Tag: health care

Top Questions Health Care Providers Should Consider in a Post-Chevron World – A Polsinelli Round Table Discussion

Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”) Centers for Medicare & Medicaid Services (“CMS”), has enjoyed broad authority to regulate health care under the “Chevron doctrine.” Under this doctrine, CMS and other federal agencies were granted broad discretion to interpret and implement the law, thus allowing them to drive how care is delivered and paid for in the United States. It was difficult for providers to successfully challenge agency rulemaking in federal court, even if they thought the agency’s interpretation of the law was incorrect. The Supreme Court’s dismantling of Chevron doctrine will have a significant impact on health care providers, which we may begin to see as we move into CMS’s annual rulemaking cycle.

The Supreme Court’s decision to overturn Chevron was expected, but it is still too soon to truly understand the full impact of the decisions on the health care industry. A round table of attorneys and policy advisors from Polsinelli’s Health Care, Public Policy and Government Investigations Department discussed the potential short and long-term implications of the decision and offer the following insights for health care providers across this ever-changing industry for navigating the web of statutes, rules and other sub-regulatory guidance post-Chevron.

1. What do the Loper/Relentless Decisions Change for Health Care Organizations in the Short-Term? Has CMS’s Authority to Regulate Health Care Gone Away or Been Substantially Limited?

“Likely, not. Many of the health care regulations are based on clear statutory language and will continue to give providers the rules for the road from a compliance standpoint. More controversial rules – like mental health parity, payment cuts, surprise billing, antidiscrimination, etc. – may be further delayed or even tabled for the short term while we learn more about how these challenges will be viewed by the courts. To the extent health care providers are struggling with a rulemaking negatively impacting them, it is worth beginning to evaluate whether challenging it may be warranted.” – Bragg Hemme

“CMS’s authority to regulate today is just like yesterday and probably tomorrow. Without a challenger to a rule, any rule continues unchanged – at least for the short-term. We have already seen; however, some regulated entities challenge a particular rule to a federal court and get some immediate regulatory relief. Members of Congress who want to see large scale changes to regulatory authority may well pursue identification of rules that were upheld in lower courts citing Chevron with an eye towards vitiating those rules with broad Congressional action. There are thousands of such cases and potentially impacted rules.” – Jennifer Evans

“Where the crux of Loper Bright unravels the courts’ existing practice of deferring to regulators’ interpretation of a statute that is unclear or ambiguous, we can expect to see increased litigation that challenges agency action arguing that the foundational law for such action was ambiguous and the agency has exceeded its statutory authority. It is unlikely we will see any change in regulator action or regulatory enforcement unless and until courts begin to overturn agency action on the basis that a statute is ambiguous and the agency that interpretated the statute was incorrect. We can also expect to see increased legislation explicitly delegating more authority to agencies.” – Meredith Duncan and Sara Avakian

2. What are Some Specific Areas of Health Care Regulation that may be Impacted?  

Health Care Fraud, Waste, and Abuse Laws

“The overruling of Chevron may have a significant effect on the application of the health care fraud and abuse laws, particularly the Physician Self-Referral Law (“Stark Law”) and Anti-Kickback Statute (“AKS”). Over the years, agencies including the HHS Office of Inspector General (“OIG”) and CMS have published hundreds of pages of rules, preamble language, and explanatory sub-regulatory guidance regarding the application of these laws. Some of these interpretations favor regulated entities, while others favor enforcers. To the extent Loper Bright represents a fundamental change in the role of agencies in clarifying or refining the scope and effect of statutory language, these implementing regulations and, thus, some longstanding health care industry practices could be impacted.” – Neal Shah

Reimbursement

“Coverage and payment rules from CMS (Medicare and Medicaid) and DHA (TriCare) may be ripe for attack. It will be interesting to see if the agencies are able or willing to engage in active negotiations to avoid or settle litigation that they did not face with Chevron deference.” – Jennifer Evans

“I anticipate that many of the routine Medicare reimbursement-related rulemakings (e.g., IPPS, OPPS, Physician Fee Schedule) will continue as they have in the past. Certain aspects of those rules or any controversial rulemakings may now be up for challenge. For instance, rules related to Disproportionate Share Hospitals have already been challenged since the Loper Bright decision. Any type of payment cut or agency effort to rein in health care costs, like Medicare drug pricing rules, surprise billing, mental health parity will also be closely scrutinized and likely challenged.” – Bragg Hemme

FDA

“Immediate impact is likely to be felt by the Lab Developed Test rule FDA is trying to finalize. Congress tried, but failed, to give the FDA statutory authority in this space via the VALID Act. The FDA went ahead and went through the rulemaking process in one year. This was lightspeed for the FDA. The rule was challenged prior to the reversal of Chevron. I expect to see the plaintiff amending their complaint now.”  – Michael Gaba

Surprise Billing

“I expect the Loper/Relentless decisions will impact the continued rollout of the regulations implementing the No Surprises Act. Since the law went into effect in 2022, regulations and guidance implementing the No Surprises Act have been vacated following challenges under the Administrative Procedures Act on four separate occasions – and that was under the prior Chevron standard, which of course was more deferential to agency decisions. But there are more rules that the Agencies are expected to issue – both as a result of the prior lawsuits and as part of their ongoing obligation to implement the law – that will have a significant impact on how the No Surprises Act functions in practice. These rules will also likely depend on the Departments’ interpretation of the No Surprises Act, and such interpretation will now not be afforded the deference that existed in the pre-Loper/Relentless landscape.” – Josh Arters

