AMARILLO, TX – The operation of a standard DME company like, “Midwestern Mobile Medical” just might lead to a severed arm, murder, voodoo, and all the eccentric characters that go along with it, at least according to the new show streaming on Apple TV+ titled, “Bad Monkey” and based on the novel by the same name. (Light spoilers for the show Bad Monkey ahead).

Since the commencement of the ongoing crackdown on bad actors exploiting the DME industry, its stakeholders have steadily worked to differentiate the bad actors from the overwhelming majority of upstanding DME suppliers working to provide essential equipment and services to patients.

Unfortunately, the bad conduct of a few subjects the entire DME industry to scrutiny because of the wide net cast by enforcement efforts to root out fraud. In Bad Monkey, a visit from two FBI agents is enough to spur the DME owner to have his own arm amputated, fake his own death, and descend deeper and deeper into crime and corruption. We have assisted many clients facing government scrutiny and the experience is never comfortable, though not nearly as bad as the fictional depiction in Bad Monkey. Almost all our clients who find themselves under scrutiny express a deeper appreciation for the truth in the expression “an ounce of prevention is worth a pound of cure.”

An Ounce of Prevention: A Thorough Compliance Program
The OIG’s General Compliance Program Guidance, updated and released last November, is one of the best methods of prevention any entity can find. The Guidance and the Seven Elements it contains have been addressed previously in Medtrade Monday articles, so this article focuses on the ways the elements can be adapted for large and small entities.

The “Right-Size” Compliance Program
Regardless of size, the OIG expects every compliance program to include the following seven elements:

• Written Policies and Procedures
• Compliance Leadership and Oversight (Compliance Officer, Committee, Board)
• Training and Education
• Effective Lines of Communication with the Compliance Officer and Disclosure Programs
• Enforcing Standards: Consequences and Incentives
• Risk Assessment, Auditing, and Monitoring
• Responding to Detected Offenses and Developing Corrective Action Initiatives

Small Organizations
Understanding that entities may face financial or staffing constraints that limit their ability to devote massive resources to a compliance program, the OIG provides recommendations for smaller organizations. These recommendations still aim to implement all seven elements, but in a modified form. One might think of these modifications as an “ounce of prevention” that allow a small entity to obtain the same benefits of a compliance program but in a less resource-demanding manner. The following summarizes the modifications a small organization can implement to cover the seven elements in their compliance programs:

• Compliance Contact – A small entity may not be able to support a designated compliance officer on a full or partial basis. The OIG recommends designating one person as the entity’s “compliance contact.” If possible, the compliance contact should not have any responsibility for the supervision of legal services to the entity and not be involved in billing, coding, or submission of claims. As always, the owner is ultimately responsible for compliance and the compliance contact should report directly to the owner for any compliance responsibilities.
• Written Policies and Procedures – A small entity will not be able to task a chief compliance officer and compliance committee and subcommittees with preparing written policies and procedures. Instead, the OIG says a small entity should utilize resources available through professional organizations, consultants, or other resources available from government agencies.
• Training and Education – A variety of options are available to conduct training and education for a small entity’s employees. They might include meetings, emails, websites, or through postings in physical or virtual common areas.
• Open Communication – A small entity may not need a “formal disclosure program,” but the entity can ensure all personnel understand the entity’s commitment to compliance and to nonretaliation. Anonymous reporting may not be feasible in a small organization, so it becomes even more important for a small organization to have policies in place to encourage reporting of reasonable concerns.
• Risk Assessments – Perform a compliance risk assessment at least once a year. This includes at least an annual audit.
• Enforcing Standards – Enforcement and disciplinary mechanisms should be in place before violations of policies or applicable laws occur. The OIG recognizes that a small entity’s enforcement standards “should have sufficient flexibility to permit personnel to ask questions and disclose mistakes.”
• Responding to Detected Offenses and Corrective Action Initiatives – The OIG’s guidance does not greatly modify this element for a small entity other than recommending a small organization be prepared in the event potential legal violations are uncovered and be prepared to address them as needed.

Large Organizations
A large organization’s compliance program will demand significant resources and expertise to develop and monitor a program that is capable of addressing the breadth and complexity faced by a large health care organization. Depending on the size of the organization, a single compliance officer may not be capable of overseeing the full program. Depending on the size of the organization, the company may need to create a department of compliance personnel with a variety of skills and expertise. Large companies should carefully select a chief compliance officer to oversee and direct such a department. The OIG recommends the chief compliance officer be selected by, and report directly, to the Board to give the officer “the stature and independence he or she needs” and ensure the entire organization receives the “strong message” of the board’s commitment to compliance.

As organizations grow, they may need to expand the compliance department’s personnel to various facility locations. They also may need to establish a Compliance Committee comprised of various members that represent the operational components involved in the compliance program. Subcommittees may be used to implement more detailed policies and procedures, training and education, audits, assessments, etc.

Boards maintain ultimate responsibility for the entity’s compliance, and as such, the OIG recommends a separate board committee involved in compliance oversight. Such a committee may even have a separate charter, specific to the committee’s oversight of health care compliance matters.

Takeaways
A compliance program is not a one-size-fits-all. The size and complexity of the program should be tailored to the organization, factoring in the size of the company and the relative risk of its operations. Tailoring can be accomplished in a variety of ways that still ensure each element of a full compliance program exists to benefit the entity and stave off the extreme discomfort and disruption of external investigation and enforcement action.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, 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].

Matthew D. Earl, JD, is an attorney with the Health Care Group at Brown & Fortunato, PC, 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. Mr. Earl can be reached at (806) 345-6360 or [email protected].

AAHOMECARE’S EDUCATIONAL WEBINAR

Billing Nonassigned:  Steps to Replace Lost Income

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Noel Neil, ACU-Serve

Tuesday, October 15, 2024

1:30-2:30 p.m. CENTRAL TIME
DME suppliers, like other health care providers, are being squeezed by traditional Medicare and Medicare Advantage (“MA”). In the traditional Medicare space, an example of this is the loss by DME suppliers of the 75/25 blended rates. To offset, at least in part, the decrease in reimbursement from traditional Medicare, DME suppliers should look seriously at billing traditional Medicare beneficiaries on a nonassigned basis. The movement to billing nonassigned is aided by the willingness of aging Baby Boomers to pay cash for “Cadillac” products, as opposed to being relegated to accepting “Cavalier” products when the DME supplier takes Medicare assignment. Billing nonassigned means that the Medicare beneficiary pays cash up front to the DME supplier and is directly reimbursed by Medicare. This program will discuss the multiple issues arising out of billing on a nonassigned basis, including the following: (i) What does it mean to bill non-assigned? (ii) If the supplier bills an item nonassigned, can the supplier set the price without limitation? (iii) Must the supplier submit a claim to Medicare so that the beneficiary can be reimbursed? (iv) Can the supplier sell a capped rental item for cash? (v) Does the supplier need to obtain documentation supporting medical necessity? (vi) Is the supplier at risk of having to repay Medicare and/or the beneficiary in the event of a subsequent audit? 

Register for Billing Nonassigned:  Steps to Replace Lost Income on Tuesday, October 15, 2024, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq. and Noel Neil.

Members:  $99
Non-Members:  $129