HHS OIG’s 13 New FAQs Sheds Mild on Put up-Public Well being Emergency Enforcement | Epstein Becker & Inexperienced

On March 22, 2023, the Workplace of Inspector Normal (“OIG”) of america Division of Well being and Human Companies up to date its Steadily Requested Questions (“FAQ”), compiling 13 FAQs designed that can assist you transition from the flexibilities of was COVID on the finish of the Public Well being Emergency (“PHE”) on Might 11, 2023. These FAQs comply with up on the OIG’s March 10, 2023 COVID-19 Public Well being Emergency Coverage Assertion, which introduced that the expiry of the general public well being emergency in Can also marks the top of the flexibilities prolonged throughout the disaster. The up to date FAQ presents a glimpse into how the investigation and enforcement of the OIG may play out after the top of the PHE. These FAQs cowl subjects together with “Normal questions on sure fraud and abuse authorities,” “Software of sure fraud and abuse authorities to sure sorts of agreements,” and “Compliance concerns.”

The overwhelming majority of ideas articulated within the up to date FAQs will undoubtedly be acquainted to many. Typically, the up to date FAQ reiterates or clarifies long-standing OIG coverage. Nonetheless, the up to date FAQ is greater than repetition; they provide coverage and clarification condensed in a single place and display that, for essentially the most half, investigation and enforcement can return to the pre-PHE establishment.

A place to begin is steerage within the up to date FAQs governing naloxone. Whereas a hospital’s provision of free naloxone on discharge could carry the Anti-Kickback Statute (“AKS”) and Beneficiary Inducements Civil Financial Penal (“CMP”), the OIG has described its provision , when sure elements are current, reminiscent of “sufficiently low threat of fraud and abuse”, particularly in mild of the drug’s position in lowering overdose deaths.

It’s value noting that the day after the OIG launched the up to date FAQs, Robert DeConti, chief counsel to the inspector common, talking on the AHLA Institute on Medicare and Medicaid cost points, provided some associated ideas . Though DeConti described the advantage of the up to date FAQs as a possibility for OIG to answer questions shortly, he cautioned that the FAQs are not any substitute for the advisory opinion course of and, due to this fact, don’t confer potential immunity. Mr. DeConti inspired trade gamers to submit extra functions. As Might 11 approaches, we will count on additional readability by way of trade participation within the FAQ course of.

Flexibilities ending Might 11, 2023: Telehealth, Stark, and Anti-Kickback

The flexibilities that expire with the top of the PHE have been outlined by the OIG in two coverage statements and an FAQ.

The primary political declaration, dated March 2020, involved telemedicine: it knowledgeable professionals that they’d not be topic to administrative sanctions for waiving or lowering the cost-sharing obligations that beneficiaries owed for telemedicine providers.[1]

The second coverage assertion, dated April 2020, mentioned that OIG wouldn’t impose sure administrative penalties for sorts of remuneration associated to waivers coated by part 1877(g) of the Social Safety Act.[2] Notably, Stark Legislation’s common waivers have exempted over a dozen sorts of remuneration and deferments.

The FAQ, additionally dated April 2020, clarified that whereas OIG has not issued such an AKS waiver, it could not impose administrative penalties on settlements that meet the overall waivers of the Stark Act.[3]

Abstract of often requested questions dated March 22, 2023

Beneath is a short abstract of the FAQs as of March 22, 2023:

Normal questions concerning some fraud and abuse authorities

(1) Preliminarily, OIG attracts a transparent line between agreements that fulfill a protected haven of AKS and people that don’t. Satisfaction of a part of the circumstances of an AKS protected haven won’t cross the enchantment: compliance requires satisfaction of All circumstances.

(2) The civil financial penalty of beneficiary incentives (“CMP”) differs from the AKS. To start with, the CMP is narrower: it applies to Medicare, Medicaid, and CHIP (versus the applicability of the AKS to any federal well being program); the CMP additionally defines “remuneration” in a different way; it applies solely to the offerer of the remuneration (vs. the applicability of the AKS to the offerer and the solicitor or receiver); and applies to remuneration prone to affect a beneficiary’s selection of provider or supplier (vs. the AKS’ broad prohibition on remuneration for referrals “to an individual for provide” of a very good or service and purchases of “any good, facility, service or object”).

(3) The OIG clarifies that an settlement that meets the motivation exceptions to CMP beneficiaries just isn’t additionally protected by the AKS, however an exception beneath the AKS AND protected by the Beneficiary Incentives CMP.

(4) OIG additionally distinguishes the Doctor Self-Refer Act exceptions (42 USC § 1395nn) (“Stark Legislation”) from the AKS exceptions. In brief, compliance with the previous doesn’t disprove the implication of intention beneath the latter.

