On December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain electronic health transactions.  Specifically, the proposed rule would adopt standards for health care attachment transactions (e.g., medical charts, x-rays, provider notes) and electronic signatures to be used in conjunction with health care attachments, and modify the standard for referral certification and authorization transaction.  The proposed rule would apply to entities regulated by the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”), and would implement certain requirements of the Administrative Simplification subtitle of HIPAA and the Patient Protection and Affordable Care Act (“ACA”) that require the Secretary of HHS to adopt and update standards for electronic health transactions, code sets, unique identifiers, as well as the electronic exchange for health information.

Continue Reading HHS Proposes Rule to Improve Standards for Electronic Prior Authorizations and Other Transactions with Health Care Attachments

On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool­—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to their products.

The tool is designed for mobile apps that access, collect, share, use, or maintain information related to a consumer’s health through features such as fitness tracking, medical record sharing, sleep monitoring, disease diagnostics, and more.

The tool guides developers through fifteen questions, including:

  • Does/will your app collect, share, use, or maintain health information?
  • Is your app for use by consumers?
  • Does your app include a device software function that is the focus of FDA’s oversight?

Based on the answer to each question, the tool directs the user to other relevant questions and highlights at each step the laws and regulations that may apply to the mobile app.  The tool covers, among other laws and regulations, the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”), the Food, Drug, and Cosmetic Act (“FD&C Act”), the FTC Act, and the 21st Century Cures Act.

The tool was first released in 2016 and included ten questions to help developers determine whether their apps would be subject to HIPAA, the FD&C Act, the FTC Act, and/or the FTC’s Health Breach Notification Rule.  The latest update to the tool adds new questions to help mobile developers understand legal requirements for their apps under the Children’s Online Privacy Protection Rule (“COPPA Rule”) and the 21st Century Cures Act but does not refine the analysis for the laws covered in the original version.  The tool is not intended to offer legal advice and is provided for informational purposes only.

On December 2, 2022, the U.S. Department of Health and Human Services (“HHS”), through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under 42 C.F.R. Part 2 (“Part 2”) with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”).  

Section 3221 of the CARES Act amended several provisions of the statute underlying the Part 2 regulations to better align Part 2 with HIPAA.  For example, as amended, the statute permits an individual’s substance use disorder records regulated by Part 2 (“SUD Records”) to be used and disclosed in accordance with a single prior consent and allows HIPAA covered entities and their business associates to disclose SUD Records for treatment, payment, and health care operations in accordance with HIPAA when an individual has provided consent to the disclosure of his/her SUD Records.  Prior to the changes made by the CARES Act, the disclosure of SUD Records required a specific, written consent for each proposed disclosure, and it was permissible to disclose SUD Records without consent only in limited circumstances (e.g., medical emergency or court order).  As a result, entities subject to both HIPAA and Part 2 were required to follow different, more restrictive procedures for the disclosure of SUD Records than for the disclosure of other protected health information (“PHI”). 

The CARES Act required HHS to engage in rulemaking to implement various statutory changes.  Specifically, the proposed rule would modify Part 2 in accordance with the CARES Act by:

  • Generally allowing for the redisclosure of SUD Records in the same manner permitted by the HIPAA Privacy Rule (i.e., allowing for a single consent to suffice for Part 2 covered entities as it relates to further disclosures of SUD Records for treatment, payment, and health care operations), though the proposed rule requires any disclosures of SUD Records to non-HIPAA covered entities or business associates be pursuant to contractual or legally equivalent restrictions on the recipient’s use and disclosure of SUD Records in accordance with those permissible under Part 2;
  • Giving individuals a right to an accounting of and restriction on disclosures of SUD Records, in accordance with the rights individuals have under HIPAA with respect to their PHI;
  • Expanding the prohibition on the use and disclosures of SUD Records in civil, criminal, administrative, and legislative proceedings against patients unless patient consent or a court order is issued;
  • Applying the same civil and criminal penalties to violations of Part 2 as apply to violations of HIPAA (e.g., the imposition of civil monetary penalties);
  • Applying the same breach notification standards to breaches of SUD Records as apply to breaches of PHI in accordance with the HIPAA Breach Notification Rule;
  • Modifying the requirements for a Part 2 patient confidentiality notice to more closely align with the requirements and content of a HIPAA Notice of Privacy Practices (“NPP”); and
  • Aligning the requirements for a valid written consent under Part 2 with the requirements for a valid HIPAA authorization under the Privacy Rule.