3. What Areas of Health Care Regulation are less Likely to be Impacted?

HIPAA

“From an HHS data privacy/security/breach perspective, the Jarkesy and Chevron decisions will arguably have very little impact unless parties are willing to challenge HHS HIPAA decisions in court. In other words, HHS OCR is proceeding as normal, and will continue to do so, particularly given that the HIPAA Rules were codified and specifically modified by Congress in the HITECH Act in 2009. However, to the extent a client would like to appeal a civil money penalty directly to a district court (Jarkesy) or attack a specific provision of sub regulatory guidance post-Chevron (Loper Bright), we could certainly attempt to do so.” – Iliana Peters

Long-Term Care

“Long term care providers are unlikely to see any immediate changes in regulation or enforcement. In most authorizing statutes, Congress delegated authority to CMS to develop and implement conditions of participation, and the guidance that has been provided interpreting those rules. It is unlikely the Loper Bright decision will cause CMS to change its survey process or the remedies imposed therefrom. However, any regulation or sub-regulatory guidance, such as the State Operations Manual, which is not expressly authorized by statute or otherwise interprets an ambiguous statute could be ripe for litigation to challenge CMS’ authority and/or CMS’ interpretation of the statute. To determine whether specific regulations and guidance is subject to challenge will require careful consideration of the Social Security Act and the deference, if any, afforded to CMS for rulemaking.” – Meredith Duncan and Sara Avakian

State Licensing & Practice Rules

“Many of the laws that impact health care providers, such as professional or facility licensing requirements and corporate practice of medicine prohibitions, are state laws that are unlikely to be immediately impacted by Loper Bright. However, Loper Bright may become a catalyst for new challenges to state-level administrative actions, which could create uncertainty related to state agency actions, such as Medical Board rules or guidance.”  – Kathleen Sutton

4. What Issues Should Health Care Organizations Anticipate in the Long-Term?

“It is unclear if there will be rule/no rule ‘chaos’ for health care organizations. When we think of all of the arrangements that default to ‘compliance with laws’ those provisions may lose meaning and effectiveness if the underlying legal rule-structure is threatened” – Jennifer Evans

“With the rise of litigation to combat potentially adverse rulemakings, we may see disagreement within the provider community to the extent some providers are ’winners’ and others are ‘losers.’ Further, we could see the same rulemaking get treated differently by courts depending on where the rules are being challenged. This will be very difficult to navigate for national providers. Hopefully, this ruling will cause regulatory agencies to take more shareholder feedback in their rulemaking. We will likely see more work needed at a Congressional level, however, if a statute is required for things that have historically been dealt with at a regulatory level, causing a slowdown.  This will be a challenge, particularly for innovative providers that are changing care models or adopting new technology, for instance. Health care rules often were behind the evolution of health care. Requiring Congressional action may present some opportunities but will not make things move faster.” – Bragg Hemme

“In the long-term, health care organizations should anticipate an increased opportunity to challenge unlawful regulations that run afoul of Congressional action. That is generally a good thing. But a negative consequence of the Loper Bright decisions is the likely impact on the agency rulemaking process, and the time it might take for agencies to issue regulations. Agencies are likely to move a bit slower when issuing new regulations in light of the dramatic change to how their rulemaking will be scrutinized by the courts going forward.” – Josh Arters

“It is likely that Congress will carefully craft new statutes and delegate more clear authority to the administrative agencies charged with enforcement. We also anticipate agencies taking more time to carefully craft their rules and guidance to mitigate the challenges that could arise based on these decisions. For providers, this will only further delay an already backlogged process.” – Meredith Duncan and Sara Avakian

“Loper Bright creates opportunities for health care organizations to challenge agency actions, but this opportunity comes at the expense of clarity and certainty that came from deference to agencies. The health care regulatory landscape is already complex and ever-changing, but the lack of uniformity that may result from different courts interpreting the same set of rules is going to create further complexity and confusion. The aftermath of Loper Bright may create a chilling effect for innovation or growth for health care businesses. Health care organizations will have to be strategic and stay up-to-date on the changing laws to maintain and grow their businesses while navigating this uncertainty.” – Kathleen Sutton

5. What can Health Care Organizations do if a CMS Rulemaking Has a Significant Impact on their Organization?

“If a rule isn’t working and there is a reasonable interpretation that the statue enabling the rule offers a better outcome, it may be time for health care organizations to start their engines and challenge rules that don’t match specific statutory requirements and fundamental principles. For example, think about adequate reimbursement and access to care. Does this reopen a provider’s ability to litigate payment rules that do not ensure access to care? Maybe.” – Jennifer Evans

“When faced with rulemaking that has a significant impact on operations, health care organizations might be presented with an opportunity to work with federal agencies to find a resolution without having to resort to litigation. Now that agencies understand that their rulemaking may be challenged under a less deferential standard, and, at least for now, most courts have held that a district court may vacate unlawful rules nationally, agencies might be more willing to find more creative and/or individualized solutions to the unique impact their rules might have on a particular health care organization.” – Josh Arters

6. Does this Decision Provide a Greater Ability for Health Care Providers to Advocate for Laws and Regulations to CMS and/or Congress?

