Category: Health

All Federal Research Agencies to Update Public Access Policies

On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably, OSTP is retracting prior guidance that gave discretion to agencies to allow a 12-month embargo on the free and public release of peer-reviewed publications, so that federal funded research results will be timely and equitably available at no cost. The memo also directs affected agencies to develop policies that:

  1. Ensure public access to scientific data, even if not associated with peer-reviewed publications;
  2. Ensure scientific and research integrity in the agency’s public access by requiring publication of the metadata, including the unique digital persistent identifier; and
  3. Coordinate with OSTP to ensure equitable delivery of federally funded research results and data.

KEY COMPONENTS OF GUIDANCE:

Updating Public Access Policies

Federal agencies will need to develop new, or update existing, public access plans, and submit them to OSTP and the Office of Management and Budget (OMB). Deadlines for submission are within 180 days for federal agencies with more than US$100 million in annual research and development expenditures, and within 360 days for those with less than US$100 million in expenditures.

Agencies will need to ensure that any peer-reviewed scholarly publication is free and available by default in agency-designated repositories without any embargo or delay following publication. Similarly, OSTP expects the access polices to address publication of any other federally funded scientific data, even if not associated with peer-reviewed scholarly publications. As a concession, federal agencies are being asked to allow researchers to include the “reasonable publication costs and costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets.1”

Ensuring Scientific Integrity

To strengthen trust in governmentally funded research, the new or updated policies must transparently communicate information designed to promote OSTP’s research integrity goals. Accordingly, agencies are instructed to collect and make appropriate metadata available in their public access repositories, including (i) all author and co-author names, affiliations, and source of funding, referencing their digital persistent identifiers, as appropriate; (ii) date of publication; and (iii) a unique digital persistent identifier for research output. Agencies should submit to OSTP and OMB (by 31 December 2024) a second update to their policies specifying the approaches taken to implement this transparency, and publish such policy updates by 31 December 2026, with an effective date no later than one year after publication of the updated plan.

IMPLICATIONS FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), OTHER FEDERAL AGENCIES, AND THEIR GRANTEES

The NIH is expected to update its Public Access Policy, potentially along with its Data Management and Sharing Policy to conform with the new OSTP guidance. Universities, academic medical centers, research institutes, and federally funded investigators should monitor agency publications of draft and revised policies in order to update their processes to ensure continued compliance.

In doing so, affected stakeholders may want to consider and comment to relevant federal agencies on the following issues in their respective public access policy development:

  • Federal agency security practices to prevent foreign misappropriation of research data;
  • Implications for research misconduct investigations and research integrity;
  • Any intellectual property considerations without a 12-month embargo, especially to the extent this captures scientific data not yet published in a peer-review journal; and
  • Costs allowable research budgets to support these data management and submission expectations.

1 Office of Science and Technology Policy, Memorandum for the Heads of Executive Departments and Agencies: Ensuring Free, Immediate, and Equitable Access to Federally Funded Research at p. 5 (25 August 2022) available at https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf

Article By Cindy L. Ortega Ramos and Rebecca M. Schaefer of K&L Gates

For more administrative and regulatory legal news, click here to visit the National Law Review.

Copyright 2022 K & L Gates

The Supreme Court Is Poised to Weigh in on a False Claims Act Circuit Split

Three pending petitions for writ of certiorari have asked the U.S. Supreme Court to resolve a split among the federal courts of appeals as to the pleading standard for False Claims Act (“FCA”) whistleblower claims.

The FCA creates a right of action whereby either the government or private individuals can bring lawsuits against actors who have defrauded the government. 31 U.S.C. §§ 3729 et seq. Under the FCA, a private citizen can act as a “relator” and bring an action on behalf of the government in what is known as a qui tam suit. The government can elect to intervene, which means participate, in the suit; if it does not, the relator can continue to litigate the case without the direct participation of the government. 31 U.S.C. § 3730. Private individuals can receive a portion of the action’s proceeds or settlement amount. 31 U.S.C. § 3730(d).

The petitions ask the Court to clarify the level of particularity required under Federal Rule of Civil Procedure 9(b) (“Rule 9(b)”) to plead a claim under the FCA. Rule 9(b) requires plaintiffs alleging “fraud or mistake” to “state with particularity the circumstances constituting fraud or mistake.”

Johnson v. Bethany Hospice and Palliative Care LLC, Case No. 21-462

In their petition for a writ of certiorari, the petitioners in Johnson asked the Supreme Court to take up the issue of whether Rule 9(b) requires FCA plaintiffs “who plead a fraudulent scheme with particularity to also plead specific details of false claims.” The Eleventh Circuit earlier affirmed the district court’s dismissal of an FCA claim based on the plaintiffs’ failure to plead “specific details about the submission of an actual false claim” to the government. Estate of Helmly v. Bethany Hospice & Palliative Care of Coastal Georgia, LLC, 853 F. App’x 496, 502-03 (11th Cir. 2021).

In particular, the relators alleged that several doctors purchased ownership interests in Bethany Hospice and Palliative Care, LLC (“Bethany Hospice”) and were allocated kickbacks for patient referrals through a combination of salary, dividends, and/or bonus payments.  Id. at 498. Among other allegations, the complaint alleged that both the relators had access to Bethany Hospice’s billing systems, and, based on their review of those systems and conversations with other employees, were able to confirm that Bethany Hospital submitted false claims for Medicare and Medicaid reimbursement to the government.  Id. at 502.

