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.
On August 19, an amendment to the Public Readiness and Emergency Preparedness Act was announced by HHS which allows pharmacists in every state to now administer childhood vaccinations to children ages 3 and older, subject to several requirements,
The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.
The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
CMS has announced that it will resume Medicare Fee-For-Service (FFS) medical reviews August 3, 2020 regardless of the status of the COVID-19 public health emergency. These audits have been suspended since March 30 as a result of the crisis and applied to prepayment reviews and post-payment reviews conducted by Medicare Administrative Contractors (MAC). read more
On January 31, 2020 the US Department of Health and Human Services (“HHS”) declared a public health emergency surrounding the COVID-19 coronavirus pandemic, which was renewed again for a period of 90 days effective July 25, 2020.
In an attempt to focus on patients over paperwork and to remove obstacles from access to patient care, HHS relaxed or suspended certain healthcare provider requirements. Several such changes directly impact current or prospective providers of durable medical equipment (“DME”) to Medicare Part B beneficiaries.
Here’s a high-level breakdown of some of those changes: read more
On June 30, 2020, State Surgeon General, Scott A. Rivkees, M.D., issued Emergency Order (“EO”) 20-011, which further extends EO 20-002 until the expiration of the Governor’s Executive Order No. 20-52, or any extensions thereof. Thus, EO 20-011 continues to allow out-of-state MDs, DOs, APRNs and PAs, to offer telehealth services to persons in Florida.
EO 20-011 continues to allow Florida licensed controlled substance prescribers (MDs, DOs, APRNs, PAs) to issue renewal prescriptions of controlled substances for non-malignant pain for existing patients. Additionally, EO 20-011 extends a qualified physician’s ability to recertify an existing qualified and certified patient’s continued use of medical marijuana using telehealth services. These further extensions are also tied to the expiration of Executive Order 20-52 and any extension thereof. read more
Today no one can live without a smart phone, and we interact with the rest of the world through a series of apps that reside on our handheld devices. From the healthcare perspective many large healthcare institutions and private companies have developed a myriad of healthcare related apps that currently reside in Apple’s App Store and Googles Play Store. You can measure your heart rate, get clinical advice, view your records, check on your health insurance coverage, make appointments and virtually interact with many different types of healthcare providers. But even in today’s hyper-electronic society it took COVID-19 to really cause an explosion in telehealth, so what does that tell us? There is a lot more room for expanding electronic interactions with patients and clients through Apps. So, here are the top five legal concerns should you address when you develop a Healthcare App: read more
When COVID-19 passes and the world begins to return to normal, you can be guaranteed that many of your old “friends” will come to visit you. To minimize future liability, pain and time, you should be preparing today for tomorrow’s visitors:
The Lawyers. Lawyers come in many flavors, and can bring good or bad news. Depending on your initial reaction to the pandemic, and your subsequent actions as the panic started to die down you may see three types of lawyers: (1) Those that represent past or present employees who have lost their job or contracted COVID-19; (2) Those that represent patients who claim malpractice based on the care that you did or did not deliver, and also those patients who assert that they contracted COVID-19 at your office; and finally (3) Those that represent creditors or debtors of your practice. The actions you should take today are many and varied and beyond the scope of this overview, however, you should be asking the following questions of yourself: (i) did you file a claim for business interruption despite the fact that your insurance broker said you were wasting your time? (ii) does your malpractice carrier cover you for liability outside of the normal scope of providing care? (iii) are your documenting your actions throughout the pandemic to demonstrate that you were acting reasonably at a time when you did not have all the facts? (iv) did you look at your business insurance policies for coverage for employee claims, or workers comp claims, or OSHA claims? (v) did you research what other similarly situated companies are doing, as you will most likely be held to the same standards? (vi) did you follow guidance from State and Federal entities? and (vii) did you provide notice during the pandemic to debtors or other parties who have breached their obligations? read more
State Surgeon General, Scott A. Rivkees, M.D., issued Emergency Order (“EO”) 20-009, which extends EO 20-002 and continues to allow out-of-state MDs, DOs, APRNs and PAs, to provide telehealth services to persons in Florida. EO 20-009 is set to expire June 30, 2020, unless otherwise extended.
Further, EO 20-009 continues to allow Florida licensed controlled substance prescribers (MDs, DOs, APRNs, PAs) to issue renewal prescriptions of controlled substances for non-malignant pain for existing patients. Additionally, EO 20-009 extends until June 30, 2020, a qualified physician’s ability to recertify an existing qualified and certified patient’s continued use of medical marijuana by using telehealth services. read more
The COVID-19 virus has and will probably continue to change the way healthcare providers and business associates interact and help their patients. As many providers are aware, a HIPAA violation is a serious issue, and can cost a healthcare entity large amounts of time and money to respond to any regulatory investigation. Recognizing that the COVID-19 pandemic has strained every corner of the economy and is THE MOST IMPORTANT issue for almost every industry, the federal government has rolled back some HIPAA protections. It is unclear how long these rollbacks will last, and it is possible that some of them may be permanent, but for now healthcare providers and their business associates can take some comfort that they can focus on delivering care and not dealing with overly burdensome regulations and investigations. The major changes include:
Telehealth. Changes include allowing physicians and other healthcare providers to offer telehealth services across State lines, so State licensing issues should not be a concern. Additionally, Providers are essentially free to choose almost any app to interact with their patients, even if it does not fully comply with the HIPAA rules. The HHS allows the provider to use their business judgment, but of course, such communications should NOT be public facing – which means DO NOT allow the public to watch or participate in the visit!
Disclosures of Protected Health Information (PHI). A good faith disclosure of such information will not be prosecuted. Examples include allowing a provider or business associate to share PHI for such purposes as controlling the spread of COVID-19, providing COVID-19 care, and even notifying the media, even if the patient has not, or will not grant his or her permission.
Business Associate Agreement (BAA). As most healthcare providers know, a BAA agreement between a provider and an entity that may have access to PHI is required by law. During the COVID-19 pandemic, the lack of a BAA is not an automatic violation.
In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner’s ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician’s ability to recertify an existing qualified patient’s use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.
Keep in mind, that to prescribe a refill of a controlled substance for chronic non-malignant pain, the practitioner must be an MD, DO, APRN, or PA licensed in Florida and designated as a controlled substance prescribing practitioner. Further, to prescribe such controlled substances using telehealth communications during this public health emergency, the patient must be an existing patient of the prescribing practitioner. read more
COVID-19 has devastated the US economy, including many parts of our Healthcare sector. The Federal Government, along with most States, have begun to respond with various financial incentives, ranging from straight out grants to loans, and everything in between. The following is an overview of some of the assistance that is currently available for the Healthcare community, along with some tips that may assist your company in applying, and what you need to do if you are lucky enough to receive some money:
The CARES Act
Paycheck Protection Program (the “PPP”). Essentially a grant from the Federal Government for payroll, employee benefits, rent/mortgage, utilities for 8 weeks. This program is available for all small businesses, and is managed through banks and private financial institutions.
Apply with multiple financial institutions, and whoever comes through first take the loan/grant;
If you receive the money keep excellent records;
You can only use the money for W-2 employees, not 1099 contractors;
There are strict rules with respect to the number of employees, and their maximum salary. The NUMBER of employees before and after the loan is critical, not the actual employee, so if you laid off someone, you don’t have to hire back that particular person, you can use the money for a new employee who fills the same position; and
If you don’t use all the money for payroll etc, don’t worry, you can either pay it back in a lump sum, or pay it back over time at 1% interest.