“Providers have always had the opportunity to make a contribution in the public policy process; Loper means it is even more important. Engagement in the public policy process does not guarantee success, but lack of involvement almost certainly means a loss.  Both the legislature and agencies may be more open to negotiated laws and regulations. These processes will take longer, however.” – Julius Hobson

“Being part of the debate in the US Congress on health care legislation (and any legislation for that matter) is now more crucial than ever. Members of Congress will no longer be able to write laws that are ambiguous, which would give the agency of jurisdiction the authority to legislate through regulatory fiat. Congress now will be required to be more prescriptive in their laws, outlining specifically in statute the intent of the law. Congress currently relies on ‘report language’ that accompanies legislation, which expresses the legislative intent; however, the report language is not the black letter of the law and more often than not, the agency of jurisdiction ignores report language.  Finally, now that the Congress will need to be more prescriptive in its drafting of legislation Congress will be required be even more deliberative in crafting a bill. This will mean that laws will require more consensus to get the bills it works on approved.”  – Harry Sporidis

“In 2019, when the Supreme Court issued the Azar v. Allina Health Services decision, every component in CMS was tasked with reviewing, analyzing, and verifying that all the guidance materials had regulatory and/or statutory support. For a few years after the decision, CMS went through the rulemaking process for any guidance/policy that was not clearly articulated or supported by regulation. Now that the Supreme Court has overturned Chevron, CMS will likely conduct a similar exercise to determine all of the policy areas where the law is ambiguous, and the Agency has made the determination on how best to carry out the law. CMS will also likely consult with its legislative arm to work with Congress to clarify such laws. This undertaking will take CMS several years to complete. While CMS is engaged its review, there is an opportunity for health care organizations to engage with CMS to review policy position that result from an ambiguous statute and reconsider a more favorable interpretation on of the law.” – Ronke Fabayo

Sara Avakian, Iliana L. Peters, Kathleen Snow Sutton, Julius W. Hobson, Jr., Harry Sporidis, and Ronke Fabayo also contributed to this article.

© Polsinelli PC, Polsinelli LLP in California
by: Bragg E. Hemme, Jennifer L. Evans, Meredith A. Duncan, Neal D. Shah , Michael M. Gaba, and Joshua D. Arters of Polsinelli PC

For more news on the Health Care Industry Post-Chevron, visit the NLR Health Law & Managed Care section.

Washington Shake-Up: Vice President Harris to Lead Democratic Nomination for 2024 Presidency

Following President Biden’s withdrawal from the 2024 presidential race on Sunday, the nation’s capital has experienced another political shock, leading to swift mobilization within the Democratic Party. President Biden quickly endorsed Vice President (VP) Kamala Harris as the Democratic nominee, triggering a rapid wave of support from Congressional leaders, governors, stakeholders, and party donors including former Speaker Nancy Pelosi (D-CA), Senate Majority Leader Chuck Schumer (D-NY), House Democratic Leader Hakeem Jeffries (D-NY), all 24 Democratic governors, EMILYs List, and the United Auto Workers.

VP Harris has secured enough backing from Democratic delegates to clinch her party’s nomination to challenge former president Donald Trump in November. With the election a little over 100 days away, we have highlighted VP Harris’ stance on key issues during her tenure in Congress and her 2020 Presidential bid.

Technology

VP Harris is very familiar with the tech industry due to her roots in Silicon Valley as San Francisco’s district attorney, and her subsequent roles as Attorney General and US Senator from California. Although she hasn’t called for the breakup of big tech like some of her former colleagues in the Senate, she has criticized tech CEOs for the data privacy practices and targeted advertising tactics that their companies deploy, and voiced support for general regulation of big tech firms. In the White House, she serves as President Biden’s lead on AI initiatives and has actively promoted policies aimed at mitigating AI risks such as algorithmic bias, disinformation, and privacy concerns, while maximizing its benefits for Americans.

Climate Change

VP Harris has a long history of challenging the oil industry for its role in pollution and is likely to take it a step further than President Biden in tackling climate change. In the 2020 Presidential race, Harris proposed a $10 trillion climate plan aimed at achieving a carbon-neutral US economy by 2045, featuring initiatives such as a climate pollution fee and the elimination of fossil fuel subsidies.

In the Senate, Harris authored legislation that would have authorized grants to fund projects that address the specific climate-related challenges faced by vulnerable communities and invest in critical upgrades to the nation’s water infrastructure.

As California’s attorney general, VP Harris brought lawsuits against major oil companies, including British Petroleum (BP) for failing to stop underground storage tanks from leaking gasoline at 800 sites across the state, and also filed an investigation into ExxonMobil over its climate change disclosures.

Health Care

Maternal health was at the forefront of Harris’ health care priorities during her tenure in the Senate and has continued in her current role as Vice President. She sponsored landmark legislation such as the Black Maternal Health Momnibus Act, aimed at tackling the crisis facing Black maternal health care. This legislation enhances data collection, expands access to prenatal, postpartum, and doula care in underserved communities, promotes implicit bias training for health care professionals, and funds research and innovation to improve health outcomes and reduce disparities for Black women. Although the bill was not enacted, it remained a priority in both chambers of Congress after Harris’ departure from the Senate. It is also the centerpiece bill of the Congressional Black Maternal Health Caucus. Harris also championed legislation aimed at addressing the impact of uterine fibroids on women’s health through initiatives such as research funding, patient support tactics, and health care provider training. Additionally, she supported legislation to establish a loan repayment program for mental health professionals working in areas with critical workforce shortages.

In her 2020 presidential campaign, Harris introduced a health care plan that proposed a gradual transition toward Medicare-for-All over a decade. Her plan allowed individuals and employers to initially buy into Medicare while maintaining strict regulations for private insurance options. She also consistently opposed efforts to restrict access to reproductive health care services.

