Little Health Law Blog

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.

3 Options Healthcare Professionals Have to Form Professional Entities in Georgia

January 26, 2021 | Little Health Law

As a healthcare and business law firm, we have many clients who wish to not only practice medicine but own their own businesses. After developing a name for their business and generally new-practice-startup-01-1 outlining the mission and purpose of the business, the next step for our healthcare business clients is to determine what kind of entity they want to create. This post intends to generally outline three options in Georgia for healthcare professionals wishing to create an entity for the purpose of providing professional services.

Limited Liability Company

Although some states offer a Professional Limited Liability Company (“PLLC”) option, Georgia does not. Instead, the Georgia Code includes a caveat expressly allowing professionals to create Limited Liability Companies (“LLCs”) for the provision of professional services. Specifically, O.C.G.A. § 14-11-1107(f) states:

3 Facts About Pain Management Clinics in Georgia

January 19, 2021 | Little Health Law

As a healthcare and business law firm, we have many clients who participate in or wish to participate in pain management clinics. Pain management clinics are a controversial topic. Although image-1-8-300x200 useful when managed correctly, these clinics are widely thought to be part of the cause for the opioid epidemic. Georgia citizens suffered and continue to suffer from the opioid epidemic, but, in 2013, Georgia took a large step toward reducing the drug problem by enacting House Bill 178 (“HB 178”) known as the Georgia Pain Management Clinic Act. Before any of our clients become involved with a pain management clinic in Georgia, we immediately advise them of the following three facts.

The Role of the Georgia Composite Medical Board

HB 178 created a section in the Georgia Code placing pain management clinics under the purview of the Georgia Composite Medical Board (“GCMB”). As such, pain management clinics require registering and applying with the GCMB. The application requires providing information about each owner, principal, manager, agent, and licensed health care worker. The GCMB will review each person or entity and ensure each passes a background check and otherwise complies with the governing laws and rules. Once approved by the GCMB, the registrant will receive a pain management clinic license number. The GCMB strongly recommends not practicing in or operating a pain management clinic until receiving the pain management clinic license number.

Tips For Interviewing With Your State Licensing Board

January 14, 2021 | Little Health Law

A critical component for physicians, dentists, nurses, respiratory therapists and other healthcare practitioners is obtaining and keeping active in good standing your professional license to 1-mRDiqjkHzUhi-i84fR2lrg-300x188 practice. In Georgia, the Georgia Composite Medical Board (“GCMB”) is the state licensing board which determines whether a license application of a physician, physician assistant, respiratory care professional, perfusionist, acupuncturists, orthotist, prosthetist, auricular detoxification specialist, resident trainee, cosmetic laser practitioner, pain management clinic and medical geneticist is granted and in good standing. The GCMB also is authorized to investigate and impose discipline as to practitioners who may be failing to comply with professional, ethical or other licensure standards. The Georgia Board of Dentistry and Georgia Board of Nursing serve similar roles for practitioners in those areas of healthcare.

One important part of applying for a professional license with a licensing board is completing and submitting timely and accurate documentation to support the application. Another is being prepared to impress the board at a personal interview in support of your license application. Here are some sound practices to remember when preparing for and participating in a board interview:

Identify any circumstances in your background that may be concerning as the board members consider your application. Be ready to explain what happened and how you learned from mistakes. If you made a mistake in practice, be prepared to disclose what you did wrong, and share lessons learned from the experience and steps you have taken to avoid repeating a mistake. For example, if you had an incident of malpractice in your background, did you complete remedial training to improve your skills and avoid a similar outcome in the future? If you were placed on probation by a licensing body in the past, be prepared to describe the efforts you made to comply with the conditions of probation and return to good standing.

Georgia Composite Medical Board Petition for Waiver or Variance

January 11, 2021 | Little Health Law

Happy New Year! We hope you all had an enjoyable holiday season and celebration bringing in the new year. As a healthcare and business law firm, we represent physicians with matters before medical-doctor-1314903-m the Georgia Composite Medical Board (“GCMB”). Herein, we discuss a tool available to any physician who believes strict application of Georgia’s rules and regulations would create an undue hardship on the physician.

