Final Rules Modernizing Stark Law and Anti-Kickback Statute Released

Selina ColemanKatie PawlitzJames SegrovesNicole Aiken-ShabanJames F. HennessyAndrew LuBy Selina Coleman, Katie Pawlitz, James Segroves, Nicole Aiken-Shaban, James F. Hennessy and Andrew Lu on Posted in Fraud and Abuse Developments

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute.

As we wrote when the proposed rules were released last autumn (see client alerts here and here), the rules reflect HHS’s attempt to create exceptions and safe harbors that refine the Stark Law’s strict-liability-based civil penalties and the Anti-Kickback Statute’s criminal penalties. The goal is to prevent certain non-abusive and beneficial arrangements from finding themselves subject to enforcement activities. As HHS itself notes, the final rules are the result of its effort to address health care industry concerns that these laws, as well as the Civil Monetary Penalty (CMP) Law, function as barriers to the delivery of value-based care that would improve quality of care, health outcomes, and efficiency.

The final rules number over 1,600 pages in current form and incorporate and address over 650 comments industry stakeholders submitted in response to the proposed rules. For our overview and analysis of the final rules, please read our client alert.

CMS finalizes rule to ensure no-cost COVID-19 vaccine

David HartmannBy David Hartmann on Posted in Centers for Medicare & Medicaid Services Regulations, COVID-19, Department of Health and Human Services, Food & Drug Administration Regulations, Other CMS Developments, Other FDA Developments

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine.

The IFR governs any vaccine that is licensed by FDA under a Biologics License Application (BLA), or, significantly, receives an Emergency Use Authorization (EUA) from the Agency. While the CARES Act obligates Medicare to cover the costs of a vaccine formally approved through the BLA process, the Act does not explicitly provide for coverage of a vaccine that is alternatively authorized by FDA under an EUA. In implementing this IFR, however, CMS reasoned that an EUA is tantamount to a BLA based partly on the rigors of the process, as well as Congress’ intent to extend no-cost, rapid access to a vaccine – particularly with respect to seniors, a large population considered at high-risk to the effects of COVID-19 and which makes up the vast majority of Medicare beneficiaries.

Under the IFR, providers would be prohibited from charging for the administration of a vaccine as a condition for receiving it free from the federal government. In addition to eliminating cost, the wide-ranging IFR’s overarching goal is to remove administrative barriers and reduce potential delays to patient access to a vaccine. As such, the IFR also endeavors to create flexibilities:

  • For states maintaining Medicaid enrollment during the COVID‑19 public health emergency; and
  • In the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 public health emergency.

Significantly, the IFR also provides:

  • Enhanced Medicare payments for new COVID-19 treatments;
  • Price transparency for COVID-19 tests; and
  • An extension of Performance Year 5 for the Comprehensive Care for Joint Replacement model.

Medicare Beneficiaries

 The IFR utilizes Section 3713 of the CARES Act in order to add FDA-authorized or approved vaccines to the list of preventative vaccines covered under Medicare Part B. In addition to covering the costs of administration, the IFR also eliminates any copayment/coinsurance or deductible.

The IFR extends the same coverage of costs to Medicare Advantage (MA) participants by paying directly for the administration of a vaccine to beneficiaries enrolled in MA plans. MA plans will directly cover the costs of administration for providers who administer the vaccine to MA beneficiaries during calendar years 2020 and 2021. Similar to traditional Medicare enrollees, any copayment/coinsurance and deductibles will be waived for MA beneficiaries.

As part of the IFR, CMS announced Medicare payment rates for single-dose and multi-dose immunizations, which can be adjusted in light of practical geographic considerations related to cost. Additionally, CMS intends to announce coding instructions through program memoranda as expediently as possible once FDA authorizes or approves a vaccine.

 Medicaid Beneficiaries and the Uninsured

 The IFR generally requires state Medicaid programs to provide vaccine administration at no cost to most beneficiaries. The IFR does so by invoking the Families First Coronavirus Response Act (FFCRA), Section 6008 of which ties a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage for the duration of the COVID-19 public health emergency. That increase in funding is conditional on states covering the costs of a vaccine and its administration for Medicaid enrollees without cost sharing during the duration of the public health emergency, with additional flexibility after its expiration. While the IFR supports this general principle it is not absolute and we thus encourage stakeholders in Medicaid and CHIP programs to consult the IFR directly to ensure compliance.

As for the uninsured, under the IFR providers will be able to seek reimbursement for administration of a vaccine through the FFCRA Relief Fund and the Provider Relief Fund, as managed by the Health Resources and Services Administration. While the lion’s share of the $175 billion appropriated to the Provider Relief Fun via the CARES Act and Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) has already been spent, the FFCRA Relief Fund is intended to make available an additional $2 billion through a combination of FFCRA and PPPHCEA funds.

What’s Next

The IFR became effective on November 2, 2020, even though it will not be published in the Federal Register until November 6, 2020. CMS will accept comments on the IFR if they are submitted on or before 5:00 PM EST on January 4, 2021.

HHS further delays compliance for Interoperability and Information Blocking Rule

Nancy HalsteadVicki TankleLauren BentlageBy Nancy Halstead, Vicki Tankle and Lauren Bentlage on Posted in Department of Health and Human Services

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an advanced copy of an interim final rule with comment period (the “Interim Final Rule”) extending the compliance dates and timeframes necessary to comply with the Final Rule. In doing so, ONC sought to provide additional flexibility for health care providers and developers of certified health IT in particular, given the sustained and unprecedented strain on the health care system due to the COVID-19 pandemic.

This is the second compliance extension since the ONC announced the Final Rule in March, also due to the pandemic.  Now, in addition to extending the compliance dates relating to information blocking, the 2015 Edition Cures Update certification criteria, and the Conditions and Maintenance of Certification requirements, ONC’s Interim Final Rule offers some technical corrections and clarifications of certain points in the Final Rule.  To the relief of many regulated actors, for instance, ONC clarifies that the information blocking provisions do not explicitly require regulated actors to purchase or update certified health IT.  Instead, regulated actors must leverage their existing health IT, certified or not, in a manner that does not interfere with appropriate requests to access, exchange, or use electronic health information.  By contrast, the 2015 Edition Cures Update certification criteria do establish new functional requirements intended to facilitate interoperability and deadlines for when such functionalities must be present for a health IT product to maintain its certification.

ONC considered several factors in determining the appropriate extension length for each requirement, establishing shorter extensions for requirements that do not require the implementation of new technology, such as the information blocking provisions.  Other requirements, such as the 2015 Edition Cures Update certification criteria, do require technological updates and, accordingly, received longer extensions.

We have outlined certain key changes to the ONC Final Rule compliance timeline below.

Information Blocking

  • General Prohibition – Information Blocking: April 5, 2021
  • Condition of Certification – Information Blocking: April 5, 2021
  • Assurances Condition of Certification – Information Blocking: April 5, 2021

Application Program Interfaces (APIs)

  • Condition of Certification – Existing API Technology: April 5, 2021
  • New Standard API Certification Criterion: December 31, 2022
  • Condition of Certification – New Standardized API: December 31, 2022

EHI Export

  • Assurances Condition of Certification – Existing Data Export Certification Criterion: April 5, 2021
  • New EHI Export Certification Criterion: December 31, 2023
  • Assurances Condition of Certification – New EHI Export Certification Criterion: December 31, 2023

For questions regarding the rules or this post, please contact Nancy Bonifant Halstead, Vicki Tankle, and Lauren Bentlage, or any Reed Smith attorney with whom you work.