Tax

With numerous tax provisions under former President Trump’s Tax Cuts and Jobs Act set to expire in 2025, all eyes are on VP Harris’ anticipated tax policy proposals. During her tenure in Congress, she championed a significant tax reform bill that would have introduced the LIFT credit—a refundable tax credit of $3,000 for single filers and $6,000 for married couples—benefiting a large portion of middle- and working-class Americans. Unlike the Earned Income Tax Credit (EITC), this credit’s amount would not depend on the number of children reported on a taxpayer’s return but would phase out as income increased. Harris emphasized that this credit aimed to boost families’ after-tax income to help them cope with rising living costs.

Additionally, she sponsored legislation in Congress aimed at protecting workers from harassment and discrimination, funding earthquake mitigation efforts, and providing housing assistance to low-income families. During her 2020 presidential campaign, Harris advocated strongly for repealing Trump’s tax law. She proposed implementing a financial transaction tax to expand Medicare coverage and advocated for taxing capital gains as part of her broader economic platform.

A Look Ahead

With midterm elections looming in the House and 33 Senate seats up for election, the impact of VP Harris’ nomination on Congressional races will be watched closely. As the first woman of color and the highest-ranking woman in US history to hold the office of Vice President, Harris’ nomination marks a pivotal moment in American politics. It may influence voter behavior, candidate strategies across the aisle, and the broader political landscape leading up to the November elections.

The Democratic National Convention (DNC) is scheduled to be held in Chicago, Illinois, from August 19 to August 22. However, due to upcoming state ballot deadlines which precede the convention date, a virtual roll call where delegates formally select Kamala Harris as the nominee will conclude by August 7. Harris is expected to choose her running mate in the coming days, as her campaign team has sent vetting materials to Arizona Sen. Mark Kelly, Michigan Gov. Gretchen Whitmer, Minnesota Gov. Tim Walz, North Carolina Gov. Roy Cooper, and Pennsylvania Gov. Josh Shapiro.

©1994-2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
For more on the 2024 Election, visit the NLR Election Law Legislative News section

Mid-Year Recap: Think Beyond US State Laws!

Much of the focus on US privacy has been US state laws, and the potential of a federal privacy law. This focus can lead one to forget, however, that US privacy and data security law follows a patchwork approach both at a state level and a federal level. “Comprehensive” privacy laws are thus only one piece of the puzzle. There are federal and state privacy and security laws that apply based on a company’s (1) industry (financial services, health care, telecommunications, gaming, etc.), (2) activity (making calls, sending emails, collecting information at point of purchase, etc.), and (3) the type of individual from whom information is being collected (children, students, employees, etc.). There have been developments this year in each of these areas.

On the industry law, there has been activity focused on data brokers, those in the health space, and for those that sell motor vehicles. The FTC has focused on the activities of data brokers this year, beginning the year with a settlement with lead-generation company Response Tree. It also settled with X-Mode Social over the company’s collection and use of sensitive information. There have also been ongoing regulation and scrutiny of companies in the health space, including HHS’s new AI transparency rule. Finally, in this area is a new law in Utah, with a Motor Vehicle Data Protection Act applicable to data systems used by car dealers to house consumer information.

On the activity side, there has been less news, although in this area the “activity” of protecting information (or failing to do so) has continued to receive regulatory focus. This includes the SEC’s new cybersecurity reporting obligations for public companies, as well as minor modifications to Utah’s data breach notification law.

Finally, there have been new laws directed to particular individuals. In particular, laws intended to protect children. These include social media laws in Florida and Utah, effective January 1, 2025 and October 1, 2024 respectively. These are similar to attempts to regulate social media’s collection of information from children in Arkansas, California, Ohio and Texas, but the drafters hope sufficiently different to survive challenges currently being faced by those laws. The FTC is also exploring updates to its decades’ old Children’s Online Privacy Protection Act.

Putting It Into Practice: As we approach the mid-point of the year, now is a good time to look back at privacy developments over the past six months. There have been many developments in the privacy patchwork, and companies may want to take the time now to ensure that their privacy programs have incorporated and addressed those laws’ obligations.

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Copyright © 2024, Sheppard Mullin Richter & Hampton LLP.
For more on Privacy, visit the NLR Consumer Protection section.

Congress Grants Five Month Extension for Telehealth Flexibilities

On Tuesday, March 16, 2022, President Biden signed into law H.R. 2471, the Consolidated Appropriations Act, 2022 (“2022 CAA”). This new law includes several provisions that extend the Medicare telehealth waivers and flexibilities, implemented as a result of COVID-19 to facilitate access to care, for an additional 151 days after the end of the Public Health Emergency (“PHE”). This equates to about a five-month period.

The 2022 CAA extension captures most of the core PHE telehealth flexibilities authorized as part of Medicare’s pandemic response, including the following:

  • Geographic Restrictions and Originating Sites: During the extension, Medicare beneficiaries can continue to receive telehealth services from anywhere in the country, including their home. Medicare is permitting telehealth services to be provided to patients at any site within the United States, not just qualifying zip codes or locations (e.g. physician offices/facilities).
  • Eligible Practitioners: Occupational therapists, physical therapists, speech-language pathologists, and qualified audiologists will continue to be able to furnish and receive payment for telehealth services as eligible distant site practitioners during the extension period.
  • Mental Health:  In-person requirements for certain mental health services will continue to be waived through the 151-day extension period.
  • Audio-Only Telehealth Services: Medicare will continue to provide coverage and payment for most telehealth services furnished using audio-only technology. This includes professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000 by HCPCS Codes 99241-99275, 99201-99215, 90804-90809 and 90862) and any other services added to the telehealth list by the CMS Secretary for which CMS has not expressly required the use of real-time, interactive audio-visual equipment during the PHE.

