Tag Archives: Patient Brokering

Feds Reconsidering Stark and Anti-Kickback Safe Harbors

The concepts of the federal Stark Law and its companion Anti-Kickback Statute (AKS) are often used interchangeably by health care industry providers, though both laws are different in applicability.

A chart detailing the differences has been prepared by HHS and can be found here: https://oig.hhs.gov/compliance/provider-compliance-training/files/starkandakscharthandout508.pdf
Health & Human Services (HHS) and its Office of Inspector General (OIG) HHS has been taking comments from industry as to ways to “update” the rules implementing the Stark Law and the AKS to meet modern evolutions in physician/employee compensation and other financial arrangements which industry believes are outdated and stifle innovation.

According to recent reporting by ModernHealthcare.com:

“Hospitals have urged HHS’ Office of Inspector General to recognize that payments between providers in the same alternative pay models do not violate federal anti-kickback laws, warning they may not participate in the programs otherwise. Alternative pay models can violate anti-kickback laws because they can include incentives and shared savings payment agreements to reduce the cost of care, which could influence a provider to use a certain vendor, refer patients to specific facilities or order more services that are paid for by federal healthcare programs. But providers told the OIG that the laws are too broad and they’re getting in the way of the move to value-based care. Some providers called on the agency to create a so-called safe harbor for payments made between hospitals, physician groups and skilled-nursing facilities in value-based arrangements to allow them to split shared savings payments.”

Relevant to the addiction treatment industry was commentary about forms of “payments” to patients.

“Providers also want to protect payments to patients to address their social determinants of health. These payments may violate anti-kickback statute because a beneficiary could feel obligated to continue receiving care from that provider.  But patients are more likely to lose weight if they have a financial incentive, according to American College of Cardiology President Dr. Michael Valentine. If physicians can pay for food, clothing or even transportation to and from healthcare visits, that could improve patient health. Valentine called for an expanded safe harbor that would allow physicians to pay patients to improve their social determinants of health.  Karen Ali, general counsel at the New Jersey Hospital Association, agreed that OIG should not penalize hospitals for these payments, as they could reduce unnecessary readmissions. ‘Hospital responsibility for patient care no longer begins and ends at the hospital door,’ Ali said. The comments are in response to a Request for Information issued by HHS’ OIG this past summer. The agency asked providers how it could encourage value-based pay arrangements. It received more than 350 responses. The CMS is also looking to soften anti-kickback regulations. It issued its own RFI to determine how it can minimize the regulatory barriers around the so-called Stark law.”

At the local (Florida) level, and now at the federal level with the adoption of the new “Eliminating Kickbacks in Recovery Act” (EKRA), the importance of updates to the AKS is relevant for two main reasons:

  1. Florida’s Patient Brokering Act (PBA), s. 817.505, Fla. Stat., holds out as “defenses” anything that is deemed a “safe harbor” within the federal AKS (meaning, if HHS/OIG says a certain action does not violate the AKS, then Florida law says it also does not violate the PBA); and
  2. EKRA, which passed at part of the SUPPORT Act of 2018, does specifically include certain “safe harbors” but also explicitly contemplates that DOJ and HHS will adopt rules to further clarify those exceptions.

As proposed rules relaxing the AKS are rolled out, we will certainly keep everyone updated.  However, we continue to strongly believe (if not know) that any such benefit given to a patient with the intent to induce patronage will continue to be disfavored as being against public policy.

Florida’s First Sober Home Patient Brokering Case Goes to Trial

Since 2016, the Office of the State Attorney for the Fifteenth Judicial Circuit of Florida (Palm Beach County, The Honorable David Aronberg, State Attorney) began significant investigations and prosecution of alleged violation of Florida’s Patient Brokering Act, which law prohibits: (A) paying for a referral; and/or (B) inducing patients to select a treatment provider by offering anything of value.

While there have been many arrests and prosecutions, the cases have ended up in plea deals.  Until now.

We believe the first defendant not to accept a plea and to go to trial beginning this morning is the case of Robert Simeone, the owner of Epiphany’s Treatment Center.

https://www.palmbeachpost.com/news/crime–law/former-deputy-state-house-candidate-faces-patient-brokering-charges/GqNYXZ6sbA7xo5PhVEfMfP/

The allegations appear to be payment to sober home providers for referrals of residents under the premise of payment of fees for Case Management services.