New Executive Order seeks to address COVID-19 impact on mental health

Lauren BentlageArielle LusardiBy Lauren Bentlage and Arielle Lusardi on Posted in COVID-19, Other HHS Developments

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic.

The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic has had on mental and behavioral health conditions due to “stress from prolonged lockdown orders, lost employment, and social isolation,” and emphasizes the importance of coordinating action across federal, state, local, and Tribal partners to effectively address these concerns. The Executive Order points to survey data issued by the Centers for Disease Control and Prevention, which indicates that during the last week of June 2020, 40.9 percent of Americans reported struggling with mental health or substance abuse issues, with 10.7 percent reporting seriously considering suicide. Accordingly, the Executive Order states that “[i]t is the policy of the United States to prevent suicides, drug-related deaths, and poor behavioral-health outcomes, particularly those that are induced or made worse by prolonged State and local COVID-19 shutdown orders.”

To address these concerns, the Executive Order focuses on the following strategies to be taken at a national level, among others:

  • Increased crisis intervention services;
  • Increased availability of and access to continuing care following an initial crisis;
  • Increased mentorship programs and support groups;
  • Increased availability of telehealth and online mental health and substance use tools and services; and
  • Public and private resources to address mental health, including factors that contribute to prolonged unemployment and social isolation.

Additionally, the Executive Order establishes a Coronavirus Mental Health Working Group (the “Working Group”) tasked with formulating an “all-of-government” collaborative response to address the mental health impacts of COVID-19. The Working Group will be co-chaired by the Secretary of Health and Human Services, Alex Azar, and the Acting Director of the Domestic Policy Council, Brooke Rollins, and will be further comprised of representatives from various federal agencies, including the Department of Justice, the Department of Housing and Urban Development, and the Office of National Drug Control Policy.

The Working Group is directed to consider the mental-and behavioral-health conditions of certain vulnerable populations who have been disproportionately impacted by the pandemic and evaluate existing protocols and evidence-based programs to identify potential strategies for improving support for these populations. Based on this review, the Working Group is further tasked with developing and submitting a plan to facilitate coordination between public and private stakeholders to improve service offerings and better assist individuals in crisis. The Working Group’s plan must be submitted to the President by November 19, 2020. Secretary Azar released a statement in support of the Executive Order, noting that it was a “welcome opportunity to increase efforts to address the mental health effects of the pandemic,” which has compounded mental health and behavioral health conditions by “adding new stresses and disrupting access to treatment.”

Finally, the Executive Order further directs the heads of agencies, in consultation with the Director of the Office of Management and Budget, to examine existing grant programs that fund mental health, medical, or related services and encourage grantees to consider adopting policies that have been shown to improve mental health and reduce suicide risk, with an emphasis on “safe in-person” services. As part of this initiative, the agencies are also encouraged to award contracts and grants to community organizations and other local entities to enhance mental health and suicide prevention services, including outreach, education, and case management services for vulnerable populations.

Patient access to health information at the forefront of government initiatives and scrutiny

Nancy HalsteadVicki TankleBy Nancy Halstead and Vicki Tankle on Posted in Department of Health & Human Services Regulations, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Other CMS Developments, Other HHS Developments, Other OIG Developments

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient). Continue Reading

CMS releases roadmap for states to accelerate adoption of value-based care

Andrew LuKelly KearneyBy Andrew Lu and Kelly Kearney on Posted in Centers for Medicare & Medicaid Services Regulations, Regulatory Developments

On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance value-based care (VBC) across their health care systems, with an emphasis on Medicaid populations, and how to share pathways for adoption­ of such approaches.  Within the 33-page letter, CMS highlights the merits of VBC; provides an assessment of key lessons learned from early state and federal experiences in implementing VBC reforms, as well as a comprehensive toolkit of available federal authorities for states to adopt for innovative payment-reform efforts within their Medicaid programs; and stresses the importance of multi-payer alignment in VBC to drive care transformation.  Notably, however, the guidance does not address prevalent concerns among providers and industry about what types of VBC arrangements could run afoul of federal and state fraud and abuse laws and/or which entities can participate in such arrangements.

Merits of Value-Based Care Arrangements

Under VBC arrangements, providers are rewarded—based on specific evidence of performance on negotiated quality measures—for helping patients improve their health, reduce the effects and incidence of chronic disease, and live healthier lives.  That is, VBC arrangements can hold providers accountable by tethering reimbursement to their ability to improve quality of care in a cost-effective manner or lower costs while maintaining standards of care, rather than the volume of care they provide.  Moreover, according to the guidance, VBC can be a part of the solution to reducing health disparities in the health care system and handling unexpected challenges, including those brought about by the COVID-19 pandemic.

Value-Based Payment as Key Driver

CMS points to value-based payment as the key driver of VBC.  Accordingly, the guidance highlights and explains critical elements of value-based payment design and operations, including:

  • Level and scope of financial risk;
  • Benchmarking; and
  • Payment operations.

Additionally, the guidance discusses in depth several key considerations for states pursuing value-based payment, including:

  • Multi-payer participation;
  • Assessment of delivery system readiness;
  • Robust health information exchange and technology;
  • Stakeholder engagements;
  • Quality measure selection; and

Availability of Alternative Payment and Delivery Models

To further facilitate the advancement of value-based payment methodologies in state Medicaid programs, the guidance outlines the key features and applicable Medicaid authorities for various payment and service delivery models, with examples of each, including:

  • Payment models built on fee-for-service architecture;
  • Payments for “episodes of care”; and
  • Payment models involving total cost of care accountability.

The guidance notes that these payment models are not mutually exclusive, and ultimately encourages states to consider the adoption of one or more of them—or, if need be, pursue other delivery system reforms via section 1115(a) waiver authority—depending on their individual program circumstances and reform goals.

Lack of Detail Surrounding What Types of Value-Based Care Arrangements are Impermissible and/or Which Entities Can Participate in Such Arrangements

Significantly, despite the strong push by CMS for state movement towards VBC, the guidance does not provide any discussion or detail about what types of VBC arrangements could run afoul of federal and state fraud and abuse laws and/or which entities can participate in such arrangements.  Without clear (or at least better) guideposts for providers and industry, active participation in VBC arrangements will continue to be stifled by ongoing concerns about the potential risk of liability.

Overall, the guidance represents a step in the right direction towards VBC at the state level.  According to CMS, although many states have made progress, there remain growth opportunities for more states to improve health outcomes and efficiency across payers through adoption of value-based payment models.  Should you have any questions related to VBC and navigating federal and state fraud and abuse laws, please do not hesitate to reach out to the health care attorneys at Reed Smith.

FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation

John D. KendziorRyan PateBy John D. Kendzior and Ryan Pate on Posted in Food & Drug Administration Regulations, Other FDA Developments

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important because by integrating patients’ voices throughout the total product lifecycle, concepts important to patients can be considered in the evaluation and surveillance of medical devices.

Goals of the Draft Guidance 

FDA recognizes there are many ways PRO instruments can be used during clinical studies.  As such, FDA issued the draft guidance with the following objectives:

  • Describing principles that may be considered when using PRO instruments in the evaluation of medical devices;
  • Providing recommendations about the importance of ensuring the PRO instruments are fit-for-purpose; and
  • Outlining best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach.

Principles to be considered for PRO Instruments

FDA outlines the following principles that should be considered when using PRO instruments in the evaluation of the medical device:

  • Establish and define the concept of interest (COI) the PRO instrument is intended to capture;
  • Clearly identify the role of the PRO in the clinical study protocol and statistical analysis plan;
  • Provide evidence showing that the PRO instrument reliably assesses the concept of interest; and
  • Effectively and appropriately communicate the PRO-related results in the labeling to inform healthcare provider and patient decision making.

