Category: Health Care Law

A Time for Clauses – Santa and No Gag

As we approach December, the impending arrival of Santa Claus is no doubt dominating discussions in many households.  However, there is another, perhaps lesser known, “clause”-related item that health plan sponsors need to keep top of mind in the coming month.

Specifically, as discussed in our blog found here, health plan sponsors must remember to file their first annual “no gag clause” attestation on December 31, covering the period from December 27, 2020 through the attestation date.

Here are some quick reminders about the requirement, along with some next steps for plans that are catching up:

  • What is the “No Gag Clause” Attestation?

The “no gag clause” attestation, which must be filed annually by December 31, requires group health plans and issuers to certify that they are not subject to agreements that directly or indirectly restrict them from disclosing provider-specific cost or quality-of-care information to certain parties, electronic accessing de-identified claims and encounter information (consistent with privacy laws) or sharing this information with a business associate.

  • How to File an Attestation

The attestation is filed electronically on CMS’s dedicated website, found here.  Instructions, frequently asked questions and a user manual can be found on CMS’s website here.

  • Who is Responsible for the Attestation?

While self-insured plans retain the ultimate responsibility for ensuring that the attestation is submitted, they can contract with their third-party administrators to file on their behalf.

For fully-insured plans, the insurance issuer’s submission of an attestation will satisfy the attestation requirement for both the plan and the issuer.

  • What Should Plan Sponsors Do Now?

For plans that have not yet begun to address the attestation, there is still time to take the necessary steps as follows:

  • If they have not already done so, plans should review their service agreement(s) to ensure that they do not contain any gag clauses.
  • Plans may also wish to obtain written confirmation from their administrators that no prohibited gag clauses are included in their applicable contracts (and, if any are, that the contracts are amended to remove them effective December 27, 2020).
  • Self-insured plans should contact their administrator(s) to coordinate who will be filing the submission.  At this stage, many administrators already have their processes in place and may not wish to file on the behalf of the plan, in which case the plan will need to do the filing.  This will make accomplishing the first two steps more important.

Getting these tasks accomplished as soon as possible will allow plan sponsors to put these prohibited clauses behind them and focus on the good Clauses of the season—Santa and Mrs.

© 2023 Proskauer Rose LLP.
For more news on No Gag Clauses, visit the NLR Health Law & Managed Care section.

Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”

All three of these FDA guidance documents provide recommendations for industry regarding the sharing of scientific information with Health Care Providers (“HCPs”)[2] on unapproved uses of approved or cleared drugs and medical devices, termed “SIUU communications” by the 2023 Draft Guidance. HCPs are permitted to prescribe medical products for unapproved uses when the unapproved use is determined to be medically appropriate for a given patient. However, manufacturers may not promote their products for an unapproved use. For this reason, FDA’s position (which is articulated to some extent across all of the above-mentioned guidance documents, but most clearly and emphatically in the 2023 Draft Guidance) is that firm[3] communications to HCPs regarding unapproved uses of approved or cleared products should include all of the information necessary for HCPs to evaluate the strengths, weaknesses, validity, and utility of the information about the unapproved use in order to make determinations regarding medical appropriateness.

In the 2023 Draft Guidance, FDA seeks to balance the interests of HCPs in learning, and manufacturers in sharing, truthful and non-misleading information about unapproved uses of approved medical products, with the intent to inform clinical practice decisions against the government’s interest in protecting patients from medical product uses that have not met applicable safety and effectiveness standards required under FDA’s premarket approval framework.

While the 2023 Draft Guidance reiterates many of the recommendations from the 2014 Draft Guidance, the 2023 Draft Guidance leverages a new “Q&A” format to provide firms with more detailed and specific recommendations, including hypothetical scenarios, around SIUU communications. Below, we restate the four Q&A questions included in the 2023 Draft Guidance and then highlight key aspects of the responses provided by FDA through brief commentary and recommended Dos and Don’ts.

Q1. What should firms consider when determining whether a source publication is appropriate to serve as the basis for an SIUU communication?

According to the 2023 Draft Guidance, any study or analysis described in a source publication that serves as the basis for an SIUU communication should be scientifically sound,[4] and should provide information that is relevant to HCPs engaged in making clinical practice decisions for the care of an individual patient; in other words, these sources should be clinically relevant.[5] While the 2014 Draft Guidance suggested that scientific or medical journal article reprints intended for distribution to HCPs should describe studies that are considered “scientifically sound” by appropriate experts, the 2023 Draft Guidance builds out this standard and provides greater insight into what types of source material would meet (and not meet) the standard.

