In reference to the November 2023 Well being Care Compliance Affiliation’s (HCCA) Healthcare Enforcement Compliance Convention, and with acknowledgment by the Chief Counsel to the Inspector Common, Rob DeConti, of the lengthy partnership between the Workplace of Inspector Common (OIG) and the HCCA, the OIG issued its new “Common Compliance Program Steering” (GCPG) on November 6, 2023. The continuing HCCA convention supplied a chance for dialogue of the GCPG’s intent, design and route at a session led by two attorneys with the Workplace of Counsel to the Inspector Common, Amanda Copsey and Laura Ellis.

The GCPG is the primary of a collection of compliance guidances anticipated to be issued by the OIG. This primary issuance comprises 91 pages of common compliance steerage, instruments and references addressed to all forms of federal well being care program suppliers and suppliers. Its issuance can be adopted by compliance steerage addressed to a number of well being care {industry} subsectors (i.e., particularly focused classes of suppliers/suppliers) that may change the present compliance guidances which have been issued over the course of the final three a long time, beginning with the 1998 Compliance Program Steering for Hospitals. The older compliance guidances can be archived after they’re changed, however nonetheless out there for reference. Subsequent as much as be issued can be compliance program guidances for managed care plans and for nursing services, anticipated in 2024. Within the interim till the precise guidances are issued, OIG recommends that recognized danger areas from the present subsector guidances be referenced and aligned to be used with the brand new GCPG and its give attention to danger assessments and risk-based compliance methods. 

The GCPG is seemingly designed to serve many compliance functions. It consists of discussions of the important thing legal guidelines in well being care fraud enforcement and consists of frameworks and questions for an evaluation of conditions beneath these legal guidelines. It consists of many beneficial references (with hyperlinks) to varied assets for compliance professionals. OIG sticks with the seven parts of compliance recognized within the U.S. Sentencing Pointers because the framework for its compliance program suggestions. Most of the compliance program implementation provisions within the GCPG are properly established and acquainted from prior steerage, CIAs, and numerous different OIG issuances, albeit now offered in a extra targeted and accessible one-stop format. For instance, OIG underscores its view of the essential position of the Board in overseeing and assuring compliance, a theme beforehand acknowledged in a number of albeit now considerably dated tips.

We advocate that the GCPG be reviewed in its entirety, however we handle a number of the key sections under which are “new” for compliance steerage.