PRO Fit-For-Purpose Criteria

As it relates to the fit-for-purpose criteria, FDA outlines three overarching principles to determine if a PRO instrument is fit for its purpose:

  1. Is the concept being measured by the PRO instrument meaningful to patients and would a change in the concept of interest be meaningful to patients?
  2. What role will the PRO instrument serve in the clinical study protocol and statistical analysis plan?
  3. Does the evidence support its use in measuring the concept of interest as specified in the clinical study protocol and statistical analysis plan?

While these points seem straightforward and clear, they are important ones that should be considered when evaluating the PRO instrument will meet FDA’s expectations. Of note, the draft guidance does not provide what level of evidence is required for a PRO to be fit-for-purpose.

PRO Instrument Best Practices

Finally, the draft guidance provides other best practices for PRO development, which include measuring concepts important to patients, ensuring PRO instruments are understandable to patients, and being clear about the role of PRO instrument in the Clinical Study Protocol and Statistical Analysis Plan.

Overall, the draft guidance provides insight into FDA’s current thinking for use of PRO instruments in medical device clinical studies and should be analyzed by sponsors considering PRO instruments. Interested stakeholders can submit comments on this draft guidance for FDA’s consideration until October 30, 2020 to docket FDA-2020-D-1564 available at https://beta.regulations.gov/docket/FDA-2020-D-1564.

[1] FDA Draft Guidance, “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation” (August 2020) (available at: https://www.fda.gov/media/141565/download).

CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations

Lara ParkinCarrie GornerBy Lara Parkin and Carrie Gorner on Posted in Centers for Medicare & Medicaid Services Regulations, Other CMS Developments, Regulatory Developments

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage of breakthrough medical devices widely available, and clarify the application of coverage standards.  In response, on September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (85 FR 54,327) that would establish an expedited Medicare coverage pathway for innovative medical devices, and codify, with some modification, the long-standing Program Integrity Manual standards to be used in making “reasonable and necessary” determinations under Section 1862(a)(1)(A) of the Social Security Act.

  1. MCIT Pathway

The proposed rule sets up the Medicare Coverage of Innovative Technology (MCIT) pathway, under which breakthrough devices, which are designated as part of the Food and Drug Administration’s (FDA) Breakthrough Devices Program, would be covered under Medicare from the moment the device receives FDA market authorization, either through receipt of FDA Premarket Approval, 510(k) clearance or the granting of a De Novo classification request. Under the MCIT proposal, an item or service that receives a breakthrough device designation from the FDA would be considered “reasonable and necessary” under section 1862(a)(1)(A) of the Act because breakthrough devices are innovative, serve unmet needs and have already met the FDA’s “unique breakthrough devices criteria.”

This coverage would continue for up to 4 years, allowing the manufacturer time to submit a National Coverage Determination (NCD) request.  Currently, Medicare coverage pathways include (among other things) local coverage determinations (LCDs) or case-by-case decisions of whether a device will be covered while CMS is processing the NCD, which can take 9-12 months.  The delay for NCDs and local coverage of immediately available coverage pathways under the LCDs result in inconsistent results nationwide. In contrast, the MCIT proposal would allow for immediate national Medicare coverage of any FDA-market authorized breakthrough device, subject to meeting the criteria under the program.  CMS proposes to work closely with the FDA through the regulatory process for these devices to ensure immediate Medicare coverage upon market authorization. The MCIT pathway would be voluntary, requiring device manufacturers to affirmatively opt in.  CMS proposes regulations codifying the MCIT pathway at 42 C.F.R. Part 405, Subpart F.

The FDA’s Breakthrough Device Program is targeted at streamlining approval of devices “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Also, these devices must be either 1) a breakthrough technology; 2) a device for which there is no approved or cleared alternatives; 3) a device that offers significant advantages over existing approved or cleared alternatives; or 4) a device whose availability is in the best interest of patients.

  1. Defining “Reasonable and Necessary”

EO 13890 also directs the Secretary to “clarify the application of coverage standards.”  Accordingly, the proposed rule would codify the long-standing Program Integrity Manual definition of “reasonable and necessary” for items and services that are furnished under Medicare Parts A and B.  CMS has the authority to determine if a particular medical product or service is “reasonable and necessary” under § 1862(a)(1)(A) of the Social Security Act. To date, there have been no formal regulations on this term, yet the Medicare Program Integrity Manual does provide instructions for Medicare contractors in this regard.

We propose that an item or service would be considered ‘‘reasonable and necessary’’ if it is—(1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is—

  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • One that meets, but does not exceed, the patient’s medical need; and
  • At least as beneficial as an existing and available medically appropriate alternative.

We also propose that an item or service would be ‘‘appropriate for Medicare patients’’ under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.[1]

The comment period is open now and runs until November 2, 2020. Comments can be submitted electronically through http://www.regulations.gov  or by mail. Specifically, CMS is requesting comments on whether it should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study. Additionally, CMS wishes commenters to provide feedback on whether the MCIT should also include diagnostics, drugs and/or biologics that utilize breakthrough approaches as they are not currently included in the MCIT pathway. A fact sheet on the proposed rule can also be found on CMS’s website at  https://www.cms.gov/newsroom/fact-sheets/proposed-medicare-coverage-innovative-technology-cms-3372-p.

 

[1] 85 FR 54,328 (emphasis added).  Codification of this proposal would revise 42 C.F.R. §  405.201.

CMS unveils additional COVID-19 LTC facility testing and reporting rules during public health emergency

James F. HennessyShaylynn VeederBy James F. Hennessy and Shaylynn Veeder on Posted in Centers for Medicare & Medicaid Services Regulations, Other CMS Developments, Regulatory Developments

On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control COVID-19 transmission during the continuing public health emergency (“PHE”).

New LTC Resident and Staff COVID-19 Testing Requirements

The IFC’s key LTC regulatory revision involves the amendment of existing infection control requirements to require COVID-19 testing for all facility residents and staff.  Applicable facilities must also electronically report COVID-19 information, including suspected and confirmed resident and staff infections, in a standardized format specified by the HHS Secretary.  Below are additional details regarding the IFC’s new testing requirements:

  • Individuals Subject to Testing. The new COVID-19 testing requirements apply to all residents and staff that physically work on-site at an applicable LTC factility.  “Staff,” for the purposes of the IFC, includes “any individuals employed by the facility, any individuals that have arrangements to provide services for the facility, and any individuals volunteering at the facility.”  CMS indicated that the new testing mandate may implicate individuals providing services for a facility “under arrangement,” including, for example, a hospice with an agreement to provide care for LTC facility residents.
  • Testing Parameters.  LTC facilities must conduct the newly required testing in accordance with forthcoming Secretary-implemented parameters, which may include testing frequency, result response timing, identification of symptoms, and asymptomatic testing guidelines.  CMS is also requiring all resident and staff COVID-19 testing to be conducted in a manner consistent with current professional standards of practice.  The IFC provides little guidance regarding what constitutes “professional standards of practice,” other than to confirm that the applicable standards are those that exist at the time the care or service is delivered.  CMS is soliciting comments regarding any other appropriate testing parameters that the Secretary should consider for implementation.
  • Testing Documentation and Policies.  CMS is also requiring that the completion and results of each resident and staff COVID-19 test be appropriately documented in staff personnel records, resident medical records, or other individual files, as applicable.  LTC facilities must also maintain appropriate policies and procedures, including those addressing instances where residents and staff refuse or are unable to be tested, access to and acquisition of testing supplies, and emergency staffing strategies.
  • Transmission Prevention.  CMS expects that LTC facilities will take action to prevent transmission when a resident or staff member presents with COVID-19 symptoms or a positive test result.  Specifically, CMS transmission prevention recommendations include restricting facility access for an affected staff member until the applicable individual is deemed safe to return to work, or, in the case of facility residents, the implementation of “cohorting” procedures, which involve the confinement of residents who are known or suspected to have COVID-19 to a specified area of the facility and not sharing staff beyond those residents’ “cohort.”

