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ALAPAC VOTER GUIDE 2022 PRIMARY ELECTION

As the political action committee representing physicians across the state, Alabama Medical PAC (ALAPAC) is pleased to provide the list of candidates chosen to receive support in the upcoming May 24, 2022, primaries. ALAPAC conducts interviews, receives feedback from physicians, and utilizes Regional Boards and a Board of Directors to vet candidates for local legislative seats and statewide offices. Click below to view voter guide.

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On-Line Reviews Can Equate to a HIPAA Trap

On-Line Reviews Can Equate to a HIPAA Trap

By: Kelli Carpenter Fleming, Burr & Forman, LLP

With almost every facet of our lives being conducted online these days, more and more consumers are turning to online reviews and comments to make business decisions. In addition, more and more businesses, including healthcare providers, are building up their online presence to achieve better search results and bolster marketing efforts.

However, unlike other industries, healthcare providers must be careful when addressing and responding to online reviews, as they could run afoul of state and federal healthcare privacy laws. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) protects patient health information, including whether or not someone was a patient of a particular healthcare practice or received services from a specific healthcare provider. Thus, if a healthcare provider responds to an online review in a manner that confirms that the reviewer (or someone else) was a patient or includes details about the services rendered, that response could run afoul of HIPAA. In fact, a North Carolina dental practice was recently fined $50,000 for disclosing a patient’s health information in response to a negative online review and failing to cooperate with the government investigation into the matter. 

While providers may naturally want to defend themselves against a negative review, their hands are a bit tied due to HIPAA prohibitions. The safest approach when dealing with online reviews is to not respond at all, as it is sometimes difficult to craft an appropriate response without running afoul of HIPAA. If a provider feels the need to respond, the provider should only provide a general response that in no way confirms whether or not someone was a patient. For example, “Please feel free to call our office at XXX-XXX-XXXX to address any concerns.” Alternatively, instead of responding, providers should approach the reviewer directly via telephone to address the complaint. In addition, practices may also encourage positive reviews online by providing information to patients on posting such reviews in an effort to over-shadow any negative reviews.

Regardless, healthcare providers should never post anything online that could identify someone as a patient of the provider without the patient’s express, written authorization. Doing so could result in a HIPAA violation.

Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare group. Kelli may be reached at (205) 458-5429 or kfleming@burr.com.

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Without the Medical Association…

2022 Legislative Recap

The last regular session of a quadrennium (four year election cycle) is historically a non-controversial session. The 2022 Regular Session, however, was anything but quiet for medicine. Coming out of pandemic- related restrictions at the State House, the Association again saw roughly 20 percent of bills and resolutions filed during the 2022 Regular Session relating to health care.

Without the Medical Association’s work during the 2022 Session, none of the progress seen in medicine this year would have occurred and many problematic bills for physicians and bills dangerous to patients could have become law.  

Moving Medicine Forward in 2022

While preventing dangerous and problematic proposals from becoming law consumes much of the Association’s advocacy efforts, at the same time the Association is trying to move medicine forward each session. The 2022 session saw big wins for the Association in extending Medicaid postpartum coverage to one-year and enacting telehealth legislation, as well as beginning conversations in updating Alabama’s rural physician tax credit to further expand access to physician-led, team-based care for patients in Alabama. 

Without the Medical Association . . . telehealth legislation with strong patient protections and establishing a framework for telehealth regulation would not have become law. One of the Association’s top priorities for 2022, MASAworked with Blue Cross Blue Shield of Alabama, community mental health advocates, hospitals, urgent cares and others to establish guardrails and a framework to allow telemedicine to continue to grow and adapt to physicians’ and patients’ needs. The law requires that – after 4 telehealth visits with the same physician for the same condition without resolution – a patient would need to be either seen in person or referred for an in-person visit within 12 months (with the ability for some exceptions to be made by rule).  As well, the new law puts safeguards around prescribing, prohibits “cold calling” of patients, and requires that virtual care be patient-initiated. As well, telepsychiatry visits would be excluded from the in-person requirements.

Without the Medical Association . . . extending postpartum coverage for women on Medicaid from 60 days to 12 months could not have become a reality. One of the Association’s top priorities for 2022, MASA worked closely with the Ivey Administration, legislators, the Alabama Medicaid Agency and the Cover Alabama Coalition to establish a 12-month Medicaid postpartum pilot program. The Association partnered with a coalition of stakeholders – including March of Dimes, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics – and highlighted the findings from the Maternal Mortality Review Committee (MMRC) that funds allocated to extend postpartum coverage could positively impact 30,000 women and improve maternal health outcomes in Alabama.

