Category: Health Care Law

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

FDA’s Digital Health High Notes from 2022

There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023 (you can find our blog post on it here). As important as these kinds of future reforms are to medical product developers, we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA) and to reflect on the transformations that have been taking place at the agency as a result of the rapid pace of innovation in the field. The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things, although FDA’s digital health policies generally remained consistent. In this post, we summarize the agency’s key actions in the digital health space in 2022.

Expanding into Extended Reality

Over the past few years, FDA has started a number of initiatives to explore the use of virtual, mixed, and augmented reality (the agency typically uses the term “extended reality” to cover all types of immersive digital systems) as therapeutic devices for use by patients in clinical environments and at home. The agency granted marketing authorization to two virtual reality devices for patient use, EaseVRx for chronic pain (de novo classification) and Luminopia One for treatment of lazy eye in children, in 2021 and the CureSight system, also for lazy eye in children, in 2022. It is also conducting multiple internal research projects on medical extended reality within the Center for Devices and Radiological Health (CDRH).

In conjunction with its internal research, FDA is engaging health care professionals and the industry to learn about possible benefits, as well as the risks and limitations, of medical extended reality systems to guide future decisions about the therapeutic and clinical uses of such devices. A meeting of FDA’s Patient Engagement Advisory Committee in July 2022 provided an opportunity for the agency to hear from experts and researchers in the field of extended reality and its uses, as well as companies developing medical extended reality devices and patients who have experienced such devices. The materials from the meeting are available here.

FDA also published a list of medical extended reality devices that have received marketing authorization on its website devoted to the Digital Health Center of Excellence (DHCoE), which is part of CDRH.

Application of extended reality technology and the metaverse to medicine is an exciting area of development, and we expect FDA to continue to be active in the space and to develop formal policies and guidance on extended reality devices in the near future.

Precertification Pilot Ends with Uncertain Future

FDA’s Software Precertification Pilot Program, launched in 2017 to explore innovative methods and approaches to regulating software as a medical device (SaMD), officially ended in September 2022 (see our previous posts on the Precertification program here and here). Although FDA was able to glean some key insights from the pilot, including a better understanding of SaMD manufacturer practices throughout the product life cycle, including design, development, and management of SaMD products, the agency ultimately admitted that it had encountered significant challenges in implementing the pilot program. Such challenges included:

  • limited statutory authorities, which hindered FDA’s ability to gather consistent and harmonized information on manufacturer practices and SaMD performance;
  • focusing only on SaMD for De Novo classification, which limited the number of eligible devices and created issues for testing pilot-specific special controls; and
  • the small number of participants (only nine SaMD manufacturer were accepted to the pilot program).

You can read FDA’s final report from the pilot program here.

FDA may use its observations from the pilot program when developing new guidance or other policies pertaining to SaMD, but any new rules or guidances must be consistent with the agency’s current statutory authorities. It is very likely that we have seen the end of any FDA software precertification program, unless or until Congress decides to grant the agency specific authority to implement a new or different regulatory regime for SaMD.

Leadership Changes at the Digital Health Center of Excellence

The past year marked a number of watershed changes at the DHCoE, including the departure of Bakul Patel, longstanding CDRH official in many capacities and the first director of the DHCoE, and the naming of a new acting director, Brendan O’Leary. Subsequently, in January 2023, the agency named Troy Tazbaz, former senior vice president at Oracle, as the new director of DHCoE. It will be interesting to see how Mr. Tazbaz, a newcomer to the agency, will direct the DHCoE in further developing the regulatory framework for digital health devices and in building strategic partnerships with industry stakeholders.

Digital Health Guidances

FDA introduced a number of new and revised guidance documents relating to digital health technologies in 2022. The following is a list with brief descriptions of each such agency guidance:

