With phenomenal growth and expansion in the Hemp Industry comes trials, tribulations, the FDA, and consumer complaints! Let’s take a look at what’s going on that might have an adverse impact on your burgeoning business or foray into Hemp a/k/a CBD.
The FDA sent letters to 15 CBD business companies in late November 2019, warning and admonishing these companies that their CBD products were being promoted to treat disease or for having certain therapeutic properties. Specifically, the FDA reviewed these companies’ websites, social media pages, marketing material, etc., finding that the companies promoted products containing cannabidiol or CBD in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Further, the FDA stated that the companies’ CBD products are unapproved new drugs sold in violation of the FD&C Act, and were misbranded under the FD&C Act. The FDA letters did not just target products sold for human use and consumption, but also targeted CBD products sold for use on pets, stating that “the products are unapproved new animal drugs that are unsafe under the FD&C Act and adulterated products under the FD&C Act.
As Commercial Real Estate continues to grow, the medical office space is evolving to cater to new trends which affect the practice of medicine as well as the real estate industry as a whole. The healthcare sector is beginning to lean toward efficient spaces, and creating greater availability in spaces.
With equipment, staff and use of extremely sophisticated technology, medical buildings utilize huge amounts of energy. With the expansiveness of the size of most properties, intense lighting needs, air and temperature control, and high-powered machinery it has been difficult to operate in a low efficiency environment.
The Office of Civil Rights within the U.S. Department of Health and Human Services recently imposed $2,154,000 in civil money penalties against Jackson Health System in Miami, Florida for multiple violations of HIPAA. The majority of the penalties were due to violations of the HIPAA Security and Breach Notification Rules, rather than for the actual breaches of confidentiality. This action by the government underscores the importance of complying with all of HIPAA, and not just the requirements to safeguard Protected Health Information.
With the legalization of medical marijuana, I could not help but think, could a medical marijuana practice be the next “pill mill” and how could that be possible with the strict requirements set forth in Section 381.986, Florida Statutes. Turns out, only a handful of physicians are prescribing the majority of medical marijuana. While this may at first blush indicate a problem, keep in mind that marijuana, even medical marijuana is still outlawed under federal law and many physicians are not willing to risk a DEA license or possibly a state license to become a physician that certifies a patient for using medical marijuana. If a physician does become a qualified physician and issues medical marijuana certifications, certain practices and behaviors should be avoided.
A Practice with Similarities to a Pill Mill
In May 2019, Department of Health filed an administrative complaint against a “qualified physician” for basically over-certifying the use of medical marijuana. Pursuant to Section 381.986, there are only 13 medical conditions for which medical marijuana may be recommended. Of those 13 medical conditions, one is a bit of a “catch-all” as it is for medical conditions of the same kind or class as or comparable to a list of ten specific conditions, i.e., cancer, epilepsy, glaucoma, positive status for HIV, AIDS, PTSD, ALS, Crohn’s disease, Parkinson’s disease, and MS. This is where the physician ran into a problem.
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.
Attention Florida prescribers and dispensers – did you know that a new law mandating electronic prescribing goes into effect on January 1, 2020?
More specifically, Florida House Bill 831, which was signed by Governor DeSantis in June 2019, requires prescribers to generate and transmit all prescriptions electronically upon licensure renewal or by July 1, 2021, whichever is earlier, unless an exemption applies.
If a practitioner is licensed to prescribe a medicinal drug, and such practitioner either (i) maintains a system of electronic health records; or (ii) is an owner, employee or contractor of a licensed healthcare facility or practice that maintains a system of electronic health records and are prescribing in their capacity as an owner, employee or contractor of the licensed healthcare facility; then they must electronically transmit their prescriptions
Essentially, as of January 1, 2020, practitioners must transmit all prescriptions electronically upon the earlier of license renewal or by July 1, 2021, unless:
It’s probably fair to say that most healthcare providers are aware of the federal Anti-Kickback Statute and the Stark Law (and if you’re not, please call me immediately!). Those two laws, along with the False Claims Act, are the sources of the huge fines and penalties that make the headlines for governmentally discovered “fraud.” However, there are a number of other regulatory provisions out there that the Office of Inspector General (OIG) is regularly policing.
One of these laws, with its origins in the Social Security Act, is the prohibition against providers hiring individuals or entities who have been excluded from participation in governmental health care programs such as Medicare or Medicaid. Hiring an excluded person or company can expose a provider/employer to Civil Monetary Penalties, which can result in significant financial hardship to the provider. And although this may seem like a simple rule to follow, recent enforcement activity shows that it may be fairly easy for an excluded person to “fall through the cracks” and wind up as your employee.
On October 23, 2019, the U.S. Department of Health and Human Services has imposed a civil money penalty of over $2 million against Jackson Health System in Florida for repeated HIPAA violations.