1. High quality and ComplianceThe OIG is now clearly recommending that compliance packages embody high quality and affected person security inside their purviews. This has been a subject of debate amongst compliance professionals for twenty years, however many well being care compliance packages nonetheless don’t embody high quality and affected person security as a significant element of this system. This focus is especially essential, from the OIG’s perspective, for hospitals, long-term care services and different entities offering residential care. These entities must also give attention to staffing wants for nursing, remedy and different medical companies the place the potential concern regarding understaffing. Understaffing, in fact, is an industry-wide downside of provide shortages within the workforce that’s well-known, however a problem for any division to handle.
2. New Entrants within the Well being Care Business and the Position of Non-public Fairness.One statement within the GCPG worthy of program consideration is addressing challenges for “new entrants” that is probably not conversant in regulatory or enterprise points within the well being care area. The OIG notes that this isn’t only a concern concerning new gamers coming into the {industry}, but in addition for brand spanking new traces of enterprise that established well being care organizations with new service choices. OIG notes as examples these well being care suppliers providing managed care plans or creating well being care applied sciences. The statement is logical as a compliance program which may be properly fitted to present operations however be inadequate for totally totally different traces of enterprise {that a} supplier engages in. 
3. Issues about non-public fairness and different non-public buyers in well being care continues to be a rising space of consideration from the federal and state enforcement authorities.The GCPG does not more than once more flag the problem, to be able to hold it on a front-burner for consideration. Feedback on the HCCA Convention from OIG indicated they anticipate issuing extra steerage sooner or later directed on the position of personal fairness in U.S. well being care.
4. OIG Assets and ProcessesIn Part VI of the Common Compliance Program Steering, OIG did a radical job summarizing and together with hyperlinks to the assorted assets that OIG maintains to help suppliers and different entities in (1) creating their compliance packages and (2) in any other case making choices on compliance points associated to the legal guidelines enforced by OIG – i.e., the Federal anti-kickback statute, Civil Financial Penalties legislation and OIG’s Exclusion authority. Some are “outdated favorites” whereas some are comparatively new to OIG’s toolbox.
   1. Compliance Toolkits; Compliance Assets for Well being Care Boards; Supplier Compliance Coaching; A Roadmap for New Physicians; and RAT-STATS Statistical Software program;
   2. Advisory Opinions;
   3. Particular Fraud Alerts, Bulletins, and Different Steering; and Secure Harbor Rules;
   4. Often Requested Questions – a comparatively new software for OIG. Starting in March of this yr, OIG expanded the subjects that it considers for brand spanking new FAQs submitted by the well being care group. This part of the GCPG features a notably good dialogue of the variations between Federal anti-kickback statute and the Beneficiary Inducement Civil Financial Penalties (CMP).
   5. Company Integrity Agreements (CIAs) – OIG notes that CIAs can function a useful resource when a well being care entity critiques its compliance packages construction and operations – together with audits that the entity ought to contemplate when creating or increasing the audit perform beneath its compliance program.
   6. Enforcement Motion Summaries – OIG posts info concerning its settlements – prison and civil, state enforcement companies, CIA reportable occasions, CIA stipulated penalties and materials breaches, CMPs and affirmative exclusions, self-disclosure settlements and grant fraud self disclosures.
   7. OIG Self-Disclosure Info. Notice that there are several types of OIG self-disclosures together with (1) well being care fraud self-disclosures when suppliers and different entities are topic to CMPs; (2) U.S. Division of Well being and Human Providers (HHS) Contractor self-disclosures to be used by entities which are awarded authorities contracts or subcontracts to supply companies to HHS; or (3) HHS Grant self-disclosures by which HHS grant recipients or sub-recipients should disclose proof of potential violations of Federal prison legislation (e.g., fraud, bribery or gratuity violations) affecting the Federal award or conduct creating legal responsibility beneath the Civil Financial Penalties Regulation or that may violate civil or administrative legal guidelines that fall inside the scope of offenses beneath 45 C.F.R. § 75.113.
5. Compliance Danger Assessments (Compliance Program Effectiveness Component 6—Danger Evaluation, Auditing, and Monitoring)As OIG notes within the GCPG, “lately OIG, the compliance group, and different stakeholders have come to acknowledge and place growing emphasis upon the significance of a proper compliance danger evaluation course of as a part of the compliance program”. In line with OIG, [the] compliance danger evaluation is a danger evaluation course of that appears in danger to the group stemming from violations of legislation, laws, or different authorized necessities. For entities collaborating in or affected by authorities well being care packages, a compliance danger evaluation focuses on dangers stemming from violations of presidency well being care program necessities and different actions (or failures to behave) which will adversely have an effect on the entity’s means to adjust to these necessities.Within the GCPG, OIG recommends that danger assessments be performed not less than yearly.  The OIG observes that the Compliance Committee – not the Compliance Officer – needs to be the entity with accountability for the efficiency to replicate that it’s the group, not any particular person, who’s accountable for the chance evaluation. Notice that OIG doesn’t recommend that the chance assessments should be performed by exterior auditors, however the GCPG does point out OIG’s perception that info gathered from each inside and exterior sources needs to be thought of within the danger evaluation. Findings from the chance evaluation needs to be reviewed, prioritized and utilized by the supplier/provider to develop the annual work plan with auditing and monitoring of prioritized danger areas. OIG consists of a number of hyperlinks to widely-accepted professional assets addressing the efficiency of danger assessments.
6. Small or Giant Entity Compliance Packages

In giant entities, the GCPG refers to OIG’s prior board steerage, and units the expectation that boards inside giant well being care organizations ought to thoughtfully consider the assets and experience they’ll want to be able to accomplish this. In line with the GCPG, the expectation outlined is a well-staffed compliance division which can embody not solely a chief compliance officer, but in addition deputy compliance officers, auditors, investigators, clinicians and knowledge consultants with the chief compliance officer ideally reporting on to the board of administrators. This part additionally specifies that “to the extent attainable, given the ability or location’s staffing constraints, the compliance officer shouldn’t have accountability for medical, monetary, authorized, or operational duties.”

Extra areas talked about on this part embody, sustaining an efficient compliance committee, reporting to the board and a advice to contemplate making a separate board compliance committee with a constitution to supervise well being care compliance. A noteworthy comment on this doc consists of that “boards of enormous organizations working in the USA however owned or managed by worldwide group ought to be certain that the dad or mum board is supplied with adequate details about the relevant legislation, Federal well being care program necessities, and the compliance dangers offered by the operation of the U.S. group.” From a sensible standpoint, this can be achieved via the dad or mum board receiving common stories from the compliance officer, or U.S. primarily based entity.

Whereas a lot of this current OIG steerage is in line with its earlier paperwork on managing an efficient compliance program, the extra give attention to expectations of a compliance program in numerous measurement entities could also be useful to the compliance division in acquiring relevant assets and commitments from the board and government administration and is often in line with numerous well being care entity settlement settlement expectations.

Key Takeaways 

Whereas the OIG notes that its GCPG strategies are voluntary, and that the “shoulds” used within the doc aren’t “shalls” or in any other case directive, entities with present compliance packages ought to evaluate the GCPG and certain implement a number of “tweaks” to these packages. The GCPG pulls collectively many compliance assets (or hyperlinks) in a single doc and is prone to develop into a ceaselessly used software by many compliance officers and their legal professionals. 

Foley is right here that can assist you handle the short- and long-term impacts within the wake of regulatory adjustments. We now have the assets that can assist you navigate these and different essential authorized concerns associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship companion, or to our Well being Care Follow Group with any questions.