  • Clinical Decision Support Software (final guidance) – After a long wait (the previous draft version was published in September 2019), FDA issued a final guidance covering clinical decision support (CDS) software devices on September 28, 2022. You can find our analysis of this critical guidance in this previous post. In addition, FDA created some helpful resources to determine the regulations that may apply to a company’s CDS software or other types of SaMD: a CDS software flowchart, and a Digital Health Policy Navigator.
  • Policy for Device Software Functions and Mobile Medical Applications (revised final guidance) – FDA issued an updated version of this guidance in September 2022 to implement changes consisted with the CDS final guidance.
  • Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (draft guidance) – In recent years, FDA has repeatedly emphasized the importance of addressing cybersecurity in medical devices and has made great efforts in keeping its policies and guidance documents aligned with current cybersecurity recommendations. This guidance describes methods for incorporating cybersecurity into the design and development process for connected medical devices (including SaMD) and for maintaining cybersecurity as part of device quality systems throughout the product lifecycle. Once finalized, this guidance will supersede final guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued in October 2014. It is also worth noting that FDORA grants the agency new authorities to require cybersecurity plans as part of premarket submissions for so-called “cyber devices,” which will need to be considered and incorporated into any upcoming final guidance on this topic.
  • Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions (final guidance) & Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions (final guidance) – This pair of final guidances describes FDA’s expectations for information included in premarket notification submissions for CADe devices, and specifically for the design of clinical studies to support marketing authorization of such devices. Many companies have developed, or are interested in developing, software with CADe functionality to detect lesions or abnormalities in radiology images for the purpose of assisting human readers, and with the rapid risk of artificial intelligence/machine learning-based software, some manufacturers may seek to develop CADe software that replaces human readers altogether. These guidances are especially useful for companies developing CADe software and preparing for clinical testing and submission to FDA.
  • Electronic Submission Template for Medical Device 510(k) Submissions (final guidance) – Although this guidance does not specifically apply to digital health technologies, it represents an important development for all medical device companies, including digital health device manufacturers. FDA released this guidance in conjunction with the announcement that CDRH will accept electronic submissions of device premarket notifications from all applicants using the electronic submission template and resource (eSTAR) tool. The guidance describes the structure of the template (and helpfully cross-references other guidance documents that relate to each section of the template). FDA has designated October 1, 2023 as the date of full transition to electronic submission for premarket notifications, meaning that FDA will no longer accept eCopies of premarket notification submissions for filing and review as of that date.

As the preceding list highlights, digital health is an active and rapidly advancing field both in the private sector and at FDA. We will continue to monitor and report on notable developments in terms of regulatory policies affecting developers and investors in the broader field.

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
For more Food and Drug Legal News, click here to visit the National Law Review

Privacy Tip #359 – GoodRx Settles with FTC for Sharing Health Information for Advertising

The Federal Trade Commission (FTC) announced on February 1, 2023 that it has settled, for $1.5M, its first enforcement action under its Health Breach Notification Rule against GoodRx Holdings, Inc., a telehealth and prescription drug provider.

According to the press release, the FTC alleged that GoodRx failed “to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google, and other companies.”

In the proposed federal court order (the Order), GoodRx will be “prohibited from sharing user health data with applicable third parties for advertising purposes.” The complaint alleged that GoodRx told consumers that it would not share personal health information, and it monetized users’ personal health information by sharing consumers’ information with third parties such as Facebook and Instagram to help target users with ads for personalized health and medication-specific ads.

The complaint also alleged that GoodRx “compiled lists of its users who had purchased particular medications such as those used to treat heart disease and blood pressure, and uploaded their email addresses, phone numbers, and mobile advertising IDs to Facebook so it could identify their profiles. GoodRx then used that information to target these users with health-related advertisements.” It also alleges that those third parties then used the information received from GoodRx for their own internal purposes to improve the effectiveness of the advertising.

The proposed Order must be approved by a federal court before it can take effect. To address the FTC’s allegations, the Order prohibits the sharing of health data for ads; requires user consent for any other sharing; stipulates that the company must direct third parties to delete consumer health data; limits the retention of data; and implement a mandated privacy program. Click here to read the press release.

Article By Linn F. Freedman of Robinson & Cole LLP

For more privacy and cybersecurity legal news, click here to visit the National Law Review.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

FDA Finalizes Cannabis Guidance Focusing on Clinical Research and Quality Considerations

On January 23, 2023, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” (the Final Guidance). The agency outlines current recommendations for drug sponsors developing cannabis and cannabis-derived compounds for use in human drug clinical research. Cannabis and cannabis-derived compounds include botanical raw materials, extracts, and highly purified substances of botanical origin.[i] FDA published the draft version of the guidance in July 2020 and received 60 public comments. Below, we outline key points from the Final Guidance.