The Eleventh Circuit held that the allegations were “insufficient” under Rule 9(b)’s heightened pleading standard for fraud cases.  Id. Even though the relators alleged direct knowledge of Bethany Hospice’s billing and patient records, their failure to provide “specific details” regarding the dates of the claims, the frequency with which Bethany Hospice submitted those claims, the amounts of the claims, or the patients whose treatment formed the basis of the claims defeated their FCA claim.  Id. In addition, the relators did not personally participate or directly witness the submission of any false claims.  Id. The Eleventh Circuit also found unpersuasive the relators’ argument that Bethany Hospice derived nearly all its business from Medicare patients, therefore making it plausible that it had submitted false claims to the government.  Id. “Whether a defendant bills the government for some or most of its services,” the Eleventh Circuit stated, “the burden remains on a relator alleging the submission of a false claim to allege specific details about false claims to establish the indicia of reliability necessary under Rule 9(b).”  Id. (internal quotation marks omitted). Because the relators did not do so here, the Eleventh Circuit affirmed the dismissal of the case.

United States ex rel. Owsley v. Fazzi Associates, Inc., Case No. 21-936

The Sixth Circuit took a similarly hardline approach in United States ex rel. Owsley v. Fazzi Associates, Inc., 16 F.4th 192 (6th Cir. 2021), ruling in favor of a strict interpretation of Rule 9(b).  The petition for a writ of certiorari in Owsley asks the Court to take up the same question as in Johnson.

In Owsley, the relator alleged that her employer used fraudulently altered data to make its patient populations seem sicker than they actually were in order to increase Medicare payments received from the government.  Id. at 195. The complaint “describe[d] in detail, a fraudulent scheme,” and alleged “personal knowledge of the billing practices employed in the fraudulent scheme.”  Id. at 196 (internal quotation marks omitted). But the Sixth Circuit ruled that these allegations were not enough under Rule 9(b). Instead, to bring a viable FCA claim, a relator’s complaint must identify “at least one false claim with specificity.”  Id. (internal quotation marks omitted). A relator can do that in one of two ways: first, by identifying a representative claim actually submitted to the government; or second, by alleging facts “based on personal knowledge of billing practices” that support a strong inference that the defendant submitted “particular identified claims” to the government.  Id. (emphasis in original). Here, though the relator alleged specific instances of fraudulent data – such as upcoding a patient with a leg ulcer to include a malignant cancer diagnosis – she did not identify particular claims submitted to the government.  Id. at 197. “[T]he touchstone is whether the complaint provides the defendant with notice of a specific representative claim that the plaintiff thinks was fraudulent.”  Id. The Owsley relator, the court held, failed to meet that critical touchstone.

Molina Healthcare v. Prose, Case No. 21-1145

The Seventh Circuit adopted a more flexible pleading standard in United States v. Molina Healthcare of Illinois, Inc., 17 F.4th 732 (7th Cir. 2021). As in Johnson and Owsley, the petition for a writ of certiorari asks the Court to weigh in on the Rule 9(b) standard under the FCA. It also presents an additional question about the requirements for an FCA claim under the implied false certification theory.

In Molina Healthcare, the relator brought an FCA claim against Molina Healthcare (“Molina”) for violating certain requirements of its Medicaid contract. The relator alleged that Molina, which had previously subcontracted with another entity for the provision of certain nursing home services, continued to collect payment for those services from the government even though it no longer provided them. Molina Healthcare, 17 F.4th at 736. Molina Healthcare received fixed payments from the government for different categories of patients. It received the highest per capita payment for patients in nursing facilities: $3,180.30.  Id. at 737-38. The relator alleged that Molina Healthcare knowingly continued to collect this rate from the government when it no longer provided a key service to nursing home patients.  Id.

The relator brought an FCA claim against Molina based on three theories of liability: (1) factual falsity (i.e., presenting a facially false claim to the government); (2) fraud in the inducement (i.e., misrepresenting compliance with a payment condition “in order to induce the government to enter the contract”); and (3) implied false certification (i.e., presenting a false claim with the “omission of key facts” instead of “affirmative misrepresentations”).  Id. at 740-741.

The Seventh Circuit held that the relator’s allegations satisfied Rule 9(b)’s pleading requirement under all three theories. First, as to factual falsity, the Court found that the relator provided sufficient information as to the “when, where, how, and to whom” Molina made the allegedly false representations.  Id. at 741. Though the relator did not have access to the defendant’s files, the information he provided “support[ed] the inference” that Molina had submitted false claims to the government.  Id. Second, as to fraud in the inducement, the Seventh Circuit found that the relator’s “precise allegations” regarding “the beneficiaries, the time period, the mechanism for fraud, and the financial consequences” again satisfied Rule 9(b)’s standard.  Id. at 741. The complaint also included details about Molina’s chief operating officer’s statements that indicated that Molina “never intended to perform the promised act that induced the government to enter the contract.”  Id. at 741-42.  Third, as to the implied false certification theory, the court found that the plaintiff adequately alleged that Molina knowingly omitted key material facts while submitting claims to the government.  Id. at 743-44.

The Supreme Court Invites Comment from the Solicitor General

Facing what appears to be a major circuit split, the Supreme Court invited the Solicitor General to file a brief “expressing the views of the United States” in Johnson in January 2022 and in Owsley in May 2022.