Without the Medical Association . . . the Maternal Mortality Review Committee (MMRC) may not have received vital funding for the third year in a row. In 2019, the Association spearheaded a coalition of stakeholders – which included March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and Johnson & Johnson – to bring awareness to the issue of increasing maternal mortality rates in Alabama and spotlight the impact this committee could have to reverse that trend if properly staffed and resourced. As she did in 2021, Gov. Ivey again supported funding for the MMRC in her initial 2023 budget request and legislators maintained that funding in the final budget. Continued funding for this committee is critical to identifying causes for high maternal mortality and crafting solutions.

Without the Medical Association . . . the crafting of what could be a legislative model for other rural states relating to anesthesia care provided by CRNA’s would not have become law. The Association partnered with the Alabama State Society of Anesthesiologists and jointly worked with the CRNA association to formulate a mutually-agreed upon bill. This new law appropriately maintains a CRNA functions under the direction of a physician who is immediately available when that physician is an anesthesiologist. The new law also states that in the absence of an anesthesiologist, a CRNA would work “in coordination” with another physician (like a surgeon) who must also be immediately available. While the Association remains committed to increasing access to care, it is equally committed to ensuring that care is of the highest quality and maintains strong patient safety protocols in both urban and rural locations. This legislation achieves both goals.

Without the Medical Association . . . discussions surrounding a long-overdue update to the existing rural physician tax credit would not have moved forward. In 1993, a law was passed with the intention of making rural areas of Alabama more competitive in the recruitment and retention of physicians to rural, underserved communities. Since then, many things have changed in rural Alabama and most agree the eligibility requirements in the current law are cumbersome and outdated. The Association worked with the bill sponsor, the Alabama Department of Revenue and the Alabama Academy of Family Physicians on the bill. It did not pass, but much progress was made toward addressing this legislation in a future session.

Without the Medical Association . . . the Board of Medical Scholarship Awards may not have maintained its funding. Gov. Ivey again recommended maintaining the additional $500,000 increase for the BMSA initially put in place in 2021. The Legislature agreed, and the total amount for physician-student-loans for 2023 remains at $1.9 million, allowing roughly 10 medical school tuition loans to be granted annually to physicians willing to set up practice in medically underserved areas of Alabama. This program remains one of the best mechanisms for expanding access to quality, physician-led care.

Without the Medical Association . . . the needs of physicians and patients as it relates to expanding broadband in Alabama and the impact on telehealth would not have been heard.A Special Session was called in January 2022 to focus on the allocation of American Rescue Plan Act (ARPA) funds.  Broadband expansion was a top priority and $277 million was allocated in support of expanding broadband in all 67 counties in Alabama.  

Without the Medical Association . . . awareness of the need to expand Medicaid would not have grown as much as it did. The Association, as part of Cover Alabama – a coalition of more than 100 organizations supporting Medicaid expansion – continues to advocate for those caught in the coverage gap. 

Fighting “Scope Creep”
(The Replacing of Education with Legislation)

Many people would like to be a physician, but few are willing to endure medical school, residency, and all the other various education and training requirements to become an M.D. or D.O. Instead of pursuing higher education, some non-physician organizations pursue legislative changes as an end-around-means to practice medicine, endangering quality care for patients.

Without the Medical Association . . . home-birth VBACs attended by non-nurse midwives could have been authorized. The Association spearheaded a coalition of partners to oppose home-birth VBACs and instead support the high national standards in place for VBACs that ensure the safety of pregnant women and their children in utero. The bill failed in committee.

Without the Medical Association . . . pharmacists could have been granted the ability to begin prescribing. Under current law, pharmacists may administer any vaccinations, but may not prescribe them. The proposed legislation would have allowed pharmacists to prescribe essentially any vaccine, clearly a slippery slope that blurs the lines between medicine and pharmacy. The Association worked with the Alabama Chapter of the American Academy of Pediatrics, the Alabama Academy of Family Physicians and the Alabama Chapter of the American College of Physicians on the legislation. Pharmacy interests bringing the bill stated the goal of the legislation was to increase access to vaccines. Working toward that goal, medicine offered several alternatives to the original bill language which would have met that goal but all of those were rejected by pharmacy interests. The bill was “passed” out of the Senate Healthcare Committee on a voice vote called by Sen. Jim McClendon, despite the absence of a quorum. It ultimately failed to make it to the floor.

Without the Medical Association . . . optometrists could have begun performing eye surgeries using scalpels and lasers as well as performing eye injections. The legislation pushed by Sen. Jim McClendon (an optometrist himself) would have allowed optometrists, who are not trained surgeons, to perform surgeries and injections on the eye and would also have given the Alabama Board of Optometry the sole power to define and regulate what is considered to be the practice of optometry, taking all authority away from the Legislature to define it. In the Senate, the bill was “passed” out of committee on a voice vote called by Sen. Jim McClendon despite vocal opposition from other senators on the Senate Health Committee. Both a public hearing on the bill and a roll call vote were also denied by Sen. McClendon. Ultimately, the bill failed when it made it to the House committee.

