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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

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

So, You Want to Be in the Pharmacy Business? Building from scratch, acquisitions & other considerations.

March 29th, 2018 by

pharmacy businessBy: Michael Silverman

Like many entrepreneurial endeavors, owning a pharmacy requires careful planning and an astute risk versus reward analysis. However, unlike other industries, venturing into a healthcare business brings with it an entire new world of regulations, and rightly so. Pharmacies don’t sell widgets they sell prescription drugs, and to people whose well-being depends on it being done correctly. As such, there’s a host of state and federal laws a pharmacy must abide by, intended to safeguard patients and the healthcare system as a whole. Don’t let regulatory hurdles alone serve as an insurmountable deterrent from entering into what can be a profitable and fulfilling profession; proactive compliance is the key to success! Here’s an overview of the general steps necessary to become a pharmacy owner, be it from scratch or by acquiring an existing practice. For the purposes of this article, let’s assume it’s a community/retail pharmacy that will be located in Florida.

So what’s better – building from scratch or buying something that’s already out there? Typical lawyer answer – it depends! But I won’t stop there; here are some considerations that must be taken into account to make a proper decision: (1) how quickly does the business need to be up and running? It’s typically a faster process to commence business by acquiring an existing pharmacy rather than buying one, but that depends on (2) what is out there in the current marketplace? If a stock acquisition, all of the known and unknown liabilities will be inherited by the new owner; proper due diligence on the pharmacy’s past is essential. read more

Pharmacy Audits: State of the Industry & Knowing Your Rights!

March 19th, 2018 by

pharmacy audit pbmBy: Michael Silverman

Pharmacy Benefit Managers (“PBMs”) act as the intermediary between insurance companies and pharmacies. PBMs contract with insurance companies on one hand and with pharmacies on the other, connecting the two so that an insured’s pharmaceutical claims may be processed at the rates set forth in the agreement between the PBM and supplying pharmacy. PBMs are paid on both sides of this transaction – by the insurance company for managing their insureds’ benefits – and by the pharmacy for processing the claims that are submitted. Processing claims for private, state, and federally funded insurance programs, PBMs play an integral role in vast majority of prescription drugs dispensed in the United States.

Part of a PBMs function is to audit a pharmacy’s claims to ensure that the claims submitted are in compliance with the PBM and insurance companies’ requirements.

Typical audits come primarily in two forms (1) desktop audit; and (2) field/on-site audit. A selected pharmacy usually will receive a letter or fax from the PBM informing an audit will be taking place. read more

Physician Joint Venture Pharmacy Opportunities Require Guidance

April 2nd, 2014 by

Final-ACO-RulesFlorida physicians are being approached to become owners of pharmacies to which they may refer, often compounding pharmacies, but may be unaware of the regulatory issues involved.  Physicians need to be aware of the core laws that apply, which include the Florida Patient Self Referral Act (FPSRA), the Florida Anti Kickback Statute, the Patient Brokering Act and the Federal Investment Interest Safe Harbor. read more