Health Care Clinics Targeted For Medical Director Requirements

By: Zach Simpson

There have been a rise in cases recently, in which practices that operate under a Health Care Clinic License have been brought under scrutiny by insurance companies trying to recoup funds through any means possible. In an effort to claw back funds insurance companies are beginning to claim that medical directors are failing to meet their statutory obligations under Florida Law which in turn can have serious monetary repercussions. Due to the clinics allegedly failing to meet their statutory obligations the insurance companies are filing suit to recoup any payments made while violating the Health Care Clinic Act obligations, and to stall any future payments due until such cases are heard.

By law, a medical director must be a health care practitioner that holds an active and unencumbered Florida license as a medical physician, osteopathic physician, chiropractic physician, or podiatric physician. The type of services provided at a clinic may dictate who would be able to serve as a clinic’s medical director, because a medical director must be authorized under the law to supervise all services provided at the clinic.

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Weave Compliance Into Your Practice For 2021

fhlf regulatory compliance

fhlf regulatory complianceBy: Jeff Cohen

A recent Department of Justice $500,000 settlement with a cardiology practice underscores the need for ensuring tighter compliance by medical practices.  There, the practice billed Medicare for cardiology procedures for which interpretive reports were also required.  Medicare paid for the procedures, but upon audit, CMS could not find the requisite interpretive reports.  The False Claims Act case settled for $500,000, but it’s likely that (1) the reimbursement by Medicare was far less, and (b) the legal fees behind the settlement weren’t too far behind the settlement amount!  Had the practice self-audited each year, would they have found the discrepancy?

Medical practices have felt the weight of price compression and regulatory load more than probably any segment in the healthcare sector.  They are doing far more for far less.  And regulations expand faster than viruses!  Hence, many have a strategy of regulatory compliance that can best be characterized as a combination of facial compliance (“We bought the manual and put it on the shelf”) and hope (“They’re not really serious about this, are they?”).  Unless you’re part of a practice of more than 20 doctors, it’s likely that you can do more to ensure regulatory compliance.

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Medical Practices & MedSpa Startups: Corporate Considerations

medspa startupsBy: Chase Howard

Deciding you want to open your own medspa or start a medical practice is the first and most important step in creating something unique and building a brand. Understanding how to properly “start” that business from a legal perspective, and doing so correctly can be the difference between success and failure.

As a physician in a private, solo-practice, or the business owner of a medspa startup, proper strategy is key. Understanding your corporate structure, developing a business plan, and compliance with the laws will help eliminate pesky obstacles that will slow your growth.

When working with start-ups the following steps should be given plenty of time and attention.Continue reading

Stem Cell Litigation Update: FDA Granted an Injunction

stem cell litigationBy: Matt Fischer

In a decision expected to cause waves through the rapidly-expanding regenerative medicine industry, a U.S. District Court Judge ruled on June 3rd that the U.S. Food and Drug Administration (FDA) is entitled to an injunction in a lawsuit filed against U.S. Stem Cell Clinic, LLC (US Stem Cell) based in Sunrise, Florida.  In her decision, U.S. District Court Judge Ursula Ungaro agreed that the FDA has the authority to regulate the popular stem cell procedure known as stromal vascular fraction (SVF) – administering processed stem cells derived from adipose tissue (i.e. fat tissue) – and that US Stem Cell is not exempt from regulation.

To recap, in May 2018, the U.S. Department of Justice (DOJ) filed complaints against US Stem Cell and a California stem cell clinic seeking permanent injunctions to prevent the marketing and administration of the SVF procedures without FDA approval.  Prior to the filing of these actions, both companies received warning letters from the FDA.  The letters also addressed the results of inspections and the need to resolve significant deviations from manufacturing practice requirements. Continue reading

Time out! Keeping Healthcare Lead Generation in Check

healthcare lead generation

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.Continue reading

DME Compliance Alert: Back Braces Under Specific Review by Medicare

medicare appeal

DME telehealth

By: Susan St. John

DME Compliance Alert: Department of Health and Human Services, Office of Inspector General, updated its work plan in January 2018 to include heightened scrutiny of off-the-shelf orthotic devices, specifically back braces for HCPCS Cods L0648, L0650 and L1833 due to one MAC identifying improper payment rates as high as 79 to 91 percent. Of specific concern is the lack of documentation of medical necessity, including Medicare beneficiaries being prescribed back braces without an encounter with the referring physician within 12 months prior to an orthotic claim being filed. The OIG plans to analyze billing trends nationwide, and expects to issue a report sometime in 2019.Continue reading