Regulatory Compliance

All posts tagged Regulatory Compliance

Medical Practices & MedSpa Startups: Corporate Considerations

by admin on August 27, 2019 No comments

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.

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adminMedical Practices & MedSpa Startups: Corporate Considerations

Stem Cell Litigation Update: FDA Granted an Injunction

by admin on June 7, 2019 No comments

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. 

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adminStem Cell Litigation Update: FDA Granted an Injunction

Time out! Keeping Healthcare Lead Generation in Check

by admin on December 7, 2018 No comments

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.

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adminTime out! Keeping Healthcare Lead Generation in Check

DME Compliance Alert: Back Braces Under Specific Review by Medicare

by admin on February 7, 2018 No comments

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.

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adminDME Compliance Alert: Back Braces Under Specific Review by Medicare