Continuous Blood Glucose Monitoring Compliance Regulation

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Continuous Glucose Monitoring (“CGM”) is an attractive new way to monitor glucose levels. Companies specializing in CGM must comply with specific healthcare laws and regulations. Such medical developments make CGM companies particularly subject to increased federal scrutiny.

Federal authorities such as the Centers for Medicare and Medicaid Services (“CMS”); the Office of the Inspector General of the Ministry of Health and Social Services (“BIG”); and the Department of Justice (“DOJ”) vigorously aims to investigate and prosecute companies that have allegedly made false statements to the government or taken advantage of federally funded benefit programs. In addition, the consequences of the new coronavirus have put unique pressure on the entire health sector.

Violating federal health laws can wreak havoc on a company’s business operations. Sanctions can include fines and penalties, restitution, injunctions and sometimes prison terms.

For this reason, it is essential to implement a comprehensive CGM compliance program that detects, corrects and monitors the internal operations of the company for non-compliance, fraud, illegality and other cases of violation. misconduct.

What Are Continuous Blood Glucose Monitoring Companies?

Continuous Glucose Monitoring (“CGM”) companies offer specialized equipment that automatically tracks a patient’s blood sugar. This piece of equipment is a sensor that is placed under the patient’s skin and measures the glucose levels between the patient’s cells.

The sensor then reads the glucose levels and sends the information to a wireless monitor. CGM companies are growing in popularity as they allow patients to view their levels multiple times a day and ultimately decide how best to handle identified deficiencies.

The popularity and success of these companies have attracted the attention of federal authorities. These federal authorities continue to assess whether all legal provisions relating to health care are being observed or whether there is fraud. It is mandatory for CGM companies to be aware of these federal laws, which are described in the next section.

Federal laws regulating companies dealing with CGM

Below are the most common federal civil and criminal laws that CGM companies should be aware of:

Elimination of bribes in the Recovery Act (“EKRA”)

EKRA prohibits laboratories, clinics, recovery centers and other clinical facilities from accepting or paying bribes for patient referrals. It is broader than other laws such as the Anti-Kickback Statute in that the health benefit programs include both state and federal health programs such as Medicare and Medicaid, as well as benefit plans. private health insurance.

Anti-return status (“AKS”)

AKS knowingly and willfully prohibits making payments to induce referred patients or generate business relating to any service payable to government health programs. Unlike EKRA, AKS only applies to federal and state health programs.

False Claims Act (“FCA”)

The FCA prohibits fraud against the government by submitting fraudulent information or making false statements. In addition to the government prosecution of FCA, the FCA contains a provision that allows qui tam lawsuits – lawsuits brought by whistleblowers.

Health Insurance Portability and Accountability Act (“HIPAA”)

HIPAA regulates the disclosure of patient health information, including health conditions and personal information such as address and social security number. The statute guarantees the confidentiality of patient information; aims to identify threats to the security of patient information; and protects against unauthorized and illegal disclosure of such information.

Fraud Program Civil Remedies Act

This law prohibits anyone from making a statement that they know to be false and prohibits them from omitting an important fact.

Article 666. Theft or corruption in relation to programs receiving federal funds

This provision makes it a federal crime for anyone to steal federal funds involved in a federal program or misappropriate property under the control or custody of the government or one of its federal agencies.

Conspiracy to defraud the United States (18 USC § 371)

This law criminalizes conspiracy to commit a felony against the United States or to defraud the United States or any of its agencies.

Mail and Electronic Fraud Laws (18 USC § 1341, 18 USC § 1343)

These laws make it a federal crime to use mail or wires to send or electronically transmit anything that was associated with or involved fraudulent acts.

Section 1001 of the United States Code

This section of the US code prohibits anyone from making false statements to the government. In general, the text of the law prohibits (1) falsifying or concealing an important fact; (2) make a substantially false or fraudulent statement; or (3) make or use a false writing knowing that it contains a false statement.

In addition to the above, there may be additional federal and state laws that apply to healthcare companies specializing in CGM.

