What you need to know about the SUPPORT Act?

In October 2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, or SUPPORT, which aims to target full manufacturer-to-prescriber line of potential opioid-related fraud and misuse. Providers, prescribers, distributors and manufacturers across the health care spectrum should be aware of the SUPPORT Act’s broad provisions that will become effective over the next few years.

The Eliminating Kickbacks in Recovery Act (EKRA) is a smaller piece of the SUPPORT Act, but it became immediately effective.

The EKRA impacts the marketing activities of clinical labs, recovery homes, and treatment facilities. The EKRA makes payment structures that were perfectly acceptable under the safe harbors under the Anti-Kickback Statute (AKS) illegal.

Specifically, the EKRA makes it a federal crime to knowingly and willfully:

solicit or receive any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or

Pay or offer any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind –

to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or

in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory.

A violation of the EKRA is punishable by up to ten years in prison and a $200,000 fine.

Unlike the AKS, the EKRA applies to all payors, including commercial health plans.

Additionally, the EKRA contains an exception for compensation paid to bona fide employees, but that exception is not applicable if the compensation paid varies with the number of individuals referred, the number of tests or procedures performed, or the amount billed to or received from a health plan.

Essentially, the EKRA makes commission based compensation for marketers employed by clinical laboratories, recovery homes, and clinical treatment centers close to impossible.

Happy new year.

2019 will be an interesting year in the health care fraud. Here is a short summary of the must watch cases of 2019.

Prosecution of Insys Therapeautics executives. Prosecutors claim CEO Michael Babich, chairman John Kapoor and four sales executives conspired to bribe doctors to prescribe the company’s powerful fentanyl painkiller spray. Prosecutors have brought racketeering charges against the defendants. Babich is set to pled guilty on January 9, 2019. The vice president of sales, Alec Burlakoff, pled guilty last month. The remaining defendants are gearing up for trial.

Prosecution of Two Former Tenet Hospital executives. Prosecutors claim that the two former executives of Tenet engaged in a scheme to accept kickbacks from the head of a clinic that served Hispanic immigrants. The case is hotly contested and there has been extensive litigation over the past two years. It looks like the case will finally go to trial in Atlanta this year.

$1 Billion Telemedicine Case. This case is out of Tennessee. It charges seven compounding pharmacies and four individuals and alleges a telemedicine scheme involving the submission of fraudulent prescriptions for reimbursement by private insurers. Interestingly, the prosecutors did not charge the doctors in this case and has identified them as victims.

In terms of appeals, United States v. Melgen is the case to watch. Melgen was convicted in a health care fraud conspiracy that alleged that the doctor performed medically unnecessary procedures on his patients, among other allegations. The appeal raises numerous issues. Two issues that have been raised and could have a big impact on other cases is whether the admission of statistical peer comparison evidence violated the Rules of Evidence and the Confrontation Clause and whether the court erred by not instructing the juror that the prosecution’s sampling of patients was not random. The issue of “sampling of patients” was hotly contested at trial. The defense claimed that the Government cherry picked the worst patients and didn’t use a statistician. I think this is a common practice by the government. Dr. Melgen is represented by Kirk Ogrosky at Arnold and Porter.

And last but not least, 2019 might be the year we finally get an opinion from the Eleventh Circuit in United States v. AseraCare. The Eleventh Circuit heard oral arguments in this case two years ago. The central issue in this case is whether, when two experts look at medical records and disagree about their meaning, a jury can side with one expert and deem billing fraudulent. A judge in Alabama decided that this type of evidence is insufficient to create FCA liability. This opinion impacts the defense of medical necessity prosecutions that usually revolve around a dispute amongst experts.

Deputy Attorney General Rod Rosenstein announced last week a change in the way cooperation credit is given to corporations in criminal cases. Rosenstein announced that the Department of Justice will allow a company to receive cooperation credit in criminal cases where the company has identified every individual who was “substantially involved in or responsible for the criminal conduct.” Under the prior DOJ policy, referred to as the Yates memo, corporations were required to turn over ALL relevant facts about individuals involved in misconduct.