Without the Medical Association . . . podiatrists could have been granted the ability to perform surgery on the ankle. The legislation would have allowed podiatrists who have completed as few as 3-years of podiatry residency (significantly less than either a general orthopaedist or an orthopaedic surgeon specializing in the ankle) to perform ankle surgery. The bill was “passed” out of the Senate Health Committee on a voice vote which was called by the Chairman of the Healthcare Committee, Sen. Jim McClendon. The bill failed on the Senate floor.

Without the Medical Association . . . a new state board could have unilaterally set the scope of practice for imaging technologists and significantly increased costs to medical practices utilizing medical imaging. Working with the Alabama Academy of Radiology, the Alabama Academy of Family Physicians and other medical specialty societies, the Association was able to reach a consensus with the technologists on their legislation to put standards in place for medical imaging. The bill did not come up for a vote this session.

Without the Medical Association . . . various “interstate compacts” for non-physicians could have enabled “scope creep” far beyond what Alabama law allows. Working with bill proponents, the Association was able to ensure that expedited licensure laws for various professions did not also water down patient safety laws in Alabama.

Beating Back the Lawsuit Industry

Plaintiff lawyers are constantly seeking new opportunities to sue physicians. Alabama’s medical liability laws have long been recognized for ensuring a stable legal climate and fostering fairness in the courtroom, as well as being a tool (like cost of living and quality of life metrics) for recruiting physicians to Alabama. But those laws come in jeopardy every session and the Association must defend against allowing more frivolous lawsuits to be filed against physicians.

Without the Medical Association . . . new vaccine-related lawsuits against physician-employers and medical practices could have become law. None of these bills passed.

Without the Medical Association . . . physicians could have been held liable for emergency medical treatment decisions of individuals believed to be a threat to themselves or others. The Association worked with the bill sponsors to remove the problematic language. The bill became law.

Without the Medical Association . . . legislation to criminalize female genital mutilation could have unintentionally created new liability issues for physicians. The Association worked with the bill sponsor and the Alabama Section of the American College of Obstetricians and Gynecologists to ensure the bill adhered to ACOG guidelines and that no new physician liability was created. The bill did not pass.

Without the Medical Association . . . new lawsuit opportunities against OBGYNs for treating ectopic pregnancies and maternal medical emergencies and also performing IVF services could have become law. The Association worked with the bill sponsor to ensure routine medical treatments like those for ectopic pregnancies, non-uterine implantations, emergency treatments and performance of in vitro fertilization (IVF) were not considered “abortions” under the bill and therefore physicians performing them could not be exposed to new liability. The bill did not pass.

Other Health-Related Legislation of Interest

Prior authorizations. The bill would have required a health insurer to communicate to a physician or other health care professional with authority to prescribe drugs within a certain time frame whether the medicine would be covered or not and why. The bill did not pass. However, the Association undertook a survey of physicians in the state earlier this year on prior authorizations across the entire testing and treatment spectrum, not just prescriptions. The Association is also establishing a workgroup to examine the findings of that survey and discuss solutions to removing barriers to patient care.

Legislation was passed to ban transgender therapy and surgery on minors. The legislation criminalizes prescribing puberty blockers and performing surgery if the intent is to assist and/or affirm in transitioning a minor patient to a gender different than the one listed on the patient’s birth certificate. The bill is now law and legal challenges to it are expected.

COVID-19 related legislation was filed regarding the powers of health officers, masking in schools, age of consent related to vaccinations, and exemptions for vaccinations. Bills were filed which (1) would have prohibited a statewide public health order from the state health officer from going into effect unless the Governor signs the order; (2) would have prohibited a county health officer from issuing an order that relates to a pandemic or outbreak unless it was approved by the state health officer; (3) would have reduced school funding if mask mandates were put in place; (4) would have created a right of a parent to determine if a child wears a mask to a public school which has ordered masks be worn; (5) changed the age of medical consent for minors’ vaccinations; and, (6) created exemptions to workplace vaccination requirements. None of these bills passed.

COVID-19 alternate treatments. The legislation would have prohibited an occupational licensing board from taking adverse action against a physician who recommends a COVID-19 treatment that is FDA approved but which is prescribed off label and would also have required a pharmacist to fill such a prescription. The legislation would also create a list of patients’ rights toward access to such treatments in the inpatient setting and would create some new causes of action against health care facilities and potentially health care personnel. The bill was “passed” out of the Senate Healthcare Committee on a voice vote called by Sen. Jim McClendon, despite the absence of a quorum. The bills did not become law.

Multiple pieces of legislation were filed related to abortion. These bills ranged in focus from (1) legislation modeled after the “Texas-style” abortion ban that utilizes civil actions by citizens for enforcement; to (2) legislation banning certain abortifacients from being prescribed for any purpose; to (3) requiring additional information and counseling be provided to patients before an abortion; to (4) banning use of state funds for abortions. None of these bills passed.

