Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
It has been a busy autumn for the enforcement of health care privacy rights. Recent activities range from settling the claim for the largest HIPAA violation in US history, to penalties imposed for filming TV shows, to actions initiated by state governments. All of these actions confirm the serious position taken by regulators nationwide to protect the privacy of protected health information (PHI).
The Big One
On October 15, 2018, Anthem, Inc., an independent licensee of Blue Cross, paid $16 million to settle its claim with the HHS Office of Civil Rights (OCR), for a breach that compromised the PHI of 79 million people. This was the largest reported breach in history. The PHI breach occurred in 2015, when hackers initiated a “spearfishing” attack via fraudulent emails. The government found that Anthem lacked appropriate information system procedures to identify and respond to security breaches, and minimum access controls to stop these kinds of attacks.
In addition to the financial penalty, Anthem agreed to a corrective action plan, in which it agreed to perform a risk analysis, and incorporate the results of the analysis into its existing processes, in order to achieve a “reasonable and appropriate level” of HIPAA compliance.
This settlement is in addition to the $115 million settlement Anthem reached last year with the victims of the breach. read more
The concept of gainsharing in the health care industry has been around for decades. Under a typical gainsharing program, a hospital and participating physicians will develop a cost-savings plan in relation to a specific procedure or service line. As the savings are realized, the hospital will then share a portion of the measurable savings with those physicians. The goal of gainsharing has always been to align physician and hospital interests, in order to improve the quality and efficiency of clinical care.
Gainsharing has not always been viewed favorably by the government. In fact, in a 1999 Special Advisory Bulletin, the Office of Inspector General (OIG) took the position that gainsharing arrangements violated the law, and that the payments could even constitute kickbacks to the participating physicians. Since then, the government has not backed off its position that gainsharing programs might violate the law. However, the OIG has also determined that it would not seek sanctions in a growing number of gainsharing arrangements. read more
In December 2016, the US Congress passed the 21st Century Cures Act, which, among other things, provided for increased funding for treatment and research of mental health and substance abuse disorders. That law also required the HHS Office of Civil Rights (OCR) to provide guidance in regards to HIPAA compliance in regards to those types of treatment. In October 2017, President Donald Trump declared the opioid addiction epidemic to be a public health emergency, which will also result in additional resources being allocated to addressing the crisis.
In connection with both the new law and the President’s declaration, OCR published its HIPAA guidance in December 2017. The guidance is intended to clarify how and when protected health information (PHI) can be shared in regards to patients in substance abuse and mental health treatment. According to OCR Director Roger Severino, “HHS is using every tool at its disposal to help communities devastated by opioids, including educating families and doctors on how they can share information to help save the lives of loved ones.” read more
On June 8, 2017 the Florida Supreme Court, in a 4-3 opinion, ruled that the legislatively-established caps on non-economic damages (such as awards for pain and suffering) in medical malpractice cases are unconstitutional. In 2014 the Florida Supreme Court determined the cap established for wrongful death claims was unconstitutional. The 2017 decision now does away with the remaining caps. read more
A recent decision by a Health and Human Services appellate panel emphasizes how strictly the government will interpret its rules and the disingenuous results that can sometimes follow when healthcare business operations best practices are less than optimal. Although the case referenced below involves a home health agency, the panel’s application of the rules applies to all Medicare providers. The resulting loss of the agency’s participation in Medicare serves as a sobering reminder that total compliance with all conditions of participation is crucial.
Vamet Consulting & Medical services was a Medicare-enrolled home health agency based in Houston, Texas. On July 14 and 15, 2014 the company conducted training for its office staff at its primary location. The training meant that all the agency’s staff would be in the back of the office, either in training or working, so the company locked its front door. read more
In 1986 President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (EMTALA) into law. Since then, the application of the law has been expanded and refined. It was one of the first laws giving the government the authority to dictate certain operations of a hospital. While other laws and regulations such as the Anti-Kickback Statute and the Stark Law have become more of a focus for health care providers, EMTALA remains an area of active enforcement. All providers with hospital privileges should therefore be aware of its application.
The policy behind the law is fairly straightforward. Hospitals with emergency departments should not be able to turn away patients needing care because of their inability to pay (no more “wallet biopsies” as part of triage). Likewise, hospitals should not be able to “dump” patients on other facilities for reasons other than for advanced care.
The requirements of the law are also very basic. If a patient comes to an emergency department and requests an examination or treatment for a medical condition, the hospital must provide an appropriate medical screening exam, within its capability, to determine whether or not the patient has an emergency medical condition. The screening provided goes beyond simple triage, and must be performed by a clinical provider such as a physician, nurse practitioner, or physician’s assistant. read more
There will likely come a time in your practice when you find yourself considering whether you should maintain a relationship with a patient. It may be that the patient is non-cooperative. Or the patient may refuse to pay his or her bill, or to follow a reasonable payment plan. Even more significantly, the patient may have engaged in behavior that is disruptive to your practice. For whatever reason, you are questioning the value of the relationship.
In those situations, the law does allow a physician to terminate a patient from his or her practice. However, careful analysis must be done in these situations, and there are several steps that should be followed. The risk of a claim of abandonment or of professional negligence makes it important to protect yourself, your practice, and the licenses of the providers within your group. You may already have a process spelled out in your policies and procedures, and if you do, that process should be followed. However, make sure your policy at least covers the points below. read more
It’s that time of year. People are scrambling around, deciding what they want to give and what they want to get. Brand new packages are being wrapped up and filed away. Excitement and tension fill the air. Everyone can’t wait for the big day; but in this season that big day doesn’t happen until the first Tuesday after the first Monday in March. But it’s never too early to start getting ready, right? In fact, the Florida Legislature is currently in session, drafting and filing bills that the sponsors hope will be considered in March and will become law in 2016. And as usual, health care is on a lot of legislative wish lists. Although all of these bills are subject to significant revision, and some may never make it out of a subcommittee, here’s a sneak peek of some of the proposed health care legislation (without editorial – for now).
Scope of Practice Expansion
Three categories of health care professionals may see significant expansion of the scope of their practice.
Both Advanced Registered Nurse Practitioners and Physician Assistants would gain the right to prescribe controlled substances pursuant to Senate Bill 676. Most of the details about specific medications and dosages is left to an administrative committee, but the bill seems to anticipate broad authority. The bill also adds references to ARNPs and PAs throughout the Florida Statutes, indicating a willingness to accept these professionals into a significant role in the delivery of care. Additionally, SB 572 would add PAs and ARNPs to the list of providers who can certify that an individual meets Baker Act criteria to justify a patient’s involuntarily confinement for mental health reasons. read more
The last few weeks have seen some significant examples of the federal government’s vigilance in policing the healthcare market. These events serve as a reminder of the highly regulated and scrutinized industry in which we work. They are also a reminder to physicians and other providers to make sure their practices and contractual arrangements can pass this scrutiny.
The most significant recent event is the $115 million settlement between the government and the Adventist Health System. This settlement resolved two whistleblower cases brought against the system by three employees. The lawsuits alleged that the Adventist Health System violated the Stark law, which generally prohibits payments to physicians for making referrals unless an exception to the law is met. The specific allegations against the Adventist Health System were that the compensation paid by the health system to some of its employed physicians exceeded fair market value; that the structure of the practice of the employed physicians did not meet the “group practice” exception; that physician compensation improperly included payment work not performed by the physicians; and that the physicians were paid for making referrals to the system. read more