The proposed rule would also modify the HIPAA Privacy Rule to require covered entities that receive and maintain SUD Records—and thus must comply with Part 2 requirements for these records—to modify their NPPs to reference patients’ rights with respect to SUD Rrecords.  For example, impacted covered entities would be required to disclose the uses and disclosures of SUD Records that are permitted or required without an authorization.

The CARES Act also contained certain antidiscrimination provisions related to SUD Records that HHS intends to implement as part of a separate rulemaking process.

Comments on the proposed rule are due by January 31, 2023.

On September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services. 

Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme – Roadmap.”  It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021.  The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.

Aim:

The MHRA’s primary aim is “to protect patients and public whilst ensuring that we accelerate responsible innovation.”  To achieve this, MHRA places emphasis on (A) safety; (B) clarity and streamlined processes (facilitated through guidance and designated standards); and (C) removing friction through a joined up offering for digital health in the UK and strengthening international convergence.

Approach:

At its core, the MHRA’s approach to developing the Roadmap is “patient centred” (noting that AIaMD raises broad questions for society) and highlights need for innovation in this sector to be inclusive across all populations.  The MHRA also wants to support manufacturers and so wants to provide tools to demonstrate conformity (working with BSI to develop standards and tools) and wants to reduce regulatory burdens on industry by driving international consensus.  To achieve this the MHRA intends to update the legislative regulatory framework for SaMD/AIaMD.  However, the majority of changes will be introduced through guidance.  The MHRA highlights that this approach is supported across the government and it has considered related areas of law when developing this framework for medical devices.

Work Packages:

The MHRA sets out a number of work packages (some as standalone packages and others nested within others).  Each package includes (i) a problem statement; (ii) the objectives that breakdown the problem; and (iii) specific deliverables that the MHRA will use to meet the objectives.  We have not covered them in detail but, in summary, these work packages cover:

  • WP 1 Qualification – the MHRA will address the lack of clarity on what qualifies as SaMD and software in a medical device, help manufacturers craft an intended purpose and clarify the concept of “manufacturer” for SaMD.
  • WP 2 Classification – reclassify software so the classification rules are proportionate to the risk.  The MHRA will reform the classification rules, explore the “airlock process” and provide guidance.
  • WP 3 Premarket Requirements – premarket requirements for software will be clarified so the requirements fit software.  The MHRA list six deliverables including reviewing the essential requirements, providing “Best practice” for development and deployment plus providing guidance on a number of topics (retrospective non-interventional studies, joint guidance with the Health Research Authority on governance of research and the importance of human-centered SaMD).
  • WP 4 Post Market – the MHRA highlights that it needs to obtain stronger safety signals for SaMD.  The MHRA will look at adverse incidents for SaMD, change management plus predetermined change control plans/protocols and best practice for expanding the intended purpose of medical devices.
  • WP 5 Cyber Secure Medical Devices – the current regulations do not consider cyber security vulnerabilities.  The MHRA will consider cyber security requirements, management of unsupported software devices (i.e., when manufacturers exit the market) and reporting of vulnerabilities.
  • WP 9 AI RIGOUR – the MHRA notes the lack of clarity on how devices using AI can best meet medical device requirements.  The MHRA intends to develop good machine learning guidance to supplement the good machine learning guiding principles published last year (see our previous blog post here).  Alongside BSI, it will map out and develop standards.  It will also develop best practice guidance and consider experimental work to detect, measure and correct for bias.
  • WP 10 Project Glass Box (Interpretability) – current regulatory requirements do not consider adequately interpretability of AIaMD and the impact this has on safety and efficacy.  The MHRA will develop best practice guidance on “human-centered SaMD” and will produce standards on the development of trustworthy AI.
  • WP 11 – Project Ship of Theseus (Adaptivity) – current systems on the notification and management of change do not fit AIaMD.  The MHRA will thus create guiding principles on adaptivity and change management, explore the concept of “drift” and significant/substantial change and set out proposals for predetermined change control plans for SaMD and AIaMD.