Do:

  • Choose scientifically sound studies that provide clinically relevant information to support your SIUU communications
    • For human and animal drugs, randomized, double-blind, concurrently controlled superiority trials are most likely to provide both scientifically sound and clinically relevant information (though other well-designed and well-conducted studies may also be appropriate)
    • For medical devices,[6] look to well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, reports of significant human experience with a marketed device as sources of scientifically sound and clinically relevant information
  • Consider studies with real-world data and associated real-world evidence, which may meet the scientifically sound and clinically relevant threshold depending on the nature of the data and underlying analyses

Don’t:

  • Rely on studies without an adequate control group, isolated case reports, or studies that lack sufficient detail to permit scientific evaluation as the sole basis for an SIUU communication
  • Rely on studies with “unreliable” data, even if you include disclaimers noting the limitations (e.g., studies that fail to control for confounding factors or fail to clearly define study endpoints)
  • Rely on articles focused on non-clinical studies as the sole basis for an SIUU communication
  • Rely on scientific data generated in early stages of medical product development as the sole basis for an SIUU communication, as such data can produce results that are inconsistent with later studies
  • Distort studies in SIUU communications or base SIUU communications on publications that distort studies or include fraudulent data
  • Continue to share an SIUU communication that is based on a study or analysis that is no longer clinically relevant (ex: subsequent research has established the findings from the study are not reliable)

Q2. What information should firms include as part of SIUU communications?

Like the 2014 Draft Guidance, the 2023 Draft Guidance emphasizes the importance of providing certain disclosures with SIUU communications to ensure such communications are not misleading and provide all the information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information. The recommended disclosures in the 2023 Draft Guidance are similar to those recommended in the 2014 Draft Guidance, but are more detailed and extensive.

Do:

  • Provide a disclosure statement with any SIUU communication, which should include:
    • A statement that the use described in the communication is unapproved and the safety and effectiveness of the medical product for the unapproved use(s) has not been established
    • Disclosure of the FDA approved use of the medical product, including any limitations and contraindication(s) specified by the product’s FDA-required labeling[7]
    • Disclosure of any limitations, restrictions, cautions, warnings, or contradictions described in the FDA-required labeling about the unapproved use(s)
    • Disclosure of any serious, life-threatening, or fatal risks posed by the medical product that are relevant to the unapproved use(s) (that are either in the FDA-required labeling or known by the firm and relevant to the unapproved use)
    • Disclosure of any financial relationships between the firm and any authors, editors, or other contributors to the publications in the SIUU communication
    • A copy of the most current FDA-required labeling (or a mechanism for obtaining the labeling)
    • The publication date of any referenced or included publication(s) (if not specified in the publication or citation)
  • For an SIUU communication based on a source publication that is primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the publication, provide a description of:
    • All material aspects of study design, methodology, and results
    • All material limitations related to the study design, methodology, and results
    • Any conclusions from other relevant studies, when applicable, that are contrary to or cast doubt on the results shared, including citations for any such studies

Don’t:

  • Omit any risk evaluation and mitigation strategy (REMS) applicable to the medical product (firms should disclose any REMS and should describe the goal(s) of the REMS)

Q3. What presentational considerations should firms take into account for SIUU communications?

The 2023 Draft Guidance offers a number of presentation-focused recommendations to ensure that SIUU communications are conveyed in a manner that enhances and does not interfere with HCP understanding of the underlying scientific information, and to avoid such SIUU communications being confused with promotional communications about approved uses.

Do:

  • Clearly and prominently present all recommended disclosures, considering type size, font style, layout, contrast, graphic design, headlines, spacing, volume, articulation, pace, and any other techniques to achieve emphasis or notice
  • For SIUU communications with both audio and visual components, present disclosures in both the audio and in text at the same time using the same/substantially similar language
  • Keep SIUU communications (including those relayed via email) separate and distinct from promotional communications about approved uses of medical products
  • Use dedicated vehicles, channels, and venues for sharing SIUU communications that are separate from the vehicles, channels, and venues used for promotional communications about approved uses of medical products. For example –
    • Present SIUU communications on a separate web page from the web page that hosts promotional communications about approved uses
    • At conferences and similar venues, ensure that SIUU communications are clearly identified and distinct from promotional communications about approved uses (e.g., by dividing booth space to allow a dedicated space for SIUU communications)
  • Use plain language in the content developed for SIUU communications to facilitate comprehension (i.e., clear and concise language that does not include technical jargon and clearly explains any scientific or technical terms)

Don’t:

  • Use persuasive marketing techniques, such as the use of celebrity endorsements, premium offers, and gifts. According to FDA, a firm’s choice to use persuasive marketing techniques suggests an effort to convince the HCP to prescribe or use the product for the unapproved use based on elements other than the scientific content of the communication
  • Include direct links from web pages that host promotional communications about approved uses to webpages that host SIUU communications
  • Utilize platforms with character limits that do not enable the firm to include the recommended disclosures for sharing SIUU communications (however, such platforms could be used to direct an HCP to an SIUU communication, subject to certain restrictions)

Q4. What additional recommendations apply to specific types of SIUU communications?

The 2023 Draft Guidance offers additional recommendations related to certain specific types of SIUU communications including journal reprints and clinical reference resources (such as clinical practice guidelines and reference texts). Of note, the 2023 Draft Guidance provides recommendations for a category of SIUU communications that is not specifically addressed in the 2014 Draft Guidance – “firm-generated presentations of scientific information from an accompanying published reprint.”