While the payment for a referral is against the plain letter of the law, payment for true, real, actual “Case Management” services is not, and which payments are not a disguise for referrals.

The question is, was a provider truly paying for Case Management services, or were payments simply labeled as “Case Management Fees” to effectively launder what were actually kickbacks for referrals?

As Simone’s defense attorney states in his Motion to Dismiss:

“The determinant issue as it relates to the charges here, in whether the case management agreements entered into between the Defendant and witnesses whom the PB SAO relies upon to support probable cause were truly for the provision of case management support services, or just a disguise for payments to induce the sober home operator/witness to refer residents to Epiphany’s.”

To answer that question, one must look at the evidence, and each prosecution stands on a case-by-case basis.

But the key issue being litigated today goes beyond that question.

In a decision which is likely to set the stage for all future prosecutions across the state is the question of “criminal intent” – does violation of the Patient Brokering Act only require payment for a referral and/or some action to induce a patient, or does that law require some form proof that there was a specific intention to violate the statute?

What if someone in good faith did not believe they were violating the statute through their actions, but it turns out that their actions violated the law?

For example, what if you believe the speed limit to be 75mph, you drive 75mph, and you intended to drive 75mph, but the actual speed limit is 65mph – did you break the law?

In large part, that is the legal issue at the heart of the Simeone prosecution this week, and part of Defendant’s Motion to Dismiss being heard likely today.

As stated in the Motion:

It must be acknowledged that indeed there did existing within the growing drug treatment industry certain treatment providers and sober home operators whose intent was not to provide quality healthcare, but instead to make money through insurance fraud, drug sales and prostitution. However, these so called “bad actors” constituted a small portion of the individuals operating businesses in the industry; and were dealt with by federal authorities.  The arrests and prosecutions of others for patient-brokering based on the system of case management, including the one here, have struck at legitimate and well-intentioned actors whose only motivations were to operate in a legal manner to provide quality care.

No matter how the court rules, we expect appeals on this legal issue, so the law will not be settled for quite some time. However, in the meantime, the entire industry is holding its collective breath.

BREAKING NEWS – Google Reinstates Ads for Addiction Treatment Centers, With Pre-certification by LegitScript

Google will start accepting ads for addiction treatment centers again, Reuters reports. The company suspended the ads in September after The Verge reported that Google ads were being used to direct people to shady addiction treatment centers and away from legitimate facilities. Starting in July, treatment centers can run ads on Google but only after they’ve been vetted by LegitScript, a firm that also verifies online pharmacies.

Google told Reuters Monday it would resume accepting ads from U.S. addiction treatment centers in July, nearly a year after it suspended the lucrative category of advertisers for numerous deceptive and misleading ads.

According to the just-released revised advertising policy press release from Google:

In May 2018, Google will update the Healthcare and medicines policy to restrict advertising for recovery-oriented services for drug and alcohol addiction. This policy will apply globally, across all accounts that advertise addiction services.

Here are some examples of addiction services that will be restricted under this new policy:

  • Clinical treatment providers for drug and alcohol addiction, including inpatient, residential, and outpatient programs
  • Recovery support services for drug and alcohol addiction, including sober living environments and mutual help organizations
  • Lead generators and referral agencies for drug and alcohol addiction services
  • Crisis hotlines for drug and alcohol addiction

Outside the United States, ads for addiction services are currently not allowed.

In the United States, advertisers will need to be certified by LegitScript as addiction services providers before they can advertise through AdWords.

Not all drug and alcohol addiction services are eligible for LegitScript Certification.

Those not eligible for certification, such as sober homes and referral agencies, are not allowed to advertise for drug and alcohol addiction services on Google.

LegitScript charges a fee for processing and monitoring applicants, but fee waivers may be available in certain circumstances.

According to John Horton, CEO of LegitScript:

All of us at LegitScript are really excited about this new program. In many ways, it’s a natural extension of the work we’ve done for years to make the rogue internet pharmacy problem — a driver of prescription drug abuse and other problems — smaller. One of the most pernicious problems our country faces today is opioid addiction and other substance abuse. In the midst of this crisis, some opportunistic addiction treatment providers have been cashing in on patients’ recovery efforts and insurance billing opportunities. The worst of these have not only failed to provide treatment, but have encouraged ongoing drug abuse in patients trying to break the habit.

