Archive for Legal Watch

New OIG Advisory Opinion Reinforces OIG’s Stance Against Turnkey Contractual Joint Ventures

New OIG Advisory Opinion Reinforces OIG’s Stance Against Turnkey Contractual Joint Ventures

By: Jessie Bekker, Burr & Forman LLP

The Office of Inspector General (“OIG”) has issued a new opinion with a familiar message cautioning providers against entering into suspect contractual joint ventures.

The OIG’s latest Advisory Opinion examined the Anti-Kickback Statute’s application to an arrangement related to the provision of intraoperative neuromonitoring (“IONM”) services (the “Proposed Arrangement”). As of the date of the Opinion, the requesting entity, an IONM provider, contracted with hospitals and surgery centers to provide the technical component of IONM services, which consisted of one of its neurophysiologists assisting during a surgery with the placement and operation of the IONM equipment. The IONM provider would arrange with a physician practice (“Practice”) to perform the personal component: remote monitoring by a neurologist of the IONM test results. The IONM provider billed its technical component services to the hospital or surgery center; the Practice billed the professional component to patients and their insurers. However, as competition grew fiercer, the IONM provider found itself at risk of falling behind its competitors who offered surgeons more lucrative opportunities, precipitating the Proposed Arrangement.

The Proposed Arrangement

Under the Proposed Arrangement, the IONM provider would assist a group of surgeons working for the hospitals and surgery centers with which the IONM provider contracted in creating a new IONM company (“NewCo”). The surgeon owners would own all of the interests in NewCo, which would contract with the existing IONM provider to provide all billing and collection services. NewCo would then contract with the Practice to provide the professional component of IONM services to NewCo’s clients. Under an agreement with the existing IONM provider, the IONM provider would supply NewCo with all of the day-to-day services, such that NewCo likely would not need to hire any of its own employees. NewCo – not the IONM provider – would contract with hospitals and surgery centers, receiving referrals for services from the surgeon owners, and would bill both the professional and technical components of the services. NewCo would compensate the IONM provider and Practice for their services through a fee, but the IONM provider anticipated NewCo’s profits would be substantial. In essence, NewCo would act as a competitor to the IONM provider with which it contracted, disrupting the IONM provider’s anticipated profits.


Generally speaking, the Anti-Kickback Statute (the “AKS”) prohibits the knowing and willful offering, payment or receipt of remuneration to induce, or in return for, the referral of an individual to a person for any item or service reimbursable by a federal health care program, like Medicare or Medicaid. The statute is intent-based and prosecutes a violation criminally. Violations constitute felonies punishable by fines and imprisonment.

OIG has long expressed its disfavor toward contractual joint ventures that exhibit certain factors pointing to their suspect nature. A contractual joint venture exists where a health care provider in one line of business (e.g., Practice) expands into a related line of business (e.g., IONM) by contracting with an existing provider of the related line of business (e.g., IONM provider) in order to provide the new related line of business to the health care provider’s patients without any substantial risk to the health care provider. The Proposed Arrangement, according to OIG, would “present a host of risks of fraud and abuse under the [AKS], including patient steering, unfair competition, inappropriate utilization, and increased costs to Federal healthcare programs.” OIG pointed to several risks raised by the Proposed Arrangement, specifically, that it could result in inappropriate steering of referrals from the surgeon owners to NewCo, the IONM provider, and the Practice of federal health care program business. Certain specific factors led OIG to its conclusion, including that the surgeon owners, as a result of contracting out its day-to-day operations to the IOMN provider, would have no real financial risk while reaping the benefits of the IOMN services provided. Additionally, both the Practice and IOMN provider are established entities that would effectively be forced to compete with themselves as a result of the Proposed Arrangement. Moreover, because the surgeon owners would have a vested interest in NewCo’s success, the OIG concluded that there would be a risk that the surgeon owners would only refer business to NewCo, the IOMN provider and the Practice in order to benefit from the billing opportunity for those services. Accordingly, OIG concluded that the Proposed Arrangement would risk violating the AKS.


The OIG Advisory Opinion highlights its longstanding concern with suspect contractual joint ventures and acts as a reminder to physicians venturing into new business lines of the risk factors that may implicate the AKS. The Advisory Opinion, just like all Advisory Opinions, is applicable only to its specific facts and should not be relied upon as definitive authority in determining the risk under the AKS of any other arrangement.

