22, 2019, which were focused on reducing the compliance burdens for providers (referred to herein at the “Proposed Rules”). CMS has also recently updated its separate advisory opinion process – effective Jan. 1, 2020 (as detailed by McGuireWoods) – and has issued rulemaking to provide additional flexibility on the writing requirements of the Stark Law exceptions effective in 2016 (as earlier discussed by McGuireWoods here).  These changes may have tied up CMS staff who might otherwise be processing the voluntary disclosures as the agency modernizes the Stark Law’s regulations.

If staff time restraints are in part responsible for the decrease in settlements (and, we should be clear, other explanations are possible), the industry could expect that 2020 will continue this trend of fewer settlements than previous years. CMS staff are currently working to finalize the Proposed Modernization Rules. In addition, the 2019 novel coronavirus (COVID-19) pandemic understandably may divert attention. CMS has issued guidance and affirmative waivers intended to give providers increased flexibility in the face of the pandemic, including with respect to the Stark Law (such guidance discussed on FCA Insider on May 2, 2020 and April 4, 2020). In addition to diverting subject matter experts, agency decision makers likely are focused on managing in light of the more pressing public health emergency rather than Stark law settlements, many of which have been pending for several years anyway.

CMS’ regulatory changes over the past several years, which each had the effect of loosening the requirements in Stark Law’s regulatory development, could also have impacted provider willingness to finalize settlements. To elaborate, providers who made disclosures with an intent to settle with CMS related to technical issues prior to this recent rulemaking, could have experienced different outcomes with the loosened standards.  For example, a self-disclosure related to the lack of a signature on a contract may no longer be deemed a technical violation of the Stark Law now that may utilize signatures on certain related documents. These changes, in turn, could be prompting providers to withdraw disclosures made prior to the rulemaking, reducing the number of settlements. At the same time, CMS staff may have still have expended time reviewing a disclosure before a provider withdraws, ultimately utilizing the same amount of staff time without a reported settlement reinforcing the potential explanation discussed above. CMS’s announced Stark Law settlement details also provides good news to providers seeking to assess the scope of any settlement liability.  As shown in the chart below, since the first year of the protocol, average annual settlements have ranged from a previous low of $67,601.83 (2016) to the current high of $136,866.49 (2015). This past year, however, set the lowest reported average settlement at $60,323.94.

Average Amount of Settlements

We will be interested to see if the lower 2019 average is the start of a trend to be continued in future years, or of it is an outlier. Decreasing settlement amounts in future years could suggest a change either in the kinds of voluntary disclosures submitted or the willingness of CMS to settle for lower amounts in voluntary disclosure scenarios. Anecdotally, we believe more physician groups are submitting voluntary disclosures today than in the protocol’s early days, which often focused on hospital-physician relationships. Such shift could be reflected in smaller average settlements (caused in part by less Medicare billings impacted by such technical violations in a physician group than a hospital billing relationship) in the last four years compared to the prior four-year period. Future trends could also indicate a change in CMS’ settlement formula, although we do not have any evidence that is the case. Alternatively, with fewer settlements, there is a greater likelihood that a single case could skew the average results positively or negatively, which could also be influencing these numbers.

One additional caveat, the reported settlements lag the date when the provider voluntarily submitted the disclosure. Providers often experience a significant period between voluntary submission and settlement with CMS through the Stark Law disclosure protocol. As such, it is possible the trends in the announced aggregated settlements result from an event or regulatory change a few years ago. Future settlement numbers may provide further context to evaluate the likelihood that such a historic event caused these trends.

McGuireWoods will continue to monitor the reported Stark Law settlements to assist clients in navigating voluntary Stark Law self-disclosures. If you have violated or potentially violated the strict liability Stark Law, we would be happy to discuss whether such conduct necessitates considering a self-disclosure.