New CMPs for LTC Data Reporting Violations

The IFC also strengthens CMS’s ability to enforce recently imposed LTC facility reporting requirements, which were established on May 8, 2020, in an effort to support ongoing COVID-19 surveillance.  Specifically, these recently implemented reporting regulations require nursing homes to report COVID-19 and infection control data to the CDC National Healthcare Safety Network (“NHSN”) at least weekly.  The IFC’s enhanced enforcement mechanisms center on the imposition of civil monetary penalties (“CMPs”) for each week that a facility fails to electronically report required COVID-19 data through the NHSN system.

As set forth under the IFC, LTC facilities must pay a $1,000 CMP for the first instance of reporting noncompliance, a figure that will increase by $500 for each subsequent weekly reporting failure.  For example, an LTC that fails to meet the data reporting requirements will receive a $1,000 CMP for the first week of reporting violations, $1,500 for the second week, and $2,000 for the third week.  This weekly $500 penalty escalation process will continue until the penalty amount reaches a $6,500 cap after 12 weeks of noncompliance.  Subsequent violations occurring beyond that 12-week period will continue to be assessed at $6,500 per week.  If a facility is unable to meet reporting requirements and/or experiences financial hardship, that facility may dispute the findings under an independent informal dispute resolution process set forth under 42 C.F.R. Part 488.431, and the facility may submit a financial hardship request to CMS.  The foregoing CMP enforcement policies will continue in effect for up to one year beyond the end of the PHE.

The IFC’s changes become effective as of the rule’s anticipated September 2, 2020, Federal Register publication, and unless otherwise noted, the changes will remain in effect only for the duration of the PHE.  Any comments must be received within 60 days of the September 2 Federal Register publication to be considered.

Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect

Carol LoepereRebecca E. DittrichTaber RueterBy Carol Loepere, Rebecca E. Dittrich and Taber Rueter on Posted in Centers for Medicare & Medicaid Services Regulations, Department of Health and Human Services, Legislative Developments, Other CMS Developments

With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the Eastern District of New York (EDNY) issued an order staying the repeal of certain parts of the former regulations. On June 19, 2020, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) published a final rule scaling back nondiscrimination regulations first released in 2016 to implement Section 1557 of the Affordable Care Act (ACA). The 2016 regulations had imposed significant requirements on health care providers to ensure that all individuals were provided “meaningful access” to care. As part of the 2016 regulations, OCR banned discrimination “on the basis of sex,” which was defined broadly as “on the basis of pregnancy, false pregnancy, termination of pregnancy, or recovery therefrom, childbirth or related medical conditions, sex stereotyping, or gender identity.” The 2020 final rule revised the 2016 regulations significantly, however. In one of its most controversial changes, OCR removed the definition of “on the basis of sex” contending that “on the basis of sex” shall revert to the “plain meaning” of the term “sex” in Title IX of the Civil Rights Act – meaning not to encompass discrimination on the basis of sexual orientation or gender identity. OCR’s decision came on the heels of a Supreme Court ruling in Bostock v. Clayton County, Ga. four days prior which concluded that discrimination “on the basis of sex” encompasses claims based on gender identity and sexual orientation under Title VII of the Civil Rights Act. Accordingly, within the course of less than a week, the Supreme Court broadly interpreted the same term that OCR severely limited.

Shortly after OCR announced its reversal of the nondiscrimination requirement based on gender identity and sexual orientation, various interest groups began mounting legal challenges. With the order issued by EDNY on August 17, 2020, we are already seeing evidence of the legal battles likely to ensue over the definition of “on the basis of sex,” placing certain parts of OCR’s final rule in legal limbo. Continue Reading

“Contrary to the Public Interest”: CMS invokes retroactive-rulemaking authority to escape consequences of Allina

James SegrovesDavid BenderBy James Segroves and David Bender on Posted in Centers for Medicare & Medicaid Services Regulations, Department of Health and Human Services, Regulatory Developments

Earlier this month and with little fanfare, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would invoke CMS’s rarely used retroactive-rulemaking authority to essentially ensure that, despite the Supreme Court’s adverse rulemaking decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), CMS will apply the same Medicare payment methodology found procedurally improper in Allina. CMS’s invocation of its retroactive-rulemaking authority to effectively circumvent Allina sets a potentially dangerous precedent that should not go unnoticed by all Medicare stakeholders. Continue Reading

CMS Releases Proposed Physician Fee Schedule Rule for 2021

Lara ParkinMegan EngelBy Lara Parkin and Megan Engel on Posted in Other CMS Developments

On August 4, 2020, the Centers for Medicare and Medicaid Services (“CMS”) posted for inspection the Proposed 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 17, 2020, and among its many proposals, would update and revise: (1) the physician fee schedule relative value units; (2) practice expense relative value units; (3) telehealth service approval and reimbursement policies; (4) the direct supervision requirement; (5) payment for teaching physicians; (6) medical records documentation policies; and (7) policies regarding opioid treatment programs.

Comments to this proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020. Continue Reading

Proposed Outpatient Prospective Payment System Rule for CY 2021

Lara ParkinLesley ReynoldsBy Lara Parkin and Lesley Reynolds on Posted in Other CMS Developments

Includes proposed changes to the OPPS and ASC payment rates and Stark Law exemptions.

On August 4, 2020, CMS posted for inspection the Proposed Outpatient Prospective Payment System (“OPPS”) Rule for 2021.  The proposed rule is scheduled for publication in the Federal Register on Wednesday, August 12, 2020 and would revise the Medicare hospital OPPS and the Medicare Ambulatory Surgical Center (“ASC”) payment systems for calendar year (“CY”) 2021.  The proposed rule would also update the requirements for the Hospital Outpatient Quality Reporting (“OQR”) and the ASC Quality Reporting (“ASCQR”) programs.  In addition, the proposed rule would establish the overall Hospital Quality Star Rating beginning with CY 2021, remove certain restrictions on the expansion of physician-owned hospitals that qualify as “high Medicaid facilities,” and clarify that certain beds are included in a hospital’s baseline number of operating rooms, procedure rooms, and beds.  Comments to this proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020.

OPPS Payment Rates:

The proposed rule would increase the payment rates under the OPPS by an OPD fee schedule increase factor of 2.6%, based on the proposed inpatient market basket increase of 3% under the inpatient payment schedule minus the multifactor productivity (“MFP”) adjustment required by the Affordable Care Act of .4%.  The proposed rule would continue to implement the statutory 2% reduction in payments for hospitals failing to meet the hospital OQR requirements.

Inpatient Only List:

The proposed rule would implement changes to the inpatient only (“IPO”) list for CY 2021.  CMS intends to eliminate the IPO list over the course of 3 years beginning with the removal of approximately 300 musculoskeletal-related services.  CMS is seeking comment specifically regarding the proposed 3-year timeline, additional services for deletion in 2021 and the sequences with which to remove services in the future.

Device Pass-Through Payments:

Devices that are eligible for pass-through payment under the OPPS are separately paid under the ASC payment system and are contractor-priced.  In the proposed rule, CMS discusses five specific applications for device pass-through payments, two of which have received preliminary approval under the fast-track application system.  CMS is soliciting comments on these devices and a final decision on all five devices will appear in the final rule.

