COVID-19 Regulations

Third Temporary Extension of the DEA’s COVID-19 Tele-Prescribing Flexibilities: Why Another Extension and What Does It Do?

November 19, 2024 | Little Health Law

Many of our healthcare and business law firm’s clients have an interest in offering more flexibility to patients. Common flexibilities we see include offering alternative pay structures and virtual visits. Since COVID-19, the use of telemedicine visits has increased and remains higher than pre-pandemic levels. Complying with telemedicine rules requires analyzing federal, state, and payor requirements. Under the federal Ryan Haight Act of 2008, a prescribing provider may prescribe controlled substances only after an in-person evaluation. An exception to that rule is when the Secretary of the U.S. Department of Health and Human Services (“HHS”) declares a public health emergency (“PHE”). 21 C.F.R. § 1300.04(i)(4). During the COVID-19 PHE, the in-person requirement was waived. Although the PHE is over, the tele-prescribing flexibility for controlled substances remain. This post discusses the reasons why the DEA continues to allow the COVID-era flexibilities and what the Third Temporary Extension (issued November 19, 2024) does. If you have questions about tele-prescribing rules that may apply to your practice or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting https://www.littlehealthlaw.com/.

At the outset, here is a summary of the COVID-Era Flexibilities from the DEA’s March 20, 2020 press release, which our firm discussed in a previous blog post. DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, if all the following conditions are met:

The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;

Medicare’s New Telehealth Rule for Mental Health Treatment

March 25, 2022 | Little Health Law

MM-0220-Telemedicine-iStock-e1581381176331-1024x814-1-e1631301250783 Given the increased use of telehealth during the Public Health Emergency (“PHE”), the Centers for Medicare and Medicaid Services (CMS) passed a final rule modifying the rules around when Medicare will reimburse for mental health visits. A previous blog post analyzed Federal laws and rules governing telehealth visits, including the general Medicare rules applicable during the PHE. This post analyzes the changes to the Medicare telehealth reimbursement rules for mental health treatment that begin the day after the PHE ends. Note, there are different rules when treatment includes for substance abuse disorders. If you have questions about telemedicine rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Essential Requirements Under Medicare’s New Rule

The CMS Vaccine Mandate: Are Vaccines Required for Remote Workers and Executives?

February 18, 2022 | Little Health Law

csm_FlatDesign-Telework_c532b56131-e1645230859515 Previous blog posts provided an overview of the Centers for Medicare and Medicaid Services’s (“CMS”) Vaccine Mandate and addressed whether boosters are required. To continue supporting our healthcare and business law firm’s clients, herein we have tackled more specific questions about CMS’s Vaccine Mandate. This blog post outlines CMS’s current stance on whether remote workers and executives are required to be vaccinated if the practice falls under CMS’s vaccine mandate. As always, the analysis herein is current as of the date this blog is posted and subject to change as agencies and courts release new decisions.

The CMS Vaccine Mandate: Are Boosters Required?

February 2, 2022 | Little Health Law

a540959b140223b6f8a472cfe17667c1672de165-3389x2260-1-scaled-e1643836004971 Our previous blog post provided an overview of the Centers for Medicare and Medicaid Services’ (“CMS”) Vaccine Mandate and addressed two basic questions of the mandate: What providers are covered and what’s the timeline to comply? Many of our healthcare and business law firm’s clients have additional questions about the requirement of CMS’ vaccine mandate (a.k.a. the “federal healthcare worker vaccine mandate”). One such question is: Does the mandate require individuals to receive a booster shot to comply with the mandate? This blog post outlines CMS’s current stance on the booster requirement. As always, the analysis herein is current as of the date this blog is posted and subject to change as agencies and courts release new decisions.

If you have questions regarding this blog post or the applicability of state and federal regulations to you or your medical practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

SHORT ANSWER: The CMS Vaccine Mandate does not require individuals to receive booster shots or additional doses in addition to the primary vaccination series, but that may change. Continue reading ›

The CMS Vaccine Mandate: What Providers are Covered and What’s the Timeline to Comply?