Additionally, the 2022 CAA allocates $62,500,000 from the federal budget to be used for grants for telemedicine and distance learning services in rural areas. Such funds may be used to finance construction of facilities and systems providing telemedicine services and distance learning services in qualified “rural areas.”

Passage of the 2022 CAA is a substantial step in the right direction for stakeholders hoping to see permanent legislative change surrounding Medicare telehealth reimbursement.

Article By Joelle M. Wilson and Laura Little of Polsinelli PC

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

© Polsinelli PC, Polsinelli LLP in California

Government Continues Aggressive Antitrust Enforcement in the Healthcare Space

On February 24, 2022, the U.S. Department of Justice (“DOJ”) filed suit to block UnitedHealth’s proposed acquisition of Change Healthcare. UnitedHealth owns the largest health insurer in the U.S., while Change Healthcare is a data company whose software is the largest processor of health insurance claims in the U.S. The DOJ alleges that the acquisition, if allowed to proceed, would give UnitedHealth unfettered access to rival health insurers’ competitively sensitive information, including health insurance pricing. According to the complaint, this would lessen competition and “result in higher cost, lower quality, and less innovative commercial health insurance for employers, employees, and their families.”

The DOJ’s challenge continues a recent trend of aggressive enforcement involving vertical mergers (i.e. transactions between firms at different levels of the supply chain), with the Federal Trade Commission challenging three vertical mergers in the last year alone. These enforcement efforts represent a material shift from the prior enforcement attitude, which often allowed parties to resolve competition concerns raised by vertical mergers through conduct remedies such as information firewalls or supply commitments. The DOJ’s decision to forego such a remedy (assuming one was proposed) signals the government’s intent to take a tougher stance on mergers in the healthcare space. President Joe Biden previously listed prescription drugs and healthcare services as an antitrust priority area in his July 9, 2021 executive order.

The complaint was filed in the District Court for the District of Columbia and can be accessed here: https://www.justice.gov/opa/press-release/file/1476676/download.

Christopher Gordon also contributed to this article.

© Copyright 2022 Squire Patton Boggs (US) LLP
For more articles about healthcare, visit the NLR Health Care Law section.

June 2020 New Jersey State Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register in June 2020:

  • On June 1, 2020, at 52 N.J.R. 1150(a), the Department of Health Commissioner issued a notice of rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) related to the qualifications an administrator of an assisted living residence or comprehensive personal care home.  This waiver was issued to ensure that a sufficient number of qualified administrators are available to staff New Jersey’s assisted living facilities and comprehensive personal care homes so that the facilities can effectively address the increasing number of both staff and residents being diagnosed with or suspected of having COVID-19.  Section 8:36-3.2 has been temporarily amended to permit individuals whose Assisted Living Administration certification had become inactive within the past three years (April 1, 2017-April 1, 2020) to restore their licenses provided that they have not been disqualified, is not under an investigation by the ALA panel or other state licensing authority, does not have a suspended, revoked or restricted certification and no failed a criminal background check.  If these bars have been cleared, then the applicant must complete a 10 hour Temporary Living Administrator Program sponsored by Longtree & Associates, LLC; successfully pass a criminal background check pursuant to N.J.A.C. 8:43I-4; and pay the current Assisted Living Administrator certification fee.

This temporary rule waiver/modification, as well as any provisional certifications issued thereunder, will expire 45 days after the end of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103 (2020). After the provisional certifications issued under this subsection have expired, individuals whose Assisted Living Administrator certifications have expired will no longer be permitted to function as certified assisted living administrators. Individuals wishing to obtain full certification as an assisted living administrator will be required to successfully complete all the requirements for restoration of such certifications set forth in this section (excluding the new subsection).

  • On June 1, 2020, at 52 N.J.R. 1151(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to the time period within which a certified medication aide candidate must sit for the medication aide exam after completing his or her medication aide training course. Pursuant to this rule waiver/modification, if a candidate’s deadline to sit for the standardized examination falls between March 1, 2020 and May 31, 2020, then the candidate shall have an additional six (6) months from the original deadline to sit for the examination. For example, if a candidate was required to sit for the examination by March 1, 2020, the deadline will be extended to August 31, 2020. The remaining provisions set forth in N.J.A.C. 8:36-9.2 shall remain in effect.

N.J.A.C. 8:36-9.2(c) requires a certified medication aide candidate to sit for the Department of Health approved standardized examination within six (6) months of successfully completing an approved medication administration training course. The standardized examinations are administered by PSI Testing Centers. In an effort to protect the community from the spread of COVID-19, PSI Testing Centers are closed and no longer administering standardized examinations. As a result, medication aide candidates that successfully completed the approved training course are not able to sit for the standardized examination within the specified time frame. Accordingly, an extension of the time period that certified medication aide candidates have to sit for the exam is warranted so that the candidates do not have to unnecessarily retake the training course to qualify for the exam and gain certification after the public health emergency concludes.