Continued Additional Payments to Cancer Hospitals:

CMS proposes to continue providing additional payments to cancer hospitals so that a cancer hospital’s payment to cost ratio (“PCR”) is equal to the weighted average PCR for other OPPS hospitals.  The 21st Century Cures Act, however, requires that the weighted average PCR be reduced by 1%.  Accordingly, CMS proposes a target PCR of .89 would be used to determine the CY 2021 cancer hospital payment.  In other words, the payment adjustments will be the additional payments needed to result in a PCR equal to .89 for each cancer hospital.

ASC Payment Rates and Additional Procedures:

For CY 2019 through 2023, CMS adopted a policy to update the ASC payment system using the hospital market basket updates.  Accordingly for CY 2021, CMS proposes to increase the payment under the ASC payment system by 2.6% for ASCs that meet ASCQR requirements.  The proposed rule would also add eleven procedures to the ASC covered procedures list, including total hip arthroplasty.

Quality Reporting:

The proposed rule would revise and codify certain administrative procedures, and create and expanded review and corrective process.  According to CMS, the proposed rule would not add or remove any quality measures.  Among other measures, the proposed rule would codify the policy requiring that Hospitals sharing the same CMS Certification Number must combine data collection and submission across their multiple campuses for all clinical measures for public reporting purposes.  The proposed rule would also codify certain, previously finalized, quality data validation policies.

Overall Hospital Star Rating:

CMS proposes a methodology to calculate the Overall Hospital Star Rating, utilizing data collected on hospital inpatient and outpatient measures that are publicly reported on a CMS website including data from the Hospital OCR Program.  CMS is also proposing to include Veterans’ Health Administration Hospitals and Critical Access Hospitals in the Overall Hospital Star Rating.  The Overall Hospital Star rating is proposed to be codified at 42 C.F.R. § 412.190.

Physician-Owned Hospitals:

The proposed rule includes two proposals related to physician-owned hospitals and the rural providers and “whole hospital” exceptions to Section 1877 of the Social Security Act, also known as the prohibition on physician self-referral or the Stark Law.

  1. The removal of unnecessary regulatory restrictions on high-Medicaid facilities:

Certain types of physician ownership, including rural providers or “whole hospital” ownership are exempt from the Stark Law’s prohibitions, provided that certain conditions are met.  Absent an exception, which may be requested only once every two years, hospitals utilizing these exemptions may not increase the number of operating rooms, procedure rooms, and beds beyond that for which the hospital was licensed on March 23, 2010.  The proposed rule would revise section 42 C.F.R. § 411.362(c)(1) to permit “high-Medicaid” facilities to request an exception to the prohibition on expansion of facility capacity more frequently than once every two years.  A “high-Medicaid” facility, under the proposed rule, could request an exception to the prohibition on expansion of facility capacity at any time, provided that the “high-Medicaid” facility has not already submitted another request for exception on which CMS has not yet issued a decision.

  1. Including beds in a physician-owned hospital’s baseline consistent with state law:

As noted above, to qualify for the rural provider or “whole hospital” exemption to the Stark Law’s prohibitions, a hospital may not increase capacity beyond that for which the hospital was licensed on March 23, 2010 (with certain exceptions).  The statute and regulations refer to this number as the hospital’s “baseline” number of operating rooms, procedure rooms, and beds.  CMS states that in interpreting and applying the physician self-referral law, CMS defers to state law with respect to whether a bed is licensed at a certain date.   Accordingly, CMS proposes to revise the definition of “baseline number of operating rooms, procedure rooms, and beds,” at 42 C.F.R. § 411.362(a) to include the following language: “For purposes of determining the number of beds in a hospital’s baseline number of operating rooms, procedure rooms, and beds, a bed is included if the bed is considered licensed for purposes of State licensure, regardless of the specific number of beds identified on the physical license issued to the hospital by the State.”  In other words, CMS will consider a bed to be “licensed” if it is within the hospital’s State-approved “bed complement.”

The inspection copy of the proposed rule is posted on the Federal Register website and is available at: https://www.federalregister.gov/documents/2020/08/12/2020-17086/medicare-program-changes-to-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center

Meeting: Advisory Panel on Hospital Outpatient Payment

On August 10, 2020, CMS published a meeting notice announcing a virtual meeting of the Advisory Panel on Hospital Outpatient Payment for 2020 (the “Panel”).  Advice provided by the Panel is considered by CMS when preparing updates to the OPPS.

The virtual meeting is scheduled for Monday, August 31, 2020 from 9:30 a.m. to 5 p.m. EDT.  Presentations and comment letters must be received by 5 pm on Friday, August 14, 2020 to be considered at the meeting.

More information on comment submission and registration, as well as the meeting agenda, is available in the Federal Register notice, available at:  https://www.govinfo.gov/content/pkg/FR-2020-08-10/pdf/2020-17398.pdf

 

New developments in False Claims Act litigation: Ninth Circuit rules that denial of government motion to dismiss is not immediately appealable as of right

Kristin ParkerCaitlin ChambersBy Kristin Parker and Caitlin Chambers on Posted in Fraud and Abuse Developments

On August 4, 2020, the Ninth Circuit, in a decision authored by Judge Wardlaw, dismissed for lack of jurisdiction an atypical appeal filed by the Federal Government from a district court’s order denying the Government’s motion to dismiss a qui tam case filed under the False Claims Act (“FCA”).  See United States v. United States ex rel. Thrower, No. 18-16408 (9th Cir. Aug. 4, 2020).  Stay tuned, however, as the Ninth Circuit’s decision is unlikely to be the last appellate decision to address the issue.

In the underlying case, the Government, after declining to intervene in an action brought by a relator in the Northern District of California, later sought dismissal under 31 U.S.C. § 3730(c)(2)(A).  Section 3730(c)(2)(A) provides that “[t]he Government may dismiss [a qui tam] action notwithstanding the objections of the [relator] if the [relator] has been notified by the Government of the filing of the motion and the court has provided the [relator] with an opportunity for a hearing on the motion.”

This case is one of several in which the Government has moved to dismiss qui tam actions consistent with principles enumerated in the so-called Granston Memo, named for its author, then-Department of Justice (“DOJ”) Civil Fraud Director Michael Granston, in January 2018.  The Granston Memo encouraged DOJ attorneys to seek the dismissal of meritless qui tam actions that do not serve the Government’s interests due to concerns including the resources required to monitor meritless FCA cases and the potential for those cases to generate adverse decisions that negatively affect government enforcement.  The memo further outlined a non-exhaustive list of factors that DOJ should use to determine whether to seek dismissal when it has otherwise declined to intervene, including: (1) curbing meritless qui tam cases; (2) preventing parasitic or opportunistic qui tam cases; (3) preventing interference with agency policies and programs; (4) controlling litigation brought on behalf of the United States; (5) safeguarding against classified information and national security interest; (6) preserving government resources; and (7) addressing egregious procedural errors.

The district court, however, denied the Government’s motion after concluding that the Government failed to meet its burden (established under earlier Ninth Circuit precedent) of demonstrating a valid governmental purpose related to the dismissal and because it failed to fully investigate the allegations of the amended complaint.  Thereafter, the Government sought immediate appellate review of the district court’s denial under the collateral order doctrine, which is a narrow exception to the final judgment rule that otherwise requires parties to wait for a final judgment before appealing any district court ruling.  However, in its recent decision, the Ninth Circuit dismissed the appeal and held that: (1) the jurisdictional question was an issue of first impression that had not been resolved by the Supreme Court; (2) the collateral order doctrine did not apply because the district court’s order did not decide important issues separate from the merits; and (3) where the Government has declined to intervene in an FCA case, the interest implicated by an erroneous denial of a government motion to dismiss is not sufficiently important to justify an immediate appeal under the collateral order doctrine.