The Supreme Court invites the Solicitor General to comment on only a handful of the approximately 7,000 to 8,000 petitions for writ of certiorari that the Court receives in a year. In the 2021 Term, for example, the Solicitor General filed what it calls a “Petition Stage Amicus Brief” in only 19 cases. Four Justices must vote to issue an invitation to the Solicitor General.

The Solicitor General’s view on whether the Court should grant certiorari has often been extremely influential. In the 2007 Term, for example, the Court denied certiorari in every case in which the Solicitor General recommended that approach. By contrast, it granted certiorari in 11 out of the 12 cases in which the Solicitor General recommended a grant. More recent data confirm that the Solicitor General’s recommendations as to whether the Court should grant certiorari remain highly influential. One study found that between May 2016 and May 2017, the Supreme Court followed the Solicitor General’s recommended approach in 23 cases (85%). At the same time, even the act of requesting the views of the Solicitor General dramatically increases the chances that the Court will take up a case. For example, between the 1998 Term and 2004 Term, one study found that the Court was 37 times more likely to grant certiorari in cases where it had invited the Solicitor General to file an amicus brief.

The Solicitor General Urges the Court to Decline Review

On May 24, 2022, the Solicitor General filed its brief in Johnson; it has yet to comment on Owsley. The Solicitor General’s amicus brief in Johnson urges the Court to deny certiorari. The Solicitor General notes that certiorari might be warranted if the courts of appeals applied a rigid, per se rule that required relators to plead “specific details of false claims.” But instead, the brief argues that the courts of appeals have “largely converged” on an approach to FCA pleading requirements that allows relators “either to identify specific false claims or to plead other sufficiently reliable indicia” to support a “strong inference” that the defendant submitted false claims to the government. According to the Solicitor General, the “divergent outcomes” among the circuit courts are merely the result of those courts’ application of a “fact-intensive standard” to various distinct allegations.

The petitioners in Johnson filed a supplemental brief in response to the Solicitor General’s views. They argue that the Solicitor General misinterpreted the Eleventh Circuit’s pleading standard, which effectively requires a relator to allege specific details about false claims to survive a motion to dismiss. In other words, the petitioners argue that in the Eleventh Circuit, the Solicitor General’s “purported” rule that a relator can either allege details about specific false claims or identify reliable indica that false claims were presented are “one and the same.”

Though the Court did not invite the Solicitor General to comment in Molina Healthcare, the petitioners in that case also filed a supplemental brief in response to the Solicitor General’s amicus in Johnson. “Everyone but the Solicitor General agrees that the circuits are hopelessly divided over whether Rule 9(b) requires a relator to plead details of false claims,” the brief argues. The brief notes that the Third, Fifth, Seventh, Ninth, Tenth, and D.C. Circuits do not require plaintiffs to plead specific details of actual false claims; by contrast, the First, Second, Fourth, Sixth, Eighth, and Eleventh Circuits require relators to plead specific details. Accordingly, the brief urges the Supreme Court to resolve the “widely acknowledged circuit split” over Rule 9(b)’s pleading standards.

The Solicitor General has a history of urging the Court to reject certiorari in FCA cases. According to the petitioners’ supplemental brief in Molina Healthcare, since the 1996 Term, the Solicitor General has recommended against review in eleven out of the twelve FCA cases in which the Court invited the Solicitor General’s views. Still, the Court granted certiorari in three of the cases in which the Solicitor General recommended against review.

Given the Supreme Court’s apparent interest in the FCA pleading standard – as evidenced by its calls for the Solicitor General’s views in Johnson and Owsley – there is a chance that it will grant certiorari in at least one of the three cases pending before it. Depending on when the Solicitor General weighs in, the Court may decide to grant certiorari in the fall of 2022.

Any Supreme Court decision that clarifies the pleading standard for FCA cases will likely affect a relator’s ability to successfully litigate qui tam actions in which the government does not intervene more than in cases in which the government does intervene. When a relator files a qui tam action, the government investigates the alleged fraud. If it intervenes in that action, it can file a complaint to include evidence it has discovered in that investigation, allowing it to meet the more stringent version of the Rule 9(b) pleading standard. Relators, however, often do not have access to the same evidence that the government does, such as specific claims data, making it far harder for a relator to meet the more stringent version of pleading standard.

Until the Supreme Court decides to weigh in, qui tam relators will continue to have an easier time satisfying the requirements of Rule 9(b) in those circuits with relaxed pleading standards. In the meantime, and whether the Court takes one of these petitions or not, any FCA whistleblower should seek legal counsel to help her identify the type of factual information that would meet the pleading requirements of the courts that apply a strict pleading requirement.

Article By Kayla Morin of Katz Banks Kumin LLP

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

Katz Banks Kumin LLP Copyright ©

Supreme People’s Court Upholds China’s First Patent Linkage Ruling – Decision Released

On August 28, 2022, 知识产权那点事 published the first patent linkage decision from the Supreme People’s Court (SPC). The SPC upheld the Beijing IP Court ruling that Wenzhou Haihe Pharmaceutical Co., Ltd.’s application for marketing authorization for a generic form of “Aidecalcidol Soft Capsule” did not fall within scope of protection of the relevant patent. China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid.

