AMARILLO, TX – In November of last year, the OIG for the Department of Health and Human Services (DHHS) issued a revised General Compliance Program Guidance (GCPG).
In a recent speech, the General Counsel for the OIG stated that the OIG “looked at the best of the best” in drafting the new GCPG and that it represented both the “culmination” of what the OIG has learned about compliance programs over the past 30 years as well as what the OIG sees in the future of compliance programs. As with the prior Compliance Program Guidances (CPGs), the new GCPG is voluntary guidance and presents the OIG’s nonbinding recommendations for compliance programs.
Unlike the prior Compliance Program Guidance Documents, that were published in the Federal Register, the new GCPG is published as a website, with individual sections accessible directly from the website at https://oig.hhs.gov/compliance/general-compliance-program-guidance/. The entire guidance may also be downloaded in PDF. The new GCPG is organized differently from prior CPGs. Prior CPGs covered both general compliance considerations and tailored risk areas specific to industry sectors.
The new GCPG, on the other hand, consolidates generally applicable compliance program recommendations into a single document. The OIG will publish additional industry-specific guidance, called “ICPGs” starting this year. The OIG intends to publish ICPGs for Medicare Advantage and nursing facilities later this year, followed by ICPGs for hospitals and clinical laboratories. OIG representatives have stated that the OIG welcomes feedback and suggestions for ICPGs for other industries as well.
With the new GCPG at hand, now may be a good time for durable medical equipment suppliers to review and refresh their own compliance programs. The new GCPG contains seven sections, including a section on Compliance Program Infrastructure, in which the OIG reiterates and updates the seven elements of a successful compliance program:
- Written policies and procedures
- Compliance leadership and oversight
- Training and education
- Effective lines of communication with the Compliance Officer and Disclosure Program
- Enforcing standards: consequences and incentives
- Risk assessment, auditing, and monitoring
- Responding to detected offenses and developing corrective action initiatives
We highlight a few of the elements below.
Written Policies and Procedures
The OIG expects health care entities to instruct their employees, contractors, and clinical staff on duties and standards of conduct through written policies and procedures. The OIG recommends entities have a written code of conduct to communicate the entity’s mission, goals, and ethical requirements, including a commitment to compliance with federal and state laws and regulations. The OIG recommends written compliance policies that address risk areas specific to the entity, such as billing, coding, sales, marketing, quality of care, patient incentives, and arrangements with physicians, other health care providers, vendors, and other potential sources or recipients of referrals of health care business.
Compliance Leadership and Oversight
In recent comments, the OIG appears to renew its focus on compliance leadership and oversight. The GCPG recommends that every entity designate a compliance officer who is a member of the entity’s senior leadership, which is the group of leaders who report directly to the CEO (or equivalent). The GCPG recommends that the compliance officer be separate from and independent of legal and finance and have independent access to the board of directors.
In addition to the compliance officer, an entity should have a compliance committee comprised of leaders from operational and supporting departments. The role of the compliance committee is to aid and support the compliance officer in implementing, operating, and monitoring the compliance program. The compliance officer should chair the compliance committee. The compliance committee should meet at least quarterly.
In addition to the compliance committee, the OIG expects the entity’s governing board to have oversight of the compliance program. The OIG recommends that boards schedule regular executive meetings with the compliance officer, without non-board members present, to permit the board and the compliance officer to have an uninhibited discussion of compliance risks and concerns.
Enforcing Standards
In addition to establishing consequences for noncompliance, new to the GCPG is the recommendation of providing incentives to encourage compliance performance and innovation. Some behaviors that entities may want to incentivize include:
- achievement of compliance goals specific to a department or role;
- achievements that reduce compliance risk; and
- performance of compliance activities outside of the individual’s typical job description (e.g., becoming the compliance representative for his or her department.
Risk Assessment, Auditing, and Monitoring
While the OIG has long recommended auditing and monitoring, new for the GCPG is the recommendation of risk assessments. For the risk assessment, entities are encouraged to look at risks to the organization that may result from violations of law, regulations, or other legal requirements. The GCPG recommends that compliance risk assessments be conducted at least annually.
The OIG recognizes that compliance programs may be structured differently depending on the entity’s size. With that in mind, the GCPG also includes suggestions for small and large entities. For small entities (i.e., entities with a small number of employees) that cannot support a compliance officer, for example, the OIG recommends designating one person as the entity’s compliance contact. The compliance contact should be separate from legal and report to the owner or CEO. The compliance contact should not be involved in billing, coding, or submitting claims.
Small entities should still have written policies, procedures, and training. The OIG suggests that small entities could use policy and procedure templates from consultants or professional organizations. The OIG also offers its own compliance training videos available to the public on its website.
Overall, the new GCPC reiterates long-standing OIG recommendations for compliance plans while also making new recommendations so that entities develop and maintain a successful compliance program.
Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].
Phuong D. Nguyen, JD, CHC is a senior attorney in the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, hospitals, physician groups, DME companies, manufacturers, and other health care providers throughout the United States. Nguyen can be reached at (806) 345-6307 or [email protected].
AAHOMECARE’S EDUCATIONAL WEBINAR
Employee Retention Tax Credit: Benefits and Pitfalls
Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Kianna L. Sitarski, Esq., Brown & Fortunato
Thursday, July 11, 2024
1:30-2:30 p.m. CENTRAL TIME
The COVID pandemic was unprecedented … and traumatic … for all of us. In response, the federal government passed laws – and issued regulations – designed to (i) provide “safety nets” to businesses, (ii) expand the provision of health care in the home, and (iii) assist families financially. A key provision is the Employee Retention Tax Credit that is designed to encourage employers, that are adversely affected by the pandemic, to keep employees on their payroll. Since its inception in 2020, the Employee Retention Credit has been modified by federal statute and IRS regulations to relieve financial struggles faced by employers. This webinar will discuss the history of the Employee Retention Credit, including eligibility and value of tax credits available for wages paid between March 2020 and December 31, 2021. The webinar will also discuss how to retroactively claim the Employee Retention credits and common pitfalls to avoid when the DME supplier is amending its tax filing. Lastly, the webinar will discuss how the DME supplier can avoid the scams that have arisen in conjunction with the Employee Retention Tax Credit.
Registration will soon be posted for Employee Retention Tax Credit: Benefits and Pitfalls on Thursday, July 11, 2024, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq., and Kianna L. Sitarski, Esq., of Brown & Fortunato.
Members: $99
Non-Members: $129
