Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
Durable medical equipment companies provide a much-needed service in Florida, helping individuals to care for themselves and families to attend to their loved one’s medical needs in the home setting.
Here’s how you can get started setting up a new DME company.
What Is a DME Company?
A DME company, or durable medical equipment company, sells or rents medical or health care items to families that need them for an extended period of time.
Things like hospital beds, glucose and other monitors, and wheelchairs fall into this category.
Because these items are usually covered by insurance or Medicare, a DME company must be able to work with insurance companies and directly with families to help them get the products they need and that their insurance will pay for.
What Do I Need to Start a Durable Medical Equipment Business?
Home Medical Equipment Application Form:This formmust be completely filled out accurately and submitted on behalf of each and every DME business location (even if all locations are owned by the same person or entity).
Background screening: A Level 2 background check will need to be passed by all who open a DME business in Florida.
Licensed Florida healthcare attorney: In addition to the basic Home Medical Equipment Application form, there may be additional forms and addendums that may be required, depending on the situation. An attorney can ensure that you waste no time and are in full compliance with regulations and deadlines.
Where Can I Find Help Setting Up My DME Business?
Not only can Florida Healthcare Law Firm help you with the application process as you set up your durable medical equipment business, but we can assist in setting up the business structure, filing for trademarks, and creating a business entity in the state of Florida. Call now to get started.
With off-the-shelf knee and lumbar orthotics (HCPCS Code OR03) included in Medicare’s Round 2021 of Competitive Bidding (and thus ability to supply such devices to beneficiaries living in competitive bid areas limited to bid-winners), non bid-winning DMEPOS providers have been scrambling to find new revenue streams for their business models.
Many such providers are looking to continue providing orthotics – such as prefabricated (HCPCS Code OR02) or custom fabricated (HCPCS Code OR01) braces.
Unfortunately, a misunderstanding that could jeopardize Medicare billing privileges seems to be spreading. It pertains to DMEPOS provider personnel/fitter requirements to enable billing for such prefabricated or custom fabricated orthotics; allow me an opportunity to clear the air. read more
Almost two years after “Operation Brace Yourself” regarding purported telemedicine and orthotic bracing fraud made national headlines, on February 4, 2021 the Department of Justice Announced that a major player in that fraud – Florida businesswoman Kelly Wolfe – recently pled guilty to criminal health care and tax fraud charges.
Operation Brace Yourself was a 2019 crackdown on the illegal use of telemarketing and telemedicine to generate fraudulent claims for DME orders, whose reach spanned continents and ultimate implications defrauded taxpayers out of billions of dollars.
According to the Department of Justice Press Release and Settlement Agreement, Mr. Wolfe was seemingly a significant mastermind in establishing hundreds of DME companies that went on to defraud US taxpayers and Medicare beneficiaries.
Here are some highlights of the recently signed Settlement Agreement between the United States DOJ, Kelly Wolfe and her company Regency, Inc. read more
Medicare’s DMEPOS Competitive Bidding Round 2021 is now in full effect as of January 1, 2021. (See previous articles about what CBID Round 2021 is all about).
DME providers either participated in the process with hopes of being awarded a bid, or they abstained from doing so. Of those who participated, with Medicare’s recent bid winner announcements, bid winners were happy and bid losers, well not so much – as only those providers awarded a contract could service a Medicare Part B beneficiary for competitively bid product(s) for patients residing in competitive bid areas (“CBA”).
Now what? What are the options for the relationships between ‘winners’ and ‘losers’ in moving forward, if any? Let’s briefly discuss subcontracting. read more
Becoming a DMEPOS provider enrolled with Medicare is no small feat or undertaking. Whether you’ve started the business from ‘scratch’ or purchased an existing entity, you need to ensure that investment is protected through active and ongoing compliance measures.
To that end, I recently hosted a webinar with Matthew Gruskin, Credentialing Director at Board of Certification (“BOC”) to discuss some of the steps necessary to do so. A copy of our presentation is available here.
Becoming “accredited” is a necessary precursor to being a Medicare Part B DMEPOS provider, and BOC is one of only nine Medicare approved DMEPOS accreditation organizations. Whether it’s through BOC or one of the other eight Medicare approved accreditation organizations, a DMEPOS business’s initial receipt of accreditation is really just a ‘first step’, insofar as if that accreditation is not maintained a DMEPOS supplier will lose their Medicare Part B billing privileges. Medicare’s DMEPOS Supplier Standard #22 specifically requires all enrolled providers to be accredited to receive and retain billing privileges.
A DMEPOS supplier must continue to abide by both Medicare’s DMEPOS Supplier Standards (which the National Supplier Clearinghouse is tasked with enforcing) and its Quality Standards (which accreditation organizations gauge compliance by) in order to stay in its good graces. Accreditation organizations conduct unannounced on-site surveys at least every three years and suppliers must also revalidate their enrollment with Medicare’s National Supplier Clearinghouse every three years, which results in an unannounced Medicare on-site visit. read more
Round 2021 of Medicare’s DMEPOS Competitive Bidding (“CBID”) Program has been a doozy to say the least!
From the complexities of the new bidding process announced in 2019 that I initially wrote here and on this article through the uncertainty regarding whether Round 2021 would ultimately be implemented given the COVID-19 pandemic, the Round 2021 CBID Program that goes into effect on January 1, 2021 is shaping up to be much different than originally anticipated. Allow me to breakdown the changes between ‘then’ and ‘now’:
Video on Round 2021 of Medicare’s DMEPOS Competitive Bidding (“CBID”) Program.
Via justice.gov – One of the largest health care fraud schemes investigated by the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and prosecuted by the Department of Justice resulted in charges against 24 defendants, including the CEOs, COOs and others associated with five telemedicine companies, the owners of dozens of durable medical equipment (DME) companies and three licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $1.2 billion in loss, as well as the execution of over 80 search warrants in 17 federal districts. In addition, the Center for Medicare Services, Center for Program Integrity (CMS/CPI) announced today that it took adverse administrative action against 130 DME companies that had submitted over $1.7 billion in claims and were paid over $900 million. Read on…
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
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
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