(5) OIG discusses the variations and distinctions between “money”, “money equal” and “in-kind” reward playing cards. “Money” refers to forex; “money equivalents” are objects that may be redeemed for money, reminiscent of checks or pay as you go Visa or Mastercard reward playing cards; and “in-kind” reward playing cards are these which might be redeemed just for sure sorts of providers or objects (reminiscent of a meal or gasoline supply service). Observe that OIG advises that the Facilities for Medicare & Medicaid Companies (CMS) could have their very own opinion on these phrases.

(6) Concerning whether or not agreements between digital well being report (“EHR”) distributors and their clients contain AKS, OIG clarifies: “presumably.” For AKS to be implicated, some or the entire EHR product would should be reimbursable beneath a federal well being care program.

(7) Noting the shift from fee-for-service to value-based care, the OIG questions whether or not the remuneration exchanged between entities with frequent possession entails the AKS. The OIG references a remaining 2020 rule establishing protected havens for value-based settlements,[4] and notes that the advisory opinion course of is offered for additional clarification of any specific settlement.

(8) Concerning the protected havens and funding pursuits of Ambulatory Surgical Facilities (ASCs), the OIG says it considers a number of elements when the investments of ASC physicians fail the Apply Revenue Take a look at: (i) whether or not the Investor Doctor refers sufferers to the ASC for procedures he won’t carry out himself; (ii) whether or not the Investor Doctor makes use of the ASC for his personal procedures and (iii) the circumstances that led the Investor Doctor to fail the Apply Revenue Take a look at.

(9) Lastly, the FAQ offers a hyperlink to annual updates on annual restrict inflation of affected person engagement instruments and helps beneath 42 CFR § 1001.952(hh).

Software of sure fraud and abuse authorities to sure sorts of agreements

(1) The OIG asks if a hospital can distribute free naloxone rescue kits to sufferers upon discharge. The availability of free objects of worth, together with such kits, to federal well being program beneficiaries, who might apparently self-apply to the hospital for reimbursable objects and providers, entails the AKS. Nonetheless, given the wants of the opioid epidemic, the OIG notes that supplying naloxone beneath comparable circumstances presents a low threat of fraud, whereas probably saving lives. The OIG suggests 4 methods to cut back your threat of fraud: (i) adjust to all different federal and state legal guidelines governing the distribution of naloxone; (ii) have a written coverage for distributing naloxone kits to at-risk sufferers and apply that coverage persistently to all sufferers presenting within the emergency division; (iii) not promote rescue kits to induce a beneficiary to obtain federally reimbursable objects or providers; (iv) make sure that the supply of free naloxone kits just isn’t contingent on the beneficiary’s selection of hospital for future reimbursable therapy or providers.

(2) The OIG additionally states {that a} Twin Eligible Particular Wants (D-SNP) plan member’s compensation for serving on the Plan Member Advisory Committee would probably not contain CMP for the beneficiary’s incentives, though it could contain the AKS. OIG discusses some elements that might scale back the danger of a violation of the AKS: (i) remuneration of modest worth and commensurate with the committee member’s time; (ii) utilizing a range course of primarily based on elements unrelated to a member’s well being “to keep away from cherry-picking”; and (iii) to not disclose the remuneration related to the place of committee.

Compliance concerns

(1) When contemplating exclusion, OIG explains how the company assesses future threat to federal well being care applications and their beneficiaries: Via standards printed April 18, 2016.[5]

(2) In assessing the “stage of threat of fraud and abuse posed by an settlement” involving the AKS, the OIG considers various elements established by Congress, that are reaffirmed by the Compliance Program Information of the OIG.[6] Since that information, the FAQ has reiterated a five-question check for whether or not an settlement is problematic:

  1. Does the settlement or apply have the potential to intrude with, or distort, medical decision-making?
  2. Does the association or apply have the potential to extend prices for federal well being care recipients or applications?
  3. Does the settlement or apply have the potential to extend the danger of extreme or inappropriate use?
  4. Does the association or apply increase issues about affected person security or high quality of care?
  5. Does the settlement or apply increase issues about guiding sufferers or suppliers to a specific merchandise or service?

[1] https://oig.hhs.gov/paperwork/special-advisory-bulletins/960/policy-telehealth-2020.pdf

[2] https://oig.hhs.gov/coronavirus/OIG-Coverage-Assertion-4.3.20.pdf

[3] https://oig.hhs.gov/coronavirus/authorities-faq.asp

[4] 85 federal. Reg. 77.684 (December 2, 2020); https://www.govinfo.gov/content material/pkg/FR-2020-12-02/pdf/2020-26072.pdf

[5] https://oig.hhs.gov/exclusions/information/1128b7exclusion-criteria.pdf

[6] https://oig.hhs.gov/paperwork/compliance-guidance/799/050503FRCPGPpharmac.pdf

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