The MHRA intends to publish deliverables in a step-wise manner.  Industry should expect to see the first sub-set of deliverables by the end of this year. 

Comment:

The UK indicated a potential benefit of leaving the EU was that it could develop a world-leading regulatory framework.  However, there has been little in the Government’s response to the Consultation on the future regulation of medical devices in the UK that would make the UK “world-leading.”  Arguably, at best many of the suggested changes merely align the UK with other jurisdictions and at worst add additional regulatory hurdles.  However, the MHRA’s latest announcements suggests that for the SaMD and AIaMD space the UK Government is committed to being world-leading and supporting innovation in a patient centered way.  The MHRA is driving forward the development of practical guidance and standards, the lack of which is often bemoaned by those working in this sector.  However, the MHRA seems alive to the issue of creating frameworks/requirements that add burdens and so is emphasizing its aim to align not only with other areas in the UK (including NICE, CQC and HRA) but also internationally.  This could be an area in which the UK is able to take a leading role in creating a regulatory system to protect patients and promote innovation.

Digital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with administrative tasks and workflow to diagnostic and decision support.  The use of artificial intelligence (“AI”) and machine learning algorithms in health care holds great promise, with the ability to help streamline care and improve patient outcomes.  At the same time, algorithms can introduce bias if they are developed and trained using data from historical datasets that harbor existing prejudices.  Both state and federal governments have taken steps to address the potential for racial and ethnic disparities in use of algorithms by healthcare facilities, demonstrating that this continues to be a top priority as new technologies are deployed in health care.

California Attorney General Rob Bonta recently sent letters to 30 hospital CEOs across the state requesting information about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in software they use to help make decisions about patient care or hospital administration.  The press release stressed the importance of identifying and combatting racial health disparities in healthcare algorithms, and the AG’s letter seeks information such as a list of all decision-making tools or algorithms the hospitals use for clinical decision support, health management, operational optimization, or payment management; the purposes for which these tools are currently used and how they inform decisions; and the names of the persons responsible for ensuring they do not have a disparate impact based on race.  Responses are due to the AG by October 15. 

The federal government also has made disparities in health care a top priority.  For example, the Department of Health and Human Services (HHS) recently issued a proposed rule regarding nondiscrimination in health programs and activities.  Amongst other proposals aimed at combatting discrimination, HHS proposed provisions related to nondiscrimination in the use of clinical algorithms in healthcare decision-making and in telehealth services.  Proposed § 92.210 states that “a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through the use of clinical algorithms in its decision-making.”  The proposed rule notes that a covered entity would not be liable for clinical algorithms they did not develop, but HHS proposes to impose liability for any decisions made in reliance on clinical algorithms if they rest upon or result in discrimination.  The proposed rule noted that the Department “believes it is critical to address this issue explicitly in this rulemaking given recent research demonstrating the prevalence of clinical algorithms that may result in discrimination.”  Comments are due to HHS by October 3.  HHS specifically seeks input on whether the provision should include additional forms of automated decision-making tools beyond clinical algorithms; whether the provision should include potential actions covered entities should take to mitigate discriminatory outcomes; and recommendations on how to identify and mitigate discrimination resulting from the usage of clinical algorithms.

These state and federal actions, as well as the associated responses, could inform ongoing dialogue about how to advance the use of digital health technologies while in parallel making progress to address inequities in health care.

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).  In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs.  As such, the MDCG has suggested actions for mitigating such challenges.  Importantly, there is a focus on flexibility and pragmatism.

Background

The introduction of the Regulations has meant that many new and existing medical devices and IVDs will need to undergo a conformity assessment by a notified body in the next few years in order to continue to be placed on the market in the EU. Additionally, the Regulations require the re-designation of notified bodies to allow them to conduct conformity assessments under the Regulations. The time-consuming process of such re-designation has led to there being an insufficient number of notified bodies available to conduct conformity assessments under the Regulations.