Posted in: Legal Watch, MVP

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Online Tracking Tools—Be Cautious.

Online Tracking Tools—Be Cautious.

By: Kelli C. Fleming, Esq., Burr & Forman LLP

The Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) recently teamed up to warn several healthcare providers about the privacy and security risks affiliated with online tracking technologies. According to the warning, these online tracking technologies may, under certain circumstances, be improperly disclosing protected health information (“PHI”) to third-parties or using such information for impermissible purposes.

Third-party tracking technologies, for example, Google Analytics, collect information about how users, oftentimes patients, interact with a provider’s website. Once collected, such information may be sent to the third-party who developed such technologies or used for marketing purposes without patient authorization. The unauthorized disclosure of this information to third-parties and the use of this information for marketing purposes could violate both HIPAA and the FTC Act. Providers who use a third-party website developer are unfortunately sometimes unaware that such technologies are even being used on their websites.

Indicating that online tracking is an area of priority, OCR issued guidance regarding online tracking technologies in December 2022. This guidance provides a general overview of how HIPAA applies to a provider’s use of online tracking technologies by addressing the following: (1) what is a tracking technology; (2) how does HIPAA apply to regulated entities’ use of tracking technologies; (3) tracking on user-authenticated webpages; (4) tracking on unauthenticated webpages; (5) tracking within mobile apps; and (6) HIPAA compliance obligations for regulated entities when using tracking technologies. This guidance is available at 

In addition to agency enforcement, lawsuits are starting to be filed for violations of privacy and confidentiality due to improper uses and disclosures stemming from online tracking technologies. Thus, providers utilizing online tracking tools or allowing website developers to use such tools should closely review the relevant guidance to ensure that any disclosures and uses are appropriate. 

Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s Health Care Practice Group. Kelli may be reached at (205) 458-5429 or

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Ethical and Legal Considerations for Caring for Patients Under the Influence of Medical Marijuana

Ethical and Legal Considerations for Caring for Patients Under the Influence of Medical Marijuana

By: Jessie Bekker, Burr & Forman, LLP

In 2021, Alabama became one of thirty-eight states to legalize the medicinal use of cannabis. Though Alabama has yet to license any providers to prescribe it, an interesting question is how the consumption of medical cannabis by a patient before an appointment could impact the ability to obtain informed consent for scheduled procedures and treatments. For example, is a person who takes some form of marijuana before a procedure considered impaired for the purposes of determining their ability to consent? Does the determination change if that person is under the influence of prescribed versus recreational marijuana (or any other substance, for that matter)?

Here are a few considerations to keep in mind when determining whether a patient who has consumed cannabis prior to showing up for his/her doctor’s appointment can be treated as scheduled—or should perhaps come back another day:

  1. Determine whether the patient can coherently and meaningfully participate in their care. Fundamentally, determining whether a patient can provide informed consent to treatment comes down to whether that person understands their condition, the benefits of the proposed care plan, and the risks of obtaining and foregoing treatment. If a patient presents for care under the influence of medical cannabis or some other prescribed drug, consider whether that patient can play an active role in their care. Consuming drugs may impact informed consent if consumption results in impaired cognitive function. Therefore, if a patient’s condition leads to a negative answer to the above questions, consider postponing care or obtaining consent from a surrogate.
  2. Consider whether a delay in care put’s the patient’s health at risk. Sometimes, patients present under the influence of drugs or alcohol, but their health requires urgent attention. If a delay in treatment has the potential to cause the patient’s condition to worsen, act on your best medical judgment. Per the American Medical Association, ask the patient’s surrogate, when available, to provide consent. Where neither the patient nor a surrogate can provide consent, initiate treatment and obtain consent from the patient or surrogate as soon as the opportunity arises. 
  3. Reschedule non-emergent appointments. If a patient is impaired after consuming medical cannabis and presents to a scheduled appointment for non-urgent treatment, consider rescheduling the appointment. Additionally, consider speaking with the patient’s prescriber to determine at which amount the patient can safely consume medical cannabis without reaching impairment, and reschedule the appointment for a date when the patient, his/her prescriber, and the treating physician all agree that the patient can receive appropriate care.