The HIPAA violations mentioned in the HHS Press Release include: 1-Loss of paper patient records in December 2012; 2-Loss of additional paper patient records in January 2013; 3-A media report containing patient information (a photo shared on social media); 4-Employees accessing the information of one patient without a job related purpose; 5- An employee’s improper access and sale of patient records in 2011.
“OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years,” said OCR Director Roger Severino. The state of the compliance program allowed for the failure of several HIPAA requirements, including provision of timely and accurate HIPAA breach notifications, performance of regular risk assessments, investigation of identified risks, audits of system activity records, and imposing appropriate restrictions on workforce members’ access to patient information. The government’s final determination is available here.
When a HIPAA breach is discovered and reported, the government will often take the time to review a covered entity’s history of compliance or non-compliance. This may include an investigation into prior issues, effectiveness of policies and procedures, and employee issues. Overlooking one suspected breach may result in the imposition of sanctions on any later breach. This is why it’s so important for a healthcare business to understand its HIPAA obligations and take them seriously.
When was the last time your business conducted a security risk assessment to understand its potential risk areas for security breaches? If you’ve never had one, or haven’t had one recently, the time is now to conduct one. “When was your last security risk assessment?” is often the first thing that the government will ask in response to a breach.
Federal fines for noncompliance with HIPAA are based on the level of negligence perceived by the Federal government at the time of the breach. Fines and penalties range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million. Simply put, your healthcare business can’t afford to bury its head and hope that it won’t be hit.
This section is a contract between you and the users of your website regarding what they can expect from the website and how they will act while on the website. You can use this section to protect you and your business from a variety of potential disasters including (but not limited to): limitless liability and intellectual property infringement.
You can use this section to limit any liability that you might create by having a website. For instance, if you give some medical advice (i.e., “Lowering your cholesterol reduces your risk for a heart attack.”), you can use your Terms and Conditions to limit a user’s reliance on that advice without additional medical intervention (“We are not your treating physician—if you have questions about your cholesterol levels, contact your physician.”).
You can also use this section to inform your users about any intellectual property protections that you might have. If your technology or services have pending or protected status, you’ll need to make your users aware of this information.
Finally, this section should establish the laws under which your website agrees to be governed. Even if the internet knows no boundaries, your website should establish its own. If your business is located in Florida, you can choose to be bound by Florida and Federal laws. It could limit any potential exposure in other states or nations.
The Children’s Online Privacy Protection Act (COPPA) protects minors under the age of 13 from having personal information collected without parental consent. How can a website operator be expected to know whether a user is 13 or under? If you plan on collecting any information from your uses, your Terms and Conditions should have a section prohibiting anyone under age 13 from accessing and using your site. It’s a simple fix that can potentially save you huge penalties.
HHS found that a home health agency incorrectly billed Medicare and did not comply with Medicare Billing requirements for beneficiaries that were not homebound and for others that did not require skilled services at all.
In August and September 2018, physicians and the owner of a home health agency were each sentenced on multiple counts of conspiracy and healthcare fraud and ordered to pay $6.5 million in restitution. One physician was sentenced to 132 months in prison following trial. A physician who pled guilty was sentenced to 27 months in prison following a guilty plea. The home health agency owner was sentenced to 42 months in prison. The defendants paid and received kickbacks in exchange for patients and billed Medicare more than $8.9 million for services that were medically unnecessary, never provided, and/or not otherwise reimbursable. Additionally, certain defendants provided prescriptions for opioid medications to induce patient participation in the scheme.
In September 2018, the co-owner and administrator of a home health agency was sentenced to 24 months in prison, ordered to pay over $2.2 million in restitution, and ordered to forfeit over $1.1 million. The co-owners participated in a home healthcare fraud conspiracy that resulted in Medicare paying at least $2.2 million on false and fraudulent claims. The owners and their co-conspirators paid kickbacks to doctors and patient recruiters in exchange for patient referrals, billed Medicare for services that were medically unnecessary, and caused patient files to be falsified to justify the fraudulent billing.
Back in February 2018, the owner of more than twenty home health agencies was sentenced to 240 months in prison and ordered to pay $66.4 million in restitution, jointly and severally with his co-defendants, after pleading guilty to one count of conspiracy to commit health care fraud and wire fraud. A patient recruiter for the home health agencies, who also owned a medical clinic and two home health agencies of her own, was sentenced to 180 months in prison. Another patient recruiter, who also was the owner of two home health agencies, was sentenced to 115 months in prison. These conspirators paid illegal bribes and kickbacks to patient recruiters in return for the referral of Medicare beneficiaries many of whom did not need or qualify for home health services. Medicare paid approximately $66 million on those claims.
Illegal kickbacks in exchange for referrals of Medicare beneficiaries, lack of medical necessity for home health services, failing to meet the guidelines, fraudulent billing, billing for services beneficiaries did not receive and fraudulent documentation continues to plague the home healthcare industry.
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.