As noted above, the Ninth Circuit is unlikely to be the last circuit court of appeals to address this unique jurisdictional issue. Another federal appellate court (the Seventh Circuit) is currently considering the same question in an appeal argued earlier this year.  See United States v. CIMZNHCA, LLC, No. 19-2273 (7th Cir.).  In the meantime, defendants faced with such qui tam actions are well advised to keep lines of communication with the Government open and advocate for such motions to dismiss when the facts and circumstances so warrant.

Final rules modernizing Anti-Kickback Statute and Stark Law under review by OMB: anticipating the future of value-based care

Rebecca E. DittrichDavid BenderBy Rebecca E. Dittrich and David Bender on Posted in Fraud and Abuse Developments

The much-anticipated final rules modernizing the safe harbors under the Anti-Kickback Statute (AKS) and the physician self-referral exceptions under the Stark Law are officially under review by the Office of Management and Budget (OMB). The Department of Health and Human Services (HHS) anticipates publishing the final rules in August 2020, although that target date is subject to change. The final rules represent HHS’s efforts to remove barriers to effective care coordination and management as part of its “Regulatory Sprint to Coordinated Care” initiative. While the proposed rules made a sweeping effort to promote a value-based health care delivery system, they left notable and significant room for public comment on the various options under consideration by HHS’s Centers for Medicare & Medicaid Services (CMS) and Office of Inspector General (OIG) to achieve their goals. As a result, health care providers eager to benefit from the protections of these potential value-based changes to AKS and Stark will be interested in CMS’s and OIG’s final decisions in the following key areas.

  1. What Qualifies as a Value-Based Activity?

In their proposed rules, OIG and CMS developed three new tiered safe harbors and exceptions that offer increasing flexibility to value-based arrangements based on the level of financial risk accepted by each participant. As a gatekeeping matter, to be protected, any value-based arrangement must be for the provision of at least one value-based activity for a target patient population that is reasonably designed to achieve a value-based purpose and must be between a value-based enterprise and one of its participants, or between participants in the same value-based enterprise. As summarized in Reed Smith’s three-part series analyzing the proposed rules, this means two or more persons or entities must collaborate, and be accountable, to achieve improved care coordination, quality, or efficiency for a defined patient population by taking, or refraining from taking, an action tailored to that improvement.

The value-based arrangement safe harbors proposed by OIG required that the value-based activities directly further coordination and management of care for the target patient population. CMS did not similarly limit the scope of value-based activities in its proposed rule, and did not define the “coordinating and managing care” concept (but sought comment on whether it should). Instead, CMS only required that the value-based activities be reasonably designed to achieve a value-based purpose. Many commenters will be interested to find out whether CMS narrows its scope—or, alternatively, OIG broadens its scope—with respect to what will be considered a value-based activity protected under a value-based arrangement.

  1. Who Qualifies as a Value-Based Enterprise Participant?

The proposed rules sought to exclude pharmaceutical manufacturers; durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) manufacturers, distributors, and suppliers; and laboratories from qualifying as value-based enterprise participants—and considered adding pharmacy benefit managers (PBMs), medical device manufacturers, and other wholesalers and distributors to the list of excluded entities. If those exclusions are maintained in the final rules, they have the potential to significantly limit value-based care and activities that would otherwise benefit from the proposed safe harbors and exceptions.

For example, despite excluding DMEPOS manufacturers, distributors, and suppliers as potential value-based enterprise participants, OIG included health technology companies. Oftentimes, however, those two entities can be one in the same. Many medical device manufacturers and DMEPOS distributors, manufacturers, and suppliers have led the digital health era by creating technologies that give patients and providers real-time insight into the data collected by the products those patients use or wear. The care coordination efforts supported by these technologies could be hindered by taking away the device or DMEPOS manufacturer’s seat at the value-based participant table. While these manufacturers, distributors, and suppliers could still sell their products to other value-based enterprise participants at fair market value, the exclusion of those entities could have a chilling effect that prevents participants from wanting to buy. How OIG ultimately handles the list of qualified value-based enterprise participants in its final rule might foreshadow the extent to which digital health technologies will play a role in value-based arrangements and care coordination moving forward.

  1. Whether the Care Coordination and Value-Based Arrangement Protections Are Limited to In-Kind Remuneration.

In their proposed rules, OIG and CMS considered limiting their care coordination safe harbor and value-based arrangement exceptions to in-kind remuneration only. If finalized, these protections would be limited to items and services only, and would not be available for any monetary remuneration, such as shared savings.

This restriction could also extend to OIG’s proposed patient engagement safe harbor, which OIG proposed to only protect in-kind patient engagement tools, such as health-related technology, patient health-related monitoring tools and services, or supports and services designed to identify and address a patient’s social determinants of health. The safe harbor would exclude monetary remuneration such as gift cards, cash, and cash equivalents. That said, OIG solicited comment in its proposed rule about whether to include vouchers under the in-kind designation, and it floated whether to allow cash or cash equivalents, but with a cap. Accordingly, it remains to be seen how far the protections for remuneration will go in the interest of value-based care.

* * *

The final rules, if published, are likely to have a significant impact on nearly every facet of the health care industry seeking to engage in value-based arrangements. Given their importance and the broad scope of considerations left open for public comment, industry stakeholders should keep in mind the three key areas discussed above when considering the ways in which the final rules could impact their organizations.

For additional information on the proposed rules, please refer to Reed Smith’s three-part client alert series.

HHS releases final rule and fact sheet to clarify Part 2: Standards for Substance Use Disorder Record Protection, Disclosure, and Registry

Catherine DavidLauren BentlageArielle LusardiBy Catherine David, Lauren Bentlage, Arielle Lusardi and Adriana Santomero on Posted in Department of Health and Human Services, Substance Abuse and Mental Health Services Administration

After nearly a full year of public comment consideration, last week, the U.S. Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced and published a Final Rule and Fact Sheet addressing 42 C.F.R. Part 2 (Part 2). Generally speaking, Part 2 affords privacy protections to patient records pertaining to federally assisted substance use disorder (SUD) treatment programs. The Proposed Rule, released in August 2019, sought to balance the privacy protections of SUD patients with the need for updated coordinated care regulations. Specifically, the Proposed Rule focused on: updating protection protocol for both Part 2 and non-Part 2 records; clarifying federal standards for obtaining patient consent to disclose SUD records to various entities; and preventing duplicative SUD program enrollments and prescriptions.

The recent Final Rule implements these changes in the following ways:

  1. The Final Rule updates standards for the protection and management of Part 2 and non-Part 2 records.

The Final Rule seeks to facilitate improved coordination of care between Part 2 and non-Part 2 providers by clarifying the applicability of Part 2 requirements to non-Part 2 providers. First, the Final Rule updates the definition of “records” in 42 C.F.R. § 2.11. Under the previous definition, there was concern as to whether non-Part 2 providers could inadvertently render their own records subject to Part 2 when treating SUD patients by using patient records received from Part 2 providers to inform their own subsequent clinical encounters with and record-keeping on those patients. Under the new definition, non-Part 2 providers may receive oral disclosures from a Part 2 provider, with consent of the patient, for treatment purposes and reduce that disclosure to writing without the disclosed information thereby becoming a Part 2 record. This allows non-Part 2 providers to receive and record important information regarding the SUDs and treatment of patients with whom they have clinical encounters, without subjecting their own records to the rigors of Part 2.

