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.
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
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
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
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
Earlier today, Governor DeSantis issued Executive Order 20-144 extending the State of Emergency declare in Executive Order 20-52 for another 60 days. Pursuant to the extension of Executive Order 20-52, the State Surgeon General’s Order 20-003 is also extended another 60 days as its expiration is tied to the expiration of Executive Order 20-52. Thus, telehealth providers from other states with valid and unencumbered licenses may continue to provide telehealth services to persons in Florida without registering with the Department of Health. Telehealth services must still be provided using two-way audio and video communications. Audio-only telephone calls are not permitted under Florida’s existing telehealth statute and have not been waived or suspended via the State Surgeon General’s Orders. read more
Access to telehealth for Medicare beneficiaries was further increased by the Trump Administration April 30, 2020. These new changes allows all health care professionals eligible to bill Medicare for services to provide services via telehealth communications and to bill the Medicare program for such services. Additionally, certain services may now be provided using audio technology only.
For a list of services eligible for reimbursement by the Medicare Program, including services requiring audio technology only, download here. There are approximately 180 different codes reimbursable by Medicare if provided via telehealth communications.
The newest relief for small business and health care providers was passed by the Senate on April 21st, by the House on April 23rd, and became law on April 24, 2020. This new Act, provides for $484 billion in additional relief to small businesses and healthcare providers. $100 billion of the relief has been allocated to the Department of Health and Human Services and of that amount $75 billion is earmarked “to reimburse health care providers for health related expenses or lost revenues that are attributable to the coronavirus outbreak.” The remaining $25 billion will be used for expenses to research, develop, validate, manufacture, purchase, administer, and expand capacity for COVID-19 test to effectively monitor and suppress COVID-19.
The $75 billion provided under the Act will remain available until expended and will be used to prevent, prepare for, and respond to coronavirus to reimburse necessary expense or lost revenues incurred as a result of COVID-19. However, if a health care provider has already had expenses or lost revenues incurred due to COVID-19 reimbursed from other sources or that other sources are obligated to reimburse (like the CARES Act), any funds received from the $75 billion cannot be used as a “double dip” by that health care provider.
A big difference for health care providers with this Act, is that unlike the CARES Act that provided a direct deposit to health care providers based on Medicare fee for services reimbursement, no application necessary, this Act requires the health care provider to apply for relief funds. Eligible health care providers include public entities, Medicare or Medicaid enrolled suppliers and providers, profit and not-for-profit entities that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 (so as to accommodate the “lost revenues” provision, this could mean any patient treated since January 31, 2020, and is not necessarily limited to patients treated for COVID-19 symptoms without testing confirmation). Health care providers should act quickly and apply for funds as soon as possible as the HHS Secretary will review applications and make payments on a rolling basis. Payment may be a pre-payment, prospective payment, or a retrospective payment as determined by the HHS Secretary. Health care providers must submit an application that includes statements justifying the need of the provider for the payment. The provider must have a valid tax id number (could be an individually enrolled physician). As with the CARES Act, HHS will have the ability to audit how relief funds are expended and must start reporting obligations of funds to the House and Senates Committees on Appropriations within 60 days from the date of enactment of this Act. Reporting will continue every 60 days thereafter. read more
Just the other day CMS issued new rules and temporary waivers to help combat the COVID pandemic. We are getting flooded with questions about telemedicine in particular and wanted to highlight some of the points of the March 31st update that relate to telehealth.
Hospitals may use and bill for telehealth services so that patients can be screened without presenting at a hospital. The telehealth screening will allow hospitals to determine the most appropriate site for care, thereby minimizing the patient’s risk of exposure to COVID-19.
Health care providers using telehealth will be able to bill for telehealth services at the same rate as in-person services of the same kind and level. Allowable telehealth services have also been expanded during the health care crisis.
Further, providers, including practitioners, may be able to temporarily enroll in Medicare to be able to assist with the current health care crisis.
Even though CMS has created some flexibility during this incredibly uncertain time…something about telemedicine laws remaining tricky and not being a one size fits all suit. Attorney Susan St. John will give you all of the details on how telemedicine set up, billing questions and more! Join us for this free webinar.
CMS has rolled out a telehealth/telemedicine tool kit to assist medical professionals with health care delivery during the current COVID-19 public health emergency.
The toolkit contains information and links concerning:
1135 Waivers – allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient health care services and items are available to meet the needs of individuals enrolled in Social Security Act programs during the emergency and that providers who provide services in good faith can be reimbursed and exempted from sanctions (provided there is no determination of fraud and abuse). 1135 waiver or modifications include:
Conditions of participation and other certification requirements;
Program participation and similar requirements;
State licensing requirements where services are rendered as long as the provider has equivalent licensing in another State (for Medicare, Medicaid, CHIP reimbursement only; State licensing still controls whether a non-Federal provider may provide services in a state he/she is not licensed in);
EMTALA sanctions for redirection for medical screening, as long as redirection is not the result of discrimination on the basis of a patient’s source of payment or ability to pay;
Stark self-referral sanctions;
Adjustment (not waiver) to performance deadlines and timetables;
Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.
With phenomenal growth and expansion in the Hemp Industry comes trials, tribulations, the FDA, and consumer complaints! Let’s take a look at what’s going on that might have an adverse impact on your burgeoning business or foray into Hemp a/k/a CBD.
The FDA sent letters to 15 CBD business companies in late November 2019, warning and admonishing these companies that their CBD products were being promoted to treat disease or for having certain therapeutic properties. Specifically, the FDA reviewed these companies’ websites, social media pages, marketing material, etc., finding that the companies promoted products containing cannabidiol or CBD in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Further, the FDA stated that the companies’ CBD products are unapproved new drugs sold in violation of the FD&C Act, and were misbranded under the FD&C Act. The FDA letters did not just target products sold for human use and consumption, but also targeted CBD products sold for use on pets, stating that “the products are unapproved new animal drugs that are unsafe under the FD&C Act and adulterated products under the FD&C Act. read more