The new policy will allow for partial credit in criminal cases as well. “If the company is unable to identify all relevant individuals or provide complete factual information despite its good faith efforts to cooperate fully, the organization may still be eligible for cooperation credit.” To receive credit, companies need only identify individuals “substantially involved in or responsible for the misconduct.”

Rosenstein noted that the DOJ wants corporations to focus on identifying the wrongdoers. Rosenstein also noted that it is inefficient for large corporations to identify every single employee that may be connected to the bad conduct.

The revised DOJ policy has been incorporated directly into the United States Attorneys’ Manual, now referred to as the Justice Manual, at 9-28:700 (“The Value of Cooperation”). This is a change from the recent DOJ practice of communicating new guidelines through memoranda named for their authors. The incorporation into the Justice Manual may signal a desire to give the revisions more authority.

Because “substantially involved” is not defined, corporations are left to guess what it means and DOJ staff are still given the authority to decide whether disclosures were sufficient to warrant participation. In the end, the problem with all these policies is that individuals are applying the policies. It remains to be seen whether DOJ staff will award cooperation credit for what they deem less than full disclosure.

One defendant in the highly publicized Insys prosecution has agreed to switch sides and become a cooperator. Former Vice President of Sales at Insys, Alec Burlakoff, has agreed to plead guilty to a racketeering conspiracy. He faces a maximum 20 year sentence. Burlakoff admits that he aggressively pushed a scheme of paying doctors to speak at events in exchange for writing prescriptions for Subsys.

The Government alleges that Insys executives conspired to bribe doctors to prescribe Subsys in order to boost sales. Subsys is an opioid that is FDA approved for cancer patients in severe pain. The government alleges that Subsys was being overprescribed to a wide range of non-cancer patients.

Burlakoff is expected to be a key government witness in the trial starting January. Burlakoff is expected to say that the six remaining defendants aggressively pursued doctors to prescribe Subsys.

Burlakoff had a key role in the scheme. The emails substantiate that Burlakoff was telling his sales team to urge doctors to prescribe Subsys for off label use not just cancer patients.

Emails also reveal that Burlakoff telling his sales team to expect a bump in sales after he paid a visit to a doctor with a large practice. The evidence further revealed the doctor was paid to speak at two Insys events the month following the visit.

Because all defendants were so close to trial and likely operating in a joint defense, it will be interesting to see whether any defendant objects to the scope of Burlakoff’s testimony based on a privilege arising from the joint defense.

The Department of Justice indicted four individuals in Tennessee in an alleged scheme involving telemedicine. The Indictment charges conspiracy to commit healthcare fraud, mail fraud, and introducing misbranded drugs into interstate commerce. According to prosecutors, the scheme involved at least $931 million of allegedly false claims.

Telemedicine involves connecting physicians and patients through electronic media. Physicians are contracted by the telemedicine companies and are paid a contracted fee. Patients pay a fee for the service. Typically, telemedicine companies do not submit claims to insurance companies.

The Indictment alleges that HealthRight LLC, a telemedicine company, fraudulently solicited insurance information from patients using its service. Any patients without insurance coverage were screened out. HealthRight LLC further procured prescriptions for pain creams and similar products preselected by defendants’ companies from unknowing doctors. Once the prescriptions were procured, defendants would massively mark up the price of the products, sometimes over 1000%, and bill to insurance companies. The Indictment further alleges that in most instances, the physician did not speak to the patient directly. Instead, physicians received electronic information claiming that the patient had specifically requested the preselected pain creams and other products.

While the Indictment alleges $931 million of allegedly false claims, the forfeiture prayer only seeks $154 million.

The Telemedicine company HealthRight LLC and its CEO pled guilty in September to an unrelated scheme involving fraudulent telemarketing of dietary supplements, skin creams, and testosterone.