Mental health “crisis center” facilities expanding. Gov. Ivey recommended in her budget and the Legislature concurred, for additional funding for two new mental health crisis centers for the state. This marks the second time in three years the state has invested heavily in mental health care infrastructure, as the construction of four other “crisis centers” was funded in the 2020 budget. 

Mental health services coordinators in public schools. Legislation was filed to require each local board of education and independent school system in the state, subject to appropriations by the Legislature, to employ a mental health service coordinator. The bill became law.

End-of-life care decisions by surrogates. The legislation provides further for the certification of a surrogate designated to make end-of-life decisions for a terminally ill patient and removes the need for notarization, replacing it instead with attestation by two adult witnesses. Neither witness may be a physician or health care provider or an employee of either of the aforementioned unless he or she is a relative of the patient. The bill became law.

Use of restraints on pregnant inmates. The legislation prohibits the use of restraints on pregnant inmates except restraints utilized by a health care professional for the safety of the pregnant woman. The bill became law.

Certificate of Need adjustments and repeal. Multiple bills were filed to modify or repeal entirely the state’s Certificate of Need laws related to construction of facilities and provision of certain health care services. None of these bills passed.

Tax credits for physicians, others serving as preceptors. The bill would have established the Preceptor Tax Incentive Program to provide an opportunity for students enrolled in certain health professions training programs to train in rural and underserved counties in the state. The bill would have provided an income tax credit incentive of $500 for each 160 hour clinical preceptorship rotation per calendar year for an otherwise unpaid community-based faculty preceptor physician for either allopathic or osteopathic  medical students. The bill would also provide an income tax credit incentive of $425 for each 160 hour clinical preceptorship rotation per calendar year for an otherwise unpaid community-based certified registered nurse practitioner, certified nurse midwife, certified registered nurse anesthetist, or physician assistant. The bill did not pass.

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“No Surprises Act” Internal Dispute Resolution System is Now Live

“No Surprises Act” Internal Dispute Resolution System is Now Live

Article by: Brandy Boone, General Counsel, Medical Association of the State of Alabama

The Centers for Medicare and Medicaid Services (CMS) announced on April 15, 2022, that their Internal Dispute Resolution (IDR) portal for determining reimbursement for services covered under the No Surprises Act is now available. The opening of the portal was delayed because of a federal district court ruling that struck down part of the interim final rule related to billing under the No Surprises Act.  Because of this delay, CMS cautioned in its announcement that there may be a backlog in handling IDR cases.  Therefore, the deadline for initiating the IDR process for parties whose open negotiation time period expired before the portal was available has been extended to May 6, 2022.  Also, CMS has indicated that requests for extensions will be granted as appropriate.

The No Surprises Act’s prohibitions on balance billing for out-of-network hospital, ambulatory surgical center (ASC) and air ambulance services went into effect January 1, 2022.  The IDR process was established to determine appropriate compensation for these out-of-network providers.  Once a provider receives a denial or initial payment from a health plan for out-of-network services, the provider and plan have a 30-day open negotiation period to determine appropriate reimbursement.  If that period ends without resolution of the billing dispute, the provider must initiate the IDR process within four business days of the end of the open negotiation period.  However, as mentioned above, for any open negotiation periods ending before the portal went live, providers have 15 days to initiate the IDR process through the IDR portal.

Providers who wish to begin the IDR process may do so here: https://www.cms.gov/nosurprises/help-resolve-payment-disputes/payment-disputes-between-providers-and-health-plans.  CMS suggests having the following information available when initiating the IDR process:  (1) Information to identify the IDR items, (2) dates and locations of services or items in dispute, (3) Type of items or services (e.g., emergency services), (4) Applicable codes for services and place of services, (5) Attestation that services or items in dispute are within scope of the IDR process, and (5) the preferred IDR entity (IDR entities make the actual determination of reimbursement for services and must be mutually agreed upon by the parties in dispute.) CMS also provides a list of certified IDR entities: https://www.cms.gov/nosurprises/Help-resolve-payment-disputes/certified-IDRE-list.

The provisions of the No Surprises Act that became effective January 1, 2022, also included a requirement for healthcare facilities to provide a good faith estimate to uninsured or self-pay patients prior to the rendering of those services. If patients entitled to receive this good faith estimate get a bill after the services are rendered that is more than $400 in excess of the good faith estimate, they can initiate the provider-patient dispute resolution (PPDR) process to determine appropriate reimbursement.  The PPDR is similar to the IDR, in that an entity agreed upon by the parties, called a Select Dispute Resolution (SDR) entity makes the actual reimbursement decision.  Patients may use CMS’ IDR portal to begin the PPDR process, and they have 120 days following the receipt of a bill that is more than $400 higher than the good faith estimate to do so.

