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.
Can an employer mandate a COVID-19 vaccination? And if so, are there exceptions/exclusions that must be addressed? Since the COVID-19 vaccines were first approved for emergency use, the debate has raged as to whether employers can or should require employees (as a condition of employment) to be vaccinated. And, with large numbers on both sides of the debate, the answer, while clear from a legal standpoint (at least for the moment at the federal level) is not without controversy or consequences.
Requirements for Mandatory Vaccine Policies
Health care employers have long required flu vaccines of their employees, absent a medical reason or religious belief. Accommodations have been made as required for those who cannot receive the vaccine. And mandatory vaccines in the health care industry provide some protection for the health and safety of patients and the care providers. The same rationale and rules apply to the COVID-19 vaccine. read more
With governments locking down communities to combat the COVID-19 pandemic, health care providers and practitioners scrambled to find ways to deliver care to patients at their homes or residences. CMS relaxed restrictions on providing health care via telehealth, allowing for all Medicare patients to receive care via two-way, audio and video communications, and even via telephone calls notwithstanding that patients may not reside in rural zip codes. Hospitals pivoted to providing services to patients in their homes, again using telehealth modalities or by deploying practitioners to a patient’s home. Skilled nursing facilities also adopted strategies of keeping patients in their homes, deploying needed skilled caregivers to the patient. And while home health services may have hit a lull in the first couple months of the pandemic, services provided by home health agencies soon started to soar. Home health agencies started to become busier than ever, with many providers reporting overall growth due to demand to receive services at home instead of hospitals, skilled nursing facilities or nursing homes. read more
With the current healthcare environment many providers looked to alternative methods of treating patients and achieving outcomes this past year due to the pandemic. To meet the needs of their patients, and their financial obligations many providers implemented services that were not customary to their practice, or their billing departments. As is the case for any office that begins to provide something new there is always the potential for error in any aspect of the practice involved with the patient or claim. Therefore, I believe it is a great time to refresh providers on the procedures for reporting and returning Medicare overpayments as they are discovered moving forward.
As many of you are aware in 2016 the Centers for Medicare and Medicaid Services (CMS) published a final rue pursuant to Section 1128J(d) of the Social Security Act (the Act), as amended by the Affordable Care Act, that requires Medicare Parts A and B health care providers to report and return overpayments 60 days after the date an overpayment is identified, or the due date of any corresponding cost report, if applicable, whichever is later. If credible information indicates that an overpayment exists, the rule requires that a reasonably diligent inquiry must be performed.
COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.
COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology. Investors are looking for growth and profitability and are finding it in healthcare. Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.
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.