The GCMB is the administrative agency in Georgia responsible for the proper licensing of physicians and enforcement of the Medical Practice Act. The Medical Practice Act places many obligations and licensure requirements on physicians wishing to practice medicine within the state of Georgia. Acknowledging that strict compliance with every requirement “can lead to unreasonable, uneconomical, and unintended results in particular instances,” the GCMB has the authority to grant petitions to waive certain rules and requirements. O.C.G.A. § 50-13-9.1(a). Georgia Code section 50-13-9.1 provides the GCMB with this authority by authorizing Georgia agencies

“to grant a variance or waiver to a rule when a person subject to that rule demonstrates that the purpose of the underlying statute upon which the rule is based can be or has been achieved by other specific means which are agreeable to the person seeking the variance or waiver and that strict application of the rule would create a substantial hardship to such person.”

Ringing in the New Year in Compliance with the Equal Pay Act

December 31, 2020 | Little Health Law

Welcome to the fifth and final of our business and healthcare law firm’s holiday-themed blog posts. We hope you have enjoyed this holiday season so far and have a great time ringing in the new new-years-eve-hero-300x300 year tonight. Happy 2021!

Many of our healthcare provider and healthcare business clients own their businesses and employ many individuals. Being an employer carries with it numerous statutory and regulatory obligations. As legal counsel, we often take the role of advising our healthcare employer clients on employment matters. Herein, we discuss the requirements placed on employers by the Equal Pay Act (“EPA”), which attempts to eliminate gender discrimination in pay.

At 29 U.S.C. § 206(d)(1), the EPA provides: “No employer having employees subject to any provisions of this section shall discriminate . . . between employees on the basis of sex by paying wages to employees in such establishment at a rate less than the rate at which he pays wages to employees of the opposite sex in such establishment for equal work on jobs the performance of which requires equal skill, effort, and responsibility, and which are performed under similar working conditions.” To avoid violating the EPA, it is useful to analyze what must be proven if an employer is accused of violating the EPA.

It’s beginning to look a lot like . . . we need a Declaratory Judgment

December 22, 2020 | Little Health Law

Welcome to the fourth of our business and healthcare law firm’s holiday-themed blog posts. We hope you are enjoying this holiday season despite the challenges COVID-19 presents. In this 104907278_christmasargument week’s post, we discuss the propriety of declaratory judgments as a litigation tool.

Many of our healthcare provider and healthcare business clients are in complex business relationships with other persons or entities. Within such relationships, it is common for the parties to have questions on whether proposed actions would violate the legal parameters of the business relationship. When these questions arise prior to any action being taken, state and federal courts generally provide a mechanism for the parties to seek a decision on the legality of the prospective action; the mechanism is an action for a declaratory judgment.

Declaratory Judgment Acts

“The Theme I’ve Been Waiting for All My Life”: CMS’ Proposed Rule Promoting Electronic Access to Health Information

December 11, 2020 | Little Health Law

Welcome to the third of our business and healthcare law firm’s holiday-themed blog posts. This week’s post is inspired by my favorite holiday movie, A Christmas Story, and the eloquent words websiteshowart15167-300x300 Ralphie wrote: “A Red Ryder BB gun with a compass in the stock, and this thing which tells time.” Analyzing Ralphie’s literary genius, he gave Miss Shields three enticing facts: the main description, a vital component, and an interesting addition. Following suit, I will provide three enticing facts of CMS’ new proposed rule.

First, the shortened name of the rule is: “Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information.” According to CMS, the purpose of the proposed rule is “[t]o drive interoperability, improve care coordination, reduce burden on providers and payers, and empower patients.” The ingenuity of the proposed rule stems from the fact that it is not only designed to grant patients better access to their records; it is designed to grant all vital parties’ necessary access to records—meaning patients, payors, and providers.

