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 November 13, 2020 Centers for Medicare and Medicaid Services (CMS) announced that all Americans will have access to the COVID-19 vaccine at no cost. CMS has clearly communicated to private insurers, Medicaid programs and Medicare that it is their responsibility to cover the vaccine at no charge to beneficiaries. CMS states that Operation Warp Speed ensures that States, provider’s and health plans have the information and direction they need to ensure broad vaccine access and coverages for all. As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine.
Beneficiaries with Medicare will not pay anything for the COVID-19 vaccine and their coinsurance/copayment and deductible amounts will be waived. In 2021, for Medicare Advantage beneficiaries, Medicare will pay directly for the vaccine and its administration for those enrolled in MA plans. MA plans are not responsible for reimbursing providers to administer the vaccine. MA beneficiaries do not pay for the vaccine and copayment/coinsurance and deductibles are waived. read more
The COVID-19 pandemic has presented hospitals and health care facilities with challenges that go beyond providing comprehensive care to patients suffering from the virus. One of the most common challenges is how to handle patient visitors. Denying or limiting visitors could be seen as a violation of patient rights, and denying access to a visit by clergy could rise to the level of religious discrimination. After receiving a number of complaints in this regard, the HHS Office of Civil Rights (OCR) recently provided some technical assistance to two hospitals that faced this issue.
In the first case, a COVID-positive patient in a Maryland hospital was separated from her newborn son. Shaken by the separation, the patient requested that a priest be permitted to visit the baby, so he could baptize the child. But the hospital had instituted a ban on all hospital visitation in response to the pandemic, so the request was denied. read more
Can an employer require employees to be vaccinated against influenza? And, a COVID-19 vaccine likely will be approved in the not-to-distant future. What about that vaccine when it becomes available? These are questions with which many organizations are grappling today. With the confluence of what is expected to be a very active influenza season and the ongoing and unprecedented COVID-19 pandemic, employers are contemplating how best to protect their workforce and clients/customers/patients.
One of the most effective ways to achieve this is a mandatory vaccine policy, but is that right for your organization? Mandatory vaccination programs are not new. Depending on your business, a mandatory vaccine policy may be the industry norm. What factors should you consider? What processes would you need to develop to address exceptions?
CAN YOUR BUSINESS MANDATE VACCINATIONS?
In general the answer is yes. Although federal and state laws may vary, such programs are permissible provided any mandatory vaccination policy incorporates processes to address the required exceptions: medical accommodations under the Americans with Disabilities Act (ADA); and religious accommodations under Title VII of the Civil Rights Act of 1964 (Title VII). read more
The trend that we are seeing affects both buyers and sellers in the health care sector with respect to entities that have received cash infusions from the Paycheck Protection Program (“PPP”) created pursuant to the CARES Act in response to COVID-19. Mergers and acquisitions can come to a significant slowdown, standstill or be terminated altogether if careful planning is not performed to account for the impact the PPP funds received by a healthcare target or seller will have on an anticipated merger or acquisition. While tax and legal considerations have typically followed along with the merger or acquisition and these considerations are important aspects of any merger or acquisition, they have taken a forefront position when it comes to planning for a change of ownership when the healthcare target or seller has received PPP funds.
As we learned earlier, health care entities requested and received PPP funds to sustain them during the public health emergency caused by COVID-19, allowing them to avoid a virtual economic shut-down. These funds were a welcome relief to keep health care entities afloat financially, providing a way to cover certain expenses such as a) payroll costs, b) rent, c) interest on any covered mortgage obligation (which shall not include any prepayment of or payment of principal on a covered mortgage obligation), and d) utilities. Using the PPP funds on these expenses allows for a recipient of the PPP funds to qualify for loan forgiveness under the PPP. That all seemed like welcome relief at the time. read more
As the country reopens in light of COVID-19 many patients are beginning to feel safe to return to practices for services. In an effort to generate additional business to make up for lost revenue many practices have turned to internet-based marketing programs, such as Groupon to help attract new patients. Such sites provide a platform for discounted services, in exchange for a fee to refer patients to those businesses. While every state and business is different, chiropractors need to be aware of the implications of working with such sites while accepting federal health care insurance reimbursements, and the marketing requirements that still must be adhered to that often go overlooked.
When a discount is offered, Groupon customers (in this case, chiropractic patients) pay fees directly to Groupon. The chiropractor is then paid a percentage of the fees collected. Such marketing might affect Federal laws, for patients covered by federal insurance programs. The federal anti-kickback statute (AKS) prohibits any person from knowingly and willfully offering or paying cash to any person to induce the person to refer a patient for services for which payment may be made under a federal healthcare program. While some safe harbors exist, none specifically fit in a case like this. read more
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.
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
I recently wrote an article titled The Top Five Legal Concerns When Developing a Healthcare App, and I received some follow up questions, including technical queries about encryption and data sharing. To answer these questions, it is important to understand the current Healthcare App state of affairs. Various reporters, governmental agencies and privacy watchdogs have installed and monitored the flow of data from Healthcare Apps installed on smart phones. These journals, articles and enforcement actions taken together provide a roadmap for Do’s and Don’ts for the sharing of data.
Almost all Healthcare Apps are free and have some disclosures about how they share your data, and both iOS and Android require the user to give permission to the newly installed App, but who really pays attention to that? Almost no one. However, this doesn’t mean that an App developer shouldn’t embrace best practices to avoid liability and bad press. 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.