On Friday, the head of the Department of Justice criminal division, Brian Benczkowski, released a memorandum regarding the selection of monitors in criminal division matters.  The new policy was announced to a small audience at New York University School of Law.  The memorandum supersedes guidance contained in Lanny Breuer’s memorandum from 2009 laying out the Department of Justice’s monitor selection process.

Mr. Benczkowski commented when announcing the new policy that “the imposition of a compliance monitor should be the exception, not the rule.”

While the new policy closes tracks the language of the 2009 Breuer memorandum, there are a few key differences designed to put limits on the number and scope of monitorships.  For instance, the memorandum requires that a monitorship be “tailored to address the specific issues and concerns that created the need for the monitor.”  The new policy requires prosecutors to consider the cost associated with monitorships and whether it can be limited scope to avoid unnecessary burdens to the business operations.  Prosecutors will also be required to consider whether the bad actors were terminated and whether a new management team was put in place.  If the bad actors are gone, this seems to be a factor weighing against the need for a monitorship.

The memorandum is located HERE.

Mr. Benczkowski also announced that the Department of Justice will do away with the compliance expert at the Department.  Instead, the Department of Justice will hire prosecutors with a compliance background and/or train prosecutors on compliance.

 

 

After a review ordered by Deputy Attorney General Rod Rosenstein, the Department of Justice has revamped and updated the United States Attorneys’ Manual.  This is the first comprehensive update of the Manual in 20 years.  The Manual is now titled the “Justice Manual.”

The most notable change for that will effect federal criminal practitioners are the changes to the “Principles of Federal Prosecution” section.  The section has been expanded and the language updated.  The updates include language that pushes prosecutors to pursue charges that carry the most substantial penalties.

A few other notable changes

    • The subsection “Need for Free Press and Public Trial” has been removed. The language was replaced with text about balancing “the right of the public to have access to information about the Department of Justice” against other factors.
    • In the section about voting rights, there are no more references to redistricting or racial gerrymandering. There are still references regarding bans on practices such as literacy tests, poll taxes, and measures that deny voting rights based on race.
    • The manual revision also cut language discouraging unnecessary charges, as well as Alford pleas.

The new Manual can be found HERE.

A big victory for the defense in the prosecution of the founder and former top executives at opioid manufacturer Insys Therapeutics.  A magistrate judge assigned to the case ordered federal prosecutors in the United States Attorney’s Office in Boston to turn over documents in the hands of ten different federal agencies’ that could potentially help the company’s former executives fight racketeering and fraud charges.

In June, the defense filed a Motion for an Order Requiring Government to Produce Exculpatory Materials in the Possession of Sister United States Attorney’s Offices and Federal Agencies.  The defense’s motion noted that the same day the Superseding Indictment was unsealed, the United States Attorney’s Office issued a press release acknowledging the joint effort and assistance of six other United States Attorney’s Offices and ten federal agencies that were part of the investigatory team.  However, when pressed by the defense for materials in the hands of the other United States Attorney’s Offices and the federal agencies, the prosecutors claimed those offices and federal agencies were not part of the “prosecution team”.

In its Motion, the defense gave examples of potentially exculpatory materials in the hands of the other ten agencies.  The examples included “any denials by Insys sales representatives or Insys physicians to any federal agent that speaker program payments were intended to be kickbacks”, “DEA communications that opioid products were not suspicious”, and “DEA or FDA communications acknowledging that off-label use of immediate release fentanyl products, such as Subsys, is medically and scientifically legitimate.”

In Opposition, the thrust of the Government’s argument was that the other offices and the other federal agencies were not part of the prosecution team and as a result its Brady obligations did not extend to those offices.  The Government also argued that Defendants didn’t establish that the information sought is material.

The magistrate judge sided with the defense.  The judge ordered prosecutors to hand over any documents in the hands of the 10 federal agencies’ that were part of the investigation that could potentially help the company’s former executives fight racketeering and fraud charges.  The motion as to the United States Attorney’s Offices was moot because those offices had alerted the court that they did not have any documents.

The Government routinely makes similar arguments related to CMS data in health care fraud prosecutions.  Hopefully, this decision paves the way for the release of more information to criminal defendants.

