Tag Archives: kickback

Travel Assistance, Patient Financial Responsibility, and Good Intentions

Last week was the annual Moments of Change conference at The Breakers Hotel in Palm Beach. A beautiful venue for a long-running gathering of providers, clinicians, and industry representatives.

The question which I heard most repeatedly asked on the exhibit floor or in breakout sessions pertained to how to assist patients (I don’t call them “clients”) and their families with the exorbitant out of pocket costs of obtaining quality treatment, such as the cost of travel. In many providers’ minds, financial barriers like this should not prevent a patient from obtaining what is essentially life-saving treatment in a community known for its robust treatment community.

As a result of these financial hardships, providers have tried to find a way to facilitate travel from the patient’s location to their programs. This concept of “travel assistance” is quite controversial in the addiction treatment space because, no matter the intention of the provider, if that offer of “travel assistance” was the reason (inducement) for the patient to choose “x” treatment center, then it is very likely that law enforcement will view such assistance as a violation of the Patient Brokering Act.

In our 10 years working specifically with treatment providers, we have been repeatedly presented with this scenario and asked what is lawful. On our end, we have spent countless hours grappling with the need to develop policies and procedures to clarify, identify, and address compliance concerns regarding financial assistance for patients who have a bona fide financial hardship. Our conclusion to date has remained the same: while the law does not explicitly state that payment of airfare is a de facto inducement or violative of the plain language of the laws against patient brokering, and while we have heard and understand the reasoning provided and the procedure used by providers has been limited to very narrow and strict circumstances, the risk to the provider of arrest is simply too great. In other words, you will have to explain it to the jury, while in the meantime, your business reputation has been soiled in the press. If a provider is not going to 100% scholarship a patient, then any other extension of good-faith credit to a patient may be viewed as illegal by regulators and law enforcement.

Fair? Maybe not. Reality? Absolutely yes.

Stated otherwise, even if at no time was it ever a provider’s intention to sway (induce) the decision-making process of any patient to receive treatment services using travel assistance, and even if such travel arrangements were facilitated solely to provide those specific patients identified as having a bona fide financial hardship with reasonable access to critical addiction treatment services, in today’s environment, law enforcement is going to assume a criminal intent is at play based upon the dozens and dozens of arrests (and reviews of business records) that have been made.  It’s simply the “zero tolerance policy” world that we live in today, based upon the atrocities we have seen by the few who care less about patients and only care about profit.

In summary, while extending credit to a patient or their family who has been legitimately verified as not having the ability to pay may not violate the plain language of Florida’s Patient Brokering Act or the federal Eliminating Kickbacks in Recovery Act, the practice remains highly suspect based upon frequent past abuses uncovered by law enforcement. Therefore, a program that engages in such practices continues to expose itself to great liability of criminal penalties, fines, and damage to reputation.

We understand that many providers have as their overwhelmingly singular goal to provide access to those seeking help, recognizing that some are facing dire financial circumstances and may not at that time have the additional financial resources to travel to their chosen treatment provider. Notwithstanding these good intentions, extending credit to patients to facilitate travel costs, even with legitimate and good faith efforts to determine bona fide financial hardship and robust efforts to collect, is considered suspect and potentially violative of the law.  Accordingly, we continue to be unable to support any practice of providing travel assistance to patients in need.  Sad, but true.

We will continue to advocate for any best practice that connects patients with addiction health care providers, recognizing that the overarching policies behind the state and federal health care laws are often in conflict with present-day realities. Even the Centers for Medicare and Medicaid Services (CMS) has recognized this reality and has been vigorously exploring ways to revamp and rewrite these laws to meet 21st century health care delivery. See https://www.fiercehealthcare.com/payer/cms-impending-overhaul-stark-law-can-only-go-so-far-experts-say

But until then, the conservative course must be the one to follow, if addiction medicine is going to ever receive the due recognition it deserves as an integral part of our national health care model.


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.

Palm Beach Court Requests Clarification on Question of “Criminal Intent” Necessary in Patient Brokering Act

Palm Beach Circuit Court Judge Joseph G. Marx issued a somewhat confusing non-final Order this morning in the closely-watched case of State v. Robert Simeone, regarding whether the State must prove that the Defendant had the required intent to violate the Patient Brokering Act when paying case management fees to the sober home operator where his patients resided.

As I reported back on July 9th,  the Defendant moved to dismiss the prosecution on the basis that he entered into agreements to pay fees to sober home operators to provide case management services for his client, and not for referrals.

The State responded, in part, that even if the Defendant was paying for case management services, if those payments also induced the sober home provider to make referrals to the Defendant, then that violates the prohibitions in s. 817.505, Florida Statutes, the Patient Brokering Act.

But what was the Defendant’s intention?  What level of “intent” does the State have to prove?

The Court today said “we don’t know.”

The State is claiming that the Patient Brokering Act is a “general intent” statute, meaning the level of criminal intent that the State must prove is that the act occurred and the Defendant intended to take the action.

The Defendant is asserting that the State must prove more; that the State must prove that the Defendant specifically intended to pay for a referral or intended to use the business arrangement between the parties as a disguise to cover up a payment for a referral.

The State believes that it must only prove that the case management arrangement was either established or continued in order to keep the referrals flowing, which is a critical distinction; that if any purpose of that payment or benefit was to induce a referral or continue a de-facto referral relationship, that would be a violation of the Patient Brokering Act.

Stated differently, the State appears to be asserting (as cited in the motions and responses) that, if and when those case management fees stopped being paid (i.e., the Defendant no longer wanted the sober home operator to provide case management services) that the referrals would end; that both parties understood that; and therefore the case management relationship continued for purposes of continuing the referrals – the case management arrangement with the sober home provider would have ended if the referrals ended; and that this establishes the required level of “intent”  by the Defendant.

The Defense has responded that the State must prove (and suggests the State will be unable to prove) that this was the actual, specific intention of the Defendant – to pay for a referral – and that the State must prove that the Defendant specifically intended for the case management arrangement to be a disguise for referral payments.  The pleadings suggest that the Defendant believed, in good faith, he was only paying for case management services, and if the sober home provider chose to refer its residents to Defendant’s treatment center, that was only the byproduct of a professional, arm’s length business relationship that developed through time and that there was no “quid pro quo.”

The Court’s Order seems to suggest, it does know the answer of what “criminal intent” standard to apply and wants a higher court to chime in.

If the “general intent” standard is ultimately to be applied, the State would only need to prove the Defendant engaged in the case management services agreement with the sober home provider, in part, to obtain referrals, even if there were other legal aspects of that business relationship.

If the “specific intent” standard is the one that the courts ultimately rule upon, then the Defendant’s state of mind does come into play and the State would have to introduce either direct or circumstantial evidence of the Defendant’s criminal intent to provide a benefit to the sober home specifically in exchange for referrals.

The Court today said, it is not sure, and needs a higher court to chime in.

The answer may not come for quite some time.

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.