  • On June 1, 2020, at 52 N.J.R. 1151(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) regarding nurse aid competency.  N.J.A.C. 8:39-43.1 sets forth certain criteria for an individual to qualify to work as a Certified Nurse Aide (CNA) in a licensed long-term care facility in New Jersey. In order to increase the number of direct care staff available to work at long-term care facilities, the Department is modifying the requirements of N.J.A.C. 8:39-43.1. Pursuant to this rule waiver/modification, Personal Care Assistants (PCA) and Certified Medical Assistants (CMA) are temporarily permitted to function in the role of a CNA in licensed long-term care facilities within New Jersey so long as the PCA or CMA meet the following conditions: (1) the CMA or PCA must complete the Temporary Nurse Aide training course at  http://educate.ahcancal.org/products/temporary-nurse-aide  prior to functioning as a CNA; (2) the facility shall provide staff a basic orientation addressing fire safety, infection control, and abuse prevention prior to allowing them to perform any duties in the facility; and (3) the facility shall maintain relevant supervision requirements for CMAs and PCAs functioning as CNAs. The remaining provisions set forth in N.J.A.C. 8:39-43.1 shall remain in effect.

Long- term care facilities that take action under the terms of this waiver/modification must also provide a written report to the Department regarding the facility’s implementation. This waiver is effective only during the period of Public Health Emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103 and 119. Within 45 days after the Public Health Emergency has ended, PCAs and CMAs will no longer be permitted to function in the role of a CNA and anyone wishing to act as a CNA will be required to satisfy the competency requirements set forth in N.J.A.C. 8:39-43.1. Long- term care facilities will also be required to resume operating in accordance with all licensure standards within 45 days after the Public Health Emergency has ended.

  • On June 1, 2020 at 52 NJ.R. 1154(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to recertification of EMTs whose certifications have expired. Pursuant to this rule waiver and modification, individuals whose EMT certification expired within the past five years (April 1, 2015 to April 1, 2020) are eligible for “COVID-19 EMT re-entry” so long as: (1) the applicant is not currently under investigation by any State EMT licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT licensing authority; (3) the applicant is not excluded from acting as an EMT pursuant to a settlement reached with any State EMT licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:40A-10.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department while certified as an EMT. If an applicant does not fall into one of these disqualification categories, the applicant may proceed with the “COVID-19 EMT re-entry” process that is outlined in the regulations.  Upon successful completion of these requirements, the Department will issue the applicant a 6-month provisional EMT certification. To obtain full certification as an EMT, the applicant must successfully complete a New Jersey approved refresher program and achieve a passing score on the National Registry EMT-Basic Certification Examination, as set forth in N.J.A.C. 8:40A-7.6, by the end of the provisional period.  Individuals issued provisional certifications under this waiver shall only provide services as an EMT in a limited capacity as specified in the regulations.
  • On June 1, 2020, at 52 N.J.R. 1156(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:41A-4.3, which set forth the requirements necessary for individuals to restore their paramedic certifications from inactive status to active status, pursuant to Executive Order No. 103 (2020).  Pursuant to this rule waiver and modification, individuals whose EMT-Paramedic certification was placed into inactive status within the past five years (April 15, 2015 to April 15, 2020) are eligible for the “COVID-19 EMT-Paramedic Re-Entry” so long as: (1) the applicant is not currently under investigation by any State EMT-Paramedic licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT-Paramedic licensing authority; (3) the applicant is not excluded from acting as an EMT-Paramedic pursuant to a settlement reached with any State EMT-Paramedic licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or EMT-Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:41A-5.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department’s Office of Emergency Medical Services (OEMS) while certified as an EMT-Paramedic and/or EMT. If an applicant does not fall into one of these disqualifying categories, then the applicant may proceed with the “COVID-19 EMT-Paramedic Re-Entry” process.  In a 2 person crew of a Mobile Intensive Care Unit, only 1 of the 2 people may possess a 6 month provisional/modified status.
  • On June 15, 2020 at 52 N.J.R. 1240(a), the Office of the Governor issued Executive Order 145 (2020) allowing elective surgeries and invasive procedures to resume on May 26, 2020.
  • On June 15, 2020 at 52 N.J.R. 1251(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:43G-31.11 regarding the maintenance of respiratory care equipment in hospitals, pursuant to Executive Order No. 103 (2020).  The waiver is effective during the period of the Public Health Emergency declared in Executive Order No. 103 and expires forty-five (45) days after the Public Health Emergency has ended.

Pursuant to this temporary rule waiver/modification, hospitals shall perform a mechanical and electrical function test on a ventilator released from State storage or from the federal stockpile prior to placing it into service and using it for the first time. The ventilator mechanical and electrical equipment function test shall consist of the following: performance of standard preoperational checks as recommended by the manufacturer; performance of a power-on self-test; and running the ventilator for a minimum of 15 minutes. Upon successful completion of the test, the hospital shall affix a sticker indicating the date that the ventilator passed the test. Hospitals shall create and maintain records showing that each State storage or federal stockpile ventilator placed into service met these requirements prior to being placed into service.

Hospitals that take action under the terms of this waiver must also provide a written report to the Department detailing the number of ventilators placed into service and any adverse outcomes attributable to these actions.  Upon the expiration of this temporary rule waiver/modification, hospitals will be required to resume operating in accordance with all licensure standards and perform the required equipment checks and maintenance. The remaining provisions set forth in N.J.A.C. 8:43G-31.11 shall remain in effect.