Background

  • The Agriculture Improvement Act of 2018 (Public Law 115-334), known as the 2018 Farm Bill, removed “hemp” from the definition of “marihuana” under the Controlled Substances Act (CSA). Now, hemp is not considered a controlled substance. “Hemp” is defined in the 2018 Farm Bill as including cannabis and derivatives or extracts of cannabis with no more than 0.3% by dry weight of the compound delta-9 tetrahydrocannabinol (THC). The Drug Enforcement Administration (DEA) still regulates as Schedule I controlled substances those botanical raw materials, extracts, and derivatives that contain cannabis or cannabis-derived compounds with delta-9 THC content above 0.3% by dry weight.
  • Cannabis and cannabis-derived compounds – even those meeting the 2018 Farm Bill’s definition of “hemp” – are typically subject to the same FDA clinical research regulatory requirements and standards as human drug products containing other substances.

Cannabis Sources and Quality Considerations

  • Sponsors may use cannabis (including hemp) in human drug clinical research if FDA deems the cannabis to be of “adequate quality.” The agency will review quality issues in the context of an investigational new drug (IND) application.
  • Historically, the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) was the only domestic, federally legal source of cannabis for clinical research. That is no longer the case. Human drug sponsors may now source cannabis regulated as a Schedule I controlled substance from other DEA-authorized growers.
  • Human drug sponsors should consider the recommendations in FDA’s final guidance, “Botanical Drug Development” (Dec. 2016). Importantly, the agency does not recommend relying on published literature as a substitute for data from a full toxicology program to support drug product development for phase 3 clinical research (and beyond). Dedicated toxicology studies are specifically recommended for 7-COOH-CBD, the major human metabolite of cannabidiol.

CSA Controlled Status

  • When a drug sponsor submits an IND to FDA as part of cannabis-related human drug clinical research, the sponsor should determine the potential controlled substance status of any botanical raw materials, drug substances, and drug products by taking into consideration the delta-9 THC content. The agency encourages sponsors to calculate the delta-9 THC content in the proposed investigational product early in the drug development process and to consult with the DEA.
  • Generally, the delta-9 THC percentage in botanical raw materials is calculated as the amount of delta-9 THC (and THCA) naturally present in a material sample relative to the sample’s dry weight prior to extraction or other manufacturing steps. For intermediates or finished products containing cannabis or a cannabis-derived compound, sponsors should calculate the total delta-9 THC percentage using the composition of the formulation with the amount of water removed (including water contained by excipients). These calculations should not be used for other purposes (e.g., Chemistry Manufacturing and Controls (CMC)).
  • FDA may have concerns with drug abuse liability. As part of the agency’s review of a new drug application (NDA), FDA may conduct an abuse potential assessment. Such an assessment could impact drug product labeling as well as DEA scheduling or rescheduling.

Copyright ©2023 Nelson Mullins Riley & Scarborough LLP

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

FOOTNOTES

[i] Fully synthetic versions of substances occurring in cannabis (e.g., dronabinol) fall outside the Final Guidance’s scope.

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an “identified” overpayment must be refunded, pursuant to the Affordable Care Act (ACA) and the False Claims Act (FCA) reverse false claims provision. As written, the proposed rule would remove the existing “reasonable diligence” standard for identification of overpayments, and add the “knowing” and “knowingly” FCA definition. As a result, an overpayment would be “identified” when the entity has actual knowledge of an identified overpayment, or acts in reckless disregard or deliberate ignorance of an identified overpayment. And, a provider is required to refund overpayments it is obliged to refund within 60 days of such identified overpayment.

If this proposed rule is finalized, the Department of Justice (DOJ) and Health and Human Services (HHS) Office of Inspector General’s (OIG) should be applying the same intent standard to their evaluation of potential reverse false claims and Civil Monetary Penalty liability.

The Lay of the Land

Currently, the applicable overpayment regulations state:

A person has identified an overpayment when the person has, or should have through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment. A person should have determined that the person received an overpayment and quantified the amount of the overpayment if the person fails to exercise reasonable diligence and the person in fact received an overpayment.