On another note, not sure why the Government wouldn’t want to turn over the information.  The Government should be transparent in its production of evidence, especially exculpatory evidence to defendants.

 

Temporary restraining orders—a first-of-its-kind against doctors allegedly prescribing opioids illegally under the Controlled Substances Act (CSA)—were served this week that forbid Michael P. Tricaso, D.O., of Akron, and Gregory J. Gerber, M.D., of Sandusky, Ohio from writing prescriptions.  The Justice Department filed two separate complaints to bar two Ohio doctors from prescribing medications and allege that an investigation revealed the doctors “recklessly and unnecessarily distributed painkillers and other drugs.”  Attorney General Jeff Sessions even made the trip to Cleveland, Ohio to make the announcement.  You can read the press release HERE for more information.

The motions for temporary restraining orders point to the Government’s authority under the Controlled Substance Act for the Attorney General to commence a civil action for appropriate declaratory or injunctive relief relating to any violation of 21 U.S.C. 843(f).

According to the filings, Dr. Tricaso was targeted by a confidential source working for the DEA at a gym.  The confidential source purchased various prescription drugs from Dr. Tricaso, including steroids and Percocet.  The transactions were recorded and Dr. Tricaso is alleged to have made some unfavorable comments including that he would only give the confidential source a prescription for 20 Percocet because that number is “under the radar.”

The allegations against Dr. Gerber are much more extensive, but defensible.  Dr. Gerber was a solo practitioner operating a pain clinic.  The Government claims that Dr. Gerber illegally issued hundreds of prescriptions that exceeded the amount for “legitimate medical purposes.”  As part of its investigation, the Government sent an undercover agent to Dr. Gerber’s offices six times.  The Government alleges that the agent was prescribed by Dr. Gerber a combination of controlled substances, including Oxycodone, with minimal medical examination and no complaints of pain.  The Government also notes that Dr. Gerber was connected to the Insys case and received $175,000 in speaker fees for promoting Subsys.

The motion for temporary restraining order directed at Dr. Gerber attaches an expert medical opinion, patient affidavit, and an affidavit from an agent.  The expert’s affidavit references a review of claims data and medical records.  The expert opines that the prescriptions exceed normal levels.

Also curious is that the Government also attaches as evidence of Dr. Gerber’s illegitimate practices correspondence from Walmart advising that, after an internal review, it will no longer fill prescriptions written by Dr. Gerber.

It will be interesting to watch these cases and see how it develops.

 

 

On Friday, the Sixth Circuit in the cases of United States v. Mehmood and United States v. Ahmadani reversed the sentences of two owners of home health care companies. The Sixth Circuit reasoned that the trial judge incorrectly applied the law in calculating the loss figure for sentencing purposes by assigning the loss figure as the gross billings to Medicare.

The Opinion states that “[i]n a case in which the defendant is convicted of a Federal health care offense involving a Government health care program, the aggregate dollar amount of fraudulent bills submitted to the Government health care program shall constitute prima facie evidence of the amount of the intended loss…”

The court noted its agreement with United States v Medina, 485 F.3d 1291, 1304 (11th Cir. 2007) (“Even though [the government’s Medicare witness] testified that Medicare would not pay a claim if they knew parties were receiving kickbacks, this is not sufficient to establish a loss to Medicare.”). Specifically, the court rejected the notion that all claims were illegitimate due to false representations about intent to follow Medicare’s anti-kickback rules.

The Opinion further states that the trial court should have taken into consideration evidence that legitimate services were provided, particularly the testimony of multiple therapists, nurses, and counselors, when calculating loss.  The Court specifically concluded that “to calculate loss for sentencing purposes, the value of any legitimate claims, if established, must be offset against the aggregate billings.”

This opinion could have a big impact on health care fraud cases. It could have the effect of narrowing the focus in health fraud prosecutions to the amount of kickbacks paid instead of gross billings. The difference could mean millions in most cases. The narrowed focus will not only reduce sentences, it will reduce restitution and forfeiture amounts.