Thus, a lack of notified body capacity and a large number of devices requiring conformity assessment means there is a risk devices will not be CE marked prior to expiry of applicable transitional provisions, which could result in a disruption to the supply of devices and a significant knock-on impact for patients. 

The MDCG’s latest publication both recognizes and attempts to assuage these concerns by proposing counter-actions aimed to “enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices”.

This blog post seeks to summarize the MDCG’s recommendations.

Increase notified body capacity

The MDCG makes eleven (11) recommendations that aim to increase notified body capacity.

It advises that notified bodies:

  • use hybrid audits;
  • avoid unnecessary duplication of work (e.g., by leveraging evidence and previous assessment results generated under the prior directives);
  • rationale and streamline internal administrative processes; and
  • be flexible when carrying out “appropriate surveillance” of legacy devices (e.g., by combining audits under the prior directives and the Regulations).

Relevant parties are advised to:

  • foster capacity-building in new and existing notified bodies; and
  • make every effort to speed up the process for designation and notification of conformity assessment bodies.

The MDCG commits to:

  • review its guidance to “eliminate [the] administrative workload” of notified bodies”;
  • explore ways of adding codes to the designation of notified bodies in a timely manner (looking at the depth of assessment and ways to make it faster); and
  • prioritize its own actions aimed at contributing to notified body capacity (including revision of its guidance on the meaning of “personnel employed by the notified body”, MDCG 2019-6 rev. 3).

Additionally, the MDCG calls for the Eudamed framework, which allows machine-to-machine upload of information, to be developed and deployed as soon as possible.

Finally, and importantly, the MDCG clarifies the status of its guidance and how it should be used.  It states:

As regards the status of MDCG guidance documents, MDCG reminds that their main objective is to assist economic operators, notified bodies and competent authorities to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG. Having regard to the status of guidance documents, economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements. Moreover, reasonable time needs to be given to integrate new guidance in the relevant systems and/or to apply them. That means that new guidance should not be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment, unless application of such guidance yields increased efficiency of the process.” (emphasis added)

Thus, the MDCG takes a pragmatic approach by indicating that those undergoing assessments under the Regulations should not have to contend with new guidance published after an application has been submitted moving the goal posts mid-assessment.  Rather, new guidance should apply only to subsequent applications.


Increase access to notified bodies

The second category of MDCG suggestions are those focusing on “access to notified bodies”. The first of these emphasizes the obligation of notified bodies to make their standard fees publicly available, to allow manufacturers, particularly SMEs that may have fee concerns, to make informed decisions. The MDCG also suggests that notified bodies develop schemes to allow allocation of capacity for SME manufacturers and first-time applicants, ensuring that such entities have access to the requisite conformity assessments.

Increase preparedness of manufacturers

The MDCG’s position paper also offers suggestions with respect to increasing the preparedness of manufacturers.  The MDCG reiterates its previous advice of ensuring timely compliance with MDR and IVDR requirements (MDCG 2022-11).  However, it notes that notified bodies can support this as the MDCG also encourages “structured dialogues” between notified bodies and manufacturers both before and during the conformity assessment, where these will enhance the efficiency and predictability of the process.

The MDCG recommends that all parties involved in the assessment process increase communication and educational offerings to manufacturers via webinars, workshops, and targeted feedback sessions. The MDCG provides the example of notified bodies working on common application guidelines for manufacturers, alongside national authorities promoting engagement with relevant stakeholders at national level.

Other actions facilitating transition to MDR/IVDR and/or shortage of devices

In its final category of recommendations, the MDCG generally encourages greater pragmatism and a reduction in the complexity of conformity assessments for safe and effective legacy devices (including orphan devices). In pursuit of such, the MDCG proposes:

  • The publication of additional guidance in respect of the practical application of Article 61 MDR (clinical evaluation), and possibly Article 56 IVDR (performance evaluation and clinical evidence), and to make appropriate use of the MDCG’s guidance on clinical evaluation equivalence for legacy devices.
  • The publication of specific guidance (including a definition) on so-called ‘orphan devices’.
  • Encouraging medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating ancillary medical substances and companion diagnostics.  In particular, allowing expedited reviews for devices already certified following consultation with a medicines authority under the prior directives.  