42 C.F.R. § 401.305(a)(2). In the 2016 Final Rule, CMS agreed “the 60-day time period begins when either the reasonable diligence is completed or on the day the person received credible information of a potential overpayment if the person failed to conduct reasonable diligence and the person in fact received an overpayment.” This reasonable diligence standard allows entities to not only determine credibility of allegations, or issues relating to, a potential overpayment but also, when credible, to conduct a properly scoped internal investigation, during which an entity also accurately quantifies any associated overpayment due for refund.

In the proposed rulemaking, CMS is suggesting instead the following standard:

A person has identified an overpayment when the person knowingly receives or retains an overpayment. The term “knowingly” has the meaning set forth in 31 U.S.C. 3729(b)(1)(A).

31 U.S.C. 3729(b)(1)(A) defines “Knowingly” as any circumstance in which “a person, with respect to information—(i) has actual knowledge of the information; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (iii) acts in reckless disregard of the truth or falsity of the information.”

The currently proposed provision has similar effect to the language CMS proposed in 2012 and, after consideration of comments, ultimately rejected in the 2014 Final Rule (Medicare Advantage and Part D) and 2016 Final Rule (Medicare Part A and Part B). In that final rulemaking, CMS removed the “actual knowledge,” “reckless disregard,” and “deliberate ignorance” terms in favor of the reasonable diligence standard, leaving practitioners to argue that CMS had lowered requisite intent to a standard less than required by the FCA.

Potential Impact

The FCA is a fraud statute, requiring intent. If a company investigating the credibility, issue, and scope of a matter (i.e., exercising reasonable diligence) also diligently determines the scope of a possible refund obligation, it would be difficult for DOJ to credibly claim an entity has acted recklessly, or with deliberate indifference to repayment under the FCA. DOJ’s general practice has been to bring reverse FCA cases when a provider does not investigate credible allegations and does not refund associated overpayments, after identifying them. For example, in a 2015 case, DOJ attorneys stated in a court conference, “[T]his is not a question … of a case where the hospital is diligently working on the claims and it’s on the sixty-first day and they’re still scrambling to go through their spreadsheets, you know, the government wouldn’t be bringing that kind of a claim.” United States ex rel. Kane v. Healthfirst, Inc., 120 F. Supp. 3d 370, 389 (S.D. N.Y. 2015).

It remains to be seen whether this change will result in an increased pursuit of reverse FCA cases. The proposed rule would eliminate an explicit diligence period (generally not to exceed six months, except in particularly complicated analyses, such as under the Physician Self-Referral or “Stark” Law) to ascertain the validity and amount of a potential obligation to refund an overpayment. The proposed rule does not explain whether providers, suppliers, and others still will have an opportunity to conduct a reasonably diligent inquiry into whether any obligation to refund exists at all, prior to the ACA 60-day clock starting to run. Ideally CMS would make clear in any preamble that the government still expects reasonable and professional efforts be undertaken before making refunds, even if that process may take some time to complete

Absent such clarity, the fact remains that it is difficult to “identify” an obligation to refund, much less any refundable amounts, without first validating the alleged overpayment and quantifying any obligation.

Additionally, this standard may prompt entities to submit an HHS-OIG self-disclosure before all facts are known. While OIG requires a disclosing party to conduct an internal investigation prior to submission, it is near impossible to thoroughly investigate issues and identify any refund 60 days from learning of a possible issue that might result in a refund (especially when multiple payors are involved). Even if a disclosing party notes within a self-disclosure that an investigation is ongoing, the disclosing party must certify that it will complete its investigation within 90 days of the submission date – which still may not be enough time based on the complexity of the allegations or claims review required. The resulting back-and-forth of incomplete information likely would create unnecessary delays in reaching a resolution and frustration among all parties involved.

We encourage all providers, suppliers, Medicare Advantage organizations, Part D participants, and other stakeholders to submit comments on this proposed rule. The public has until 5 p.m. ET on February 13, 2023 to submit comments, which are accepted, electronically or by mail.

Article By Kara (Schoonover) Sweet, Lisa M. Noller, and Lawrence W. Vernaglia of Foley & Lardner LLP

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

© 2023 Foley & Lardner LLP

CMS Issues Calendar Year 2023 Home Health Final Rule

On November 4, 2022, the Centers for Medicare & Medicaid Services (CMS) published the calendar year 2023 Home Health Prospective Payment System Rate final rule, which updates Medicare payment policies and rates for home health agencies.  Some of the key changes implemented by the final rule are summarized below.