Uncategorized

HHS OIG Adds Audit of CARES Act Provider Relief Funds to Work Plan

By Timothy Fry and Jeffrey Alberg

On May 22, 2020, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) updated its Work Plan to reflect its planned audit of the $50 billion disbursed by HHS to hospitals and other providers under the Public Health and Social Services Emergency Fund (Provider Relief Fund), which McGuireWoods most recently discussed in a May 22 legal alert. The Provider Relief Fund was included as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and reimburses eligible healthcare providers for expenses and lost revenue attributable to the 2019 novel coronavirus (COVID-19). The Work Plan is used by OIG to set forth its planned and ongoing agency evaluations, audits, and inspections. The OIG expects to release its audit findings in fiscal year 2020.

The Provider Relief Fund audit will be conducted by OIG’s Office of Audit Services. These audits examine the performance of HHS programs and/or grantees and are intended to provide HHS with an independent assessment of the HHS programs and operations.

As is standard for all OIG Work Plan announcements, the OIG set forth the general details of its audit objectives. The announcement provided that OIG will obtain data and interview HHS officials to gain an understanding of how Provider Relief Fund payments were calculated and review Provider Relief Fund payments for compliance with CARES Act requirements. In addition, the OIG will seek to determine whether HHS’ controls over Provider Relief Fund payments ensured that payments were correctly calculated and disbursed to eligible providers. Such an audit may be in part a response to congressional interest; the U.S. House of Representatives included changes to the Provider Relief Fund program in its passage of H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), as discussed in item 2 of a May 18 legal alert. The Senate is not expected to pass the HEROES Act, but such changes may be included in future legislation.

For background, the CARES Act, as supplemented by the Paycheck Protection Program and Health Care Enhancement Act, appropriated $175 billion total to the Provider Relief Fund to assist providers financially impacted by COVID-19. The CARES Act statutory language called for HHS to review applications prior to disbursement of the fund but HHS largely disbursed the funds without requiring a formal application or review. The $50 billion to be audited by OIG was allocated to Medicare facilities and providers affected by COVID-19. The initial $30 billion was automatically distributed between April 10, 2020 and April 17, 2020 in proportion to providers’ Medicare fee-for-service payments in 2019, as discussed in an April 10 legal alert. On April 24, 2020, HHS began distributing an additional $20 billion to providers based on their share of 2018 net patient revenue, which was automatic for certain providers that file annual cost report information to the government, and began accepting submissions from certain other eligible providers of their financial data for subsequent waves of distributions, as discussed in an April 27 legal alert.

In addition, on May 26, 2020, OIG announced its Strategic Plan for COVID-19 Oversight (Strategic Plan). In the Strategic Plan, OIG reiterated its intention to conduct audits and evaluations of the Provider Relief Fund in order prevent, detect, and remedy waste or misspending. OIG specifically highlighted its plan to fight fraud and abuse that diverts funding from its intended purposes or exploits emergency flexibilities granted to healthcare providers. OIG is also likely to consider whether the Provider Relief Fund (and other COVID-19 responses) were successful so HHS can leverage lessons learned from these programs in the future.

McGuireWoods is continuously monitoring information released by HHS and the Trump administration regarding the fund. Please contact the authors or any of the McGuireWoods COVID-19 Response Team members for additional information on the Provider Relief Fund and its availability to healthcare providers and for assistance with the documentation and attestation and reporting process.

OIG, Regulatory

OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry

By Timothy Fry, Brett Barnett and Jon Steinberg

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory flexibility to ensure necessary care responding to COVID-19, particularly with respect to the federal anti-kickback statute (AKS) and civil monetary penalty (CMP) beneficiary inducement prohibition provisions. OIG responses are publicly available through a frequently asked questions (FAQ) posting on the OIG COVID-19 portal. OIG has continued to update this FAQ since its initial publication, including those inquiries discussed in a May 13 post, most recently providing guidance on the following question:

Physician groups may provide face masks to a nursing home. A physician group that contracts with a nursing home to provide care to that nursing home’s residents questioned whether it could assist the nursing home by providing face masks at no-cost or reduced cost. OIG opined that the physician group providing face masks as personal protective equipment (PPE) to the nursing home posed a low risk of fraud and abuse so long as the following conditions were met:

  1. The decision to provide face masks must be directly connected to addressing the COVID-19 outbreak such as the nursing home suffering a shortage as a result of supply chain disruptions.
  2. The physician group only provides the face masks during the period of the COVID-19 public health emergency.
  3. The physician group does not market the provision of the face masks.
  4. The provision of the face masks is not contingent on the nursing home’s past or anticipated referrals to the physician group.

OIG views the provision of the face masks as a low risk of fraud and abuse because the physician group benefits from lowered risk of infection to its physicians.

OIG further clarified that it views the provision of the face masks as a low risk of fraud and abuse not only because of the importance of PPE in general, but because the physician group benefits from lowered risk of infection to its physicians who interact with the nursing home staff and residents due to the face mask’s use. This position suggests that OIG could negatively view a similar arrangement where the physicians were not contracted to provide services to the nursing home patients. In such a situation, OIG could view the donation of PPE to violate the AKS as a free or discounted good to an actual or potential referral source.

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McGuireWoods will continue to monitor OIG’s release of further FAQs as additional providers utilize this inquiry mechanism. Providers may welcome the flexibility provided by OIG exercising enforcement discretion during the COVID-19 pandemic, recognizing the statements do not bind all investigative bodies who could take a different view. OIG will likely continue to require such arrangements to end at the end of the COVID-19 public health emergency declaration, and therefore, providers should plan for the post-pandemic period depending on the arrangement when utilizing these statements.

McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.

OIG, Regulatory

OIG Updates Enforcement Responses to COVID-19 Arrangement Inquiries

By David Pivnick, Timothy Fry, Brett Barnett and Jon Steinberg

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory flexibility to ensure necessary care responding to COVID-19, particularly with respect to the federal anti-kickback statute (AKS) and civil monetary penalty (CMP) beneficiary inducement prohibition provisions. OIG responses are publicly available through a frequently asked questions (FAQ) posting on the OIG COVID-19 portal. OIG has continued to update this FAQ since its initial publication, actively posting responses to the following topics with the specific limitations described below:

  1. Providers prescribing extended courses of treatment may assist established patients with transportation. An oncology group practice that temporarily closed a particular office location due to patient and staff exposure to COVID-19 questioned whether it could provide transportation assistance to established patients (e.g., vouchers or reimbursement for taxis or ridesharing services) so that the patients could continue receiving oncology care at one of the practice’s other locations. This transportation assistance likely would not satisfy the mileage requirement of the already-existing AKS local transportation safe harbor. OIG opined that transportation assistance that does not meet the local transportation safe harbor would pose low risk of fraud and abuse so long as the following conditions are met:
    1. First, the transportation assistance is provided by an “eligible entity” to an “established patient” as defined under 42 C.F.R. § 1001.952(bb).
    2. Second, the transportation assistance must be provided only when necessary because of the COVID-19 outbreak, and only during the period of the public health emergency.
    3. Third, the transportation assistance must not be air, luxury, or ambulance-level transportation.
    4. Fourth, access to the transportation assistance must not be related to the past or anticipated volume or value of federal health care business associated with that patient.
    5. Fifth, the established entity may not publicly market or advertise the transportation assistance or market or advertise any health care items or services during the course of the transportation.
    6. Sixth, any drivers or persons arranging for the transportation may not be paid on a per-beneficiary-transported basis.

OIG went beyond simply dealing with office closures caused by the COVID-19 outbreak, noting urban providers may similarly want to offer such assistant for patients who would typically take public transport. Such purpose is acceptable under OIG’s guidance. While the question posed only related to an oncology group, OIG expanded the scope of its opinion by stating that transportation assistance would likely present a low risk of fraud and abuse for other physicians prescribing extended courses of treatment such as chemotherapy, dialysis, radiation therapy, cardio/pulmonary rehabilitation treatment, or behavioral health services.