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New Rules Replace Old Guidelines on Medical Record Management

New Rules Replace Old Guidelines on Medical Record Management

The Board of Medical Examiners and Medical Licensure Commission recently made substantial changes to their joint guidelines for medical record management, beginning with changing them from guidelines to rules.  The new rules provide for more specific regulation of the management of medical records by Alabama physicians, including establishing a new minimum time frame for retention and appropriate methods for destruction of records, providing expanded criteria for patient notification when closing or leaving a practice, and detailing the steps for disposition of medical records in a variety of practice departure scenarios. 

The previous guidelines recommended physicians retain patient medical records for “such period as may be necessary to treat the patient, and for such additional time as may be required for medical legal purposes,” without establishing a minimum time frame.  The new rules provide that physicians must retain patient medical records, with some exceptions, for a minimum of seven years from the physician’s last professional contact with the patient. For records of minors, including immunization records that have not been transmitted to ADPH’s Immunization Registry, the rules require retention for the longer period of seven years from the last professional conduct or two years after the minor reaches the age of majority.  Mammograms and reports must be retained for ten years, but x-rays and other imaging may be destroyed after five years if separate written reports exist.

Although the previous guidelines did address retention of records, if not in a detailed manner, they did not address destruction of medical records at all.  The new rules list appropriate methods for destruction of records and also require the maintenance of a destruction log.

Recommendations for transfer or disposal of medical records in the previous guidelines included the responsibility of physicians to provide “reasonable notice” to “active patients” when the physician retired or otherwise left a medical practice. However, the guidelines provided no definition or detail for either of those terms.  The new rules define “active patients” as any patients treated by a physician at least once in the preceding 36 months.  “Notification” is defined as a HIPAA-compliant electronic message or form letter sent U.S. mail to the active patient’s last known address.  The “reasonable” qualifier for notification from the previous guidelines has been quantified in the new rules as “no less than 30 days” before a qualifying event like retirement or after the death of a physician.

While the previous guidelines provided the same basic guidance for notification and disposal of records – reasonable notice to active patients – regardless of whether the qualifying event was retirement, termination from employment or otherwise leaving a practice, the new rules provide specifically for notification and disposition of medical records in the following circumstances: (1) Physician death; (2)Physician retirement; (3) License suspension or revocation; (4) Departure from a group; and (5) Sale of a medical practice.  The new rules also require physicians to make arrangements for patients to access their records when voluntarily unavailable.

Physician members with questions on the new Board of Medical Examiners and Medical Licensure Commission Joint Rules on Medical Records Management can contact the Association’s Legal Department at 334-954-2540.  They can also find all of the requirements of the new rules here: https://www.albme.gov/resources/licensees/medical-records/

 1Ala. Admin. Code 540-x-9-.10; Ala. Admin. Code 545-x-4-.08.

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Federal District Court Issues First Court Opinion Regarding EKRA’s Commission Based Payments

By James A. Hoover, Esq., Burr & Forman, LLP

A Federal District Judge in the United States District Court, District of Hawaii issued the first court opinion interpreting the prohibition of the payment of commissions by clinical laboratories to employees or independent contractors that was implemented by the Eliminating Kickback in Recovery Act of 2018 (“EKRA”).  Judge Kodayashi entered her decision on October 18, 2021 in the case S&G Labs Hawaii, LLC v Graves.  

In S&G Labs, the court ruled that the commission payments made to an employee of a clinical laboratory were legitimate compensation payments and did not violate EKRA notwithstanding the fact the payments were made to a salesman who introduced S&G Labs to physicians, counseling centers and other entities that referred patients to the lab. In so ruling, the Court emphasized the salesman had no contact with any individual whose own specimens were tested.  

As a refresher, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act) seeks to prohibit “patient brokering” practices by some recovery homes and treatment facilities. Section 1822 of the SUPPORT Act, signed into law and effective as of October 24, 2018, contains EKRA, now codified at 18 U.S.C. § 220. Although EKRA was created to address “patient brokering,” EKRA arguably prohibits a much broader scope of conduct by stating:

“whoever, with respect to services covered by a health benefit program… knowingly and willfully (1) solicits or receives any remuneration… directly or indirectly, overtly or covertly, in cash or in-kind, in return for referring a patient or patronage to… a laboratory, or (2) pays or offers any remuneration… directly or indirectly, overtly or covertly, in cash or in-kind (A) to induce a referral of an individual to a… laboratory or (B) in exchange for an individual using the services of that … laboratory, shall be fined not more than $200,000, imprisoned not more than 10 years, or both, for each occurrence”)

18 U.S.C. 220(a) (emphasis added).

EKRA also contains an exception to the prohibition set out above.  The exception states that “a payment made by an employer to an employee or independent contractor…if the employee’s payment is not determined by or does not vary by–(A) the number of individuals referred to a particular… laboratory; (B) the number of tests or procedures performed; or (C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular… laboratory.” 18 U.S.C. 220(b)(2).