On November 10, 2021, the Beijing IP Court announced that the plaintiff of the case, Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, claimed that it was the patentee as well as the holder of the marketing license for the patented drug “Aidecalcidol Soft Capsule”, and the patent involved in the drug was CN 2005800098777.6 entitled “ED-71 preparation.” The plaintiff discovered that the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the National Medical Products Administration (NMPA) for a generic drug marketing license application named “Aidecalcidol Soft Capsule”. The public information on the Chinese listed drug patent information registration platform showed that the defendant had made a 4.2 category statement regarding the generic drug (the generic drugs do not fall into the scope of protection of the related patents). Therefore, the plaintiff filed a drug patent linkage lawsuit with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the Amended Patent Law, requesting the court to confirm that the generic drug “Aidecalcidol Soft Capsule” that the defendant applied for registration fell into the scope the rights of Patent No. 2005800098777.6 enjoyed by the plaintiff.

 

The Beijing IP Court held:

The technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the involved patent, so the technical solution does not fall within the protection scope of claim 1 of the involved patent. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff’s claim that the involved generic drug falls within the protection scope of claims 1-6 of the involved patent cannot be established, and the court will not support it.

In the decision, the Supreme People’s Court stated there were two key points:

1. In the process of drug marketing review and approval, disputes arising from the patent rights related to the drug to be registered between the drug marketing license applicant and the relevant patentee or interested parties are only one type of the related patent rights between the two parties – often referred to as drug patent link disputes. For chemical generic drugs, the drug regulatory department of the State Council conducts drug marketing review and approval based on the application materials of the generic drug applicant, and decides whether to suspend the approval of the relevant drugs according to the effective judgment made by the people’s court [or the China National Intellectual Property Administration] on such disputes within the prescribed time limit. Therefore, when judging whether the technical solution of a generic drug falls within the scope of patent protection, in principle, it should be compared and judged on the basis of the application materials of the generic drug applicant. If the technical solution actually implemented by the generic drug applicant is inconsistent with the declared technical solution, it shall bear legal responsibility in accordance with the relevant laws and regulations on drug supervision and administration; if the patentee or interested party believes that the technical solution actually implemented by the generic drug applicant constitutes infringement, a separate lawsuit for patent infringement may also be filed. Therefore, whether the technical solution actually implemented by a generic drug applicant is the same as the application materials is generally not within the scope of examination to confirm that the dispute falls within the scope of patent protection.

2. The court of second instance held that both the donation [to the public] rule and the estoppel rule can constitute a restriction on the application of the principle of equivalence, both of which aim to achieve a reasonable balance between equitably protecting the interests of the patentee and safeguarding the interests of the public. If the conditions for limiting the application of the principle of equivalence are met, there is usually no need to judge whether the two features constitute similar means, functions, and effects, and whether those skilled in the art can conceptualize them without creative work. In this case, since Haihe Company claimed the application of the estoppel rule by virtue of the amendment of the claims by Chugai Pharmaceutical Co., Ltd., and claimed the application of the donation rule by the patent text as the result of the amendment, the court of second instance first rendered a judgment on whether the rules on estoppel should be applied on the basis of the amendment of the claims by the patentee.

The case numbers are:

北京知识产权法院（2021）京73民初1438号民事判决书

最高人民法院（2022）最高法知民终905号民事判决书

The full text of the decision courtesy of 知识产权那点事 is available here (Chinese only).

Article By Aaron Wininger of Schwegman, Lundberg & Woessner, P.A.

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

© 2022 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

FDA Publishes 2022 Retail Food Program Standards

  • On August 24, 2022, FDA announced that it had published the 2022 edition of its Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards). The standards are intended to provide information on the key elements of an effective retail food regulatory program for local, tribal, state, and territorial regulatory agencies.
  • The Retail Program Standards provide recommendations for creating and managing retail food regulatory programs. Recommendations include how to provide effective inspections, reinforce proper sanitation, implement foodborne illness prevention strategies, and identify areas for improvement.
  • This year’s edition of the Retail Program Standards considers comments that were made during the Conference for Food Protection 2020 Biennial meeting, including reformatted curriculum forms and alternative sampling methods. A list of jurisdictions currently enrolled in the Retail Program Standards is available here. 

    Article By Food and Drug Law Practice Group at Keller and Heckman LLP

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

© 2022 Keller and Heckman LLP

Do I Have to Sign Over All My Assets when I Enter a Long-Term Care Facility?

I get asked some version of this question fairly frequently. I generally reassure clients that most facilities simply require you to pay month-to-month, and you can leave at any time. Now I may have to change my response, as news broke this week that a New Jersey woman allegedly had all her assets stolen by the very entity she trusted to care for her.

The woman entered a facility for a short-term rehab stay with every intention of returning home. Apparently the facility thought otherwise, as they enlisted a financial company to “assist” the woman in liquidating her assets to pay for her facility care and spend down to apply for Medicaid. I and other elder lawyers, along with several consumer protection agencies in the state, have long warned consumers about nonlawyer Medicaid advisors. These entities work closely with the nursing home industry, often having the same ownership and leadership. In this case, the POA is both an officer with the facility and the principal of the Medicaid advisor company that was hired to make the resident Medicaid eligible without her knowledge.