  • Home Health Payment Rates. Instead of imposing a significant rate cut, as was included in the proposed rule released earlier this year, CMS has increased calendar year 2023 Medicare payments to home health agencies by 0.7 percent or $125 million in comparison to calendar year 2022.

 

  • Patient-Driven Groupings Model and Behavioral Changes. A -3.925 percent permanent adjustment to the 30-day payment rate has been implemented for calendar year 2023. The purpose of this adjustment is to ensure that aggregate expenditures under the new patient-driven groupings model payment system are equal to what they would have been under the old payment system. Additional permanent adjustments are expected to be proposed in future rulemaking.

 

  • Permanent Cap on Wage Index Decreases. The rule finalizes a permanent 5 percent cap on negative wage index changes for home health agencies.

 

  • Recalibration of Patient-Driven Groupings Model Case-Mix Weights. CMS has finalized the recalibration of the case-mix weights, including the functional levels and co-morbidity adjustment subgroups and the low utilization payment adjustment thresholds, using calendar year 2021 data in an effort to more accurately pay for the types of patients home health agencies are serving.

 

  • Telehealth. CMS plans to begin collecting data on the use of telecommunications technology under the home health benefit on a voluntary basis beginning on January 1, 2023, and on a mandatory basis beginning on July 1, 2023. Further program instruction for reporting this information on home health claims is expected to be issued in January of 2023.

 

  • Home Infusion Therapy Benefit. The Consumer Price Index for all urban consumers for June 2022 is 9.1 percent and the corresponding productivity adjustment is a reduction of 0.4 percent. Therefore, the final home infusion therapy payment rate update for calendar year 2023 is an increase of 8.7 percent. The standardization factor, the final geographic adjustment factors, national home infusion therapy payment rates, and locality-adjusted home infusion therapy payment rates will be posted on CMS’ Home Infusion Therapy Services webpage once the rates are finalized.

 

  • Finalization of All-Payer Policy for the Home Health Quality Reporting Program. CMS has ended the temporary suspension of Outcome and Assessment Information Set (OASIS) data collection on non-Medicare/non-Medicaid home health agency patients. Beginning in calendar year 2027, home health agencies will be required to submit all-payer OASIS data, with two quarters of data required for program year 2027. A phase-in period will occur from January 1, 2025 through June 30, 2025, and during that time the failure to submit the data will not result in a penalty.

 

  • Health Equity Request for Information. The comments received from stakeholders providing feedback on health equity measure development for the Home Health Quality Reporting Program and the potential future application of health equity in the Home Health Value-Based Purchasing Expanded Model’s scoring and payment methodologies are summarized in the final rule.

 

  • Baseline Years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model. For the Expanded Home Health Value-Based Purchasing Expanded Model, CMS is: updating definitions, changing the home health agency baseline calendar year (from 2019 to 2022 for existing home health agencies with a Medicare certification date prior to January 1, 2019, and from 2021 to 2022 for home health agencies with a Medicare certification date prior to January 1, 2022); and changing the model baseline calendar year from 2019 to 2022 starting in 2023.

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Copyright © 2022 Robinson & Cole LLP. All rights reserved.

Colorado Legalizes Therapeutic Psychedelics – Now What?

Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.

Colorado voters narrowly approved Proposition 122 with nearly 53% of the votes (as of the morning of November 14th 97% of the votes have been counted). Their vote thus enacted the Natural Medicine Health Act of 2022 (NMHA) which legalizes supervised or facilitated therapeutic sessions for adults twenty-one years and older using certain psychedelic plants and fungi. Click here for our initial takeaways and a high-level summary of key provisions of the NMHA.

Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below are key dates and next steps as Colorado navigates implementation of the NMHA.