  • On June 15, 2020, at 52 N.J.R. 1251(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 10:161B-11.10, which would permit individuals receiving opioid treatment services to receive medication that they can take at home, pursuant to Executive Order No. 103 (2020).  In order to ensure the clients of OTPs have access to needed medications, the Department is waiving the requirements of N.J.A.C. 10:161B-11.10 and permitting facilities to provide medication to clients at locations other than the location listed on their OTP facility license, in accordance with the guidance issued by the Drug Enforcement Agency (DEA078) on April 7, 2020. The intent of the guidance is to provide OTPs greater flexibility in the delivery of take-home doses of methadone to their patients. OTPs must still adhere to certain standards. Specifically, before using the unregistered off-site location, the OTP must first contact its State Opioid Treatment Authority (SOTA) and receive the SOTA’s approval to use the offsite location. Additionally, the OTP must receive approval from the local DEA field office. Once the SOTA approves the location, it should contact the local DEA field office. If the SOTA does not contact the DEA field office, the OTP must contact the field office itself. The facility must submit the approvals received from the SOTA and the DEA field office to the Department. Each day, the facility may only transport those take-home methadone doses to the off-site location that the facility reasonably anticipates will be delivered to clients that day. The facility cannot transport a reserve of methadone to the off-site location. Any methadone not delivered to clients at the off-site location must be returned to the facility’s DEA-registered location the same day. No methadone may be stored at the off-site location when a facility staff member is not present

All OTPs that take action under the terms of N.J.A.C. 10:161B-11.10 shall provide a written report to the Department detailing the extent to which the facility implemented the terms of this waiver/modification and any adverse outcomes attributable to such implementation. OTPs may operate under the terms of this waiver/modification as necessary until the conclusion of the public health emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103. Upon the conclusion of the public health emergency, OTP facilities will be required to resume determining eligibility for take-home medication under the criteria set forth in N.J.A.C. 10:161B-11.10(a).

  • On June 15, 2020, at 52 N.J.R. 1253(a) the Department of Human Services Commissioner issued a notice of rule waiver modification/suspension of certain rules at N.J.A.C. 10:51-1.25(j)(3), N.J.A.C.10:167A-1.27(j)(4) and N.J.A.C. 10:167C-1.25(j)(3), which require signatures by Medicaid/NJ FamilyCare, Pharmaceutical Assistance to the Aged and Disabled (PAAD) and Senior Gold beneficiaries at the time a prescription is dispensed or delivered. During the public health emergency, beneficiaries of these programs will no longer be required to provide signatures at the time a prescription is dispensed or delivered. The pharmacist must document in the patient’s profile the date the beneficiary received the prescription.
  • On June 15, 2020, at 52 N.J.R. 1287(a), the Department of Health Commissioner issued a public notice announcing the cancellation of the call for certificate of need (CN) applications for new home health agencies in accordance with the provisions of N.J.A.C. 8:42 and N.J.S.A. 26:2H-1 et seq. In accordance with N.J.A.C. 8:33-4.1(a), the next scheduled call for new home agencies will be July 1, 2022. The Department will continue to monitor the utilization and availability of home health services and, should the need arise, issue a future call for these services prior to July 1, 2022.
  • On June 15, 2020, at 52 N.J.R. 1287(b), the Department of Health Commissioner issued a public notice of postponement of  the certificate of need call for applications for home health care services in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for July 1, 2019, is hereby postponed.  The Department is in the process of gathering and evaluating data to determine whether there is currently a need for home health care services. Accordingly, it is necessary to delay the call for home health care services to allow the Department sufficient time to complete its evaluation of need, and to provide potential applicants and affected parties sufficient time to respond appropriately to a certificate of need call notice in the event the Department determines that a call is appropriate. If the Department proceeds with the call, then a call for home health care services will be published in an upcoming publication of the New Jersey Register, providing the necessary time for both potential applicants and interested parties to respond to the call notice. In the alternative, if the determination is made to cancel the call, then the Department will publish a cancellation notice in the New Jersey Register.
  • On June 15, 2020, at 52 N.J.R. 1247(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing published a notice of administrative correction to the text of N.J.A.C. 13:37-7.2, pertaining to the education requirements for certification. Effective April 20, 2020, the Board deleted then-existing N.J.A.C. 13:37-7.2(b) and recodified then-existing subsections (c) and (d) as (b) and (c). (See 51 N.J.R. 922(a); 52 N.J.R. 896(a).) As part of the April 20, 2020 rulemaking, the Board inadvertently did not update the cross-reference at subsection (c) to account for the recodifications in this section. The Board is correcting that oversight to change the cross-reference at now-codified subsection (c) to refer to the “requirements of (a) and (b) above.”
© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

HHS Laboratory Data Reporting Guidance for COVID-19 Testing

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) issued new Laboratory Data Reporting Guidance for COVID-19 Testing (Guidance) and related Frequently Asked Questions. Under the Guidance, in addition to providing the results of COVID-19 testing, laboratories will be required to report demographic information, including the patient’s age, race, ethnicity, sex, residence zip code, and county. The Guidance further recommends reporting the patient’s name, street address, date of birth, ordering provider address, and ordering provider phone number to state and/or local public health departments, although this data would not be collected by the Centers for Disease Control and Prevention (CDC) or HHS. Data for each test completed must be submitted within 24 hours of the results being known or determined, providing public health officials with “nearly real-time data.

Reporting is required for both diagnostic and serologic testing, and the Guidance specifically includes laboratory testing that relies on home-based sample collection. Laboratories, defined to include “laboratories, non-laboratory testing locations, and other facilities or locations offering point-of-care testing or in-home testing related to SARS-CoV-2,” must comply with the new requirements by Aug. 1, 2020. The Guidance specifies that reporting should be made through existing channels to state or local public health departments that will, in turn, submit de-identified data to the CDC.

According to HHS, “[t]he new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues.” HHS also indicated that the requirements may help officials understand and address disproportionate impacts of COVID-19 on certain demographic groups and ensure equitable access to testing.