The MDCG also notes that it will endeavour to formulate a “coordinated, transparent and coherent approach” in respect of derogations from applicable conformity assessment procedures (i.e., in the interest of public health, patient safety or patient health).

Comment

Although this is merely a position paper, it shows that the MDCG and regulators are acutely aware of the lack of capacity of notified bodies and the impact of the delay in notified body review. Whether these recommendations will lead to any concrete changes is yet to be seen but the recommendations may encourage notified bodies to take a more pragmatic and flexible approach to the conformity assessment of medical devices and IVDs.  This could help manufacturers complete the conformity assessment (and ultimately CE mark their devices) under the Regulations more efficiently. The further guidance that the MDCG indicates is forthcoming is also encouraging.

On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems.  Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app that processes or stores sensitive data.

The guidelines set out a number of security levels and a security risk assessment.  The risk assessment takes into account the following aspects: (1) the apps’ purpose; (2) its architecture; (3) the source code; (4) third party software integrations; (5) cryptographic implementation; (6) authentication mechanisms; (7) data storage and protection; (8) auditing of paid resources; (9) network communication; (10) platform-specific interactions; and (11) resilience.  The guidelines also include specific security requirements for digital healthcare apps with biometric authentication mechanisms.

The guidelines are based on state-of-the-art security techniques used in the healthcare sector and the Office’s findings in several of its projects.  They also take into account feedback received from industry stakeholders, the German Federal Institute for Drugs and Medical Devices, and the German Federal Commissioner for Data Protection and Freedom of Information.

The Office offers a certification to healthcare apps that comply with the guidelines.

On April 6, 2022, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) published a request for information (“RFI”) seeking public comment on implementing certain provisions of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, indicating that a rulemaking or further guidance related to the HITECH Act may be forthcoming.  Specifically, the RFI seeks input as to how covered entities and business associates are voluntarily implementing recognized security practices.  OCR will consider the implementation of such practices when making certain determinations relating to the resolution of potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule.  The RFI also seeks input on the process for distributing to harmed individuals a percentage of civil monetary penalties (“CMPs”) or monetary settlements collected pursuant to the HITECH Act.  Although HIPAA does not provide a private right of action, the potential for sharing in monetary penalties or settlements could incentivize individuals to report potential HIPAA violations to OCR.

Continue Reading OCR Seeks Comments Related to Recognized Security Practices and Distribution of Civil Monetary Penalties under the HITECH Act

On March 2, 2022, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) posted an advisory opinion concluding that a digital program for the treatment of substance use disorders would raise minimal fraud and abuse risk.  OIG advisory opinions address the application of certain fraud and abuse enforcement authorities to the requesting party’s existing or proposed business arrangements.

Advisory Opinion No. 22-04 is notable given OIG’s consideration of the unique aspects of the requestor’s digital treatment program, which provides digital tools and contingency management incentives (“CM Incentives”), including cash equivalents, in order to motivate behavioral health changes in individuals who suffer from substance use disorders.  As digital health companies consider unique offerings to improve health outcomes and reduce costs, this advisory opinion provides some guidance on potential guardrails for designing digital health offerings.  The advisory opinion also follows the recent release of a Healthcare Common Procedure Coding System (“HCPCS”) code for qualifying digital therapeutics by the Centers for Medicare and Medicaid Services (“CMS”).  These developments will continue to support digital health companies, as well as drug or device manufacturers considering digital health offerings that complement their products (e.g., drug adherence apps and companion apps to smart devices), in navigating the complex and evolving digital health market.

Background on the Program

OIG issued the opinion in response to a request submitted on behalf of a digital health company (“Requester”).  Requester contracts with a variety of entities, including health plans, addiction treatment providers, employee assistance programs, and other institutions (“Customers”), to provide substance abuse treatment services and CM Incentives to individuals through smartphone and smart debit card technology.  Requester certified that the program is evidence-based, protocol-driven, and consistent with published principles issued by the National Institute on Drug Abuse.