Treating a person who is impaired presents issues regarding informed consent. Still, not all consumption of drugs, like medical cannabis, will implicate the patient’s ability to meaningfully participate in their care. As Alabama’s medical cannabis industry takes shape, these questions may arise more frequently. When making delicate determinations about a person’s ability to consent to care, work with that patient and their surrogate and/or other providers, where appropriate, to best meet the patient’s needs.

Jessie Bekker is an Associate at Burr & Forman LLP and practices exclusively in the firm’s Healthcare Practice Group. Jessie may be reached at (205) 458-5275 or

Posted in: Legal Watch, Medical Cannabis

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The 11th Circuit Applies SCOTUS Ruling In Recent Alabama Physician Controlled Substances Conviction

The 11th Circuit Applies SCOTUS Ruling In Recent Alabama Physician Controlled Substances Conviction

By: Jim Hoover with Burr & Forman, LLP

On June 27, 2022, the Supreme Court of the United States (SCOTUS) heard an appeal emanating from a conviction of a local doctor in Mobile, Alabama for violating the Controlled Substances Act (CSA).  The justices specifically examined the convictions of Dr. Xiulu Ruan who is serving a prison sentence of more than 20 years. The Government charged Dr. Ruan with unlawfully dispensing and distributing drugs in violation of the CSA.  Dr. Ruan argued that the drugs were dispensed pursuant to a valid prescription, and were for a legitimate medical purpose by him acting in the usual course of his professional practice.  Dr. Ruan further argued that he did not knowingly or intentionally deviate from this standard.

The SCOTUS opinion heavily scrutinized 21 U.S.C. § 841(a), which makes it a federal crime for any person except as authorized to knowingly or intentionally manufacture, distribute or dispense a controlled substance.  As provided by the regulation, a prescription is only authorized when a doctor issues the prescription “for a legitimate medical purpose…acting in the usual course of his/her professional practice.”  The Department of Justice (“DOJ”) argued “knowingly or intentionally” merely refers to the knowing or intentional distribution of a controlled substance.  The SCOTUS held that once a defendant-doctor meets the burden of producing evidence that his or her conduct was “authorized,” the DOJ “must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner” in order to secure a conviction for improper prescribing.  

The SCOTUS ruled that prosecutors relying on the CSA for excessive prescribing of opioids and other addictive drugs must prove that the doctors knew the prescriptions lacked a legitimate medical purpose.  The SCOTUS vacated the Eleventh Circuit court of appeals opinions and directed it to consider whether the jury instructions given at the conclusion of the trial were consistent with this SCOTUS opinion.  

In an opinion published on January 5, 2023, an Eleventh Circuit panel held that the jury instructions used to convict Dr. Ruan for violating the CSA was inconsistent with the SCOTUS opinion. The Eleventh Circuit panel recognized that in order to obtain a conviction under 21 U.S.C. § 841(a), the government must prove beyond a reasonable doubt that a defendant (1) knowingly or intentionally dispensed a controlled substance, and (2) knowingly or intentionally did so in an unauthorized manner.  “What matters is defendant’s subjective mens rea.”  The Eleventh Circuit panel went on to say that “[W]ithout further qualification, the phrase ‘good faith’ encompasses both subjective and objective good faith. In the context of § 841 though, as the Supreme Court has explicitly held, only the subjective version is appropriate.  The instruction given by the district court did not contain any qualification to make this clear to the jury.”  

The Eleventh Circuit could not conclude that the district court’s error was harmless.  Accordingly, it vacated the defendant-doctor’s substantive drug conviction under 21 U.S.C. § 841(a).  However, the Eleventh Circuit held that the district court’s instructions were proper or any error in the instructions were harmless error as they related to the convictions for (1) conspiracy to violate the CSA, (2) conspiracy to commit health care fraud in violation of 18 U.S.C. §§ 1347 band 1349, (3) violation of the Anti-Kickback Statute, (4) conspiracy to commit mail or wire fraud, (5) conspiracy to violate RICO, and (6) substantive money laundering and conspiracy to commit money laundering.    Thus, the Eleventh Circuit vacated in part and affirmed in part the district court’s ruling and remanded the case to the district court for further proceedings consistent with the Eleventh Circuit’s opinion.