Discussion of such firm-generated presentations in the 2023 Draft Guidance represents a departure from the 2014 Draft Guidance, which stated that reprints (as well as clinical reference resources) regarding unapproved uses (of cleared or approved medical products) should not be “marked, highlighted, summarized, or characterized” by medical product manufacturers to emphasize or promote an unapproved use. The 2023 Draft Guidance provides new flexibility in this regard, expressly acknowledging that firms may develop their own presentations of scientific information from an accompanying reprint provided such presentation is truthful, non-misleading, factual, unbiased, and provides all the information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information. The 2023 Draft Guidance includes a number of recommendations for firms to follow to prepare and distribute firm-generated presentations of information from an accompanying reprint.

Do:

  • Include the full reprint with the firm-generated presentation
  • Include the disclosures outlined above in Q2, and clearly disclose what portions of the communication are firm-generated
  • Follow the presentational considerations outlined in Q3

Don’t:

  • Imply that the study, analysis, or underlying data or information from the reprint(s) represents larger or more-general experience with the medical product than it actually does
  • Present information, such as excerpts, quotes, etc., from the reprint(s) out of context, without the information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information
  • Include representations or suggestions about the safety or effectiveness of the medical product for the unapproved use(s) that are not consistent with the reprint
  • Present any conclusions or representations about safety or effectiveness for the unapproved use without expressly attributing such statements to the reprint, and without immediately following such statements with a disclosure of any financial relationships between the firm and any authors, editors, or other contributors to the publications in the SIUU communication
  • Use statistical analyses or techniques to indicate clinical significance or validity of a finding not supported by the data or information in the reprint
  • Use tables or graphs or other presentational elements to distort or misrepresent the relationships, trends, differences, or changes among the outcomes evaluated in the reprint

Conclusion

While the 2023 Draft Guidance veers from the 2014 Draft Guidance in some respects, many of the same principles have been pulled through into the current guidance. As such, a medical product manufacturer who has already implemented the recommendations from the 2014 Draft Guidance should not face too heavy of a lift to adjust its activities to align with the 2023 Draft Guidance. While the landscape has not shifted drastically overall, firms should still closely review the additional detail and clarifications provided by the 2023 Draft Guidance to mitigate potential risk in navigating the often murky regulatory waters of engaging in off-label and pre-approval communications.

ENDNOTES

[1] Comments on the 2023 Draft Guidance are due by December 26, 2023.

[2] The 2023 Draft Guidance only applies to HCPs engaged in making clinical practice decisions for the care of an individual patient. Per the 2023 Draft Guidance, HCPs include physicians, veterinarians, dentists, physician assistants, nurse practitioners, pharmacists, or registered nurses who are licensed or otherwise authorized by law to prescribe, order, administer, or use medical products in a professional capacity. The 2014 Draft Guidance applied to “health care professionals,” but the term was not specifically defined.

[3] As defined by the 2023 Draft Guidance, firms are the “persons legally responsible for the labeling of medical products, and includes applicants, sponsors, requestors, manufacturers, packers, and distributors of medical products, and licensees of such persons, and any persons communicating on behalf of these entities.”

[4] To be “scientifically sound,” at a minimum, studies should meet generally accepted design and other methodological standards for the particular type of study performed, taking into account established scientific principles and existing scientific knowledge.

[5] Additionally, statistical robustness is generally necessary, though not sufficient, to determine if a study or analysis is appropriate for an SIUU communication. While statistical robustness factors into the rigor of the design and methodology of a study, it does not assure that the study relates to outcomes of clinical relevance to HCPs.

[6] Notably, while the 2014 Draft Guidance stated that journal articles discussing significant non-clinical research could fall within FDA’s enforcement discretion policy under the guidance, the 2023 Draft Guidance clarifies that, generally, sharing articles focused on non-clinical studies alone would not be consistent with FDA’s enforcement discretion policy as a non-clinical study alone is unlikely to provide information that is clinically relevant.

[7] “FDA-required labeling” includes, but is not necessarily limited to, the labeling reviewed and approved by FDA as part of the medical product premarket review process. For a prescription human drug (including biological products), this consists of the FDA-approved prescribing information that meets the requirements of 21 CFR 201.100. For a device, it includes the labeling approved during the review of a premarket approval application or De Novo classification.

©2023 Epstein Becker & Green, P.C. All rights reserved.
For more news on FDA Guidance on Medical Products, visit the NLR Health Law & Managed Care section.

Biden Executive Order Calls for HHS to Establish Health Care-Specific Artificial Intelligence Programs and Policies

On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House priorities and policies related to the use and development of artificial intelligence (AI) across different sectors, including health care.

The Biden Administration acknowledged the various competing interests related to AI, including weighing significant technological innovation against unintended societal consequences. Our Mintz and ML Strategies colleagues broadly covered the Executive Order in this week’s issue of AI: The Washington Report. Some sections of the Executive Order are sector-agnostic but will be especially relevant in health care, such as the requirement that agencies use available policy and technical tools, including privacy-enhancing technologies (PETs) where appropriate, to protect privacy and to combat the improper collection and use of individuals’ data.

The Biden Administration only recently announced the Executive Order, but the discussion of regulating AI in health care is certainly not novel. For example, the U.S. Food and Drug Administration (FDA) has already incorporated artificial intelligence and machine learning-based medical device software into its medical device and software regulatory regime. The Office of the National Coordinator for Health Information Technology (ONC) also included AI and machine learning proposals under the HTI-1 Proposed Rule, including proposals to increase algorithmic transparency and allow users of clinical decision support (CDS) to determine if predictive Decision Support Interventions (DSIs) are fair, appropriate, valid, effective, and safe.