Second, the new rule requires each payer to use an Application Programming Interface (“API”) that allows each payer’s system to communicate with other payers. The new rule also does not require patients to request the transfer of claims data. As such, a patient’s new payer will have access to all of his or her claims data almost immediately upon enrollment. Importantly, on the new API, payers can send “patient claims, encounter data, and clinical data directly to providers[].” Verma, Seema, Reducing Provider and Patient Burden and Promoting Patients’ Electronic Access to Health Information, CMS.gov (Dec. 10, 2020).

12 Days of the Georgia Composite Medical Board

December 4, 2020 | Little Health Law

Welcome to the second of our business and healthcare law firm’s holiday-themed blog posts. As I am sure we all noticed during 2020, many people took the opportunities presented this year to relocate. Study: Pandemic Spurred a Wave of Relocations, Washington Post (July 3, 2020). I heard from many who always wanted to move, generally to be closer to family, and finally decided to take the plunge once the shutdown began.

When physicians and other medical professionals choose to move to a new state, there is a process that must be completed. As attorneys who assist physicians and other medical professionals with licensing, we assisted many physicians this year who desired to move to Georgia and acquire the proper license to work here. Given that we will likely continue to see this behavioral trend, we wish to, herein, acquaint non-Georgians and Georgians alike with Georgia’s medical professional licensing board by providing the following 12 facts:

The licensing Board in Georgia is known as the Georgia Composite Medical Board (“GCMB”).

Let’s Talk Turkey…Considering Federal Age Discrimination Laws Before Reducing Your Healthcare Work Force

November 25, 2020 | Little Health Law

Welcome to the first of our holiday-themed (at least in title) blog posts. As we approach the holidays at the conclusion of a financially challenging year, cost savings may be on the minds of many index healthcare business owners. Healthcare employers may be considering—or have already considered—measures to save money and reduce payroll. 2020 was a difficult year for most businesses, and reducing payroll is an oft-appealing way to reduce expenses. Frequently, a business’s highest paid earners are also among the older employees. That fact prompts a look at the Age Discrimination in Employment Act of 1975 (“ADEA”) prior to making any employment decisions, such as eliminating positions.

For healthcare employers with 20 or more employees, the ADEA governs and makes it an unlawful employment practice to “discharge any individual or otherwise discriminate against any individual with respect to [her] compensation, terms, conditions, or privileges of employment, because of such individual’s age.” 29 U.S.C. § 623. The regulations create a protected class for individuals who are “40 years or older.” 29 C.F.R. § 1625.2. To be certain, the ADEA and accompanying regulations do not require preferential treatment of employees over 40, and “[f]avoring an older individual over a younger individual because of age is not unlawful discrimination.” Id.

An employee establishes a prima facie case of age discrimination by showing he or she “was (1) a member of the protected age group, (2) subjected to an adverse employment action, (3) qualified to do the job, and (4) replaced by or otherwise lost a position to a younger individual.” Johnson v. Unified Gov’t of Athens-Clarke Cnty., 209 F. Supp. 3d 1335, 1341–42 (M.D. Ga. 2016). The fourth prong, however, is generally not satisfied when it comes to position eliminations because the older employee was not replaced by anyone. See Mazzeo v. Color Resolutions Int’l, LLC, 746 F.2d 1264, 1271 (11th Cir. 2014). The law accounts for this by altering the fourth prong in “reduction in force” cases, requiring the employee to “present sufficient evidence from which a reasonable jury could find that the employer intended to discriminate on the basis of age through its employment decision.” Zaben v. Air Prods. & Chems., Inc., 129 F.3d 1453, 1459 (11th Cir. 1997). One such “method of establishing a nexus between age discrimination and adverse employment action is by statistical proof of a pattern of discrimination.” Pace v. S. Ry. Sys., 701 F.2d 1383, 1388 (11th Cir. 1983).