  1. Mental health providers could provide phone or data service for patients. Mental health and substance abuse disorder providers questioned whether they could accept donations in order to fund phone, service, or data plans for financially needy patients who do not have their own cell phones and otherwise would not be able to access those plans. The providers clarified that any such funding would be for providing medically necessary services while in-person care is unavailable. In response, the OIG opined that providing a cell phone and related phone, service, or data plan by a mental health or substance abuse disorder provider to patients poses a low risk of fraud and abuse so long as the following safeguards are employed:
    1. First, the provider must determine, in good faith, that the patient is in financial need before providing a cell phone or plan.
    2. Second, the provider must determine, in good faith, that the patient needs a cell phone or plan in order to access medically necessary services related to his or her mental health or substance abuse disorder.
    3. Third, all services provided using the cell phone or plan are medically necessary.
    4. Fourth, the provider uses the funding from a public entity, private charity or health plan solely to provide access to a cell phone or plan.
    5. Fifth, the provider must not market the cell phone or plan.
    6. Sixth, the provider must offer the cell phone or plan only to “established patients” as defined under 42 C.F.R. § 1001.952(bb).
    7. Seventh, the provision of the cell phone or plan is limited to the period of the public health emergency, requiring that the patient return the phone, the provider cease funding the plan, or both, at the end of the period.

OIG clarified that its response  applies only to any potential fraud and abuse concerns associated with the relationship between the provider and the patient, and it did not contemplate any risks associated with the relationship between the donor and the provider or patient. While the question focused on receipt of funds from a donor the OIG noted that there are too many potential relationships that could implicate—and present risk under—the federal fraud and abuse laws to address through the FAQ process.

  1. A hospital can suspend rental charges for a federally qualified health center look-alike. OIG opined that a hospital could assist a federally qualified health center look-alike (FQHLA) by waving rental charges during the public health emergency. Under the Stark Law blanket waivers, which OIG adopted for the AKS, below market rental charges to a physician are protected. However, an FQHLA is not a physician. Nonetheless, OIG opined that a hospital suspending rental charges and foregoing the accrual of interest for a FQHLA poses a low risk of fraud and abuse so long as the following conditions are met:
    1. First, the suspension of rent and accrual of interest is set out in a written document that lays out all material terms and is signed by the parties.
    2. Second, the suspension of rent and accrual of interest is not conditioned on the volume or value of Federal health care program business generated between the FQHLA and the hospital.
    3. Third, the arrangement allows the FQHLA to refer patients to any individual or entity it chooses.
    4. Fourth, the suspension of rent and accrual of interest is only made available to an FQHLA when necessary because of the COVID-19 outbreak.
    5. Fifth, the suspension of rent and accrual of interest is only available for the period of the public health emergency.

OIG has previously expressed significant concerns with laboratories …. Here, however, OIG opined that the proposed arrangement would pose a low risk of fraud and abuse.

  1. A clinical laboratory can pay fair market value fees to a retail pharmacy for costs related to collection sites. In this fact-specific scenario, a clinical laboratory that bills payors, including Federal health care programs, questioned whether it could pay fair market value to a retail pharmacy that sets up COVID-19 testing collection sites and incurs costs associated with running the sites. OIG has previously expressed significant concerns with laboratories offering anything of value as it could be seen as inducing referrals. This has been the case for payment for collecting, processing, and packaging patient specimens as it will likely be more than fair market value. Here, however, OIG opined that the proposed arrangement would pose a low risk of fraud and abuse so long as the following conditions are met during the public health emergency:
    1. First, the retail pharmacy must actually incur costs associated with running the sites.
    2. Second, the payment for the items and services provided by the retail pharmacy must be fair market value.
    3. Third, the retail pharmacy must not submit claims to Federal health care programs that reimburse it, in whole or in part, for the costs associated with running the site. In addition, the retail pharmacy cannot receive payments from programs like the CARES Act Provider Relief Fund that could theoretically compensate the retail pharmacist for these services. Any such reimbursements or grants could allow double payment indicating an unlawful intent.

