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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

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

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

Pharmacy or DME: The Time is Ripe to Become Both

August 13th, 2018 by

pharmacy dmeBy: Michael Silverman

People looking to enter the direct-to-consumer medical supply business often question whether becoming a pharmacy or durable medical equipment provider (DME) is a “better” endeavor.

Now, more than ever, due to industry changes and because of the synergies between the two, the answer is “ become both.”

Think about it. read more

Independent Pharmacy Owners: Trump Proposal May Improve PBM Issues

July 5th, 2018 by

independent pharmacy ownerBy: Michael Silverman

President Trump has stated that one of his greatest priorities is to reduce the price of prescription drugs. Alex Azar II, secretary of the Department of Health and Human Services (“HHS”), believes that while the United States’ system enabled it to become a world leader in the development of cutting edge drugs is also one that has not prioritized the needs of its own citizens.

On May 11, 2018 Trump directed his Administration to fix the injustice of high drug prices to ensure they come down, and unveiled his “blueprint” to put “American Patients First” though a 44 page document released on HHS’ website.

Pharmacy Benefit Managers (PBMs), previously largely unknown ‘middlemen’ in the U.S. pharmaceutical industry, whose impact on our healthcare system is just slowly beginning to emerge from the shadows, have been taking a lot of flak from independent pharmacy owners, politicians, and the media for being a cause of the high drug costs that the Trump Administration has vowed will be reduced.

read more

Prescribing & Dispensing Controlled Substances: Legal Update

June 5th, 2018 by

dispensing controlled substancesBy: Michael Silverman

A new law has been passed in Florida that pertains to prescribing and dispensing controlled substances. On March 19, 2018 Governor Scott signed HB21, which becomes effective July 1, 2018. Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, among other requirements, the new regulations establish: read more

Telemarketing Compliance: Legal Considerations Before You Call

May 15th, 2018 by

telemarketing complianceBy: Michael Silverman

Miami resident Adrian Abramovich certainly wasn’t laughing on Thursday May 10th, 2018 when the Federal Communications Commission (“FCC”) levied a $120 MILLION dollar fine on him for his alleged involvement in an illegal robodialing campaign. FCC Chairman Ajit Pai stated that Abramovich did not dispute that he had placed more than 96 million telemarketing robocalls over a three month period in 2016 without the recipient’s consent. Furthermore, Chairman Pai stated that Abramovich’s telemarketing campaign utilized caller ID “spoofing” which masks the calling party’s true phone number and causes the recipient’s caller ID to indicate that the call was being made by a local number. Abramovich’s telemarketing activities allegedly violated a variety of state and federal regulations; caller ID spoofing, for example, is expressly prohibited by the Florida Telemarketing Act, § 501.616(7).

With the record-breaking fine imposed on Abramovich, the FCC is sending a loud and clear message that it will not tolerate those individuals or entities that violate telemarketing laws. Any person or business engaged in telemarketing (be it a healthcare provider with a single telephonic sales representative or a business devoted to telemarketing with a 100 person call center) must heed the FCC’s unsubtle hint that enforcement activity of telemarketing laws is only heating up. read more

Florida Telemarketing Law: What You Need to Know

May 14th, 2018 by

florida telemarketing lawBy: Michael Silverman

Like it or not, telemarketing is a huge component of American businesses, and the healthcare industry is no exception. Many insurance companies, physicians, medical equipment and pharmacy providers heavily rely on telemarketing to expand their client base.

Take a moment to reflect – are you engaged in telephonic marketing or sales? Be it a healthcare businesses’ own internal based sales team or a third party providing such services, many individuals and entities are telemarketing and don’t even realize. If conducting telephonic sales either out of a Florida based location, or if calling into Florida, then listen up! There is a Florida telemarketing law that requires all such marketers to register for a telemarketing license or file for an exemption therefrom. While it’s not a new regulation, it’s one that is often overlooked and one that carries serious consequences for non-compliance.

What am I talking about?

Florida Statute Title XXXIII, Ch. 501 §§ 501.601 through 501.626, or more colloquially known as The Florida Telemarketing Act.

BEFORE doing business, The Florida Telemarketing Act requires individuals or entities looking to conduct telemarketing activities within the State to either (1) obtain a Commercial Telephone Seller Business License, as well as to license its individual sales representatives, or (2) have an approved exemption from such licensure on file. For the purposes of the Florida Telemarketing Act, this includes individuals/entities calling either into or calling out of the State! Unwanted telemarketing calls are one of the largest sources of consumer complaints in America; an individual or entity engaged in telemarketing will not “fly under the radar.” A called party will inevitably file a grievance with the state or federal government over telemarketing calls. If the activity falls under Florida’s jurisdiction, regulators will investigate and will penalize those persons or businesses involved if they are not adhering to the regulations outlined in the Florida Telemarketing Act. So what’s required to become licensed or exempted?

The license or exemption is issued by the Florida Department of Agriculture and Consumer Services – Division of Consumer Services (“FDACS”). A commercial telephone seller must obtain a license from FDACS, in accordance with §501.605, or have an exemption from such licensure on file, in accordance with §501.604.

Option 1 – Apply for the Commercial Telephone Seller Business License read more