January 25, 2022 | Little Health Law

021721125026-e1643150049878 Many of our healthcare and business law firm’s clients have questions about whether CMS’ vaccine mandate (a.k.a. the “federal healthcare worker vaccine mandate”) applies to their workforce. The vaccine mandate landscape is evolving. For instance, the OSHA vaccine mandate applicable to 100+ employee-businesses was overruled by the Supreme Court. The analysis herein is current as of the date this blog is posted and subject to change as agencies and courts release new decisions.

If you have questions regarding this blog post or the applicability of state and federal regulations to you or your medical practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

The CMS Vaccine Mandate

CMS’ vaccine mandate requires all staff at Medicare and Medicaid-certified provider facilities, except for those with approved medical or religious exemptions, to be vaccinated. The mandate is still being tested in court however, the Supreme Court has preliminarily agreed with the federal government that the mandate is valid and has ruled that the mandate is in effect now, pending further litigation. As such, the CMS vaccine mandate is now active.

Prescribing Controlled Substances Based on Telemedicine Visits During the COVID-19 Public Health Emergency

September 17, 2021 | Little Health Law

image_4-e1631547014743 Last week, our blog post discussed the general rules permitting telemedicine in Georgia. Often, our healthcare and business law firm’s provider clients who conduct telemedicine also need to understand the requirements around prescribing controlled substances based on telemedicine visits. This post intends to outline some of the relevant prescribing rules in Georgia and the exceptions due to the Public Health Emergency (PHE) created by COVID-19. This post intends to outline some relevant Georgia rules and regulations relating to telemedicine. If you have questions about telemedicine or prescribing rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Georgia Rules on Prescribing Controlled Substances via Telemedicine

As discussed in our prior blog post on the general telemedicine rules, we look to the Medical Board’s rules on Unprofessional Conduct, among other rules, to decipher what is allowed in Georgia. Rule 360-3-.02 defines Unprofessional Conduct to include subsection (5), which provides that Unprofessional Conduct could include: “Prescribing controlled substances . . . and/or dangerous drugs . . . for a patient based solely on a consultation via electronic means with the patient, patient’s guardian or patient’s agent.” As such, the general rule prohibits prescribing controlled substances via a telemedicine consult. However, the rule does “not prohibit a licensee from prescribing a dangerous drug for a patient pursuant to a valid physician patient relationship in accordance with O.C.G.A. § 33-24-56.4 or a licensee who is on-call or covering for another licensee from prescribing up to a 30-day supply of medications for a patient of such other licensee nor shall it prohibit a licensee from prescribing medications when documented emergency circumstances exist.” Rule 360-3-.02(5). There are other exceptions related to specific Schedule II controlled substances.

3 Takeaways from the EEOC’s Guidance on Employer’s Requiring COVID-19 Vaccinations

June 28, 2021 | Little Health Law

As a healthcare and business law firm, we work with many employers and employees to navigate complex employment matters, oftentimes with an eye towards federal employment regulations. 021721125026-300x188 The COVID-19 pandemic has impacted employment in the United States. Now that the Country is reopening and people are returning to work, a question on everyone’s mind is: “Can my employer require me to get the vaccine”? The Equal Employment Opportunity Commission (“EEOC”) recently released guidance answering that question. This post intends to outline the EEOC’s position; it does not address the potential impact of state and local rules on this topic. If you have questions regarding this blog post, employment matters, or EEOC rules and regulations, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com

The EEOC Hearing

To assist in developing its guidance, on April 28, 2021, the EEOC held a hearing to discuss the impact of the pandemic on workplace civil rights. During the hearing, the EEOC heard from experts in economics, policy, disability rights, and many more. The hearing transcript and audio is available here. It may be important going forward to consider that the EEOC hearing was held before the CDC issued new guidance on May 13th pertaining to fully vaccinated individuals.

The Impact of COVID-19 & HB 307 on Telemedicine in Georgia

June 7, 2021 | Little Health Law

As a healthcare and business law firm, we work with may healthcare providers and employers who wish to integrate telehealth into their business models and, understandably, have questions. 4-300x169 What is telehealth versus telemedicine? What laws and rules govern the practice of telemedicine? Has COVID-19 impacted telemedicine? Etc. This post intends to outline some of the rules and laws relevant to practitioners, including the impact of HB 307 on telehealth in Georgia. If you have questions regarding this blog post or telehealth, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com.