OIG further emphasized that it was not opining on what constitutes a fair market value, but that the parties must determine an appropriate amount themselves. This guidance suggests how critical fair market value would be for such a relationship with a clinical laboratory, unlike some of the other questions discussed above.

In addition to certain factual circumstances, OIG responded to questions about why they did not adopt all of the Stark Law blanket waivers in its guidance McGuireWoods recently discussed. Essentially, OIG viewed the difference in the Stark Law and AKS in such a way that the waivers related to “referrals” (including those on ownership) as opposed to “remuneration,” as well as CMS’ waiver on non-written arrangements, meant that it was not warranted to offer similar protection. That said, OIG encouraged specific circumstances to be submitted for response during this COVID-19 public health emergency to OIGComplianceSuggestions@oig.hhs.gov.

* * * * *

McGuireWoods will continue to monitor OIG’s release of further FAQs as additional providers utilize this inquiry mechanism. Providers may welcome the flexibility provided by OIG exercising enforcement discretion during the COVID-19 pandemic assuming that OIG’s FAQ responses continue to provide. OIG will likely require such relationships to end at the end of the COVID-19 public health emergency declaration, and therefore, providers seeking to utilize these statements in care to their communities should plan to terminate the relationship at the end of the pandemic.

McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.

Regulatory

Price Gouging Investigations Are Coming: What Industry Needs to Understand

By Alex J. Brackett, Kevin M. Lally and Sarah A. Zielinski

In response to the national coronavirus health crisis, federal and state Attorneys General have elevated the investigation and prosecution of COVID-19-related crime, including price gouging, to the forefront of their enforcement priorities. Attorney General William Barr created a national COVID-19 task force staffed with attorneys from all 94 United States Attorney’s Office to coordinate expedited federal enforcement actions for price gouging. Multiple state Attorneys General have created similar task forces, established federal-state partnerships, or publicly pronounced that they will zealously pursue prosecution of companies that engage in price gouging. The Federal Trade Commission also has authority to regulate price gouging. Simple complaint forms are linked to the home pages of many of these organizations, and industry-wide investigations into the sales of certain goods have already begun in some jurisdictions.

Given the breadth of products and services covered by price gouging laws, and the potentially tight pricing tolerances of the caps under some laws, companies and industries that think they are immune from scrutiny should think again.

To date, several federal and state price gouging cases have been filed and thousands of complaints are being investigated. As states re-open and grand juries reconvene, federal and state law enforcement can be expected to actively pursue investigations and prosecutions against companies engaged in the manufacture, distribution or sale of a wide variety of consumer and healthcare goods and services that experienced price spikes following federal or state emergency declarations. The industries and the specific goods and services that will be targeted for investigation will vary by jurisdiction. The federal and state statutes and orders lack uniformity regarding the items covered, the extent of price increase prohibited and the time parameters covered. As a result, price increases on a particular good or service that may be legal in one jurisdiction may be deemed criminal price gouging elsewhere.

Federal Price Gouging Enforcement (Healthcare and PPE Focused)

Under federal law, the current anti-gouging order took effect on March 23, 2020, when President Donald Trump issued Executive Order 13910 invoking the Defense Production Act to designate select health and medical resources, as identified by the Secretary of Health and Human Services, as protected items. Tailored to address the current health crisis, these items include various types of personal protective equipment, medical equipment, and sterilization materials. Until such time as the Secretary of Health and Human services terminates this designation, it is a Class A misdemeanor punishable by up to one year imprisonment to sell any designated item at prices in excess of the prevailing market rates.

