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.
This section is a contract between you and the users of your website regarding what they can expect from the website and how they will act while on the website. You can use this section to protect you and your business from a variety of potential disasters including (but not limited to): limitless liability and intellectual property infringement.
You can use this section to limit any liability that you might create by having a website. For instance, if you give some medical advice (i.e., “Lowering your cholesterol reduces your risk for a heart attack.”), you can use your Terms and Conditions to limit a user’s reliance on that advice without additional medical intervention (“We are not your treating physician—if you have questions about your cholesterol levels, contact your physician.”).
You can also use this section to inform your users about any intellectual property protections that you might have. If your technology or services have pending or protected status, you’ll need to make your users aware of this information.
Finally, this section should establish the laws under which your website agrees to be governed. Even if the internet knows no boundaries, your website should establish its own. If your business is located in Florida, you can choose to be bound by Florida and Federal laws. It could limit any potential exposure in other states or nations.
The Children’s Online Privacy Protection Act (COPPA) protects minors under the age of 13 from having personal information collected without parental consent. How can a website operator be expected to know whether a user is 13 or under? If you plan on collecting any information from your uses, your Terms and Conditions should have a section prohibiting anyone under age 13 from accessing and using your site. It’s a simple fix that can potentially save you huge penalties.
Many physician groups and health care companies will enter the market at some point to sell their business. In the rare case, the selling group will already have a buyer who is ready and willing to pay and close on the business sale. More often than not however, most sellers will utilize the services of a business broker to help find a suitable buyer, and will compensate the broker on a commission basis upon closing. Unlike real estate closings, whereby the main concern is the title of the property being conveyed, medical practice sales require much more detailed representation on all aspects of the business, including but not limited to, real property, existing contracts, existing patients, and medical equipment.
Before signing a business broker listing agreement, ensure that the following points are considered to avoid potential pitfalls: read more
Via justice.gov – One of the largest health care fraud schemes investigated by the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and prosecuted by the Department of Justice resulted in charges against 24 defendants, including the CEOs, COOs and others associated with five telemedicine companies, the owners of dozens of durable medical equipment (DME) companies and three licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $1.2 billion in loss, as well as the execution of over 80 search warrants in 17 federal districts. In addition, the Center for Medicare Services, Center for Program Integrity (CMS/CPI) announced today that it took adverse administrative action against 130 DME companies that had submitted over $1.7 billion in claims and were paid over $900 million. Read on…
There are perfectly compliant ways to engage with healthcare marketers, and then there’s this; here are some of the latest real-life examples:
“DME BRACE CAMPAIGN – $40 to $150 PER LEAD PER BRACE”
“DME DIABETIC LEADS $40 PER LEAD, INSURANCE AND DOC INFO INCLUDED”
“PAIN CREAM/LIDOCANE LEADS FOR SALE, RX INCLUDED”
These marketers are seemingly holding auctions for the sale of federally protected patient health information out to the highest bidder! Couldn’t make this stuff up – if you’re in this industry, a quick gander at your (business) social media platforms will quickly confirm it. read more
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. read more
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. read more
A recent ruling by a state trial court handling the Palm Beach County Sober Home Task Force prosecutions against providers of addiction treatment and sober home services is creating lots of confusion and alarm around the state and could have very far reaching consequences for the entire healthcare industry well beyond addiction treatment.
The issue presented by the prosecution focuses on whether a person charged with violating the state’s Patient Brokering Act (PBA) can be found guilty even if he/she didn’t know what he was doing was unlawful. The PBA broadly prohibits paying someone for patient referrals, very much like the federal Anti-Kickback statute. If allowed, the client would have gotten legal advice, paid for it, followed it, and still not be able to show a judge or jury that, despite all their best efforts, they simply followed the law as instructed.
Can a healthcare facility or provider be guilty of violating a criminal law [the PBA] if they’d gotten legal advice and followed it? Traditionally, the answer would be a clear “no.” The argument against the State’s position would be something like “How can someone intend to violate a criminal law if they got legal advice regarding how to comply with it and then followed that advice?” The argument of the state might look something like “We don’t even think the judge or jury ought to be able to hear that the person got legal advice and followed it.” The court punted the issue to the appellate court. read more
Monty Ray Grow was a defensive back on the Florida Gators’ football team from 1990 until 1993. He contracted to play for the Kansas City Chiefs in 1994 and then for the Jacksonville Jaguars in 1995 and 1996. On February 5, 2018, he was convicted by a federal jury in Miami for his chief role in a massive healthcare marketing scheme designed to defraud Tricare.