We will focus this post on the Executive Order health care-specific directives for the U.S. Department of Health and Human Services (HHS) and other relevant agencies.

HHS AI Task Force and Quality Assurance

To address how AI should be used safely and effectively in health care, the Executive Order requires HHS, in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, to establish an “HHS AI Task Force” by January 28, 2024. Once created, the HHS AI Task Force has 365 days to develop a regulatory action plan for predictive and generative AI-enabled technologies in health care that includes:

  • use of AI in health care delivery and financing and the need for human oversight where necessary and appropriate;
  • long-term safety and real-world performance monitoring of AI-enabled technologies;
  • integration of equity principles in AI-enabled technologies, including monitoring for model discrimination and bias;
  • assurance that safety, privacy, and security standards are baked into the software development lifecycle;
  • prioritization of transparency and making model documentation available to users to ensure AI is used safely;
  • collaboration with state, local, Tribal, and territorial health and human services agencies to communicate successful AI use cases and best practices; and
  • use of AI to make workplaces more efficient and reduce administrative burdens where possible.

HHS also has until March 28, 2024 to take the following steps:

  • consult with other relevant agencies to determine whether AI-enabled technologies in health care “maintain appropriate levels of quality”;
  • develop (along with other agencies) AI assurance policies to evaluate the performance of AI-enabled health care tools and assess AI-enabled health care-technology algorithmic system performance against real-world data; and
  • consult with other relevant agencies to reconcile the uses of AI in health care against federal non-discrimination and privacy laws, including providing technical assistance to and communicating potential consequences of noncompliance to health care providers and payers.

AI Safety Program and Drug Development

The Executive Order also directs HHS, in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, to organize and implement an AI Safety Program by September 30, 2024. In partnership with federally listed Patient Safety Organizations, the AI Safety Program will be tasked with creating a common framework that organizations can use to monitor and track clinical errors resulting from AI used in health care settings. The program will also create a central tracking repository to track complaints from patients and caregivers who report discrimination and bias related to the use of AI.

Additionally, by September 30, 2024, HHS must develop a strategy to regulate the use of AI or AI-enabled tools in the various phases of the drug development process, including determining opportunities for future regulation, rulemaking, guidance, and use of additional statutory authority.

HHS Grant and Award Programs and AI Tech Sprint

The Executive Order also directs HHS to use existing grant and award programs to support ethical AI development by health care technology developers by:

  • leveraging existing HHS programs to work with private sector actors to develop AI-enabled tools that can create personalized patient immune-response profiles safely and securely;
  • allocating 2024 Leading Edge Acceleration Projects (LEAP) in Health Information Technology funding for the development of AI tools for clinical care, real-world-evidence programs, population health, public health, and related research; and
  • accelerating grants awarded through the National Institutes of Health Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) program and demonstrating successful AIM-AHEAD activities in underserved communities.

The Secretary of Veterans Affairs must also host two 3-month nationwide AI Tech Sprint competitions by September 30, 2024, with the goal of further developing AI systems to improve the quality of health care for veterans.

Key Takeaways

The Executive Order will spark the cross-agency development of a variety of AI-focused working groups, programs, and policies, including possible rulemaking and regulation, across the health care sector in the coming months. While the law has not yet caught up with the technology, the Executive Order provides helpful insight into the areas that will be topics of new legislation and regulation, such as drug development, as well as what may be the new enforcement priorities under existing law such as non-discrimination and data privacy and security. Health care technology developers and users will want to review their current policies and practices in light of the Biden Administration’s priorities to determine possible areas of improvement in the short term in connection with developing, implementing, and using AI.

Additionally, the National Institute of Standards and Technology (NIST) released the voluntary AI Risk Management Framework in January 2023 that, among other things, organizations can use to analyze and manage risks, impacts, and harms while responsibly designing, developing, deploying, and using AI systems over time. The Executive Order calls for NIST to develop a companion resource to the AI Risk Management Framework for generative AI. In preparation for the new AI programs and possible associated rulemaking from HHS, organizations in health care will want to familiarize themselves with the NIST AI Risk Management Framework and its generative AI companion as well as the AI Bill of Rights published by the Biden Administration in October 2022 to better understand what the federal government sees as characteristics of trustworthy AI systems.

Madison Castle contributed to this article.

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Does the “Patent Eligibility Restoration Act of 2023” Revive Diagnostic Claims?

On June 22, Senator Chris Coons, along with Thom Tillis introduced the “Patent Eligibility Restoration Act of 2023” (hereinafter “the Act”) to amend 35 USC s. 101 to clarify the scope of patent-eligible subject matter. Section 101(b) would be amended to delete “includes a new use of a known process” and insert “includes a use, application, or method of manufacture of a known or naturally occurring process.” A section (k) would be added to define the term “useful” as meaning that the invention or discovery has a “specific and practical utility” from the perspective of a POSA. So far, so good. The use of a naturally occurring process can be read to cover the use of a naturally occurring correlation, an “If A then B” claim. The recognition of the discovery of the utility of a naturally occurring correlation, which leads to a diagnostic conclusion would seem to be included in this broad language.

