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If you are facing a healthcare regulatory compliance audit make sure that you are well represented by an experienced attorney. These matters are nothing to be overly worried about but it’s always a good idea to make sure you have all your bases covered. Working with a team of lawyers is the best way to ensure you get a favorable outcome while eliminating frustration and headache. Running a medical business isn’t easy as there are more rules and regulations you have to follow than with other businesses. However, that doesn’t mean you have to do it alone as you will get the support you need from the best legal team in Florida.

At Florida Health Care Law Firm we have worked with clients in all areas of the medical field and handled many cases involving healthcare regulatory compliance audit and more. When you work with our team, you will have the full support of our services. That means if you have questions regarding opening a treatment center, implementing policies and procedures, selling or buying a business or anything else, you will have the full support of our team. Visit us today to learn more and meet with a lawyer who can assist you.

A healthcare regulatory compliance audit is not something you want to take lightly. While you may not have done anything wrong, the fact is that your business is about to be put under review and that needs to be taken seriously. When this happens, you need to ask yourself these questions:

  • Where can I get facts? One of the things we all continue to do is to go online and check out websites and blogs to get “facts.” These sites don’t provide real facts because even if the information is correct, it may not apply to us. That’s why you need to speak with an attorney who can get you the right information you need in order to make the best possible decisions.
  • Do I need an attorney? Going into an audit, you may or may not need the help of a lawyer. It’s difficult to say but one thing is for certain, you should speak with a lawyer before the meeting to know whether or not you will need one as well as to get legal advice that can help you during the case.
  • What about other issues? Once completed you do not want this matter to become a recurring one. That’s why it’s always smart to work with a legal team that can assist you in these matters as well as others. Whether you are opening up a call center, selling a practice, hiring a new physician or anything else, it’s a matter of convenience and peace of mind that you are able to get real help when you need it.

At the Florida Health Care Law Firm our team is standing by to assist you with any healthcare regulatory compliance audit matters you may need assistance with. Be sure to call us today for more information and find out what your legal options are.

CMS Hospital Price Transparency Requirements

November 19th, 2019 by

hospital price transparencyBy: Karina Gonzalez

On November 15, 2019 Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring hospitals to publicly disclose “standard charges, including payer-specific negotiated rates for items and services. Hospitals will be required to comply by January 1, 2021. The proposed rule is subject to 60 days of comment.

The final rule requires hospitals to make public in a machine-readable file online all standard charges (including gross charges, discounted cash prices, payer-specific negotiated charges) for all hospital items and services.  It requires hospitals to de-identify minimum and maximum negotiated charges for at least 300 “shoppable” services. read more

DMEPOS Round 2021 Competitive Bidding: Potential Pitfalls

March 27th, 2019 by

2021 competitive biddingBy: Matt Fischer

With the 2021 competitive bidding round on the horizon for durable medical equipment (DME) providers, both those that are established as well as those fairly new to the industry must take note of the potential pitfalls that may be encountered when competing to become a Medicare contract supplier.

The durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program was first established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.  Under this program, DMEPOS suppliers submit bids (i.e. applications) and compete to furnish specific items in competitive bidding areas commonly referred to as CBAs.  Additionally, suppliers are not just bidding for the rights to a particular CBA but also for a single payment amount that will replace the current Medicare fee schedule payment.  The payment will be determined by using the bids submitted.  As of December 31, 2018, all contacts have expired.  As a result, there is currently a temporary gap period.  The upcoming bidding process is loaded with requirements.  Therefore, compliance with each requirement is crucial.  Here are a few pitfalls to watch out for:  read more

Law Enforcement Referrals by UPICs

March 26th, 2019 by

UPIC investigatorBy: Matt Fischer

CMS contractors such as Unified Program Integrity Contractors (UPICs) are tasked with ensuring that Medicare pays the right amount for covered services by legitimate providers.  Specifically, a UPIC’s main goal is to identify cases of suspected fraud, waste and abuse, and additionally, to take immediate administrative action to protect federal program funds.  Within its administrative action toolkit, apart from the common pre- or post-payment reviews and payment suspensions, UPICs have the ability to refer cases of potential fraud to law enforcement agencies. read more

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

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

Behavioral Analysis Medicaid Providers: Florida’s Latest Enforcement Target

July 20th, 2018 by

behavioral analysis medicaidBy: Matt Fischer

Florida’s Agency for Health Care Administration (“AHCA”) is the state’s chief health policy and planning organization.  AHCA is also responsible for the state’s Medicaid program.  One of the agency’s latest targets are behavioral analysis providers who treat children with autism.  Recently, AHCA imposed a temporary six-month moratorium on enrollment of new providers due to newly discovered fraud and abuse.  AHCA states that the temporary moratorium will allow the agency the time to complete a full assessment of the current provider population.  In other words, all behavioral analysis providers will experience heightened scrutiny in the coming months if not already.  This can include in-person interviews and requests for records.  Given this increased regulatory action, it is important for behavioral analysis business owners to be aware of the audit process and to prepare for likely future reviews.

Here are a few of the notable findings cited by AHCA regarding the identified fraud and abuse: read more