Tricare is a health benefit program that provides civilian benefits for U.S Armed Forces military personnel, retirees, their dependents, and some military reservists. Tricare is a Department of Defense Program.
In September 2014, Grow entered into an agreement with a compounding pharmacy in Pompano Beach, Florida, wherein the pharmacy would pay Grow’s marketing company a commission equal to fifty percent (50%) of what the pharmacy netted in Tricare reimbursement from Grow’s referral of Tricare beneficiaries to the pharmacy. (Later on, Grow became an employee of the pharmacy.) Grow then used his commission to offer and pay recruiters to convince Tricare beneficiaries to use this pharmacy. Additionally, Grow offered and paid Tricare beneficiaries themselves to use this pharmacy. read more
Before doing business in Florida, an entity providing substance abuse marketing services must be licensed by Florida’s Department of Agriculture and Consumer Protection. This includes includes either telephone solicitation from a location in Florida or solicitation from other states or nations for substance abuse and addiction treatment centers located in Florida.
As of November 27, 2017, only the following entities are licensed by the State of Florida to provide marketing services to substance abuse and addiction treatment centers:
A Way and a Means, LLC (Delray Beach, Florida)
Addiction International Holdings, LLC d/b/a The Addiction Advisor d/b/a The Recovery Miracle (Boca Raton, Florida)
Advanced Recovery Systems, LLC (Winter Park, Florida)
Bandwidth Interactive Company d/b/a Local Management (Boca Raton, Florida)
Delphi Behavioral Health Group, LLC (Fort Lauderdale, Florida)
Freedom From Addiction, LLC (Miami Beach, Florida)
Infoworx Direct, LLC d/b/a Addiction Hope and Help Line (Boca Raton, Florida)
Invigorate Solutions, LLC d/b/a Local Management (Boca Raton, Florida)
Meridian Treatment Solutions, LLC (Lauderdale by the Sea, Florida)
NPA Consulting Group, LLC (Pompano Beach, Florida)
Palm Partners, LLC (Palm Springs, Florida)
Parent Team, LLC (Santa Rosa, California)
Pryme Time Media, LLC (Sunrise, Florida)
R360, LLC (Fort Lauderdale, Florida)
Redwood Recovery Solutions, LLC d/b/a com (Riviera Beach, Florida)
Ring2Media, LLC (Westport, Connecticut)
Rybchinskiy Inc. (Boynton Beach, Florida)
Sober Network, Inc. (Delray Beach, Florida)
The Addiction Network, LLC (North Miami, Florida)
True Choice Health Group Limited Liability Company (Pompano Beach, Florida)
United Addiction Specialists, LLC (Hollywood, Florida)
USR Holdings, LLC (Coconut Creek, Florida)
It is a third degree felony for: any person to work for an entity that does not have a current and valid license; or for any entity to invite telephone calls or other communications with a substance abuse marketer who is soliciting clients without a current and valid substance abuse marketing license; or for any person or entity to solicit without a license; or for any person who otherwise violates the law requiring licensure either directly or indirectly. Any person who is convicted of a second or subsequent violation commits a felony of the second degree.
Concepts that drive sober home relationships like Anti-Kickback Statute, Patient Brokering Act and Safe Harbor have become ingrained in the minds of nearly every addiction treatment provider’s thought process, especially in Florida with the development of the Sober Home Task Force. Providers now seem to fully embrace ideas like–
There’s a federal law (the Anti-Kickback Statute, the “AKS”) that can bring criminal liability for marketing done incorrectly;
There’s a state law, the Florida Patient Brokering Act (“PBA”), that can do the same;
Complying with the federal safe harbors and the bona fide employee exception is important, even when there are no state or federal healthcare program dollars involved;
Paying anyone for marketing, not just on a commission based sales model, without fully appreciate the applicable laws is dangerous, costly and invites criminal inquiries and liability; and
Achieving compliance with applicable federal law should be part of any recovery business’ overall compliance plan.
Recovery providers must become familiar with not only the AKS and state restrictions like the PBA, but also the law’s permitted examples, so called “Safe Harbors,” which specify specifically permitted arrangements (42 CFR 1001.952). The “personal services arrangement and management contract” Safe Harbor, for instance, has particular application in the area of marketing, as does the AKS exception for “bona fide employment arrangements,” which apply to “bona fide” W-2 employees (entailing direction, supervision and control), but not independent contractor relationships. read more