Second, the Final Rule revises 42 C.F.R. § 2.12 to clarify that records generated by non-Part 2 providers based on their own patient encounters are generally not covered by Part 2 protections, even to the extent the records include information about a SUD and its treatment. However, if any SUD records from a Part 2 program are incorporated into non-Part 2 provider records, then the entire record would become subject to Part 2. To avoid the application of Part 2 requirements to non-Part 2 provider records, the Final Rule advises that the respective records should be “segregated.” Segregating the received Part 2 record from the non-Part 2 provider’s own record will allow the provider to ensure that the non-Part 2 records can be distinguished from the received record and, thus, not become subject to Part 2 requirements.

Importantly, the revisions to § 2.11 and § 2.12 work in concert to permit a Part 2 Program to make a disclosure with the patient’s consent, orally or in writing, to a recipient non-Part 2 provider and allow the non-Part 2 provider to subsequently have her own encounter with the patient and create her own patient record, which will not be subject to Part 2, even to the extent the non-Part 2 provider records information about the patient’s SUD and its treatment within that record. Notably, the requirement remains for received Part 2 records to be segregated from non-Part 2 providers’ own created records in order to insulate the latter from Part 2 regulations. Together, these changes are intended to promote secure SUD record management and facilitate care coordination among Part 2 and non-Part 2 providers.

2. The Final Rule clarifies parameters for patient consent to disclose Part 2 treatment records.

The Final Rule also revises the patient consent requirements under Part 2 in an effort to remove barriers to care coordination and expand patients’ ability to consent to disclosure of their own information.

Previously, in order for a Part 2 program or other lawful holder to disclose patient information to an entity that (1) did not have a treating provider relationship with the patient and (2) was not a third-party payor, Part 2 required the written consent document to designate both the name of the recipient entity and the name of a specific individual designated to receive the information. The Final Rule revises the consent requirements to remove the distinction between entities with a treating provider relationship and entities without a treating provider relationship, and to permit the consent to merely designate the name of the individuals or entities to whom a disclosure may be made. For instance, with this update, a patient now may simply name “Social Security Administration” as the recipient entity, without needing to also designate a specific individual at the agency to receive the information. These changes will allow patients to more easily disclose their own information to entities with which they do not have a treating provider relationship. Notably, however, the Final Rule preserves certain treating provider relationship distinctions for recipient entities that are research institutions or those that facilitate the exchange of health information.

Additionally, the Final Rule clarifies the scope of permitted disclosures with patient consent for “payment and health care operations” under 42 C.F.R. § 2.33(b) by incorporating a list of 19 illustrative (but not exhaustive) examples of permissible activities into the regulatory text. Notably, these examples include the same examples provided by SAMHSA in the preamble to the 2018 Final Rule. Additionally, we note that although SAMHSA indicated in the Proposed Rule that “health care operations” do not include disclosures for care coordination and case management, SAMHSA revised this position in the Final Rule based on public comments and the passage of the CARES Act, which expressly permits disclosure of Part 2 information for these purposes. As such, the Final Rule specifically includes care coordination and case management services in the list of permissible activities under § 2.33(b). Further, although this list of permissible activities will provide some clarity to Part 2 providers, SAMHSA also included language that permits disclosures for “other payment/health care operations activities not expressly prohibited,” which leaves the restriction on disclosures subject to interpretation.

3. The Final Rule provides methods for programs and providers to track SUD program enrollments and activities.

Finally, the Final Rule also seeks to remove barriers to the exchange of information among Part 2 and non-Part 2 providers in an effort to ensure the appropriate use of opioid therapies and reduce the risk of diversion and adverse events. First, the Final Rule expands § 2.34, relating to central registries containing information about individuals applying for withdrawal management or maintenance therapy for SUDs. This expansion permits non-Part 2 providers with a treating provider relationship with a patient to query central registries to determine whether the patient is receiving opioid treatment through an opioid treatment program (OTP). Queries can be used to prevent duplicative enrollments and/or to inform the provider’s decision making regarding the prescription of opioid medications. Second, the Final Rule adds a new section, § 2.36, which explicitly permits Part 2 programs, including OTPs, to enroll in prescription drug monitoring programs (PDMPs) in their respective states and report to the PDMP when prescribing or dispensing medications. These changes will help improve care coordination among providers treating patients with SUDs and will improve access to complete patient information, which will in turn enable providers to make more informed decisions regarding patient care.

These revisions to Part 2 were intended to clarify the parameters of patient consent for SUD disclosure and increase the ease of coordinated care among Part 2 and non-Part 2 providers. HHS asserts the Final Rule will also improve the quality of care for those with SUDs as well as further align Part 2 standards with HIPAA regulations. As both Part 2 and non-Part 2 providers are affected by the Final Rule, it will be important for all impacted entities to revisit their policies on maintaining and disclosing SUD patient records in order to achieve compliance with SAMHSA standards.

Reed Smith will soon issue a Client Alert to describe the Final Rule in greater detail, and advise on the implications of this agency action.

Bipartisan bill proposes to leverage CFIUS in assessing pharmaceutical supply chain

Michael J. LowellSarah WronskyAlison PetersManasi VenkateshPaula SalamounBy Michael J. Lowell, Sarah Wronsky, Alison Peters, Manasi Venkatesh and Paula Salamoun on Posted in Legislative Developments

On June 30, 2020, United States Senators Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) introduced legislation proposing the Committee on Foreign Investment in the United States (CFIUS), an interagency committee authorized to review certain transactions involving foreign investment in the United States for national security concerns, assist the Federal Trade Commission (FTC) in “conduct[ing] a study on the United States’ overreliance on foreign countries and the impact of foreign direct investment in the U.S. pharmaceutical industry.” In the last decade, CFIUS reviewed a number of mergers and acquisitions in the healthcare industry that resulted in a foreign person obtaining control of a U.S. pharmaceutical supplier, among other pharma entities. More recently, CFIUS jurisdiction was expanded to include not only the review of transactions that result in foreign control of a U.S. business, but also certain non-controlling foreign investments as well, including investments in biotech and companies working with genetic information of U.S. citizens.

The United States Pharmaceutical Supply Chain Review Act (full text available here),  comes on the heels of another bipartisan initiative sponsored by Senators Rubio and Warren earlier this year, the Strengthening America’s Supply Chain Act and National Security Act, which focuses on combating U.S. supply chain dependence on Chinese medical supplies. Both Acts build on Senator Rubio’s plan to protect U.S. business interests from what he describes as China’s quest for “global dominance” through China’s government-backed manufacturing and innovation initiative, Made in China 2025. In a broader context, these bipartisan Acts are consistent with the U.S. Government and CFIUS’s continued focus on China-related transactions as well as those involving other foreign parties, with particular emphasis on transactions impacting U.S. critical infrastructure (see, e.g., May 1, 2020 Executive Order on Securing the United States Bulk-Power System).

In this case, the United States Pharmaceutical Supply Chain Review Act would require the FTC and the Secretary of the Treasury, acting through CFIUS, to provide Congress with a report on the following:

  1. An assessment of: (A) the supply chain of the pharmaceutical industry of the United States and the effect of concentration and reliance on foreign manufacturing within that industry; (B) the effect of foreign investment in the pharmaceutical industry of the United States on domestic capacity to produce drugs and active and inactive ingredients of drugs; and (C) the effect of foreign investment in technologies or other products for sequencing or storage of DNA, including genome and exome analysis, in the United States, including the effect of such investment on the capacity to sequence or store DNA in the United States.
  2. The number of reviews and investigations conducted by the Committee, in each of the 10 fiscal years preceding the year in which the study is conducted, with respect to covered transactions (as defined in section 721(a) of the Defense Production Act of 1950 (50 U.S.C. 4565(a))—(A) in the pharmaceutical industry of the United States; or (B) relating to the sequencing or storage of DNA in the United States.
  3. A short description of each such review or investigation, including whether the transaction was approved or prohibited. See United States Pharmaceutical Supply Chain Review Act.