But now things get a bit sketchy. The Act would abolish all the current judicial, e.g. Chakrabarty, exclusions but would add a set of statutory exclusions that overlap the judicial exclusions in some places. The exclusions include “an unmodified human gene”—good-bye Myriad—and an unmodified natural material as that material exists in nature, e.g., water. This exclusion would not jeopardize diagnostic claims since a per se is not being claimed.

More troublesome, Section C of the exclusions would include a process that “occurs in nature wholly independent of, and prior to, any human activity.” Diagnostic claims are process claims that are based on the recognition of the utility of a correlation that takes place in the body. The utility of the diagnostic claim lies solely in the recognition of the utility of the correlation. If a man has an elevated level of PSA he is at risk of developing, or may already have, prostate cancer. But isn’t the relationship between PSA levels and cancer/no cancer a process that occurs in nature wholly independent of, and prior to, any human activity, such as sampling and measuring the level of PSA in the blood? Please read the Act and tell me why I am wrong.

© 2023 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

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CMS Takes Steps to Lower SNF Medicare Payment Error Rates

With the Medicare Comprehensive Error Rate Testing program projected error rate for skilled nursing facilities (SNFs) showing a significant increase in 2022 (15.1%, up from 7.9% in 2021), the Centers for Medicare and Medicaid Services (CMS) has instructed each of its Medicare Administrative Contractors (MACs) that review SNF Medicare claims to initiate a five-claim probe and educate medical review for each SNF in the MAC’s jurisdiction.

CMS surmises that the source of the increase in improper payments may lie with the change from resource utilization group (RUG) IV to the patient driven payment model (PDPM) and has noted that the primary root cause of SNF errors is missing documentation.

MACs are instructed to implement the five-claim probe on a rolling basis beginning with the top 20% of SNFs that show the highest risk. If any improper payments are identified, the MAC will adjust (or deny) the claim(s) and offer either widespread education or 1:1 individualized education depending on the error rate. 1:1 education will include claim specific information and allow the SNF to review the claim decision, ask questions and receive feedback.

Beginning June 5, 2023, SNFs nation-wide should be on the lookout for a prepayment probe and educate record request from the MAC and be prepared to respond within 45 days.

Copyright © 2023, Sheppard Mullin Richter & Hampton LLP.

For more Healthcare Legal News, click here to visit the National Law Review.

No More Surprise Medical Bills: Providers Score More Victories in First Year of No Surprises Act Arbitrations, But Claims Backlog Otherwise Complicates Implementation

In the year following the implementation of the arbitration process established under the federal No Surprises Act (NSA), more than 330,000 disputes have been submitted for resolution. This figure far outpaces the predictions of the US Departments of Health and Human Services (HHS), Labor, and the Treasury (the Departments), and complicates the implementation of the NSA.

*This is the eighth article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here.

As background, Congress passed the NSA in 2020, effective in 2022, to curb so-called “surprise” medical bills — balance bills received by patients in situations where they have no control over who is involved in their care. Frequently, patients incur these bills when they obtain emergency care from out-of-network facilities or non-emergency services at in-network facilities where at least one member of the care team is out-of-network. In these situations, the NSA forbids out-of-network providers from balance billing the patients to collect the difference between billed charges and what the patient’s health insurance actually paid. Instead, to protect patients and ensure that reasonable payments are made to providers, the NSA establishes an alternative dispute resolution process, allowing eligible parties to submit disputed claims to independent dispute resolution entities (IDREs) to determine appropriate out-of-network payment rates.

Dispute resolution was intended to be streamlined and efficient, but IDREs have been inundated with submissions in the year since the NSA became effective. The volume of claims has created a significant backlog, hindering providers’ ability to obtain timely and appropriate reimbursement for the services they rendered. In an effort to promote transparency, the Departments recently issued a “status update” on the arbitration process. The report revealed several key findings regarding the volume, eligibility, and outcomes of claims submitted under the NSA to date.

Key Findings of the Status Update Report

First, the report provided insight into the overall numbers of claims that have been filed since the NSA became effective. Since the federal claims submission portal first went live in April 2022, disputing parties have initiated more than 330,000 arbitration submissions. This figure is nearly 14 times greater than the Departments’ initial estimates. The sheer volume of claims has drastically slowed the adjudication of claims submitted under the NSA.

Second, the report states that IDREs have rendered determinations in favor of one party or the other in only a small fraction of cases, with approximately 42,000 disputes decided as of March 31, 2023. Of these, initiating parties (typically health care providers) have prevailed approximately 71% of the time.

Third, to date, IDREs have closed more cases than they have decided. Overall, more than 100,000 claims,  – more than four times the amount anticipated by the Departments, have been closed. There are various reasons for this. Some claims were closed following successful negotiations between the parties. Others were closed due to one or both parties failing to submit the required fees mandated under the NSA. A large number — nearly 40,000 — were closed for eligibility reasons. Non-initiating parties have challenged the eligibility of more than a third of claims submitted for arbitration, balking at approximately 120,000 disputes. Non-initiating parties frequently object that claims are not eligible for arbitration under the NSA for multiple reasons, including lack of timely negotiation or arbitration submission, or because the disputed claims involve insurance programs outside the scope of the NSA.