Some facilities require or coerce residents to hire these Medicaid advisors to prepare Medicaid applications for them. Unfortunately, they are not lawyers, and their allegiance is clearly to the facilities and not the residents or their families. Therefore, they fail to advise residents of opportunities to protect assets or income. Even worse, in many cases they failed to complete or submit the application or did so in a negligent manner, resulting in the application being denied. But unlike when an attorney messes up, there is no recourse for families, as these entities do not carry malpractice insurance. Sometimes the Medicaid advisor will simply close up shop and disappear – only to resurface later with a different organization.

There have been prior reports of facilities and the Medicaid advisors they work with requiring residents to sign POAs and even accessing resident accounts through questionable means. These latest allegations, however, bring this situation to a new level. It is alleged that the resident was forced to sign a POA when she did not have the capacity to do so due to medications she was prescribed. It was further alleged that Future Care Consultants liquidated the resident’s assets without her knowledge, and the funds were not returned when she left the facility. The family also alleges they were prevented from visiting or communicating with the resident.

The allegations are reminiscent of the movie I Care a Lot, which I have previously criticized as being completely unrealistic. However, in recent months, I have had clients report they were threatened by facilities if they used the services of an attorney. It is essential that consumers know their rights. You cannot be required to sign a POA. You cannot be forced to hire anyone to file your Medicaid application. And you cannot be prevented from using an attorney if you wish to do so.

Article By Shana Siegel of Norris McLaughlin P.A.

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

©2022 Norris McLaughlin P.A., All Rights Reserved

School Law Update: CDC Adjusts Direction on Exposure Quarantine Requirements for Employees

CDC Adjusts Direction on Exposure Quarantine Requirements for Employees

On August 11, 2022, the CDC updated its COVID-19 guidance as the risk of severe illness, hospitalization, and death from COVID exposure has significantly declined. More specific guidance for school districts was issued by the CDC, which can be found here.

In addition, the Department of Public Instruction has published guidance entitled “COVID-19 Infection Control and Mitigation Measures for Wisconsin Schools 2022/2023,” which can be found here.

While we published a Legal Update on the recent CDC guidance changes last week, that Update primarily focused on the private sector. This Update is primarily focused on the impact the new CDC guidance will have on school districts and identifies some of the key changes.

The more significant mask guidance has been reduced. Guidance now indicates that if COVID-19 is at a high Community Level, universal indoor masking in schools is recommended. The CDC also recommends masking in health care settings such as the school nurse’s office. The updated CDC guidance makes significant changes to quarantine and isolation protocols. Asymptomatic (exposed) children and staff, regardless of where the exposure occurred or vaccination status, no longer need to quarantine. Students or staff who self-identify as close contacts may continue to attend school/work if they remain asymptomatic.

Students or staff who come to school with symptoms or develop symptoms while at school should be asked to wear a well-fitting mask or respirator while in the building and be sent home. If testing is unavailable at school, students and staff should also be encouraged to get tested. Symptomatic people who cannot wear a mask should be separated from others as much as possible; children should be supervised by a designated caregiver who is wearing a well-fitting mask or respirator until they leave school grounds but masking with a high quality mask is suggested for 10 days from exposure.

If the school provides COVID-19 testing, a symptomatic student or staff member may remain in school if they are tested immediately onsite, and that test is negative. Best practice would include wearing a mask, if possible, until symptoms are fully resolved. If the student is “too ill” to be in school (fever, severe cough, vomiting, diarrhea, etc.), they should be sent home regardless of COVID-19 test results. If the symptomatic student or staff cannot be tested immediately, they should be sent home and encouraged to use an at-home-test-kit or be referred to a testing site.

Students and staff who test positive for COVID-19 should isolate for at least 5 days. If they are asymptomatic, they may end isolation after Day 5 (return Day 6). If they had symptoms, they may return to school/work after Day 5 if:

  • they are fever-free for 24 hours (without the use of fever-reducing medication)

  • their symptoms are improving

If the individual still has a fever or other symptoms have not improved, they should continue to isolate until the symptoms improve. Once isolation has ended, people should wear a well-fitting mask or respirator around others through Day 10. Testing is not required to determine the end of isolation or mask use following COVID-19 infection.

Article By James R. Macy, Ryan P. Heiden, and Anthony S. Wachewicz III of von Briesen & Roper, s.c.

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

©2022 von Briesen & Roper, s.c

EPA Updates Safer Chemical Ingredients List, Adding 22 Chemicals and Changing the Status of One Chemical

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”

EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” According to EPA, the chemical was originally listed on the SCIL based on data from a closely related substance that EPA marked with a grey square earlier this year. EPA’s process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL web page to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that the data required are determined on a case-by-case basis. In general, data useful for making such a determination provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA then removes the chemical from the SCIL 12 months after the grey square designation.

According to EPA, after this update is made, there will be 1,055 chemicals listed on the SCIL. EPA is committed to updating the SCIL with safer chemicals on a regular basis. EPA states that the SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use the SCIL to promote the safer chemicals they manufacture;
  • Retailers use the SCIL to help shape their sustainability programs; and
  • Environmental and health advocates use the SCIL to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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

©2022 Bergeson & Campbell, P.C.

Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

The directive bolstered efforts already underway by the Biden Administration. A week before the E.O. was signed, HHS Secretary Xavier Becerra directed the HHS Office for Civil Rights (OCR) to take steps to ensure privacy protections for patients who receive, and providers who furnish, reproductive health care services, including abortions.[3] The following day, OCR issued two guidance documents to carry out this order, which are described below.