State Price Gouging Enforcement (Consumer Goods and Services Focused)

State price gouging laws and orders are far more varied. Some states have issued anti-gouging orders accompanying COVID-19 emergency declarations that are largely consistent with federal law. Many other states rely on price gouging statutes triggered by declarations of emergency that incorporate within their scope a wide array of goods and services, including fuel, pharmaceuticals, food and water, clothing, cleaning and hygiene materials, building supplies, and shipping and other transportation services. A small number of states do not have statutes proscribing price gouging, although many of them have indicated intention to pursue price gouging via unfair and deceptive trade practices or other consumer protection laws.

Importantly, state laws vary significantly in how price gouging is defined. In many states, there is a statutorily-set price cap that compares prices charged during the period when the emergency is in effect with prices charged for the same good or service during a defined time period prior to the emergency declaration (e.g., 10% above the price charged for that good or service on a particular day or over a number of days prior to when the emergency was declared). The tolerance cut-off and the comparative timeframe differ from state to state. Other states eschew price caps and rely on more amorphous terms such as “unconscionable” or “excessive” price increases. States with defined caps do tend to allow for larger price increases if they are tied to higher costs, but still tend to apply a cap (e.g., 10% over cost plus standard markup).

Compliance Challenges and Strategies

The patchwork of federal and state statutes and orders can make it difficult for companies operating regionally, nationally or internationally to remain in full compliance with price gouging laws during the COVID-19 crisis—particularly as many may not be aware that they are currently, and for some weeks have been, subject to pricing caps in states into which they sell goods or services. Adding to this difficulty is the fact that the current patchwork will unravel in a non-uniform way, with standards, timing and enforcement vigor that will vary by jurisdiction. Companies that find themselves out of compliance with these laws could be exposed to significant legal and reputational risks, as branding a corporation as a profiteer that cold-heartedly placed financial gain over national security and citizen health during a global pandemic will be a politically tempting headline to grab.

However, there are ways to manage these risks.  Companies that manufacture, distribute, or sell goods or services that fall within the scope of the anti-gouging statutes or orders should examine both their prices and their pricing mechanisms to confirm compliance. In the event that the price for a designated good or service increased from March 2020 to the current date, companies should assess the following:

  • Is the price increase the direct result of increased costs on the supply side, including, labor, materials and supplier price increases?
  • Was the good or service sold at a price beyond the prevailing market rate within a community or across the industry (and if so is there a justification)?
  • Did the price increase exceed a state-defined tolerance level, the most common of which is 10% above pre-crisis pricing (or 10% above cost plus standard markup)?
  • Can you document how and why prices increased, and is that information being preserved?
  • If prices are out of tolerance in certain markets, are you able to bring them into alignment with applicable caps?
Price Gouging Laws Guide

McGuireWoods has implemented a price gouging team ready to respond to your inquiries regarding the application of federal and state price gouging mandates. For an overview of the Price Gouging Laws for each state and jurisdiction, click here.

For additional guidance on the effects of these laws or orders, please feel free to contact Alex Brackett, Kevin Lally, or Sarah Zielinski.

McGuireWoods’ Government Investigations & White Collar Litigation Department is a nationally recognized team of nearly 60 attorneys representing Fortune 100 and other companies and individuals in the full range of civil and criminal investigations and enforcement matters. Our team is comprised of a deep bench of former senior U.S. officials, including a former Deputy Attorney General of the United States, former U.S. Attorneys, more than a dozen federal prosecutors, and an Associate Counsel to the President of the United States. Strategically centered in Washington, D.C., our Government Investigations & White Collar Litigation Department has been honored as a Law360 Practice Group of the Year and earned the trust of international companies and individuals through our representation in some of the most notable enforcement matters over the past decade.

McGuireWoods has published additional thought leadership analyzing how companies across industries can address crucial business and legal issues related to COVID-19.