Although this reporting requirement is being imposed by HHS, it is unclear what impact the new data may have at a national level. Under HHS’s COVID-19 Strategic Testing Plan issued on May 24, 2020, states are largely responsible for developing and implementing their own COVID-19 testing strategies.

©2020 Greenberg Traurig, LLP. All rights reserved.

For more on COVID-19 testing, see the National Law Review Coronavirus News section.

COVID-19 Daily Self Screening Video

Daily self-screening is one of the simplest ways to help stop the spread of COVID-19. Designed to educate employees, COVID-19 Daily Self-Screening video provides an overview of symptoms and steps a staff member can take to help break the chain of transmission, if they do get sick. Part of a series aimed at supporting a “Work Together, Healthy Together” workplace health and safety program, our videos are intended to be shared with you workforce. In connection with Polsinelli’s efforts to provide resources and support to businesses in our own communities and beyond, we hope you and your team find this valuable.

© Polsinelli PC, Polsinelli LLP in California

The CDC Warns Against Using Antibody Testing Results to Make Workplace Decisions

This week, the Centers for Disease Control and Prevention (the “CDC”) released interim guidelines addressing COVID-19 antibody testing. The CDC expressed concerns about the current accuracy of antibody testing and advised businesses against using the results of antibody testing (also known as serologic testing) to make any decisions about returning workers to the workplace.

Although the guidance notes that antibodies may offer some protection from reinfection and may decrease the likelihood that an individual infects others, the CDC has determined that there are myriad issues with the effectiveness of current antibody testing, including widespread false positive results. The CDC guidance states that “additional data are needed before modifying public health recommendations based on [antibody] test results, including decisions on discontinuing physical distancing and using personal protective equipment.” The CDC also recommends that even if individuals have tested positive for COVID-19 antibodies, they should continue to take precautionary measures (such as wearing facemasks) to prevent the spread of infection.

As the U.S. Equal Employment Opportunity Commission (“EEOC”) has not weighed in on this issue to date, it is still unclear whether employers’ use of antibody testing to inform workplace return decisions might implicate the Americans with Disabilities Act (“ADA”) or other discrimination laws.  But given the direct affirmative guidance from the CDC, employers should continue to refrain from using antibody or serologic testing results to determine which workers may return to the workplace.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Corbin Carter at Mintz.
For more CDC Guidance, see the National Law Review Coronavirus News section.

CARES Act Provider Relief Fund – Acceptance of Funds Comes with Conditions

Healthcare providers are among those financially adversely affected by the COVID-19 pandemic.

A survey conducted by the Medical Group Managers Association (“MGMA”) on April 7 and 8, 2020, found that 97% of medical practices have experienced a negative financial impact directly or indirectly related to COVID-19.  MGMA also indicates that, on average, practices report a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis.

In response to the financial impact on healthcare providers, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed into law on March 27, 2020, appropriated $100 billion in relief funds to hospitals and other healthcare providers under the Public Health and Social Services Emergency Fund, also called the “CARES Act Provider Relief Fund.” On April 10, 2020, the United States Department of Health and Human Services (“HHS”) released the initial terms and conditions related to the distribution of the initial $30 billion of the $100 billion.  Rather than await the submission of applications by healthcare providers, HHS has begun a rapid delivery of relief funding to healthcare providers and suppliers that are enrolled in Medicare and received Medicare fee-for-service reimbursement in 2019.  These eligible healthcare providers are being allotted a portion of the initial $30 billion distribution based upon their proportionate share of the approximately $484 billion of Medicare fee-for-service reimbursements made in 2019.

Healthcare providers identified as eligible to receive funds from this first distribution should have received an email to that effect.  Eligible healthcare providers have begun receiving payments via the Automated Clearing House account information on file used for reimbursements from The Centers for Medicare and Medicaid Services (“CMS”).  Healthcare providers that normally receive a paper check for reimbursement from CMS will receive a paper check in the mail.

These payments are not loans and, if used consistent with the applicable terms and conditions, will not need to be repaid.  Healthcare providers must sign an attestation confirming receipt of the funds and agreeing to the terms and conditions of payment within 30 days via the online payment portal.  Should a healthcare provider choose to reject the funds, the healthcare provider within 30 days of receipt of payment must complete the attestation to indicate this and remit the full payment to HHS.  The portal will guide the healthcare provider through the attestation process to accept or reject the funds.

The healthcare provider is required to certify, among other things, that it provides or provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.  In a recent update, HHS clarified that to meet this requirement, care does not have to be specific to treating COVID-19, as “HHS broadly views every patient as a possible case of COVID-19.” HHS also clarified that a healthcare provider’s eligibility is not adversely affected if it ceased operations as a result of the COVID-19 pandemic, so long as the healthcare provider provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.

In addition to imposing use restrictions for the funds and recordkeeping requirements, the CARES Act authorizes the HHS Office of Inspector General (“OIG”) to audit both interim and final payments made under the program.  Healthcare providers that elect to accept the funds must be prepared to submit to these OIG audits.  Because the funds are limited to necessary expenses or lost revenues due to the pandemic not otherwise reimbursable from other sources, there may be differences in OIG’s interpretation of whether the funds were used for an appropriate purpose.  At a minimum, this may necessitate returning certain disallowed funds following an audit.

Failure to abide by the terms and conditions could result in False Claims Act liability for healthcare providers that do not make proper use of the funds.  Thus, recipients of the funds should carefully consider their ability to comply with the terms and conditions and should ensure that proper controls are in place for proper use of the funds.

© 2020 Ward and Smith, P.A.. All Rights Reserved.

For more on CARES Act funding, see the Coronavirus News section of the National Law Review.