Continuous blood glucose monitoring companies are important companies in that they provide a service and technology that is very beneficial to patients but, at the same time, innovative and based on specialized technology. Federal authorities tend to scrutinize new developments, especially in the healthcare industry, despite the healthcare company’s goal or the results it achieves. For this reason, it is imperative that you retain the services of a health care defense lawyer as soon as you become or suspect you are investigated. A lawyer can help your CGM business set up, implement and monitor an effective compliance program that identifies and corrects instances of non-compliance. – Dr Nick Oberheiden, founding lawyer of Oberheiden PC

CGM Compliance Checklist

Below is a comprehensive checklist for successful CGM compliance. It includes key policies that should be included in the compliance program; important steps to take to monitor compliance; and the internal practices to be adopted within the CGM company for best practices.

CGM compliance program

  • Hire a law firm with experience in analyzing the effectiveness of your CGM compliance program. Lawyers are skilled negotiators and advocates for healthcare companies’ compliance with federal laws and regulations. A lawyer can help CGM companies implement a robust compliance program and defend it against federal charges or allegations of non-compliance.

  • Enforce and practice comprehensive due diligence practices. Due diligence is a critical step a business takes before entering into a transaction. Examples of strong due diligence measures include background checks; second opinion; and payment verification.

  • Develop effective risk assessment procedures. Risk assessment measures should reflect the particular needs of the business, including its target customers. They should also be used before, during and after major transactions such as mergers or acquisitions.

  • Use annual employee compliance training. The training allows all company personnel to stay abreast of the latest developments in healthcare and federal laws relating to the industry. Training should be mandatory and apply to individuals at all levels and positions within the CGM company.

Compliance monitoring

  • Conduct regular external audits by independent compliance auditors to regularly assess compliance. These auditors should be independent professionals trained to provide impartial advice on the effectiveness of the compliance program. Surprise audits can be beneficial as they inform CGM companies of their compliance at any time of the year.

  • Regularly assess internal controls. CGM companies must implement policies that assess the internal controls of their accounting practices. This helps prevent internal cases of fraud, abuse or other misconduct.

  • Implement detailed record keeping arrangements. Compliance programs can’t just look good on paper; they must be effective in practice and this effectiveness must be properly documented and recorded.

  • CGM Compliance Code of Conduct. The code of conduct within a company defines the internal working environment by ensuring that compliance, the fight against retaliation, the fight against corruption and due diligence remain the top priorities.

Internal policies

  • Pay attention to changes in the legal and regulatory environment. CGM companies should ensure that their compliance programs are updated to reflect changes in the legal and regulatory environment.

  • For example, recent changes to federal law due to the novel coronavirus have required drastic changes within the healthcare industry.

  • The increased focus of the federal government on medical necessity and documentation has forced healthcare companies to adopt more detailed verification and documentation policies.

  • Focus on high risk areas. Special attention should be paid to high risk transactions such as those involving sales to foreign parties or foreign entities or high value transactions.

  • Make sure your business has a successful but anonymous anti-retaliation program in place. No business is immune to the possibility of disgruntled employees. It is therefore essential that CGM companies put in place a safe and secure means for staff to report violations or misconduct anonymously without retaliation.

  • Guarantee a work environment with clear communications and an honest culture. Senior managers should encourage an attitude of frequent and open communication.

Conclusion

CGM compliance is essential not only for the proper functioning of CGM companies, but also to avoid unnecessary federal scrutiny. CGM companies must ensure that their internal compliance programs contain strict policies requiring compliance with federal law.

Violating federal health laws governing your business could expose your business to federal investigation, substantial fines and penalties, restitution orders, injunctions, loss of the ability to receive government funding or doing business with the government, loss of business and business contacts, and damage to reputation.

Imprisonment is also a possibility. For this reason, it is imperative to always maintain ongoing compliance with federal law. Retaining the advice of an experienced federal defense lawyer can help you achieve these goals.

Oberheiden PC © 2021 Revue nationale de droit, volume XI, number 196


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