CMS Guidance, Regulatory, Stark Law

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers During COVID-19 Pandemic

By Timothy Fry, Gretchen Townshend, Jeffrey Alberg and Erica Jewell

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance on the scope and application of the blanket waivers to the Physician Self-Referral Law (Stark Law) issued by the Department of Health and Human Services (HHS) on March 30, 2020, for use during the 2019 novel coronavirus (COVID-19) public health emergency. As discussed in an April 3, 2020, McGuireWoods client alert, the blanket waivers temporarily protect those financial relationships and referrals (and the claims submitted as a result thereof) specifically enumerated by HHS as pertaining to at least one outlined COVID-19 purpose. These blanket waivers were given a retroactive effective date of March 1, 2020, and thus protect those referrals and financial relationships from that date until the public health emergency ends.

To take advantage of the blanket waivers: (i) the provider must be acting in good faith to provide care in response to the COVID-19 pandemic; (ii) the financial relationship or referral must be one protected by one of CMS’ 18 permitted relationships; and (iii) the government must not determine that the resulting financial relationship creates other fraud and abuse concerns.

CMS’ waiver guidance provides informative clarification on many broad issues related to the blanket waivers’ intersection with existing Stark Law exceptions. Here are six key clarifications set forth in the blanket waiver guidance:

1. Compliance With Non-Waived Requirements of an Applicable Exception. CMS clarified that the blanket waivers waive only specific, enumerated elements of Stark Law exceptions, but the financial relationships or referrals, as applicable, must still satisfy all non-waived requirements of an applicable exception. For example, the blanket waivers allow an entity to exceed the annual nonmonetary compensation limit, but the other requirements of the nonmonetary compensation exception, such as the prohibition on physician solicitation of the compensation, still apply. The failure to satisfy one or more of the other non-waived requirements of an applicable exception would still trigger the Stark Law’s referral and billing prohibitions.

The failure to satisfy one or more of the other non-waived requirements of an applicable exception would still trigger the Stark Law’s referral and billing prohibitions.

2. Amendment of Compensation Arrangements. CMS’ guidance reiterated permissible modifications to compensation arrangements during and after the public health emergency. CMS reminded parties that its previous preamble guidance allows amendments to remuneration terms of a compensation arrangement, even within the first year after an amendment, provided that, each time the remuneration terms are amended:

  1. all requirements of an applicable exception are satisfied,
  2. the amended remuneration is determined prior to its effectiveness,
  3. the formula for the amended remuneration does not take into account the volume or value referrals or other business generated by the referring physician, and
  4. the overall arrangement remains in place for at least one year following the amendment.

Parties seeking to utilize the blanket waivers in existing compensation arrangements during the COVID-19 pandemic must still satisfy all non-waived requirements of an applicable exception. Following the expiration of the public health emergency, the arrangement should then be modified to ensure it complies with an applicable Stark Law exception without use of the waivers. This clarification should give providers comfort to utilize the waivers to revise compensation, for example, knowing that the arrangement can be revised again at the end of the public health emergency.

Alternatively, CMS suggested that, rather than amending an arrangement, the parties could instead utilize one of the blanket waivers through a new arrangement. For example, if a hospital leasing office space to a physician is considered financial support to the physician due to the COVID-19 pandemic, instead of reducing office rent below fair market value (FMV) through a waiver, the hospital could leave the lease alone and instead enter into a separate compensation arrangement, such as a loan, to provide further support that would enable the physician to cover the rental payments.

3. Application to Indirect Compensation Arrangements. CMS confirmed a point made in a prior McGuireWoods alert that the blanket waivers apply only to direct compensation arrangements. The waivers explicitly do not apply to an indirect compensation arrangement between an entity and a physician or the immediate family member of the physician, as defined at 42 CFR § 411.354(c)(2). CMS noted, however, that parties with indirect compensation arrangements may request an individual Stark Law waiver.

