Category: Health Law

A new policy recently issued by the Justice Department states that the Department will not use its enforcement authority to effectively convert agency guidance documents into binding rules. The new policy has broad ramifications and applies to government enforcement actions as well as civil lawsuits. The policy prohibits Department components from issuing guidance documents that effectively bind the public without undergoing formal rulemaking.

The term “guidance documents” includes any agency statement of general applicability and future effect, such as Medicare billing manuals, special fraud alerts, and frequently asked questions. The Department may continue to use guidance documents to simply explain or paraphrase legal mandates from existing statutes or regulations, but guidance documents cannot create binding requirements that do not already exist by statute or formal regulation.

While the new policy is viewed favorably by most in the health care industry and gives health care providers a new tool to fend off allegations of wrong doing, it may lead to confusion as providers try to interpret complex and confusing statutes and rules.

In the 1990s, I wrote about a health care entity’s responsibility for medical waste. At that time, a hospital client had contracted with a low cost medical waste disposal company thinking that they would be saving money. The medical waste disposal company dutifully picked up the hospital’s medical waste and provided documentation to the hospital showing that the waste had been properly disposed of in accordance with legal and regulatory requirements. The hospital was happy, until the day they received notice that the hospital was a potentially responsible party for a super fund waste site located several thousand miles away from the hospital. It turned out that the medical waste disposal company had forged the documentation and dumped the untreated medical waste at the super fund waste site. The hospital was linked to the waste site through IV bags found at the site, with patient names and the hospital’s identification attached.

HIPAA had not yet been enacted in the 1990s and protected health information (PHI) was not the hospital’s primary concern. However, had the medical waste dumping happened today, the hospital would have to address not only the EPA super fund waste problem, but also HIPAA issues.

The take away. Think beyond medical records when addressing PHI and beware of low cost solutions to waste disposal.

Licensure compacts allow nurses to have one multistate license, with the ability to practice in their home state and other compact states. The Enhanced Nursing Licensure Compact ( eNLC) was recently implemented and allows nurses to practice in person, or via telehealth, across states that are a part of the compact. The eNLC covers registered nurses, licensed practical nurses and vocational nurses. The Enhanced Nurse Licensure Compact (eNLC) is intended to increase access to care while maintaining public protection at the state level. Under the eNLC, nurses are able to provide care to patients in other eNLC states, without having to obtain additional licenses. Nurses with an original NLC multistate license will be grandfathered into the eNLC. New applicants residing in compact states will need to meet the uniform license requirements for a multistate license.

Advanced practice nurses are covered by the Advanced Practice Registered Nurse (“APRN”) Compact. The APRN Compact, approved May 4, 2015, allows an advanced practice registered nurse to hold one multistate license with a privilege to practice in other compact states. The APRN Compact will be implemented when 10 states have enacted the legislation. So far, fewer than 10 states have enacted the APRN Compact. Hopefully, eNLC implementation and the expansion of telehealth will spur additional states to enact the APRN Compact.

With the implementation of the eNLC, a licensed nurse residing in compact states may treat a patient located in any of the compact states under one multistate license. Nurses are further enabled to provide services via telehealth with the added protection and standards of the eNLC. Reimbursement remains a concern.

Health care providers have come to rely on the Office of the Inspector General (OIG) Advisory Opinions (AO) as regulatory guidance. For the first time ever, late last fall, the OIG rescinded an advisory opinion, that was originally issued in 2006 and modified in 2015.

According to the OIG, the charity that sought and received the AO, breached two commitments made in its AO request. The original AO, which contained assurances about protection from anti-kickback statute liability and civil monetary penalties was revoked retroactively, exposing the charity to potential liability for past acts that the charity believed were protected by the AO. The charity had proposed modifications to the AO when it learned of the potential revocation. But, the proposal was rejected by the OIG with the OIG stating that it did not trust the charity.

The take away for providers is that commitments made in a request for an AO must be kept. An AO is not a blank check. It can be revoked retroactively.

Dr. Oluwafemi Charles Igberase entered the United States in October 1991 on a nonimmigrant visa. In November 1991, January 1995, and September 1998, Igberase obtained fraudulent social security numbers using other names and false identifying information. Between 1992 and 1998, Igberase obtained three certifications from the Educational Commission for Foreign Medical Graduates (ECFMG) under different names, dates of birth and fraudulent social security numbers, in order to practice medicine and get into a residency program in the United States. The ECFMG Committee on Medical Education Credential subsequently revoked or suspended two certifications in December 1995, after learning that they were fraudulently obtained. In 1998, after receiving his third ECFMG certification in the name of Charles John Nosa Akoda, Igberase was admitted to a residency program in New Jersey. Igberase was dismissed from the program two years later after officials learned that the social security number he used did not belong to him.

In 2016, Dr. Igberase pled guilty to using a fraudulent Social Security number to obtain his medical license. His medical license was subsequently revoked. Prior to revocation of his medical license, Dr. Igberase obtained medical staff privileges at a hospital and delivered hundreds of babies. The hospital was sued in a putative class action for negligent credentialing and the case is pending. In its defense of credentialing Dr. Igberase, the hospital recently argued that it had no duty to ensure that a physician is using his real name and placed the blame on the Maryland Board of Physicians for granting Dr. Igberase a medical license.

To our hospital clients, you should verify that a physician is using his or her real name and that he or she has proper training and credentials.

A Health System recently agree to pay $6 million to settle allegations that a subsidiary submitted false claims to Medicare for unnecessary rehabilitation therapy services. The Health System was also required to enter into a 5-year corporate integrity agreement with the U.S. Department of Health and Human Services Office of Inspector General. The billed services were allegedly unreasonable, not medically necessary and unsupported by the medical records.

The case was originally filed by whistle blower employees. In its defense, the Health System argued that the not medically necessary findings were highly subjective conclusions and that the care was appropriate. The Health System settled the case for $6 million, however, to avoid “an unsustainable and ultimately unacceptable allocation of financial and personnel resources.”  Assuming that the care was appropriate, better documentation of medical necessity might have saved the Health System $6 million.

I am about to work with the Illinois Hospital Association (IHA) on the third edition of IHA’s Record Retention Reference. I worked with IHA on the first two editions and look forward to working on the third. I hope we call it Records Management Reference and not Record Retention because records management is broader and more encompassing than record retention.

I am a strong believer in records management. Records should not be hoarded and should be easy to retrieve when needed. I shudder when I hear that colleagues have 6,000 or more emails in their inbox and get chest pain when files are covered high on colleagues’ desks and cover the floors.

If you have suggestions, comments or stories relating to records management, let me know. I have a few good ones I can share with you over a cocktail.