  • The Colorado Department of Regulatory Agencies (DORA) must establish the Natural Medicine Advisory Board (Board) and appoint initial members to the Board by January 31, 2023. The Board must have 15 members who will be appointed by the Governor with the consent of the Colorado Senate. The primary role of the Board is to advise DORA as to implementation of the NMHA program.
  • By September 30, 2023, and annually thereafter, the Board must make recommendations to DORA on certain areas related to natural medicine, such as recommendations related to product safety, herm reduction, and cultural responsibility, training programs, educational and experiential qualifications for facilitators, regulatory considerations for each type of natural medicine and the rules to be promulgated by DORA.
  •  DORA has until January 1, 2024 to adopt rules and establish the qualifications, education and training requirements that facilitators must meet prior to providing natural medicine services to participants.
  • By September 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines, and any categories of licensure as determined by DORA.
  • Once applications are accepted, DORA must make decisions on licensure applications within 60 days of receiving an application.
  • From the launch of the NMHA program until June 1, 2026, “natural medicines” are limited to psilocybin and psilocyn. After June 1, 2026, upon recommendation by the Board, DORA may add one of more of the following to types of natural medicines that can be provided under the NMHA program: dimethyltryptamine, Ibogaine, and Mescaline (excluding peyote).

A notable takeaway and something to watch for in the forthcoming rules is a focus on social equity. Seemingly applying lessons learned from the rollout of the state’s cannabis program, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program. Specifically, DORA is required to adopt rules which: (i) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (ii) promote the licensing of and provision of natural medicine services to (a) persons from communities that have been disproportionally harmed by high rates of controlled substances (including cannabis); (b) persons who face barriers to access to health care; (c) persons who have traditional or indigenous history with natural medicines; and (d) persons who are veterans by, offering, at a minimum reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.

In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license and individuals are limited to having a financial interest in five healing centers. Currently, the definition of “individuals” does not include corporations. However, DORA could establish a rule which includes corporations in this limitation and would arguably level the playing field in this budding market.

We will continue to monitor developments and closely follow the rulemaking process as Colorado designs and implements this historical new program.

Article By Lauren P. Carboni of Foley & Lardner LLP

For more biotech, food, and drug legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of three of the big federal fraud and abuse laws that the government actively enforces; but they are not an exclusive list.  The summary below is a primer on the three main federal fraud and abuse laws and is intended to increase your basic understanding of these laws.

False Claims Act (FCA)

PROHIBITIONS:

  • Prohibits the submission of false or fraudulent claims, false statements material to a false claim, and conspiracy to commit violation
  • Prohibits concealing or avoiding obligation to repay money to government (failure to return overpayments)
  • Claims that violate AKS or Stark can also be considered false claims
  • Common false claims include lack of medical necessity; quality of care; billing/coding issues; off-labeled marketing; retention of overpayments

EXCEPTIONS:

  • n/a

PENALTIES:

  • Treble damages and as of May 9, 2022 per claim penalties between $12,537 and $25,076
  • Regulated by the DOJ

Physician Self-Referral (Stark)

PROHIBITIONS:

  • Prohibits referrals of designated health services by a physician (or an immediate family member) if the physician has a financial relationship with the entity performing the designated health service
  • Regulates financial relationships with physicians (and physician’s immediate family members) only

EXCEPTIONS:

  • The arrangement must completely satisfy an exception or it violates the Stark law

PENALTIES:

  • No criminal enforcement; CMP enforcement for knowing violations: per violation penalties– 3x claims and/or per circumvention scheme penalties; Nonpayment of claims arising from prohibited arrangement; Recoupment of amounts received; Exclusion from federal health programs; FCA liability
  • Regulated by CMS

Anti-Kickback Statute (AKS)

PROHIBITIONS:

  • Prohibits offers of, solicitation of, or payment or receipt of remuneration intended to induce referrals for health care services covered by a government program
  • Covers provision of anything of value to a person who refers, orders/purchases or recommends

EXCEPTIONS:

  • Voluntary safe harbors exist, but arrangements are not required to fit within a safe harbors

PENALTIES:

  • Applies to either party involved in an arrangement that violates AKS; Criminal penalties $100,000 /violation, up to 10 years imprisonment); Civil penalties (CMP3x unlawful remuneration and $100,000/violation); Exclusion from federal health programs; FCA liability
  • Regulated by the OIG

Providers should also be aware of other enforcement statutes such as the Eliminating Kickbacks in Recovery (“EKRA”), the Civil Monetary Penalties Act (“CMP”), and the Travel Act, to name a few, in addition to being well versed in the relevant state health care fraud and abuse frameworks.