Program Enrollment and Operation

Individuals may be referred to the program by a Customer or may self-refer.  An enrollment specialist, under the supervision of a licensed clinical supervisor, determines what type of services are appropriate for individuals enrolled in the program (each a “Member”).  For example, Members might receive the following services from the Requestor via smartphone:

  • Automated appointment reminders and attendance verification;
  • Medication reminders and self-administration verification;
  • Saliva drug testing, breathalyzer alcohol testing, Smokerlyzer CO testing for tobacco, and saliva cotinine testing for e-cigarettes, all verified via self-video;
  • Self-guided cognitive behavioral therapy (“CBT”) modules;
  • Various surveys and assessments;
  • Certified recovery coaching;
  • Community reinforcement and family training; and
  • Daily support groups.

Requestor is not a provider or supplier under any Federal health care program.  However, Members may or may not receive federally reimbursable services (e.g., a federally-reimbursable counseling session) from another supplier or provider, including from a Customer.

Services are provided and CM Incentives are distributed according to an evidence-based, automated algorithm over a 12-month period, which is divided into three phases of approximately four months each.  During the initial  “anchor” phase, the Member undergoes frequent substance testing and receives active CM Incentives for achieving specified behavioral health goals.  During the second “build phase,” substance testing frequency and CM Incentives decrease.  Finally, the “maintenance phase” reinforces behavioral health goals through non-incentive reinforcements.

Requestor provides CM Incentives through a smart debit card.  Members are eligible to receive CM Incentives based on (1) verified substance tests consistent with medical expectations (70% of potential CM Incentives); (2) treatment attendance (20%); and (3) completion of self-guided CBT modules and other features, including follow-up self-assessments (10%).  CM Incentives are capped at $200 per month, with an annual maximum of $599.00 per Member per year.

Customer Payment for the Program

Requestor contracts with various Customers, and individual Members and their families can also pay for the Program directly.  Requester offers two payment models: a flat monthly fee per eligible, active Member and a pay-for-performance model, under which Requestor is paid upon a Member achieving certain agreed-upon abstinence targets.

CM Incentives are held in reserve until the Member has successfully met specified targets.  When a Member does not engage with the application during a given month, the system designates that Member as “inactive.”  Customers are not billed any fees for inactive Members, and unspent CM Incentive fees are held in reserve until the Member becomes active again.

Legal Analysis

OIG found that two aspects of the program could potentially implicate the Federal anti-kickback statute (“AKS”) and the Beneficiary Inducements CMP.  First, even though Requestor does not bill Federal health care programs, it does collect fees from Customers and provide services that could incentivize a Member to receive a federally billable service (e.g., a federally-reimbursable counseling session).  Additionally, there is at least a theoretical risk that a Customer could pay Requestor’s fees to generate business or reward referrals of federally reimbursable services.  Some of the fees a Customer pays are passed on to Members as CM Incentives, based in part upon utilization of services that could be billable to Federal health care programs by another provider or supplier, including the same Customer.

Nonetheless, OIG determined that the program presents a minimal risk of fraud and abuse for four reasons.

  1. The program is protocol-driven and evidence-based.  Requestor cited reputable sources stating that CM is “highly effective” and “cost-efficient” for the treatment of substance abuse disorders.
  2. The risk of overutilization of federally reimbursable services is low.  According to OIG, the CM Incentives have a “relatively low [monetary] value.”  Additionally, a substantial portion of CM Incentives are not tied to federally payable services, and the Requester itself never bills Federal health care programs for services furnished.
  3. The risk is low that a Customer would pay Requestor’s fees to generate business or reward referrals of federally reimbursable services.  The fees paid by Customers do not vary based on the volume or value of federally reimbursable services rendered by that Customer.  Instead, the program is protocol-driven and set by the Requestor.
  4. Safeguards mitigate the risk of fraud and abuse associated with cash and cash-equivalent remuneration.  Requestor has full control over what services a Member needs and what CM Incentives are attached to such services.  Additionally, the smart debit card cannot be used at bars, liquor stores, casinos, or certain other locations and cannot be used to convert credit to cash.  The Requestor can also monitor use of the smart debit card, allowing recovery coaches and providers to be alerted in the event of a blocked purchase.