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EKRA and SUPPORT Act Impact: Legal Breakdown

March 11th, 2019 by

By: Susan St. John

Most everyone knows that laws are being implementing in federal and state government to address the opioid crisis in the US. One such law is the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law in October 2018 by President Trump. While the SUPPORT Act seeks to increase access to treatment for substance use disorders and prevention of substance use disorders, it also contains language to prevent abuse of the process to increase treatment access. Specifically, incorporated into the SUPPORT Act is the Eliminating Kickbacks in Recovery Act (“EKRA”) which directly targets unlawful referrals to recovery homes, clinical treatment facilities, and laboratories.

EKRA is similar to prohibited kickbacks and patient brokering pursuant to Sections 456.054 and 817.505, Florida Statutes, using similar language as both Florida statutes. EKRA makes it unlawful… read more

DME Provider Alert: Medicare Competitive Bidding is Back!

March 8th, 2019 by

Medicare Competitive BiddingBy: Michael Silverman

Not tomorrow, but relatively soon. And with a vengeance! We knew the current Competitive Bidding Program moratorium wouldn’t last forever, and that the floodgates that opened as of the first of this year would eventually be reined in.

Indeed, on March 7, 2019 the Centers for Medicare and Medicaid Services (“CMS”) announced a new round of Competitive Bidding, which will commence on January 1, 2021 and last through December 31, 2023.

The largest changes from previous rounds of Competitive Bidding that immediately stand out are: read more

What’s the Deal with CBD Laws?

February 11th, 2019 by

CBD LawsBy: Michael Silverman

As reported in various media, on January 24, 2019 a trucker got into some hot water when he and his big rig were passing through Idaho en route to California from Oregon. In going through a weigh station and having his cargo inspected, state police didn’t take to kindly to what he was transporting.

His haul? Almost 7,000 pounds of hemp.

His customer? A company that intended to wholesale that crop to businesses that manufacture hemp-derived CBD.

Why the fuss? Drug sniffing dogs alerted to his cargo, and field tests indicated the presence (not concentration) of THC. The trucker was immediately apprehended, spent four days in jail, and was freed after posting $100,000 bond.

The company that hired the trucker to transport the product maintains that the load was indeed hemp, that the amount of THC in the hemp was within permissible federal limits, and that it was improperly confiscated. They want it back! So much so, that they’re suing for it; they filed a lawsuit against both the police and the prosecutor. read more

Genetic Testing HIPAA Warning: Legal Considerations

January 14th, 2019 by

genetic testing hipaaBy: Jacqueline Bain

You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.

Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would. read more

Litigation Alert: Pharmacies with Prescription Refill Reminder Programs Take Note

January 14th, 2019 by

Prescription Refill Reminder ProgramsBy: Michael Silverman

Pharmacies using automated dialers for prescription refill reminders and relying on the statutory prescription refill reminder exemption to the TCPA’s prohibition on the use of automated dialing equipment as an impenetrable blanket against liability need to think again.

The case of Smith v. Rite Aid Corporation, 2018 WL 5828693 (W.D.N.Y. Nov. 7, 2018), revolves around a Rite Aid pharmacy’s use of a prescription refill reminder program to contact a patient to pick up a prescription. The pharmacy placed several calls per week intended to remind the patient to come into the store to pick up their prescription. However, an innocent bystander instead of the intended recipient of the mediation received the calls; either due to error in taking the phone number down or a due to the number being reassigned (which happens to thousands of numbers on a daily basis!). The unintended recipient of the multiple prescription refill reminder calls filed a class action lawsuit under the federal Telephone Consumer Protection Act (“TCPA”), which provides for statutory penalties of $500-$1,500, per call. read more

Time out! Keeping Healthcare Lead Generation in Check

December 7th, 2018 by

healthcare lead generationBy: Michael Silverman

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

Marketing for DME & Pharmacy Providers: Know Your Subcontractor!

November 13th, 2018 by

marketing for dmeBy: Michael Silverman

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

Fighting Back Against CMS Recoupment: A New Option

November 13th, 2018 by

CMS recoupmentBy: Matt Fischer

Fighting a large extrapolated overpayment demand from a Medicare Administrative Contractor (MAC)?  Facing bankruptcy?  Appealed to the Office of Medicare Hearing and Appeals (OMHA) with no hearing date in sight?  For providers and business owners who answer yes, there is a new potential remedy…a temporary injunction.

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.       read more

PHI Breach Penalty Dollars Rolling in for Healthcare Enforcement

November 1st, 2018 by

PHI BreachBy: Dave Davidson

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. read more

Pharmacy Billing Basics: Know Your Payor!

October 10th, 2018 by

pharmacy billingBy: Michael Silverman

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