Compounded Bioidentical Hormone Replacement Therapy (cBHRT) in Jeopardy of Being Added to the FDA’s “Difficult to Compound List”

Currently, cBHRT is not on FDA’s list of difficult to compound products, falling under certain exemptions of the FD&C Act, particularly, Sections 503A and 503B. Under Section 503A, a human drug compounded for an identified individual patient based on a prescription qualifies for exemption from three sections of the FD&C Act: 1) current good manufacturing practice for drugs; 2) labeling of drugs with adequate directions for use; and 3) approval of human drug products under new drug applications or abbreviated new drug applications. One of the criteria for these exemptions is that the Secretary has not identified the drug, by regulation, as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. However, before the Secretary may promulgate regulations to add a drug to the difficult to compound list, it must convene and consult an advisory committee on compounding of such drug(s), unless the Secretary finds that issuance of such regulations before consultation is necessary to protect the public.Continue reading

DME Scheme of Greed Knows No Bounds

Durable Medical EquipmentBy: Susan St. John

In yet another take-down of an illicit scheme to defraud the Medicare Program and ChampVA, as well as other insurers, Patsy Truglia has been sentenced to 15 years in federal prison. He has also had assets forfeited since these assets were acquired with money from his ill-gotten fraud scheme. In total, Mr. Truglia and his co-conspirators collected approximately $18.5 million from Medicare, ChampVA, and insurance using a scheme of telemarketing, telemedicine, and multiple DME providers or “store fronts.”

The scheme used telemarketers to collect beneficiaries personal and medical information to create orders for DME products such as knee, back, and wrist braces. These orders were then provided to telemedicine practitioners for signature – often without a valid telehealth communication. In essence, there was no attempt at having a practitioner exercise independent judgment as to the medical necessity of these DME products. Instead, these practitioners were paid for their signatures on the pre-filled order forms as part of the “scheme of greed.” From January 2018 to 2019, this scheme of greed resulted in approximately $12 million in payment to Truglia and his co-conspirators.Continue reading

PPP Standing in the Way of Healthcare Mergers and Acquisitions

fhlfhealthcaretransactionsduringpandemic

fhlfhealthcaretransactionsduringpandemicBy: Susan St. John

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.Continue reading

Florida State Surgeon General’s Emergency Order 20-011 Continues to Allow Out-of-State Practitioners to Offer Telehealth Services to Persons in Florida

telemedicine extension

telemedicine extensionBy: Susan St. John

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.Continue reading

Florida State Surgeon General’s Emergency Order 20-009 Continues to Allow Out-of-State Practitioners to Offer Telehealth Services to Persons in Florida

By: Susan St. John

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.Continue reading

Breaking News – State Surgeon General Issues Order 20-007 May 9th

florida breaking healthcare news on controlled substancesBy: Susan St. John

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.Continue reading

Governor DeSantis Issues Executive Order 20-114 Extending State of Emergency

By: Susan St. John

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.Continue reading

Access to Care via Telehealth Increases Again in Second Round of Changes Due to COVID-19

By: Susan St. John

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.

More Relief on the Way: H.R. 266 – Paycheck Protection Program and Health Care Enhancement Act Signed by the President

HHS Stimulus Payment action required on Second Round

HHS Stimulus Payment action required on Second RoundBy: Susan St. John

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.Continue reading

Webinar | Emergency Telemedicine Education: From Setup to Billing and COVID-19

emergency telehealth webinarJust 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.
  • Importantly, a patient’s home may now serve as the originating site for Medicare telehealth services. CMS is also allowing for required supervision of lower level clinicians to be accomplished through virtual technology if appropriate for a patient’s particular situation.
  • 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.

April 14 @ 12:00 pm – 1:00 pm

Free