In addition to the objections lodged by non-initiating parties, the IDREs have an independent duty to confirm that all claims submitted for arbitration are eligible under the NSA. These determinations require IDREs to engage in what can be a complex and time-consuming analysis of each claim, frequently requiring the submission of additional information from the parties. The report finds that these eligibility determinations represent the primary cause for the delays in processing arbitration submissions.

Finally, in an effort to help resolve delays, the status update includes that the Departments have begun to require initiating parties to submit additional information to assist IDREs in evaluating the eligibility of claims. The Departments have also modified the arbitration portal to require the input of additional information to enable non-initiating parties to identify disputed claims. These are among the “ongoing technical and operational improvements” the report states the Departments have been making over the last year.

Looking Ahead: Additional Legislation and Ongoing Court Challenges

The report highlights a series of problems that have hampered the implementation of the NSA, including larger-than-expected dispute volume, complex eligibility determinations, and technical issues. Collectively, these problems have left many parties awaiting arbitration awards and payment.

Meanwhile, the legal challenges to the Departments’ implementing regulations under the NSA continue, and HHS Secretary Xavier Bacerra recently testified before Congress regarding the implementation of the NSA. These developments have fueled speculation that Congress may step in and pass additional legislation to streamline the arbitration process. While these events play out, providers should continue to submit timely open negotiation notices and IDR initiation forms to preserve their rights under the NSA.

A copy of CMS’s report can be found here.

© 2023 ArentFox Schiff LLP

For more Healthcare Legal News, click here to visit the National Law Review.

The End of the COVID Public Health Emergency and Its Effect on Employee Benefit Plans

The COVID-19 public health emergency ends on May 11, 2023. The emergency resulted in two big changes to welfare plans: the relaxation of certain notification and timing requirements, and the requirement for plans to cover COVID testing and vaccination at no cost to plan participants. While the public health emergency ends May 11, 2023, plans have a grace period until July 11 to take certain actions and come into compliance with the normal rules.

Plan Sponsor Requirements

Before the grace period ends, plan sponsors will generally need to follow the rules that existed before COVID. Among the most important of these rules are the requirements for plan sponsors to:

  • Timely provide all notices, including those for HIPAA and COBRA.
  • Review COVID-related coverage under their employee assistance programs (EAPs) to determine if such coverage would be considered “significant medical care,” which can result in additional reporting and compliance obligations.
  • Review telehealth options to ensure they are properly integrated and provided by an entity that can comply with the post-COVID requirements. Telehealth rules were substantially relaxed during COVID. With telehealth now expected and utilized by more participants, getting telehealth right is more crucial than before.

Plan Sponsor Decisions

With the end of the public health emergency, plan sponsors must also make several important decisions with respect to their employee benefit plans:

  • Whether testing will continue free of charge or will be subject to cost sharing.
  • Whether non-preventative care vaccines for COVID will continue to be free of charge.
  • Whether costs for certain COVID-related services will continue to be posted.

As they are mostly based on what costs the plan sponsor or plan will cover going forward, these plan sponsor decisions are largely business-related. In the absence of a choice by the plan sponsor, the insurance provider will likely make a default choice. The important legal consideration is that the plan documents and employee communications should be consistent and accurately reflect the plan sponsor’s decisions.

Participant Requirements

In addition to the changes for plan sponsors, the end of the public health emergency will result in the reinstatement of a number of rules applicable to participants. Participants will need to:

Follow the HIPAA Special Enrollment timing rules.

Elect COBRA within the 60-day window for elections.

Make all COBRA payments timely.

Timely notify the plan of disabilities and qualifying events under COBRA.

Follow the timing limitations of their plans and insurance policies regarding filing claims, appeals, and external reviews.

Next Steps

First, plan sponsors should decide what COVID-related coverage will remain fully paid by the plan, if any. Some insurance companies are already starting to communicate with participants, and maintaining a consistent message will avoid unnecessary problems.

Second, plan sponsors should review their EAP and telehealth coverages for compliance with the rules that will soon be in effect. To the extent necessary, plan sponsors should update the documentation for their plans.

Finally, plan sponsors should consider a voluntary reminder communication to participants. Many rules have been relaxed over the last two years or so, and participants may be confused regarding the rules. A reminder may save stress for participants and those administering the plan, and will also serve to document the plan sponsor’s intention to properly follow the terms of the plan.

© 2023 Varnum LLP

For more healthcare legal news, click here to visit the National Law Review.

Software as a Medical Device: Challenges Facing the Industry

SaMD Blog Series: Introduction

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical devices. We will be addressing various considerations including technology, data, intellectual property, licensing, and contracting.

The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, SaMD need not be part of a physical device to achieve its intended purpose. For instance, SaMD could be an application on a mobile phone and not be connected to a physical medical device.