As an initial matter, telehealth and telemedicine are distinct terms. Telemedicine is a subset of telehealth. The definitions of both are found within Georgia’s insurance code. Telehealth is defined as “the use of information and communications technologies, including, but not limited to, telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health related education, public health, and health administration.” O.C.G.A. § 33-24-56.4(b)(6). “Telemedicine” is defined as:

[A] form of telehealth which is the delivery of clinical health care services by means of real time two-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management, and self-management of a patient’s health care by a health care provider practicing within his or her scope of practice as would be practiced in-person with a patient, and legally allowed to practice in this state, while such patient is at an originating site and the health care provider is at a distant site.

Clinical Laboratories & COVID-19: Guidance for Record Retention and Sharing

February 1, 2021 | Little Health Law

As a healthcare and business law firm, we assist many clinical laboratories in compliance and regulatory matters, and because of COVID-19, Georgia has seen a rise in the number of clinical lab-testing-adobe-stock-300x200 laboratories. A compliance question faced by many of our clients, particularly those who conduct COVID-19 testing, is how to properly maintain and share patient records. Herein, we note some of the rules around retaining and sharing patient records under Georgia law for clinical laboratories.

Record Retention

Georgia Code, Title 31, Chapter 22 provides rules for Clinical Laboratories. For entities that meet the definition of “clinical laboratory,” section 31-22-4(f) provides that “[r]ecords involving clinical laboratory services and copies of reports of laboratory tests shall be kept for the period of time and in the manner prescribed by the department.” The department refers to the Georgia Department of Community Health (“DCH”). DCH’s rules require reports of “all clinical laboratory services, including records of laboratory test requests and reports” to be retained for at least two (2) years for general laboratory records and quality control records, at least five (5) years for records of immunohematology and cytology, and at least ten (10) years for surgical pathology records. Rule 111-8-10-.26.

Telework as a Reasonable Accommodation During the COVID-19 Pandemic: Part 2—Telework as a Reasonable Accommodation

November 3, 2020 | Little Health Law

Last week, we posted Part 1 of this blog series. Therein, you will find a discussion of employment discrimination laws that are potentially triggered when an employee requests to telework for tixeo-virtual-openspace-300x202 health, safety, or disability reasons. In Part 2, we examine how the state of businesses during the COVID-19 pandemic impacts the discussion of whether telework is a reasonable accommodation.

For many years, employers have asserted that regular attendance at the job site is an essential job function, and employers have often been successful with this argument and, consequently, avoided providing telework as a reasonable accommodation. See, e.g., EEOC v. Ford Motor Co., 782 F.3d 753, 775 (6th Cir. 2015) (collecting cases). Prior guidance from the Equal Employment Opportunity Commission (“EEOC”) stated that considerations as to whether telework is a reasonable accommodation “include whether there is a need for face-to-face interaction and coordination of work with other employees; whether in-person interaction with outside colleagues, clients or customers is necessary; and whether the position in question requires the employee to have immediate access to documents or other information located only in the workplace.” Work at Home/Telework as a Reasonable Accommodation, EEOC Guidance (Feb. 3, 2003). Because of the spread of COVID-19, many businesses have now operated on a telework model and done so successfully. In fact, the Brookings Institute suggests up to half of American workers were working from home in April of this year. Telecommuting Will Likely Continue Long After the Pandemic, Brookings Institute (Apr. 6, 2020). Now that teleworking has been widely, and often effectively, used, the conversation around teleworking as a reasonable accommodation has evolved.

In September, the EEOC offered its guidance on the subject. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, EEOC (Sept. 8, 2020). Therein, the EEOC recognized, “There may be reasonable accommodations that could offer protection to an individual whose disability puts him at greater risk from COVID-19.” Id. § D.1. An employer, however, is not automatically required to grant telework as a reasonable accommodation simply because the employee was allowed to telework for the purpose of slowing the spread of COVID-19. In sum, “[i]f there is no disability-related limitation that requires teleworking, then the employer does not have to provide telework as an accommodation.” Id. § D.15. If the employee has such a limitation and teleworking is a reasonable accommodation, the employer must show telework imposes an undue hardship.