Jim Hoover is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare group. Jim may be reached at (205) 458-5111 or

Posted in: Legal Watch, Opioid

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Is it the End of Non-Compete Agreements for Alabama Healthcare Companies? The Federal Trade Commission Proposes a Ban

Is it the End of Non-Compete Agreements for Alabama Healthcare Companies? The Federal Trade Commission Proposes a Ban

By: Howard Bogard and Matthew Scully, Burr & Forman

Under Alabama statutory law, “professionals” are exempt from non-compete agreements, which serve to restrict competing activity within a defined geographic area and time period.  The law does not define the term “professional” but, with respect to the healthcare industry, Alabama courts have found that professionals include physicians and physical therapists.  Based on case law, other healthcare professionals who practice independently, have direct patient contact, and are separately licensed might also be found to fall under the professional exemption. 

However, on January 5, 2023, the Federal Trade Commission (“FTC”) announced a Notice of Proposed Rulemaking that would prohibit and rescind all non-compete provisions in employment contracts. The public has 60 days to offer comment on the proposed rule, and a final rule will be published thereafter.

Background on the FTC Act

Section 5 of the FTC Act declares, “Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared unlawful.”  On November 10, 2022, the FTC Commission issued a Policy Statement concerning its interpretation of Section 5, stating that part of its role is to identify unfair methods of competition, which the Commission defined as conduct undertaken by an actor in the marketplace that (1) is coercive, exploitative, collusive, abusive, deceptive, predatory, or overly restrictive, and (2) negatively affects competitive conditions (e.g., reduces output, limits choice, lowers quality, reduces innovation, impairs market participants, or reduces potential competition).

Building off the Policy Statement — as well as President Biden’s July 2021 Executive Order calling for the FTC to limit non-compete agreements — the FTC announced on January 5, 2023 a Notice of Proposed Rulemaking labeling non-compete agreements as unfair methods of competition. The FTC found that non-compete agreements reduce workers’ wages, stifle new businesses and new ideas and hinder workers’ economic liberty.  Indeed, the proposed rule specifically relied upon a study that showed non-compete clauses increase consumer prices and concentration in the healthcare sector.

The proposed rule defines non-compete agreements as “a contractual term between an employer and a worker that prevents the worker from seeking or accepting employment with a person, or operating a business, after the conclusion of the worker’s employment with the employer.” The proposed rule would:

  • Prohibit an employer from entering into or attempting to enter into a non-compete agreement with a worker;
  • Require employers to rescind existing non-compete agreements with workers;
  • Prohibit any contractual provision that would require a worker to repay training costs upon separation within a specific time period if the required payment is not reasonably related to the actual costs incurred by the employer; and
  • Put at risk other agreements (e.g., protection of confidential information) if the agreement could prevent a worker from seeking or accepting employment with a person or operating a business after the conclusion of the worker’s employment with the employer.

Moreover, the proposed rule would define “worker” broadly as any natural person who works, whether paid or unpaid, for an employer, which would include an employee, independent contractor, extern, intern, volunteer, apprentice or sole proprietor who provides a service to a client or customer. The only exception to the FTC’s proposed ban is a limited exclusion for non-compete agreements between the seller and buyer of a business.

Impact on Alabama Healthcare Companies 

Given that the proposed rule reverses over a hundred years of legal precedent enforcing non-compete agreements, it is likely that any final rule will be subject to years of litigation, with the U.S. Supreme Court likely ruling on the FTC’s authority to issue the non-compete ban. If the FTC’s rule is upheld, it would arguably have a marginal impact on Alabama healthcare providers currently protected by the Alabama professional exemption (although it would serve to solidify such exemption). An FTC ban on all non-compete agreements in an employment setting would, however, prevent healthcare companies from using such agreements with employed “non-professionals.”  For example, many dermatology and pathology practices, clinical laboratories, diagnostic imaging centers, and durable medical equipment providers, to name a few, commonly use non-compete agreements with marketing and sales staff and certain employees who are not likely covered by the Alabama professional exemption, such as aestheticians, laboratory technicians, and senior management.  If the FTC’s proposed rule is finalized and upheld by the courts, healthcare companies would be prohibited from using non-compete agreements in any form with employees (both professionals and non-professionals). The question then becomes what tools other than non-compete agreements (such as trade secret laws and confidentiality and non-solicitation agreements) might employers use to protect valuable investments in employees, and how sufficient are these alternatives?