Although the guidance issued by OCR clarifies the privacy protections as they exist under current law post-Dobbs, it does not offer patients or providers new or strengthened privacy rights. Indeed, the guidance illustrates the limitations of HIPAA regarding protection of health information of individuals related to abortion services.

A.  HHS Actions to Safeguard PHI Post-Dobbs

Following Secretary Becerra’s press announcement, OCR issued two new guidance documents outlining (1) when the HIPAA Privacy Rule may prevent the unconsented disclosure of reproductive health-related information; and (2) best practices for consumers to protect sensitive health information collected by personal cell phones, tablets, and apps.

(1) HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care

In the “Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe,”[4] OCR addresses three existing exceptions in the HIPAA Privacy Rule to the disclosure of PHI without an individual’s authorization and provides examples of how those exceptions may be applied post-Dobbs.

The three exceptions discussed in the OCR guidance are the exceptions for disclosures required by law,[5]  for purposes of law enforcement,[6] or to avert a serious threat to health or safety.[7]

While the OCR guidance reiterates that the Privacy Rule permits, “but does not require” disclosure of PHI in each of these exceptions,[8] this offers limited protection that relies on the choice of providers whether to disclose or not disclose the information. Although these exceptions are highlighted as “protections,” they expressly permit the disclosure of protected health information. Further, while true that the HIPAA Privacy Rule itself may not compel disclosure (but merely permits disclosure), the guidance fails to mention that in many situations in which these exceptions apply, the provider will have other legal authority (such as state law) mandating the disclosure and thus, a refusal to disclose the PHI may be unlawful based on a law other than HIPAA.

Two of the exceptions discussed in the guidance – the required by law exception and the law enforcement exception – both only apply in the first place when valid legal authority is requiring disclosure. In these situations, the fact that HIPAA does not compel disclosure is of no relevance. Certainly, when there is not valid legal authority requiring disclosure of PHI, then HIPAA prohibits disclosure, as noted as in the OCR guidance.  However, in states with restrictive abortion laws, the state legal authorities are likely to be designed to require disclosure – which HIPAA does not prevent.

For instance, if a health care provider receives a valid subpoena from a Texas court that is ordering the disclosure of PHI as part of a case against an individual suspected of aiding and abetting an abortion, in violation of Texas’ S.B. 8, then that provider could be held in contempt of court for failing to comply with the subpoena, despite the fact that HIPAA does not compel disclosure.[9] For more examples on when a covered entity may be required to disclose PHI, please see EBG’s prior blog: The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe.[10]

Notably, the OCR guidance does provide a new interpretation of the application of the exception for disclosures to avert a serious threat to health or safety. Under this exception, covered entities may disclose PHI, consistent with applicable law and standards of ethical conduct, if the covered entity, in good faith, believes the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. OCR states that it would be inconsistent with professional standards of ethical conduct to make such a disclosure of PHI to law enforcement or others regarding an individual’s interest, intent, or prior experience with reproductive health care. Thus, in the guidance, OCR takes the position that if a patient in a state where abortion is prohibited informs a health care provider of the patient’s intent to seek an abortion that would be legal in another state, this would not fall into the exception for disclosures to avert a serious threat to health or safety.  Covered entities should be aware of OCR’s position and understand that presumably OCR would view any such disclosure as a HIPAA violation.

(2) Protecting the Privacy and Security of Individuals’ Health Information When Using Personal Cell Phones or Tablets

OCR also issued guidance on how individuals can best protect their PHI on their own personal devices. HIPAA does not generally protect the privacy or security of health information when it is accessed through or stored on personal cell phones or tablets. Rather, HIPAA only applies when PHI is created, received, maintained, or transmitted by covered entities and business associates. As a result, it is not unlawful under HIPAA for information collected by devices or apps – including data pertaining to reproductive healthcare – to be disclosed without consumer’s knowledge.[11]

In an effort to clarify HIPAA’s limitation to protect such information, OCR issued guidance to protect consumer sensitive information stored in personal devices and apps.[12] This includes step-by-step guidance on how to control data collection on their location, and how to securely dispose old devices.[13]

Further, some states have taken steps to fill the legal gaps to varying degrees of success. For example, California’s Confidentiality of Medical Information Act (“CMIA”) extends to “any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information.”[14] As applied, a direct-to-consumer period tracker app provided by a technology company, for example, would fall under the CMIA’s data privacy protections, but not under HIPAA. Regardless, gaps remain as the CMIA does not protect against a Texas prosecutor subpoenaing information from the direct-to-consumer app. Conversely, Connecticut’s new reproductive health privacy law,[15] does prevent a Connecticut covered entity from disclosing reproductive health information based on a subpoena, but Connecticut’s law does not apply to non-covered entities, such as a period tracker app. Therefore, even the U.S.’s most protective state privacy laws do not fill in all of the privacy gaps.

Alongside OCR’s guidance, the Federal Trade Commission (FTC) published a blog post warning companies with access to confidential consumer information to consider FTC’s enforcement powers under Section 5 of the FTC Act, as well as the Safeguards Rule, the Health Breach Notification Rule, and the Children’s Online Privacy Protection Rule.[16] Consistent with OCR’s guidance, the FTC’s blog post reiterates the Biden Administration’s goal of protecting reproductive health data post-Dobbs, but does not go so far as to create new privacy protections relative to current law.

