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.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations. The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.
The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA. CLIA prohibits a laboratory director from directing more than five non-waived laboratories. Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position. The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position. read more
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
DOES YOUR BUSINESS NEED A MANDATORY VACCINE POLICY?
Given the above, does a mandatory vaccine policy make sense for your organization? This may depend on several factors, including the following:
Are your employees in direct contact with clients/customers/patients?
Is that contact prolonged and in indoor spaces where air circulation may be limited?
If one or more of your employees become ill, does that jeopardize continuity of your business?
If you answer “YES” to one or more of these questions, you may want to consider implementing a mandatory flu vaccine.
In order to effectively implement a mandatory vaccination policy, you must develop both the policy and the process to manage exceptions (i.e. requests for accommodations). The process generally involves the submission of an employer-developed form along with any additional supporting documentation. The accommodations process should include review of information submitted by the employee in support of the accommodation, request for additional information as and when appropriate, an interactive process between the employer and employee in evaluating any potential accommodation, and ultimately a determination if the requested accommodation poses an undue burden that is more than de minimis on the employer. 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
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.
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
Since the beginning of the COVID pandemic many healthcare businesses are exploring various ways to increase their referrals, and although exchanging fees and gifts in return for referrals may sound like an easy way to obtain additional business, there are state and federal laws that strictly prohibit such activities that are discussed in greater detail below.
Two of the most important laws that all physical therapists should be aware of are the Anti-Kickback Statute and the Stark Law which are used to ensure that medical decisions are not made based on financial incentives. However, each of the laws do have distinctions that you need to be aware of. read more
For some reason, wearing or refusing to wear masks has become a point of personal expression and a topic charged with much emotion. We hear stories every day about confrontations with consumers in the retail industry. But what about when a patient refuses to wear a mask?
In many states and counties, face coverings are still mandated in public. Failure to wear a mask can result in civil or criminal fines or penalties. In a medical practice, even where not required by local authorities, masks may be required. In fact, some of the state Boards of Medicine have adopted minimum standards for safe practice. Those standards frequently include the requirement for both provider and patient to wear masks during all health care encounters. Where the regulations or Board of Medicine standards require all individuals to wear face coverings, a health care provider is well within his/her right to enforce those regulations within the office where health care services are being provided and to discharge a patient who refuses to comply. However, caution must be exercised when discharging a patient from a medical practice.
In general, the state Boards of Medicine do not require physicians to treat patients who are physically and mentally capable of wearing face coverings but refuse to do so. But there are circumstances where a physician may have a duty to provide care and, in such instances, exceptions to the general rule may apply. 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