At the same time, addressing opioid addiction rates requires effective drug treatment strategies: patients and their families need to know which treatment providers are credible and legitimate, and which ones should be avoided. We hope that our program will help provide patients and our partners (like Google) information about which programs provide genuine treatment and which are, in essence, scams.

An important note about cadence: during the first three months, we’re going to intentionally take it slow. Irrespective of how many applications we receive, we’ll probably only certify about 20 to 30, simply so that we can make sure and get the process right. After that, we’ll ramp up the speed. (This goes into the “lessons learned” bucket from our existing healthcare merchant certification program.) This also works well with Google’s timeline, since they have indicated they will actually begin allowing these advertisers in July.

To learn more about LegitScript Certification and submit an application, visit LegitScript’s website.

US advertisers that are certified by LegitScript must also be certified by Google before they can begin advertising.

Advertisers with LegitScript Certification can request certification with Google starting in July, when the form is published.

Interest in treatment for abuse of opioids and other prescription drugs has soared in recent years amid what authorities have described as a nationwide epidemic.

Scammers found that Google ads were an easy way to defraud treatment-seekers in an industry in which regulations vary greatly by jurisdiction, authorities and patient advocacy organizations have said.

Google suspended alcohol and drug treatment advertising on search pages and millions of third-party apps and websites in the U.S. in September, the week after tech publication The Verge posted a lengthy story about scams. Google expanded the prohibition globally in January.

The move cut off at least $78 million annually worth of advertising in the U.S. alone, research firm Kantar Media estimated.

Most advertisers can buy ads through Google with few hurdles to clear. But Google has adopted additional vetting for locksmiths, garage-door repairers, drug makers and online pharmacies following public pressure. Google has said it also will begin seeking more documentation from political advertisers this year.

The addiction treatment rules apply to in-person facilities, crisis hotlines and support groups.

LegitScript will evaluate treatment providers on 15 criteria, including criminal background checks and license and insurance verification. They must also provide “written policies and procedures demonstrating a commitment to best practices, effective recovery and continuous improvement,” according to LegitScript, which will charge $995 upfront and then $1,995 annually for vetting.

The National Association of Addiction Treatment Providers and the National Center on Addiction and Substance Abuse support the standards, John Horton, chief executive of LegitScript, said in an interview last week.

A vetting process for sober-living houses and non-U.S. treatment centers has yet to be set, he said.

Horton acknowledged the “extra step” may frustrate rehab centers.

“It’s unfortunate, but this is one way the market gets cleaner and people get the help they deserve,” he said.

Marcia Lee Taylor, chief policy officer of the Partnership for Drug-Free Kids, to whom Google has donated advertising space, said earlier efforts to certify treatment services have failed because there was no “business incentive to answer all these invasive questions.”

Tying access to the world’s biggest online advertising system to certification makes applying worthwhile, Taylor said.

The new rules do not affect free business listings on Google Maps, which also have been susceptible to fraud. Google said it is continuously developing ways to combat Maps spammers.

More about this new model will be part of my presentation “Public Policy and the Law of Marketing Treatment Programs” at the 2nd Annual Treatment Center Executive & Marketing Retreat hosted by the Institute for the Advancement of Behavioral Healthcare in Hilton Head, SC, April 30 – May 1, 2018.

Massachusetts AG Launches Probe of Addiction Treatment

The Massachusetts attorney general’s office is investigating patient brokering of Massachusetts residents that recruited them to treatment centers in other states, according to people contacted by the office and others familiar with the matter.

Jillian Fennimore, a spokeswoman for Attorney General Maura Healey, confirmed the office is conducting a criminal investigation of addiction treatment centers. She would not provide details of the probe, including whether particular entities or individuals were being targeted.

The investigation follows reporting by STAT and the Boston Globe based on alleged insurance fraud.

“It is critical that people struggling with addiction can safely access treatment services,” Healey said. “Unfortunately, those seeking to make a profit off of this epidemic are targeting vulnerable patients with illegal treatment and recovery scams.”

The attorney general’s office also indicated it is taking a broader look at sober home operators in Massachusetts. Sober homes offer group living for people in recovery from drug addiction. Healey’s office said it was looking into allegations of poor living conditions in some sober homes, false advertising, and the failure of some operators to maintain a sober environment.