B.  Despite the Biden Administration’s Guidance, Questions Remain Regarding the Future of Reproductive Health Privacy Protections Post-Dobbs

Through E.O. 14076, Secretary Becerra’s press conference, OCR’s guidance, and the FTC’s blog, the Biden Administration is signaling that it intends to use the full force of its authorities – including those vested by HIPAA – to protect patient privacy in the wake of Roe.

However, it remains unclear how this messaging will translate to affirmative executive actions, and how successful such executive actions would be. How far is the executive branch willing to push reproductive rights? Would more aggressive executive actions be upheld by a Supreme Court that just struck down decades of precedent permitting access to abortion? Will the Biden Administration’s executive actions persist if the administration changes in the next Presidential election?

Attorneys at Epstein Becker & Green are well-positioned to assist covered entities, business associates, and other companies holding sensitive reproductive health data understand how to navigate HIPAA’s exemptions and interactions with emerging guidance, regulations, and statutes at both the state and Federal levels.

Ada Peters, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Washington, DC office and Jack Ferdman, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Boston office, contributed to the preparation of this post. 

[1] 87 Fed. Reg. 42053 (Jul. 8, 2022), https://bit.ly/3b4N4rp.

[2] Id.

[3] HHS, Remarks by Secretary Xavier Becerra at the Press Conference in Response to President Biden’s Directive following Overturning of Roe v. Wade (June 28, 2022), https://bit.ly/3zzGYsf.

[4] HHS, Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe (June 29, 2022),  https://bit.ly/3PE2rWK.

[5] 45 CFR 164.512(a)(1)

[6] 45 CFR 164.512(f)(1)

[7] 45 CFR 164.512(j)

[8] Id.

[9] See Texas S.B. 8; e.g., Fed. R. Civ. Pro. R.37 (outlining available sanctions associated with the failure to make disclosures or to cooperate in discovery in Federal courts), https://bit.ly/3BjX4I2.

[10] EBG Health Law Advisor, The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe (June 17, 2022), https://bit.ly/3oPDegl.

[11] A 2019 Kaiser Family Foundation survey concluded that almost one third of female respondents used a smartphone app to monitor their menstrual cycles and other reproductive health data. Kaiser Family Foundation, Health Apps and Information Survey (Sept. 2019), https://bit.ly/3PC9Gyt.

[12] HHS, Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone1 or Tablet (last visited Jul. 26, 2022), https://bit.ly/3S2MNWs.

[13] Id.

[14] Cal. Civ. Code § 56.10, Effective Jan. 1, 2022, https://bit.ly/3J5iDxM.

[15] 2022 Conn. Legis. Serv. P.A. 22-19 § 2 (S.B. 5414), Effective July 1, 2022, https://bit.ly/3zwn95c.

[16] FTC, Location, Health, and Other Sensitive Information: FTC Committed To Fully Enforcing the Law Against Illegal Use and Sharing of Highly Sensitive Data (July 11, 2022), https://bit.ly/3BjrzNV.

Article By Alaap B. Shah, Allen R. Killworth, Marylana Saadeh Helou, and Devon Minnick of Epstein Becker & Green, P.C.

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

Do You Have a College Student? Important Healthcare, Financial, and Educational Documents That They (and You) Need

August is upon us and you may soon be sending children off to college. If your child is age 18 or older, you and your child will need to take some simple steps so that, in the event of an emergency, you will be able to make health care and financial decisions for your child and have access to your child’s medical information and financial accounts. The same is true if you are to have access to your child’s educational records.

Medical Information. Once your child reaches age 18, your child is deemed to be an adult by law and you no longer have a legal right to make health care decisions on behalf of your child or to access your child’s health care information. As a result, if you have an adult child, your child must execute certain legal documents naming you as his or her health care agent and permitting you to access his or her medical information:

  1. Your child must execute a “Health Care Proxy” naming you as his or her agent for health care decisions. In this document, your child authorizes you to make health care decisions on your child’s behalf if he or she becomes unable to make or communicate such decisions him or herself. The child may also share his or her own wishes regarding medical treatment.
  2. Your child must also sign a “HIPAA Authorization Form.” The Health Insurance Portability & Accountability Act of 1996 (generally known as “HIPAA”) protects the privacy of an individual’s medical information, and health care providers may require written consent from a patient to share information with family members, including parents of an adult child. Your child’s college or university may also have policies in place preventing it from sharing medical information without the student’s consent. This form will serve as written permission authorizing those providing health care services to your child to share medical information with you as your child’s health care agent.
  3. In addition, you should be in contact with the health services department of your child’s college or university. The institution may provide its own form for authorizing the release of medical information that can be kept on record with the institution’s health services department.

Financial Accounts. If you are to have the ability to act on behalf of your adult child with respect to financial matters, your child also needs to execute a “Durable Power of Attorney” naming you as your child’s agent with respect to the child’s assets and finances. If your child is attending college away from home, is studying abroad, or undergoes a medical emergency, it may be useful for you to access your child’s accounts on his or her behalf. This allows you to pay bills for a child out of their accounts, make deposits and open or close accounts. In addition, a durable power of attorney allows you to handle other financial tasks for the child, like filing tax returns or renewing a lease.