The Act intends to leverage certain CFIUS data in order to increase transparency and identify vulnerabilities in the U.S. pharmaceutical supply chain. As a practical matter, however, the utility of such data may be limited. For example, most CFIUS reviews related to U.S. pharmaceuticals in the last ten years arose from parties who voluntarily notified CFIUS of the transaction. Any data provided by CFIUS pursuant to the Act would not capture unreported (i.e., ‘non-notified’) transactions that avoided CFIUS review and therefore the proposed report may not be indicative of overall investment or industry trends.  In addition, the Act directs CFIUS to provide “a short description of each such review or investigation, including whether the transaction was approved or prohibited” but does not address whether the report to Congress would be classified.  CFIUS is generally bound by statute to maintain strict confidentiality of such information and ordinarily would not be authorized to release transaction details or results publicly.

Notwithstanding those practical limitations, the Act reflects an intensifying scrutiny by U.S. government on the role foreign parties serve in the domestic healthcare industry, particularly after COVID-19 illuminated vulnerabilities in the domestic medical supply chain capacity. For example, earlier this year, formerly reliable trade partners such as India significantly restricted exports of certain critical active pharmaceutical ingredients (APIs), the requisite components used in generic drugs. Similarly, as recently as May, as U.S. health care workers faced a dire shortage of personal protective equipment (PPE), the Food and Drug Administration (FDA) banned 65 of the 80 authorized manufacturers for N95-style face masks that were later determined to be ineffective at blocking COVID-19. With respect to pharmaceuticals, the global pandemic has left legislators, medical professionals, and policy analysts alike struggling to protect Americans’ access to critical drugs (including those to assist COVID-19 patients), as an estimated 80 percent of APIs are imported from abroad.

If signed into law, the U.S. Pharmaceutical Supply Chain Review Act would provide critical data on medical supply trade patterns as well as domestic manufacturing capacity. The Act may also prompt legislation requiring significant changes to upstream and downstream supply chains of U.S. pharmaceutical companies importing APIs.

Reliance on telehealth ramps up during COVID-19, and may be here to stay

Kelly KearneyAndrew LuBy Kelly Kearney and Andrew Lu on Posted in Department of Health and Human Services, Regulatory Developments

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers.  In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S.  However, despite the technical allowance for telehealth, many regulatory, privacy, and financial barriers have stood in the way of allowing telehealth to be the norm — that is, until the COVID-19 pandemic.

Once shelter-in-place orders went into effect across the country, there was great appeal to patients in being able to still get medical treatment and advice without leaving the safety of their homes.  Thus, federal and state regulators acted quickly to amend regulations, issue temporary waivers, and publish guidance documents setting out ways patients could communicate with, and be treated by, their providers virtually.  Many regulators even relaxed certain licensing requirements to allow providers a broader reach so that they could treat patients located in other states via telehealth.

The outcome of this quick call to action was a huge boom in telehealth — a week before the shelter-in-place orders went into effect, Medicare reported there were 11,000 telehealth visits in one week.  One month later, this number skyrocketed to 1.3 million in a single week.  The apparent success of telehealth thus far has left many wondering why this mechanism was not widely utilized before the pandemic, and the answer likely comes down to data protection and insurance.

Specifically, first, the Health Insurance Portability and Accountability Act (HIPAA) requires health care providers and insurers to protect patient data and the electronic transmission of the same.  Without the assistance of regulatory legal counsel to advise on how best to navigate privacy laws in an arguably new and nuanced space, many health care providers opted away from telehealth rather than run the risk of violating HIPAA.  Second, until the pandemic, Medicare and Medicaid would not cover telehealth services unless, for example, the patient was in a rural area or suffered a rare condition.  Now, during COVID-19, the U.S. Department of Health and Human Services (HHS) has eased many of the rules that previously made telehealth visits financially difficult.

Although many of the regulation amendments, waivers, and guidances are allegedly temporary and only in effect during the COVID-19 crisis, many industry stakeholders are wondering if they might outlast the HHS’s lift of the public health emergency.  As the state boards and federal agencies continue to adapt to these unprecedented times, we recommend that health care providers stay attuned to the laws of the states in which both they, and their patients, are located, as well as public postings and guidance documents released by federal agencies, such as the U.S. Food & Drug Administration.  Should you have any questions related to telehealth during COVID-19 and in the future, please do not hesitate to reach out to the health care attorneys at Reed Smith.

Office for Civil Rights issues final rule scaling back nondiscrimination requirements for health care covered entities as Supreme Court broadens discrimination protections

Carol LoepereRebecca E. DittrichTaber RueterBy Carol Loepere, Rebecca E. Dittrich and Taber Rueter on Posted in Department of Health and Human Services

A final rule published by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) significantly scales back nondiscrimination regulations first released in 2016. The final rule, which was published in the Federal Register on June 19, 2020, implements Section 1557 of the Affordable Care Act (ACA) and pares back numerous nondiscrimination regulations applicable to covered health care entities in an effort to reduce regulatory costs and eliminate duplicative legal obligations.

In doing so, the final rule drastically changes the interpretation of  Section 1557’s scope, waters down stringent requirements designed to promote universal access to covered programs and providers, and alters enforcement provisions. Despite these notable changes, certain core nondiscrimination provisions remain, such as communication and access standards for disabled and limited English proficiency (LEP) individuals. As a result, covered entities will need to understand how their obligations under the final rule change, what remains the same, and what to look out for moving forward when it becomes effective on August 18, 2020. Below are the new rule’s main takeaways.

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FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency

John D. KendziorRyan PateBy John D. Kendzior and Ryan Pate on Posted in Food & Drug Administration Regulations, Other FDA Developments

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel restrictions, site closures, etc.—have impeded drug and device industry innovation. Many clinical trials have been delayed; others cannot get up and running. Meanwhile, participant enrollment continues to present a challenge due to fear of infection, and logistics firms are working tirelessly to smooth unprecedented supply chain interruptions. The expected downstream effect is delayed access to important medical products. FDA’s latest guidance therefore aims to protect the continuity of clinical trials and equip sponsors to adapt to these challenging circumstances without compromising trial integrity and safety. Likewise, the guidance is not limited to trials for the development of COVID-19 treatments; the recommendations apply equally to other diseases

FDA’s statistical considerations for modifying clinical trials to address the impact of COVID-19 begin with three guiding principles:

  • Proactive planning: Sponsors should update statistical analysis plans prior to modifying primary or secondary endpoints.
  • Bias avoidance: Sponsors should not propose trial modifications that have the potential to bias the interpretation of findings and should implement safeguards such as a data monitoring committee.
  • Appropriate data selection: While making trial modifications, sponsors should focus on summaries of participant-specific data, such as null values, treatment discontinuation, treatment interruptions, trial withdrawal, and endpoints.

FDA’s guidance concludes by applying the above principles to scenarios that sponsors commonly encounter in the COVID-19 context. In each case, FDA offers detailed statistical considerations for trial design and analysis strategies. For example, FDA stresses the importance of performing sensitivity analyses to evaluate the impact of any change in endpoint definition or ascertainment.

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