Article By Courtney G. Tito of Nelson Mullins

For more criminal law and business crimes legal news, click here to visit the National Law Review.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

Five States Put Abortion Questions on the Ballot; Health Care and Other Employers Should Stay Tuned

In the wake of the landmark decision in Dobbs v. Jackson Women’s Health Organization, we have been closely monitoring legal developments across the country. In addition to well publicized “trigger laws” that were effectuated as a result of the U.S. Supreme Court’s order, states have taken up a variety of legislative actions in response to the ruling, which placed authority for the regulation of abortion with the states.

On Election Day, five states will have voters consider various proposals in light of Dobbs and its directive that abortion law belongs with the people. Here is a run-down of abortion-related ballot initiatives that will be put to a popular vote on November 8, 2022.

A Constitutional Amendment for California

On the ballot in California is Proposition 1: Constitutional Right to Reproductive Freedom, which would amend the state Constitution at Article I, Section 1.1, to provide that the state cannot “deny or interfere with an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.” Any amendment to the California Constitution requires a simple majority of voters. If the amendment is passed, changes take effect the fifth day after the Secretary of State files the statement of the vote for the election.

Should Proposition 1 pass, it would add express protection for reproductive freedom, including decisions about abortion and contraception, to the state constitution, under its existing guaranteed right to privacy. If the proposition does not pass, it will not affect the status quo of reproductive rights in California: while current protections for abortion and other reproductive medical care would not be constitutionally guaranteed, they would remain in place under state law.

California currently has strong protections for the right to abortion, generally only prohibiting abortion at viability. Since the Dobbs decision earlier this year, California has promoted access to abortion, including launching abortion.ca.gov, a website dedicated towards providing information on reproductive health care services to people both inside and outside of California. Recently, in late September, Governor Gavin Newsom signed a package of 12 bills of abortion protections, aimed towards improving access to abortion and protecting patients and clinicians who undergo or provide them.

With the backdrop of an already-strong California legal reproductive health network, consistent polling indicates the ballot measure is expected to pass by a wide margin. Passage of the proposition will likely signal and establish the state as a refuge for individuals from more restrictive states seeking abortions.

Michigan May Modify its Constitution, Too

Michigan will also turn to its voters to decide whether its state constitution should be amended to include protections for abortion. The Michigan proposal, referred to as “Proposal 3 of 2022 – ‘Reproductive Freedom for All’ Petition,” seeks to protect the right to an abortion with a constitutional amendment that declares a right to reproductive freedom. The petition sets forth proposed language for a new section of the Michigan Constitution, stating, in part, that “[e]very individual has a fundamental right to reproductive freedom, which entails the right to make and effectuate decisions about all matters relating to pregnancy, including but not limited to prenatal care, childbirth, postpartum care, contraception, sterilization, abortion care, miscarriage management, and infertility care.”

Proposal 3 would take effect 45 days following the ballot initiative if approved by the majority of voters. It would (1) establish new individual rights to reproductive freedom, to broadly include the right to make and carry out all decisions relating to pregnancy; (2) permit state regulation of abortion in limited circumstances; (3) forbid discrimination in enforcement of reproductive rights; (4) prohibit adverse action by the state with respect to “potential, perceived, or alleged pregnancy outcomes;” and (5) invalidate state laws that conflict with the Constitution as amended by Proposal 3.

If Proposal 3 is not passed and the state constitution remains as is, the future of the right to an abortion in Michigan will be unclear. Michigan has a pre-Roe ban that, if enforced, would prohibit abortion in nearly all situations and make abortions in non-life saving circumstances potentially prosecuted as manslaughter. However, a Michigan Court of Claims judge granted a permanent injunction in Governor Gretchen Whitmer’s suit to block local prosecutors from enforcing the ban. The ban is subject to an ongoing lawsuit.

Given the uncertainty of the ballot initiative’s outcome, Michigan employers should closely monitor the results of the November 8, 2022 vote.