EKRA on its face implicates any financial relationship between a clinical laboratory and an individual or legal entity that generates business for the lab. Although EKRA’s text is similar to the federal healthcare program anti-kickback statute, 42 U.S.C. 1320-7b(b) (the “AKS”), it is arguably much broader in scope for a number of reasons.  First, EKRA defines “laboratory” to include any CLIA-certified laboratory.  Second, the statute defines “health benefit program” to mean “any public or private plan or contract… under which any medical benefit, item, or service is provided to any individual.” Thus, EKRA applies to payments by any payor, such as commercial insurance and even self-pay, not just by government-funded plans.   

Relating to EKRA, the question before the Court in S&G Labs dealt directly with compensation paid by S&G Labs to an employee.  The compensation arrangement involved a compensation arrangement that included a base salary of $50,000.00 and a percentage of monthly net profits generated by the employee’s client accounts and by the client accounts handled by S&G employees whom the relevant employee managed.  The employee’s commission-based compensation resulted in him receiving more than $1.8 million in 2018 alone.

S&G Labs is a medical testing facility that performs urinalysis screening for legal substances, as well as for controlled substances for physicians, substance abuse treatment facilities and other types of entities.  The Court analyzed the definition of “laboratory” and “clinical laboratory” and concluded that S&G Labs was a laboratory for EKRA purposes.  

Next, the Court compared EKRA’s statutory language of “remuneration” and “individual” with the AKS’ statutory language for those terms.  The Court ruled, in light of the statutory construction of EKRA and the AKS, that the employee’s compensation from S&G constituted remuneration under EKRA.  

The Court also analyzed whether the remuneration paid to the employee was paid to “induce a referral of an individual to” S&G labs.  The Court opined that undoubtedly the employee’s “…commission-based compensation structure induced him to try to bring more business to S&G, either directly through the accounts he serviced himself, or through the accounts of the personnel under his management. However, the ‘client’ accounts they serviced were not individuals whose samples were tested at S&G. Their ‘clients’ were ‘the physicians, substance abuse counseling centers, or other organizations in need of having persons tested.’”  Thus, the Court concluded the compensation arrangement did not violate § 220(a) and the exception in § 220(b) was not applicable.  

Although the commission-based sales compensation arrangement in the employment agreement was upheld in this instance, this opinion is extremely narrow in its implications.  As a result, notwithstanding this opinion, EKRA remains a thorny problem for all laboratories and those who refer to them and requires much thought and consideration before using such commission-based compensation arrangements for clinical laboratories.  

Jim Hoover is a Partner at Burr & Forman LLP and practices exclusively in the firm’s Healthcare Practice Group. Jim may be reached at (205) 458-5111 or jhoover@burr.com.

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OIG Revises Self-Disclosure Protocol for First Time Since 2013

By: Catherine (Cat) Kirkland, Partner at Burr Forman, LLP

The Office of Inspector General (“OIG”) provides a way for physicians and other healthcare providers to voluntarily disclose evidence of potential fraud directly to the government through its Health Care Fraud Self-Disclosure Protocol (“SDP”). Self-disclosure through the SDP gives physicians and other providers with an opportunity to avoid or mitigate government investigations, civil/administration litigation, and hefty fines. 

On November 8, 2021, the OIG issued a revised SDP, with several notable updates from the OIG’s previous 2013 version:

  • Online SDP Submissions Only. The OIG requires all disclosures to be made online via the OIG’s website. Previously, disclosures could be mailed, faxed, or even emailed (with permission) to OIG contacts. While online submissions are now required, providers can still tailor their submission by uploading supporting documents (including, for example, a letter outlining the reason for the disclosure) through the OIG’s online portal.
  • Damage Estimates Required. The OIG requires disclosures to include an estimate of damages to each Federal health care program (broken out by program type) and/or a certification from the disclosing party stating that a damages estimate will be supplemented within ninety (90) days of disclosure.
  • Minimum Settlement Amounts Increased. The OIG revised the minimum settlements under the SDP.  Kickback-related submissions now require a minimum settlement of $100,000 (up from $50,000) and all other SDP matters require a minimum settlement of $20,000 (up from $10,000). These minimum settlement amounts apply even if the estimated damages are significantly less than the minimum amount.
  • SDP Inappropriate for Disclosures Related to HHS Grants or Contracts. The OIG also used this update to carve out disclosures related to HHS grants or contracts through a separate disclosure process.
  • OIG Coordination with the Department of Justice (“DOJ”). The OIG also clarified that it would coordinate, as needed, with the DOJ to resolve self-disclosures involving potential criminal conduct.

The SDP remains a valuable way for physicians or other providers to mitigate risk related to potential fraud. For self-disclosures made via the SDP, the OIG has “instituted a presumption against requiring integrity agreement obligations” and the OIG believes “that persons that use the SDP and cooperate with the OIG during the SDP process deserve to pay a lower multiplier on single damages than would normally be required[.]”[1]

A physician or other healthcare provider may utilize the SDP when the provider has reasonably assessed that a potential violation of Federal criminal, civil, or administrative laws has occurred. Examples of conduct that could be disclosed via the SDP include: employment of an individual who has been excluded from Medicare or Medicaid, billing for services provided by an unlicensed and/or non-credentialed individual, and/or arrangements resulting in a kickback or payment for a referral.