With the proliferation of SaMD also comes the need for those building and using it to firmly grasp legal and regulatory considerations to ensure successful use and commercialization. Over the next several weeks, we will be addressing some of more common issues faced by digital health companies, investors, innovators, and clinicians when developing, utilizing, or commercializing SaMD. The Food and Drug Administration (FDA) has already cleared a significant amount of SaMD, including more than 500 algorithms employing artificial intelligence (AI). Some notable examples include FDA-cleared SaMD such as wearable technology for remote patient monitoring; doctor prescribed video game treatment for children with ADHD; fully immersive virtual reality tools for both physical therapy and mental wellness; and end to end software that generates 3D printed models to better plan surgery and reduce operation time. With this rapid innovation comes a host of legal and regulatory considerations which will be discussed over the course of this SaMD Blog Series.

General Intellectual Property (IP) Considerations for SaMD

This edition will discuss the sophisticated IP strategies that can be used to protect innovations for the three categories of software for biomedical applications: SaMD, software in a medical device, and software used in the manufacture or maintenance of a medical device, including clinical trial collaboration and sponsored research agreements, filing patent applications, and pursuing other forms of protection, such as trade secrets.

Licensing and Contracting with Third Parties for SaMD

This edition will unpack engaging with third parties practically and comprehensively, whether in the context of (i) developing new SaMD or (ii) refining or testing existing SaMD. Data and IP can be effectively either owned or licensed, provided such licenses protect the future interests of the licensee. Such ownership and licensing are particularly important in the AI and machine learning space, which is one area of focus for this edition.

FDA Considerations for SaMD

This edition will explore how FDA is regulating SaMD, which will include a discussion of what constitutes a regulated device, legislative actions to spur innovation, and how FDA is approaching regulation of specific categories of SaMD such as clinical decision support software, general wellness applications, and other mobile medical devices. It will also examine the different regulatory pathways for SaMD and FDA’s current focus on Cybersecurity issues for software.

Health Care Regulatory and Reimbursement Considerations for SAMD

This edition will discuss the intersection of remote monitoring services and SaMD, prescription digital therapeutics and how they intersect with SaMD, licensure and distributor considerations associated with commercializing SaMD, and the growing trend to seek out device specific codes for SaMD.

Our hope is that this series will be a starting point for digital health companies, investors, innovators, and clinicians as each approaches development and use of SaMD as part of their business and clinical offerings.

© 2023 Foley & Lardner LLP

For more information on Healthcare, click here to visit the National Law Review.

 

Health Care Immigration: Alleviating the U.S. Nursing Shortage

The nursing shortage has been a persistent problem in the United States for decades, with experts predicting it will only worsen in the coming years. Many factors contribute to the nursing shortage, including an aging population, the retirement of experienced nurses, and an increasing demand for healthcare services. One potential solution to the shortage is immigration law, which can help bring in qualified nurses from other countries to work in the United States.

The nursing shortage is a complex issue that affects the entire healthcare system. Nurses play a crucial role in providing high-quality care to patients, and their absence can have serious consequences for patient outcomes. According to McKinsey, the United States may have a gap of between 200,000 to 450,000 nurses available for direct patient care by 2025. This shortage is not limited to registered nurses; there is also a shortage of licensed practical nurses, nurse practitioners, and other healthcare professionals.

One way to address the nursing shortage is to attract qualified nurses from other countries. The United States has a long history of welcoming immigrants from all over the world, including healthcare professionals.

Employment Immigration Sponsorship to Meet U.S. Nursing Demands

Several immigration options are available for nurses who wish to work in the United States. The most common options are the H-1B visa, the TN visa, and the EB-3 visa:

  • The H-1B visa is a non-immigrant visa that allows employers to temporarily hire foreign workers in specialty occupations. Registered nurses qualify as workers in a specialty occupation, so they are eligible. The H-1B visa is valid for up to three years and can be extended for an additional three years. However, there is a cap on the number of H-1B visas issued each year and the competition for these visas is often high.
  • The TN visa is a non-immigrant visa available to Canadian and Mexican citizens under the North American Free Trade Agreement (NAFTA). Nurses who are citizens of Canada or Mexico and have the necessary qualifications can apply for the TN visa to work in the United States. The visa is valid for up to three years and can be renewed indefinitely.
  • The EB-3 visa is an immigrant visa available to foreign workers in skilled or unskilled positions. Nurses qualify as skilled workers and can apply for the EB-3 visa. The visa requires an employer to sponsor the nurse, who must have a permanent job offer in the United States. The EB-3 visa is subject to a lengthy application process and may take several years to obtain.

In addition to these options, certain state-specific programs allow foreign nurses to work in those states. For example, the Health Professional Shortage Area (HPSA) program allows foreign nurses to work in areas with a shortage of healthcare professionals. The Conrad State 30 program allows foreign nurses to work in certain states for up to three years if they agree to work in underserved areas.

It is important to note that each immigration option has its own set of requirements and limitations. Nurses who are interested in working in the United States and health care providers seeking foreign talent must consult with an experienced immigration attorney to determine the best option for their specific situation.

Overall, immigration law provides options for foreign nurses who wish to work in the United States. As they take advantage of these options, the nursing shortage in the United States can be alleviated, and patients can receive the high-quality care they need and deserve.