Howard Bogard is a partner with Burr & Forman LLP and is the Chair of the firm’s Health Care Industry Group. Howard may be reached at (205) 458-5416 or Matthew Scully is a partner with Burr & Forman LLP and exclusively practices labor and employment law. Matthew can be reached at (205) 458-5321 or

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Federal Trade Commission Proposes Rules Banning Non-compete Agreements

Federal Trade Commission Proposes Rules Banning Non-compete Agreements

By: Brandy Boone, General Counsel

On January 5, 2022, a year and a half after President Biden signed an executive order encouraging the Federal Trade Commission (“FTC”) to limit or ban non-compete agreements, the FTC announced a proposed rulemaking that will prohibit employers from using non-compete agreements that restrict where an employee, or independent contractor, can work after leaving employment. 

The Rule will not only ban the use of non-compete agreements in future employment or contractor relationships, but it will also require employers with current non-compete agreements to notify employees or contractors that the non-compete agreements are rescinded and no longer in effect.  The FTC cites the unfairness of non-compete agreements as a method of competition as the primary reason for the rule, but also estimates the proposed rule could increase worker earnings by almost $300 billion per year, save up to $148 billion on annual health costs, and increase the number of companies within the same industry. 

Specifically within the healthcare industry, this change will likely lead to more competition between hospitals and ambulatory surgical centers for physician employees and contractors. The FTC’s proposed rule seeks public comment, particularly in three areas, (1) whether franchisees should be covered under the rule; (2) whether senior executives should be covered under the rule; and (3) whether the rule should affect low and high wage workers differently.  The public comment period will last 60 days from the date that the proposed rule is published in the Federal Register, and although the notice of rulemaking was announced on January 5th, it has not yet been published in the Federal Register. 

You can read the rule here and a fact sheet summarizing the rule here.

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by Lindsey Phillips with Burr & Forman, LLP

On November 28, 2022 the Office for Civil Rights (“OCR”) at the United States Department of Health and Human Services (“HHS”) announced proposed changes to the regulations at 42 CFR Part 2 (“Part 2”). Part 2 protects the confidentiality of medical records related to treatment for substance abuse disorders and was first promulgated in 1987 to address concerns that relaxed access to these types of records would promote fear of discrimination and deter individuals from seeking help and treatment for substance abuse disorders. While the rationale supporting Part 2 is good in theory, it has presented practical challenges for patients and healthcare providers alike because its protections and provisions often conflict those afforded by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and other medical record privacy laws.

The proposed changes, which are set out in the Notice of Proposed Rulemaking (“NPRM”), are part of a broader initiative to promote value-based care, enable better coordination among healthcare providers, facilitate patient autonomy and engagement, and protect the privacy of patients’ medical records. Upon announcement of the NPRM, Secretary Xavier Becerra noted that “varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges.” He went on to say that the changes proposed in the NPRM would “improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.” OCR’s Director expressed similar sentiments and further noted that the HHS “understands how critical it is for patients to better align the Part 2 rules and program with HIPAA” and that the changes would decrease the burdens on both patients and providers “while protecting confidentiality of treatment records.”

This article briefly identifies some of the proposed changes contained in the NPRM. The proposed changes are loosely separated into two categories. The first category outlines the proposed changes that appear to relax the current provisions found in Part 2; the second category outlines the proposed changes that purport to create protections and enforcement mechanisms for violations of Part 2.

Proposed Changes Relaxing Current Requirements Found in Part 2

  • Permitting Part 2 programs to use and disclose Part 2 records based on a single prior consent signed by the patient for all future uses and disclosures for treatment, payment, and health care operations;
  • Permitting the redisclosure of Part 2 records as permitted by the HIPAA Privacy Rule by recipients that are Part 2 programs, covered entities under HIPAA, and business associates under HIPAA; and
  • Modifying the Part 2 confidentiality notice requirements to mirror those found in HIPAA.