The OIG regularly publishes SDP settlements online with the provider’s name and a brief description of the settlement. Examples of recent settlements involving physicians and/or physician practices that self-disclosed to the OIG include:

  • In August 2021, a New York based primary care and urgent care group agreed to pay $50,000 after disclosing that its providers and their immediate family members received cost-sharing write-offs, gifts, and/or meals, potentially in violation of physician self-referral and anti-kickback laws.  
  • In May 2021, a family medicine group in Illinois agreed to pay $62,000 after disclosing that the group had submitted claims to Medicare for services provided by a nurse who was later discovered to be unlicensed. 
  • In March 2020, a multi-specialty group in Hawaii agreed to pay $240,000 after disclosing that the group had submitted claims for evaluation and management services provided by a physician that were not supported by the medical record.

Navigating whether self-disclosure to the OIG is appropriate and how to comply with the SDP rules can be challenging.  Please do not hesitate to contact us should you have any questions about the SDP or any of the underlying issues that could give cause to disclose. 

Catherine (Cat) Kirkland is a Partner at Burr & Forman LLP and practices with the firm’s Health Care Industry Group. Cat may be reached at ckirkland@burr.com or at 251-340-7271.


[1]      OIG’s Health Care Fraud Self-Disclosure Protocol, issued on April 17, 2013, and amended on November 8, 2021, is available at: https://oig.hhs.gov/documents/self-disclosure-info/1006/Self-Disclosure-Protocol-2021.pdf.

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Summary of SB 15 (new state law regarding parental consent for COVID vaccine)

Summary of SB 15 (new state law regarding parental consent for COVID vaccine)

NOTE: As introduced, SB15 would have added new lawsuit opportunities against pediatricians and pediatric practices into the vaccine passport law. The Medical Association worked successfully with the Alabama Chapter of the American Academy of Pediatrics and others to stop that. However, attempts to resolve the vaccine passport law’s broad language currently applying to all vaccinations – including childhood vaccinations – were unsuccessful. That issue will have to be resolved at some point in the future. Other than the new parental consent requirement detailed below for a minor to receive a COVID-19 vaccine, the vaccine passport law’s effect on pediatric practices remains unchanged.

During the recent Special Legislative Session, the State Legislature passed and the Governor signed into law Senate Bill 15 (“SB15”), which effectively requires written consent from a parent or legal guardian before administration of a COVID-19 vaccine to a minor. Prior to enactment of SB 15, Alabama’s general consent law for minors provided that:

“Any minor who is 14 years of age or older, or has graduated from high school, or is married, or having been married is divorced or is pregnant may give effective consent to any legally authorized medical, dental, health or mental health services for himself or herself, and the consent of no other person shall be necessary.” Ala. Code §22-8-4 (1975).

However, during the Special Session, the Legislature created an exception to §22-8-4 in the text of SB15 by using the phrase “Notwithstanding section 22-8-4, Code of Alabama 1975…” prior to the new requirement for written parental consent. Thus, any minor who meets the conditions of §22-8-4 and is allowed to seek medical treatment on his or her own may still do so, EXCEPT when seeking a COVID-19 vaccine, which will now require parental consent.

Physicians who are unfamiliar with §22-8-4 should note that while this statute allows a minor who meets one of the above-stated conditions to consent for medical treatment without the additional consent of a parent, it does not prohibit a parent or legal guardian of a minor who meets one of these conditions from being able to consent on behalf of the minor. Therefore, SB15 does not create a situation where physicians must obtain consent from one party for a COVID-19 vaccine and another party for all other treatment.

However, the Legislature did not address within the text of SB15 another less-used consent statute for minors:

“Any minor who is married, or having been married is divorced or has borne a child may give effective consent to any legally authorized medical, dental, health or mental health services for himself or his child or for herself or her child.” Ala. Code §22-8-5 (1975).

Section 22-8-5 duplicates some of the conditions from §22-8-4, but also provides a distinctly separate condition, allowing any minor who has “borne a child” to not only give effective consent to medical treatment for herself, but also for her child. While the number of minors who have a child old enough to safely receive a COVID-19 vaccine is likely low at this time, this could change if vaccines are approved for use in children under the age of 5. Nevertheless, written consent from a minor for a COVID-19 vaccine for her own child would be in compliance with SB15 as it is written. The situation left unresolved by SB15 is whether a minor who has borne a child can seek a COVID-19 vaccination without the written consent of her parent. Physicians should consider on a case by case basis the circumstances of a minor who meets this condition and is seeking a COVID-19 vaccine.