Immigration Policy Updates are Critical to Close the Nursing Shortage Gap

While there exist many employment immigration visas that help alleviate the pressure of the ongoing nursing shortage on the health care industry, immigration laws, regulations, and administrative policies can make it difficult for foreign nurses to work in the United States. Strategic updates to these laws, regulations, and administrative policies are critical to permit foreign nurses to enter the nursing labor market.

One change is to streamline the visa process for foreign nurses. Currently, the process of obtaining a visa to work in the United States can be time-consuming and complicated. Many foreign nurses face significant barriers such as language proficiency exams, educational requirements, and visa quotas. By simplifying the visa process and reducing these barriers, the United States could recruit more foreign nurses to work here.

Another change is to provide incentives for foreign nurses to come to the United States. For example, the government could offer financial assistance to help them cover the cost of their relocation and provide support services to help them adjust to their new home. Additionally, employers could offer signing bonuses, tuition reimbursement, and other benefits to attract foreign nurses.

Finally, immigration agencies can develop partnerships with other countries to increase the number of nurses trained abroad. Many countries, particularly developing nations, have large numbers of qualified nurses who are unable to find work in their home countries. By partnering with these countries, the United States could help train more nurses and provide them with opportunities to work in the United States.

The nursing shortage is a serious problem that requires innovative solutions. Immigration law already plays a crucial role in addressing the shortage. This role, however, can grow through streamlining the visa process, providing incentives for foreign nurses to come to the United States, and creating partnerships with other countries.

Article By Raymond G. Lahoud of Norris McLaughlin P.A.

For more immigration legal news, click here to visit the National Law Review.

©2023 Norris McLaughlin P.A., All Rights Reserved

The FTC Announces First Health Breach Notification Rule Enforcement Action

On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies.

In a first-of-its-kind proposed order, filed by the Department of Justice on behalf of the FTC, GoodRx will be prohibited from sharing user health data with applicable third parties for advertising purposes, and has agreed to pay a $1.5 million civil penalty for violating the rule. The proposed order must be approved by the federal court to go into effect. The Health Breach Notification Rule requires vendors of personal health records and related entities, which are not covered by the Health Insurance Portability and Accountability Act (HIPAA), to notify consumers and the FTC of unauthorized disclosures. In a September 2021 policy statement, the FTC warned health apps and connected devices that they must comply with the rule.

According to the FTC’s complaint, for years GoodRx violated the FTC Act by sharing sensitive personal health information with advertising companies and platforms—contrary to its privacy promises—and failed to report these unauthorized disclosures as required by the Health Breach Notification Rule.  Specifically, the FTC claims GoodRx shared personal health information with Facebook, Google, Criteo and others. According to the FTC, since at least 2017, GoodRx deceptively promised its users that it would never share personal health information with advertisers or other third parties. GoodRx repeatedly violated this promise by sharing sensitive personal health information—such as including its users’ prescription medications and personal health conditions.

The FTC also alleges GoodRx monetized its users’ personal health information, and used data it shared with Facebook to target GoodRx’s own users with personalized health and medication-specific advertisements on Facebook and Instagram.

The FTC further alleges that GoodRx:

  • Failed to Limit Third-Party Use of Personal Health Information: GoodRx allowed third parties it shared data with to use that information for their own internal purposes, including for research and development or to improve advertising.
  • Misrepresented its HIPAA Compliance: GoodRx displayed a seal at the bottom of its telehealth services homepage falsely suggesting to consumers that it complied with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a law that sets forth privacy and information security protections for health data.
  • Failed to Implement Policies to Protect Personal Health Information: GoodRx failed to maintain sufficient policies or procedures to protect its users’ personal health information. Until a consumer watchdog publicly revealed GoodRx’s actions in February 2020, GoodRx had no sufficient formal, written, or standard privacy or data sharing policies or compliance programs in place.

In addition to the $1.5 million penalty for violating the rule, the proposed federal court order also prohibits GoodRx from engaging in the deceptive practices outlined in the complaint and requires the company to comply with the Health Breach Notification Rule. To remedy the FTC’s numerous allegations, other provisions of the proposed order against GoodRx also:

  • Prohibit the sharing of health data for advertising: GoodRx will be permanently prohibited from disclosing user health information with applicable third parties for advertising purposes.
  • Require user consent for any other sharing: GoodRx must obtain users’ affirmative express consent before disclosing user health information with applicable third parties for other purposes. The order requires the company to clearly and conspicuously detail the categories of health information that it will disclose to third parties.  It also prohibits the company from using manipulative designs, known as dark patterns, to obtain users’ consent to share the information.
  • Require the company to seek deletion of data: GoodRx must direct third parties to delete the consumer health data that was shared with them and inform consumers about the breaches and the FTC’s enforcement action against the company.
  • Limit Retention of Data: GoodRx will be required to limit how long it can retain personal and health information according to a data retention schedule. It also must publicly post a retention schedule and detail the information it collects and why such data collection is necessary.
  • Implement a Mandated Privacy Program: GoodRx must put in place a comprehensive privacy program that includes strong safeguards to protect consumer data.

© 2023 Dinsmore & Shohl LLP. All rights reserved.

For more Cybersecurity and Privacy Legal News, click here to visit the National Law Review

FOOTNOTES

[1] 16 CFR Part 318