Proposed Changes Creating Patient Protections and Enforcement Procedures

  • Creating two patient rights that parallel those afforded to patients under HIPAA:
    • The right to an accounting of disclosures, and
  • The right to request restrictions on disclosures for treatment, payment, and health care operations;
  • Requiring disclosures to the Secretary for enforcement;
  • Applying HIPAA penalties to Part 2 violations;
  • Requiring Part 2 programs to establish a process for receipt of complaints of Part 2 violations; and
  • Prohibiting Part 2 programs from requiring patients to waive the right to file a complaint as a condition of eligibility and providing treatment

While HHS has stated that the proposed modifications will not only increase coordination among providers but also afford more protections for patients, the proposed changes do present some concerns and tensions among stakeholders. Accordingly, all stakeholders are encouraged to participate in the public comment and feedback process. Stakeholders have 60 days after the publication of the NPRM in the Federal Register to provide commentary. The NPRM was published in the Federal Register on December 2, 2022, so stakeholders have until January 31, 2023 to provide comments. 

Lindsey Phillips is an associate at Burr & Forman LLP practicing exclusively in the firm’s Healthcare Industry Group. Lindsey may be reached by telephone at (205) 458-5370 or by e-mail at

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by Lindsey Phillips with Burr & Forman, LLP

The No Surprises Act (the “Act”), which became effective on January 1, 2022, was enacted in an effort to provide uniform protections against surprise medical bills. Surprise medical bills often arise when patients unknowingly receive medical care from out-of-network healthcare providers and are billed for the difference between the amount a patient’s health plan would pay for in-network providers and the full amount charged for the medical services received by the patient.

The Act generally prohibits surprise billing in three main categories: 1) when emergency services are provided by out-of-network providers or emergency facilities; 2) when non-emergency services are provided by out-of-network providers at in-network health care facility visits; and 3) when air ambulance services are provided. In these three instances, providers generally are prohibited from billing a patient for an amount that exceeds the in-network limit on cost-sharing.

So, in light of the prohibition on surprise billing, how can out-of-network healthcare providers recover payment for their services? The Act establishes a mandatory Independent Dispute Resolution (IDR) program, that was revised in August 2022, by which out-of-network providers can attempt to receive payment from health plans and insurers for the services they have provided.

The first step is for the provider and health plan or insurer to negotiate a reasonable payment amount. When there is disagreement about the amount owed by the plan or insurer to the provider, either party can initiate an open negotiation period by issuing a notice to the other party within 30 days after the provider’s receipt of the insurer or plan’s initial payment or denial notice. The notice must contain certain information, which includes, but is not limited to, information regarding the services provided and a proposed out-of-network rate for the services and items provided.  Once this notice is sent, the parties have 30 days to reach an agreement on the payment amount owed to the provider. If the parties reach an agreement regarding the payment amount, then the plan or insurer must remit the agreed-upon payment to the provider within 30 days of the agreement.

If the parties are unable to reach an agreement on their own, then either party can initiate the Act’s IDR program by providing notice to the other party and the Department of Health and Human Services (or the Department of Labor or Department of Treasury)[1]. The applicable Department will then provide a list of certified IDR entities. The parties will then have three business days to jointly select a certified IDR entity. If the parties are unable to agree on an IDR entity, then the applicable Department will randomly select an IDR entity.

After an IDR entity is selected, each party must submit a proposed payment amount along with supporting documentation for its proposal. The IDR entity will then select the offer that it determines best represents the value of the services provided. In making this determination, the IDR entity should consider the information submitted by the parties, the Qualifying Payment Amount for the applicable year for similar services, and other factors including, but not limited to, the provider’s experience, quality of outcome measurements, and the complexity of the services provided. The IDR entity should also weigh the credibility of the information received. Once the IDR entity reaches a determination, it must issue a written decision that fully explains the basis for its decision, including the information it relied on in determining which amount best represented the value of the services provided. Once the IDR entity renders its decision, the parties are required to comply with the IDR entity’s decision within 30 days.   

Lindsey Phillips is an associate at Burr & Forman LLP practicing exclusively in the firm’s Healthcare Industry Group. Lindsey may be reached at (205) 458-5370 or

[1] Oversight of the No Surprises Act’s provisions is conducted by either the Department of Health and Human Services, Department of Labor, or Department of Treasury depending on the nature of the plan, policy, and provider.

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Federal Cures Act “Information Blocking” Compliance Date Approaching

Federal Cures Act “Information Blocking” Compliance Date Approaching

The 21st Century Cures Act (Cures Act), passed by Congress in 2016, included a provision in Title IV, Section 4004 against “information blocking,” defined in the Act as a practice or practices, “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”  The Act further required the Office of National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) to promulgate rules (the rules) for enforcement on information blocking.  