Vermont’s Vote

In Vermont, abortion remains legal after Dobbs under state law. However, on November 8, 2022, voters will have the opportunity to further protect abortion rights through a ballot initiative. This initiative, referred to as Proposal 5, asks registered Vermont voters whether they are in favor of amending the state’s constitution to add the following language: “That an individual’s right to personal reproductive autonomy is central to the liberty and dignity to determine one’s own life course and shall not be denied or infringed unless justified by a compelling State interest achieved by the least restrictive means.” Passage would guarantee the right to access and obtain an abortion as well as other reproductive care, and prohibit government infringement of reproductive rights absent a compelling state interest, which would need to be achieved through the least restrictive means.

Should Proposal 5 pass, the resulting constitutional amendment is not expected to significantly alter the legal landscape of abortion in Vermont, which currently has strong protection for the right to abortion. If approved, the amendment will become part of Vermont’s constitution on November 22, 2022.

In Contrast, Kentucky Seeks to Constitutionally Exclude Abortion Rights

Kentuckians will cast their votes deciding whether to amend the state’s constitution to explicitly provide that the state constitution offers no protection for a right to abortion. The proposal further clarifies that there is no constitutional right to use public funds for abortion. “Constitutional Amendment 2” poses the following question to voters: “Are you in favor of amending the Constitution of Kentucky by creating a new Section of the Constitution to be numbered Section 26A to state as follows: ‘To protect human life, nothing in this Constitution shall be construed to secure or protect a right to abortion or require the funding of abortion?’”

If the majority of votes are affirmative, a new section will be added to Kentucky’s constitution. This does not constitute an outright abortion ban, but rather prohibits courts from finding an implicit right to an abortion within the state’s constitution. Kentucky laws restricting abortion, including those triggered by Dobbs, are among the most restrictive in the nation. Approval of Constitutional Amendment 2 would not alter these laws or their existing narrow exceptions, which permit the procedure only when necessary to preserve the health or life of the mother.

An advisory from the Kentucky Attorney General provides further color on the ramifications of the amendment, noting that Amendment 2 does not ban abortion, but rather ensures that elected officials of Kentucky’s General Assembly, and not courts, would regulate abortion. The Advisory also explains that implementation of Amendment 2 would not amend other provisions in the state’s constitution.

Montana’s Ballot – NOT a Proposed Constitutional Amendment

Abortion is currently legal in Montana, as a 1999 Supreme Court ruling held that the state constitution protects abortion under its right-of-privacy provision. However, in 2021, a number of restrictive abortion laws were enacted, including a law that prohibits abortions after 20 weeks. These laws are under legal challenge by abortion providers and are temporarily enjoined pending litigation.

Meanwhile, on the ballot for November 8 is a referendum on LR-131, also known as the Born Alive Infant Protection Act. The Act proposes a new statute that would classify any infant born alive as “a legal person” and require the provision of “medically appropriate and reasonable care” to such person. This would include all infants born alive from an induced labor, C-section, or attempted abortion. The Act also includes a provision mandating providers, employees, and volunteers to report a failure to comply to law enforcement, and sets forth criminal penalties. Violation of this law would be a felony with a maximum sentence of 20 years in prison or a fine of up to $50,000. The proposed law is aimed at health care workers, and does not impose liability on parents or other parties.

Health care providers have raised concerns that the broad language of the bill could lead to unintended consequences, particularly for OB/GYN practitioners. Health care providers would be required to take “medically appropriate and reasonable care” to keep any infant alive, but these terms are not defined in the bill. Health care workers that could be held liable include doctors, nurses, and “any individual who may be asked to participate in any way in a health care service of procedure.”

If approved by the Montana electorate, the law would take effect on January 1, 2023. Hospitals and other health care providers would need to reexamine their operating procedures to comply with the bill, should it pass, including compliance with the mandatory reporting requirement.

Keeping Up With The Changes

We continue to track litigation, legislative developments, and the entirety of the post-Dobbs legal landscape as it continues to shift. Our 50-state survey and other resources provide employers, health care providers, life sciences stakeholders, and others impacted by these rapidly changing circumstances with in-depth analysis and monthly updates. Election Day results will be another element of this evolving story.

Article By Susan Gross Sholinsky, Amy K. Dow, and Catherine Kang of Epstein Becker & Green, P.C.

For more labor and employment legal news, click here to visit the National Law Review.

©2022 Epstein Becker & Green, P.C. All rights reserved.