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.
In a fraudulent operation that the Department of Justice calls, “unprecedented”, elderly or disabled patients nationwide were lured into providing their DNA for testing in a widespread genetic testing fraud scheme powered by a large telemarketing network. The doctors involved were paid to write orders prescribing the testing without any patient interaction or with only a brief telephone conversation.
The average physician employment contract exceeds twenty pages, not including exhibits. While they all include basic terms related to compensation, length and restrictions, many simply do not contemplate important terms that have serious impacts on physician’s daily lives. A physician’s first employment contract is the most significant financial decision of their lifetime. The same can be said for each subsequent contract, which means that understanding, and negotiating, your contract is the most valuable investment you can make prior to entering into a contract.
To understand what’s in your employment contract, simply read it over a few times. To understand not only how those terms affect you, but also what isn’t in your contract, hire an experienced health care lawyer.
I am a successful physician who works for a thriving practice that is affiliated with a local hospital or Ambulatory Surgical Center (“ASC”). The hospital/ASC was so impressed with my professionalism and skills that they retained me to perform certain additional duties and services for them. Of course, they are paying me for my time and services. This is great, I love my work, I am generating two sources of respectable income – all is good.
Not so fast!
As can sometimes be the case, all is good while there is smooth sailing and while the money is coming in. However, once there is a bump in the road, a hiccup in a procedure, or a third party employee files a complaint with the Equal Employment Opportunity Commission (“EEOC”); the Florida Commission on Human Relations (“FCHR”); Department of Labor (“DOL”) or any federal or state agency complaining about some alleged incident in their workplace. Their filing of a lawsuit can be against you individually, against your practice or against the hospital/ASC. Not to mention, a lawsuit can be filed by a patient or third party against the practice or the hospital/ASC. Then what?
A Final Rule recently issued by CMS will require Medicare, Medicaid, and CHIP (Children’s Health Insurance Program) providers and suppliers to disclose current and previous affiliations (direct or indirect) with a provider or supplier that: (1) has uncollected debt; (2) has been or is excluded by the OIG (Office of Inspector General) from Medicare, Medicaid or CHIP, or (3) has had its billing privileges with either of these three programs denied or revoked. Such provider affiliations may lead to enrollment being denied if it poses a risk to fraud, waste or abuse.
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.
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.