The rules, which have been in effect since April 2021, apply the information blocking provisions of the Cures Act to “actors,” defined to include health care providers like physicians and hospitals, as well as health information exchanges and health information technology (HIT) developers or vendors.  They currently require physicians to make the following electronic health information, otherwise known as the United States Core Data for Operability, version 1 (USCDIv1) accessible to patients in the electronic health record with no delay:  Consultation notes, discharge summary notes, history and physical, imaging narratives, laboratory report narratives, pathology report narratives, procedure notes, and progress notes.  

On October 6, 2022, physicians and other actors will be required to provide patient access to all electronically maintained health records, with the exception of psychotherapy notes and information compiled in anticipation of litigation, to avoid charges of information blocking.  The rules further provide that by December 31, 2022, electronic health record systems must have updated technology to allow easier patient access to electronic health information.

Because HIT vendors are also considered actors and must comply with information blocking rules, physicians who are not yet in compliance or preparing for upcoming compliance dates should work with their HIT vendors to develop a compliance plan for this section of the Cures Act. They should also become familiar with exceptions provided in the rules where delays or denials of access are not considered information blocking.  Finally, physicians should be on the alert for notice from ONC and HHS on the penalties for health care providers for information blocking.  Potential penalties for HIT vendors and health information exchanges found to be participating in information blocking have already been determined by rule to include fines up to $1 million per violation. To date the potential penalties for health care providers found to be information blocking are “disincentives” to be determined by HHS using a formula and criteria not yet developed.

Resources for Physicians on Information Blocking:

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Prepare Your Practice for Expanded Information Blocking Requirements

Prepare Your Practice for Expanded Information Blocking Requirements

By: Catherine (Cat) Kirkland, Burr & Forman LLP

Is your practice ready? Starting October 6, 2022, physicians and group practices will be required to make full electronic health information available for access, exchange, and use to patients (among others) in a reasonable manner. This deadline marks the end of a multi-year phase-in from the U.S. Department of Health and Human Services (HHS) of “information blocking” rules set forth in the 21st Century Cures Act Interoperability and Information Blocking Regulations.

The Cures Act defines information blocking as “a practice by an actor that is likely to interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or specified in an information blocking exception.” Physicians, hospitals, and group practices, among many other provider types, are all specifically defined as “actors” under the Act and are therefore subject to the regulations. The Act defines EHI as information contained within a designated record set, which for a physician or group practice would include medical records, billing records, and other documents used by the physician or practice in conjunction with patient care (ex: scans received, emergency department records, etc.).

Examples of prohibited information blocking might include:

  • Implementing a blanket (and not individualized) approach of withholding laboratory or other test results from a patient portal until a physician can evaluate the results;
  • Charging a fee for physical copies of a patient’s EHI, when the fee does not meet HHS’ fee exception criteria; or
  • Purposefully limiting what EHI is shared in a patient portal if the portal technology would allow for full EHI access.

A practice is not considered information blocking if it meets one of eight exceptions. Five of these exceptions relate to why a provider might not fulfill a request for access, exchange, or use of EHI, including: 1) prevention of harm (a very limited exception requiring a patient-by-patient analysis); 2) privacy protection (ex: if state or federal law require a patient consent to set-up a portal and the patient has not consented); 3) safeguarding security of the EHI; 4) infeasibility (ex: hurricanes or uncontrollable events); and 5) if the provider’s IT is temporarily unavailable. Each of these exceptions contain key conditions that must all be demonstrated by the provider before the exception can be claimed.

The Cures Act authorizes the HHS Office of Inspector General to investigate any claim of information blocking and in 2021, HHS established an online portal for complaints. Any complaint submitted through HHS’s portal could result in an OIG investigation and potentially penalties or disincentives.

The overall industry response to the expanded rules has been one of concern and confusion with a major push for HHS to release more guidance before the October 6 deadline. However, waiting on additional HHS guidance is not a defense to the information blocking rules. Physicians and group practices should be proactive in their compliance by reviewing the rules and exceptions carefully. Physicians should ensure that all policies, procedures, and/or compliance programs comply with the rules, address rule exceptions, and require documentation of when an exception is used and why.

Catherine (Cat) Kirkland is a partner at Burr & Forman LLP and practices exclusively in the firm’s Health Care Practice Group. Cat may be reached at (251) 340-7271 or by email at

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