SB15 provides a penalty for non-compliance within the act, allowing the Attorney General to seek an injunction to stop “a threatened or continuing violation of this section.” Physicians should consider a standard written consent form for COVID-19 vaccinations for minors and should fully document the circumstances of any judgment calls presented by §22-8-5, to avoid an injunction from the State.

Read SB15 here.

By Brandy Boone, General Counsel
Medical Association of the State of Alabama

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ALAPAC Announces Second Round of Contributions of 2022 Election Cycle

The Alabama Medical PAC (ALAPAC), the official political committee of Alabama physicians and the Medical Association, has announced its second round of contributions for the 2022 election cycle.

In 2021, ALAPAC launched a new governance model comprised of Regional Boards which work in conjunction with the Board of Directors to vet candidates for local legislative and Congressional races as well as statewide races. This model grants local physicians across the state authority in determining how physician contributions to ALAPAC are dispersed. If you have interest in participating on an ALAPAC Regional Board, please contact us here.

Regarding candidates for the Alabama Senate and Alabama House, in October, ten of ALAPAC’s 11 Regional Boards met and considered contributions for candidates. In all, 33 candidates for legislative races were recommended to receive ALAPAC support from the respective Regional Boards of physicians in those areas. The ALAPAC Board of Directors then considered and concurred in each recommendation made by the Regional Boards.    

“Each of the candidates receiving ALAPAC support at this time are men and women the Medical Association has worked well with across a multitude of issues,” ALAPAC Chair David Herrick, M.D., said. “ALAPAC will continue to identify and support candidates for office medicine can work with to address the increasing number of challenges facing patients, physicians and our state.”

To see who ALAPAC contributed in the first round, click here.

Alabama Senate

Sen. Greg Albritton (R) – Range
Sen. Gerald Allen (R) – Tuscaloosa
Sen. Vivian Figures (D) – Mobile
Sen. Randy Price (R) – Opelika

Sen. David Sessions (R) – Grand Bay
Sen. Shay Shelnutt (R) – Trussville
Sen. Larry Stutts (R) – Tuscumbia

Alabama House of Representatives

Rep. Russell Bedsole (R) – Alabaster
Rep. Chris Blackshear (R) – Smiths Station
Rep. Napoleon Bracy (D) – Prichard
Rep. Chip Brown (R) – Mobile
Rep. Corley Ellis (R) – Columbiana
Rep. Jeremy Gray (D) – Phenix City
Rep. Laura Hall (D) – Huntsville
Rep. Corey Harbison (R) – God Hope
Rep. Wes Kitchens (R) – Arab
Rep. Kelvin Lawrence (D) – Hayneville
Rep. Joe Lovvorn (R) – Auburn
Rep. Parker Moore (R) – Decatur
Marcus Paramore (R) – Troy

Rep. Kenneth Pascal (R) – Pelham
Rep. Phillip Pettus (R) – Killen
Rep. Ben Robbins (R) – Sylacauga
Rep. Proncey Robertson (R) – Mount Hope
Rep. Ginny Shaver (R) – Leesburg
Rep. Randall Shedd (R) – Baileyton
Rep. Matt Simpson (R) – Daphne
Rep. Kyle South (R) – Fayette
Rep. Scott Stadthagen (R) – Hartselle
Rep. David Standridge (R) – Hayden
Rep. Shane Stringer (R) – Citronelle
Kerry Underwood (R) – Tuscumbia
Rep. Margie Wilcox (R) – Mobile

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Discussion with Decisionmakers: Rep. Ed Oliver

Discussions with Decisionmakers

Representative Oliver represents Alabama’s 81st District covering Chilton, Coosa, and Tallapoosa Counties. He is the Vice-Chair on the House Health Committee. After graduating from the University of Alabama, Representative Oliver attended the Command and General Staff College and served in the Army as a helicopter pilot and then an ambulance helicopter pilot. He is also an avid and knowledgeable hunter.

What first prompted you to consider running office?

I get to do work for rural Alabama and I understand rural health. It felt like a great opportunity and I took it.

How does your background help serve you on the Health Committee and also the Legislature?

Everybody is a product of their experiences. I enjoy speaking with physicians.

What are some of your legislative priorities this term?

I’m working on a 9-1-1 bill that establishes a standard for 911 operators.

 What are some health-related issues important to your district and your constituents?

Access to healthcare. Specifically, when it comes to ambulance care. People really value quick and efficient healthcare.

What do you think people understand the least about our health care system?

Medical workers are not trying to rip you off, they are simply trying to keep their doors open. Doctors are good people.

If you could change anything about our state’s health care system, what would it be?

I would like to see smaller and rural hospitals more financially well off and offer more service.

How can the Medical Association – and physicians statewide – help you address Alabama’s health challenges?

What you all do is the best thing.  All of our services are in populated areas.  I would like to see doctors and nurses get paid better in my district and in rural areas.  It is very hard to get a doctor to stay in a rural area.

What is the one thing you would like to say to physicians in your district?

I appreciate all that they do and I want them to stay in my district.

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