In a previous post, we discussed some common due diligence and compliance issues of ketamine clinics (see Here with Here). In this article, we discussed a healthcare compliance plan and the importance of preparing a compliance plan for ketamine clinics. The Ministry of Health and Human Services (“HHS”) (among other agencies also has a Medical Insurance and Medicaid Service Center or “CMS”), and its department is called the Office of the Inspector General (“OIG”). As stated on the website of the Office of Inspection:

HHS OIG is the largest office of the inspector general in the federal government, with approximately 1,600 offices dedicated to combating fraud, waste and abuse, and improving the efficiency of the HHS program. Most of OIG’s resources are used to monitor health insurance and Medicaid programs, which account for a significant portion of the federal budget and affect the country’s most vulnerable citizens. Our government oversight extends to programs under other HHS agencies, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the Food and Drug Administration.

OIG is one of the main regulatory agencies to combat fraud and abuse in the healthcare industry. If the healthcare provider accepts federal reimbursements (such as Medicare, Medicaid, VA, etc.), various federal medical fraud and abuse laws (such as anti-anti-statutes, Stark law, false claims laws, etc.) will come into play. ). Although not all ketamine clinics are Medicare participating providers, we are seeing more and more such clinics adopting Medicare reimbursement. Therefore, for ketamine clinics, OIG supervision is becoming more and more common.

In addition, in addition to the aforementioned federal laws, most states have various forms of their own fraud and abuse laws in addition to the company’s medical standards practices. Any well-designed compliance plan should include all applicable state and federal medical laws.

Why develop a compliance plan?

Compliance programs have good business significance, especially in the highly regulated healthcare sector. Just like the old medical motto: “An ounce of prevention is better than a pound of cure.” Fines, fines and other remedies imposed by OIG can be very costly, and in some cases, they may be violated. Sentenced to prison under federal law.

In addition, a comprehensive compliance program can also save costs for healthcare providers. As the Office of Supervision pointed out, “These programs can also benefit physicians by simplifying operations.” OIG individual and group physician practice compliance program, Federal Reserve 65 Reg. 59345 (October 5, 2000). OIG continues to point out that the compliance program can also: (1) speed up and optimize the reasonable payment of claims; (2) reduce billing errors; (3) reduce the chance of review by CMS or OIG; and (4) avoid self-recommendation and The anti-kickback laws are in conflict. ID.

under Federal Sentencing Guidelines (Hereinafter referred to as the “Guidelines”), any entity (health care or other) convicted of a crime under an effective compliance program can apply for certain relief. When determining the amount of fines, the “Guidelines” instruct the court to determine the “convictable score” by calculating aggravating and mitigating factors. Although the compliance program does not exempt individuals from criminal charges or convictions, it does show that the organization and/or individual has taken reasonable efforts to prevent, detect and correct any misconduct. In addition, the compliance program may reduce the initial “flexibility score” by as much as 60%. Conversely, failure to comply with procedures is considered an aggravating factor for criminal scoring.

Failure to develop a compliance plan will have real consequences.

What are the elements of an effective compliance program?

OIG has issued several different compliance programs for the healthcare industry.For the purposes of this article, we rely on OIG’s compliance program for individuals and small physician practices Because it is the closest to the Ketamine Clinic (“OIG Compliance Guide”).

As pointed out in our previous article, the seven elements of an effective compliance program include:

1. Internal monitoring and auditing through regular audits;
2. Implement compliance and practice standards through the development of written standards and procedures;
3. Designate a compliance officer or contact person to supervise compliance work and implement standards of practice;
4. Appropriate training and education on practice standards and procedures;
5. Respond appropriately to violations discovered by investigating allegations and disclosing incidents to appropriate government entities;
6. Establish open communication channels, such as (1) discussing how to avoid errors or fraud in employee meetings, and (2) community bulletin boards to provide practitioners with the latest information on compliance activities; and
7. Implement discipline standards through widely publicized guidelines.

65 Federal Reserve. Reg. At 59436.

The OIG compliance guide details these seven elements. Although a complete discussion of each element is beyond the scope of this article, some key points are listed below.

In the first step, audit and monitoring, OIG divides it into two sub-parts: (1) standards and procedures, and (2) claim submission for review. In accordance with standards and procedures, ketamine clinics should regularly review their compliance programs and their fraud and abuse policies and procedures. Healthcare compliance and the legal environment are constantly evolving and changing. New laws were passed, new regulations were promulgated, and new court decisions were issued. Therefore, it is essential that the latest compliance plan must cover areas applicable to specific practices.

Conducting a claim review is a way to check whether your practice complies with various state and federal laws. As the Office of Oversight pointed out: “In addition to the standards and procedures themselves, it is recommended that bills and medical records be reviewed to ensure that they comply with applicable coding, billing and documentation requirements.” ID. At 59437. In addition, self-audits can be used to determine whether:

• The bill is accurately coded and accurately reflects the services provided (as recorded in the medical record);
• The document is completed correctly;
• The services or goods provided are reasonable and necessary; and
• There are any incentives for unnecessary services.

ID.

Each of the aforementioned regions complies with certain federal legal requirements. For example, to bill Medicare, the doctor certifies that the service is reasonable and necessary. If this turns out to be incorrect, the physician and/or practicing physician may be responsible for submitting false claims to the federal government.

The second element of the compliance plan is the development and implementation of policies and procedures derived from the compliance plan. Generally, for small practices, form compliance policies and procedures can be purchased and then tailored to the needs of individual practices. In addition, as pointed out by the Ombudsman:

In addition, if a physician practice agency cooperates with a physician practice management company (PPMC), an independent practice association (IPA), a physician hospital organization, a management service organization (MSO) or a third-party billing company, the practice can be included in these compliance standards. The entity’s procedures and procedures (if applicable) are incorporated into its own standards and procedures. Many physicians have found in practice that the appropriate use of third-party compliance standards and procedures will bring many benefits. The result is a consistent set of standards and procedures for a group of physician communities, and only one entity can monitor and follow The process needs to be improved.

ID. At 59348. Regardless of whether it is formulating its own policies or adopting policies of other entities, it is essential that all employees are trained and retrained in compliance programs, policies and procedures. Simply making a plan, but doing nothing, is just a waste of time and resources. In order for a compliance program to take effect, compliance must be a routine activity of any healthcare organization.

Is there a “one size fits all” approach to compliance planning?

Every healthcare practice is different, and you have to focus on your own compliance issues. Providers should pay attention to the most common problems in their practice. The important thing to remember is that the compliance plan should be tailored to the provider’s specific needs and risk areas. In addition, the Office of Inspection has also recognized that the resources and problems of small medical service providers are not the same as those of large multi-state hospital systems. As the Ombudsman pointed out:

The degree of implementation will depend on the scale and resources of the practice. Smaller physician practices may merge each component in the way that best suits the practice. In contrast, larger physician practices often have methods to incorporate these components in a more systematic manner. For example, larger practitioners can use both this guide and the third-party medical billing compliance program guide (the guide provides a more detailed compliance program structure) to create a compliance program specific to the clinic. ID. At 59436.

Ultimately, healthcare providers need to spend some time familiarizing themselves with the legal risks faced by their practices. Healthcare is a legally extremely complex field with countless legal requirements. Ignorance of the law is by no means a defense to legal proceedings. Given that violations of health care laws involve significant risks, like all other health care providers, a compliance program should be an indispensable tool for any ketamine clinic.