Regulatory compliance is a mandatory investment for any healthcare business owner looking to stay out of serious and personal legal peril, let alone one hoping to keep their company viable.
Yet there is seemingly an onslaught of providers that blatantly run afoul of many of these regulations, knowingly or not, or those that believe they may have found a loophole.
Concerning the latter, there is an important mantra that such DME and pharmacy providers should remember and live by: “[W]hat a provider cannot do directly, it cannot do indirectly through an intermediary.”
Marketing for DME – What exactly am I talking about?
DME providers enrolled with CMS (should) know they cannot solicit or ‘cold call’ Medicare Part B beneficiaries, per the Federal Anti-Solicitation Statute, and that they cannot offer anything of value to a potential patient that could induce them to utilize them as a provider, in accordance with the Beneficiary Inducement Statute.
Multiple health care businesses have scored wins this year in their fight to prevent CMS from recouping payments before having an opportunity for an Administrative Law Judge (ALJ) hearing. The similarity? They each sought a temporary injunction in federal court. Arguing that the alleged recoupments would cause the businesses to close, employees to lose their jobs and patients would be forced to change their providers, the businesses were granted temporary injunctions enjoining CMS from starting recoupment until the ALJ appeal stage had reached a conclusion.
The Office of Inspector General (OIG) announced the launch of a new tool on its website titled the “Fraud Risk Indicator”. The OIG has stated that the purpose for the tool is to provide guidance on how it has evaluated risk in settling False Claims Act (FCA) cases and to publicize information about where FCA defendants fall on the OIG’s risk spectrum. This tool can benefit patients, healthcare industry professionals and other individuals who may find this information relevant. This tool will also benefit the public with information about providers charged under the FCA that are at high risk for committing healthcare fraud. The Indicator shows the Risk Spectrum from Highest Risk to Lower Risk.
Private money (e.g. private equity) is in full swing purchasing medical practices with large profit margins (e.g. dermatology). This is NOT the same thing as when physician practice management companies (PPMCs) bought practices the 90s. Back then, the stimulus for the seller was (a) uncertainty re practice profits in the future, and (b) the stock price. Selling practices got some or all of the purchase price in stock, with the hopes the purchasing company stock would far exceed the multiplier applied to practice “earnings” (the “multiple”). Buyers promised to stabilize and even enhance revenues with better management and better payer contracting. If the optimism of the acquiring company and selling doctors was on target, everyone won because the large stock price made money for both the buyer and seller. The private equity “play” today is a little different.
Today’s sellers are approaching the private equity opportunity the same way they did with PPMCs, except for the stock focus since most private equity purchases don’t involve selling doctors obtaining stock. Sellers hope their current practice earnings will equate to a large “purchase price.” And they hope the buyer have better front and back office management that will result in more stable and even enhanced earnings. And for this, the private equity buyer takes a “management fee,” which they typically promise (though not in writing) to offset with enhanced practice earnings.
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.
Earlier this year, Jeff and Autumn and I had a conversation about my motivations and passions outside of the law. We all knew that I was professionally passionate about compliance but they didn’t know that I’ve been personally passionate about veterans and their stories since I was in college. I majored in European history and concentrated on modern history including, of course, World War II. The final for one class was to write the story of someone who lived through the war, whether in military service or on the home front. I’ve been hooked on seeking out veterans’ personal stories of the war ever since.
A couple of years ago, a friend went on her first Honor Flight, and its something I’ve wanted to do ever since. Honor Flight’s primary purpose is to honor our veterans by taking them to visit their war memorials in Washington D.C. Honor Flight was founded by Earl Morse, Physician Assistant and Retired Air Force Captain who worked in a Department of Veteran Affairs clinic in Springfield, OH. When the World War II Memorial opened in 2004, Earl asked one of his patients who had served in World War II if he would be visiting his memorial. He was disheartened to learn that the vet couldn’t afford to travel to his memorial. Earl also happened to be an amateur pilot, and arranged for several small planes to transport his patient and his comrades to the memorial erected to honor them. Now, 14 years later, Honor Flight has hubs all over the nation and a waiting list of 35,000 World War II, Korea and Vietnam veterans waiting for their chance to fly. The flights are entirely free for veterans.
In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits.
There are two criminal cases pending in Palm Beach County that threaten to put a bullet in the heart of healthcare professionals and businesses and also the law practices that advise them. Both State v. Simeone and State v. Kigar have a motion from the State pending before them to block any testimony that the defendants received legal advice concerning a contract entered into by an addiction treatment facility and a sober home. The State alleges that the contract violates the state Patient Brokering Act (PBA) because it was essentially a ruse whereby the addiction treatment facility was just paying for the sober home to refer patients. Now the State wants to make sure that the entire issue of the defendants being advised by counsel never sees the light of day.
How is this possible? How can it be that a client can seek legal counsel, get advise (and presumably follow it), and then be blocked from presenting that evidence? The State argues that the PBA has no wording that requires them to prove intent. And if intent isn’t an element to be proven, the argument goes, then evidence of the client intending not to violate the law by getting advice beforehand is inadmissible!
Federal law enforcement has traditionally prosecuted individuals utilizing healthcare fraud and abuse laws such as the Federal Anti-Kickback Statute, the False Claims Act, the Physician Self-Referral Law also known as the Stark Law as well as other administrative tools including exclusions and civil monetary penalties. In addition to these laws, federal law enforcement also has at their disposal other fraudulent act statutes such as mail and wire fraud. The facts of a case, however, may not provide for federal standing. For example, when individuals take out federal government payors out of the picture or from an arrangement as a way of avoiding federal jurisdiction. The new solution to this issue…a law enacted in 1961, the Travel Act.
By: Susan St. John
As many chiropractors are likely aware, they cannot “opt-out” of Medicare. Even if a chiropractor has not enrolled to be a Medicare provider, a Medicare beneficiary may require the chiropractor to submit a claim to or bill the Medicare program on his/her behalf for chiropractic services rendered. For chiropractic services to be covered by Medicare, the patient must have a condition necessitating treatment and manipulative services rendered must have a direct therapeutic relationship to the patient’s condition. The manipulative services must provide a reasonable expectation of recovery or improvement of function. Further, the Medicare patient’s condition must be acute and not a chronic subluxation without objective clinical improvement anticipated. Manipulative treatment beyond treating the acute phase, that is, a chronic condition, is considered maintenance therapy and is not covered. Thus, a chiropractor needs to carefully consider at what point a Medicare beneficiary’s treatment becomes palliative or maintenance therapy which would not be covered and thoroughly explain this to the patient. The chiropractor has a duty to let the patient know when treatment is no longer curative or therapeutic, but rather maintenance therapy.
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.