Alternatively, CMS reiterated that in many cases, particularly those with physician organizations, a waiver for an indirect compensation arrangement would likely be unnecessary. The Stark Law regulations require an owner of a physician organization to “stand in the shoes” of his or her organization, such that the arrangement applies directly to such physician. Further, for employees of a physician organization, the physician has the option to also “stand in the shoes” of the physician organization. Therefore, for physician practices, at a minimum, the parties can utilize a blanket waiver by having all physician owners and employees “stand in the shoes” of the organization and treating the arrangement as a direct relationship.

4. Repayment Options for Loans Between a DHS Entity and a Physician. CMS’ blanket waivers Nos. 10 and 11 permit loans with interest rates below FMV or on terms that are unavailable from a third-party lender during the COVID-19 pandemic. After inquiries requesting the ability to pay loans back in kind, or via non-cash repayment, CMS clarified that neither the Stark Law exceptions nor the blanket waivers require cash payment to satisfy a loan. As a result, parties may repay a loan in kind through the provision of professional services. That said, like in other clarifications and as required by the blanket waivers, the other elements of the exception need to be maintained — here, most critically, that repayment by services would need to be FMV in-kind payments. It will also need to be commercially reasonable and may also implicate the federal anti-kickback statute (AKS). Notably, the Office of Inspector General (OIG) also issued a policy statement adopting certain blanket waivers (discussed in an April 7, 2020, McGuireWoods client alert), which likewise protects remuneration under the AKS protected by the blanket waivers, like the loans noted above, which should provide some additional comfort.

5. Repayment of Owed Amounts Post-COVID-19. CMS also clarified that loans granted pursuant to the waivers could be repaid after the public health emergency. This would be true with respect to payments below FMV for office space, equipment, items or services provided during the public health emergency where payment obligations (but not the application of the below-FMV rates) extend beyond the emergency. CMS assured parties that completing the terms of the arrangements after the emergency would not necessarily result in noncompliance under the Stark Law.

CMS assured parties that completing the terms of the arrangements after the emergency would not necessarily result in noncompliance under the Stark Law.

To be compliant with the Stark Law, post-arrangement repayments may occur so long as appropriate repayment terms are set out at the start of the arrangement. For example, assume an arrangement provides for a physician to provide services to a hospital through Dec. 31, 2020, and provides for compensation to the physician by the hospital upon the presentation of a final invoice. In this situation, even if the hospital is presented with a final invoice on Jan. 15, 2021, for the services provided through Dec. 31, 2020, the fact that the hospital does not complete its repayment obligation until after Dec. 31, 2020, does not result in noncompliance under the Stark Law. CMS’ guidance reiterated that such repayment scenarios are permissible under Stark Law even outside the public health emergency.

While CMS provided flexibility on repayment of loans, CMS made it clear that any disbursement of loan proceeds or other remuneration after the termination of the blanket waivers must satisfy all requirements of an applicable exception, without the support of the waiver; i.e., one could not build a financial arrangement where the non-FMV remuneration would continue after the public health emergency.

6. Restructuring of Existing Recruitment Arrangements With Income Guarantees. CMS negatively responded to inquiries asking whether the blanket waivers address the extension or other restructuring of existing physician recruitment arrangements, but suggested an alternative approach. Specifically, CMS pointed to its 2007 advisory opinion, CMS-AO-2007-01, to explain that hospitals could not extend an income guarantee under an existing physician recruitment arrangement. CMS rationalized that a Stark Law-compliant recruitment arrangement should not be amended after the recruited physician has already relocated.

However, CMS made it clear that hospitals (or other entities) had alternative avenues under the blanket waivers to assist a recruited physician experiencing financial difficulties due to the public health emergency. For example, a hospital could utilize blanket waiver No. 5 to reduce rental charges below FMV or blanket waiver No. 10 to give a loan to the recruited physician with an interest rate below FMV or on terms that are unavailable from a lender. In both cases, the other requirements of the blanket waiver or the applicable exception would need to be maintained, but it may allow a hospital to continue support to recently recruited physicians without violating the recruitment arrangement exception.

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