Educational Records. Finally, the Family Educational Rights and Privacy Act (FERPA) protects the educational records of a child who has turned 18 or is enrolled at a postsecondary institution from access by his or her parents. If the child’s parents claim the child as a dependent on their tax returns, the parents may still access the child’s education records without the child’s consent. However, institutions may be reluctant to allow access to education records for any child over the age of 18 without a “FERPA Waiver” signed by the child, regardless of their status as a dependent. If you would like to have access to your child’s educational records, you should contact the institution to request a FERPA Waiver form.

Article By John H. Ramsey and Kerry L. Spindler of Goulston & Storrs

For more public education and services legal news, click here to visit the National Law Review.

2022 Goulston & Storrs PC.

Medicare CERT Audits and How to Prepare for Them

CERT audits are an unfortunate part of doing business for healthcare providers who accept Medicare. Failing the audit can mean the provider has to pay back overcharges and be subjected to increased scrutiny in the future. 

The best way to be prepared for a CERT audit is to have a compliance strategy in place and to follow it to the letter. Retaining a healthcare lawyer to craft that strategy is essential if you want to make sure that it is all-encompassing and effective. It can also help to hire independent counsel to conduct an internal review to ensure the compliance plan is doing its job.

When providers are notified of a CERT audit, hiring a Medicare lawyer is usually a good idea. Providers can fail the audit automatically if they do not comply with the document demands.

What is a CERT Audit?

The Comprehensive Error Rate Testing (CERT) program is an audit process developed by the Centers for Medicare and Medicaid Services (CMS). It is administered by private companies, called CERT Contractors, which work with the CMS. Current information about those companies is on the CMS website.

The CERT audit compares a sampling of bills for Medicare fee-for-service (FFS) payments, which were sent by the healthcare provider to its Medicare Administrative Contractor (MAC), against medical records for the patient. The audit looks at whether there is sufficient documentation to back up the claim against Medicare, whether the procedure was medically necessary, whether it was correctly coded, and whether the care was eligible for reimbursement through the Medicare program.

Every year, the CERT program audits enough of these FFS payments – generally around 50,000 per year – to create a statistically significant snapshot of inaccuracies in the Medicare program.

The results from those audits are reported to CMS. After appropriately weighing the results, CMS publishes the estimated improper payments or payment errors from the entire Medicare program in its annual report. In 2021, the CMS estimated that, based on data from the CERT audits, 6.26 percent of Medicare funding was incorrectly paid out, totaling $25.03 billion.

The vast majority of those incorrect payments, 64.1 percent, were marked as incorrect because they had insufficient documentation to support the Medicare claim. Another 13.6 percent were flagged as medically unnecessary. 10.6 percent was labeled as incorrectly paid out due to improper coding. 4.8 percent had no supporting documentation, at all. 6.9 percent was flagged as incorrectly paid for some other reason.

The CERT Audit Process

Healthcare providers who accept Medicare will receive a notice from a CERT Contractor. The notice informs the provider that it is being CERT audited and requests medical records from a random sampling of Medicare claims made by the provider to its MAC.

It is important to note that, at this point, there is no suspicion of wrongdoing. CERT audits examine Medicare claims at random.

Healthcare providers have 75 days to provide these medical records. Failing to provide the requested records is treated as an audit failure. In 2021, nearly 5 percent of failed CERT audits happened because no documentation was provided to support a Medicare claim.

Once the CERT Contractor has the documents, its team of reviewers – which consists of doctors, nurses, and certified medical coders – compares the Medicare claim against the patient’s medical records and looks for errors. According to the CMS, there are five major error categories:

  • No documentation

  • Insufficient documentation

  • Medical necessity

  • Incorrect coding

  • Other

Errors found during the CERT audit are reported to the healthcare provider’s MAC. The MAC can then make adjustments to the payments it sent to the provider.

Potential Repercussions from Errors Found in a CERT Audit

CERT audits that uncover errors in a healthcare provider’s Medicare billings lead to recoupments of overpayments, future scrutiny, and potentially even an investigation for Medicare fraud.

When the CERT audit results are brought to the MAC’s attention, the MAC will adjust the payments that it made to the provider. If the claims led to an overpayment, the MAC will demand that money back.

But Medicare Administrative Contractors (MACs) can go further than just demanding restitution for overpayments. They can also require prepayment reviews of all of the provider’s future Medicare claims, and can even suspend the provider from the program, entirely.

Worse still, CERT audits that uncover indications of Medicare fraud may be reported to a law enforcement agency for further review. This can lead to a criminal investigation and potentially even criminal charges.

Appealing a CERT Audit’s Results

With penalties so significant, healthcare providers should seriously consider hiring a lawyer to appeal the results of a CERT audit.

Appeals are first made to the MAC, requesting a redetermination of the audit results. The request for redetermination has to be made within 120 days of receiving notice of the audit results. However, if the provider wants to stop the MAC from recouping an overpayment in the meantime, it has to lodge the request within 30 days.

Providers can appeal the results of the redetermination, as well. They can request a reconsideration by a Qualified Independent Contractor within 180 of the redetermination, or within 60 days to stop the MAC’s recoupment process.

Providers who are still dissatisfied can appeal the case to an administrative law judge, then to the Medicare Appeals Council, and finally to a federal district court for review.

How to Handle a CERT Audit

The best way to handle and to prepare for a CERT audit is to hire Medicare audit attorneys to guide you through the process. It would also help to start internal audits within the company.

For providers who have been notified that they are under an audit, getting a lawyer on board immediately is essential. An experienced healthcare attorney can conduct a thorough internal investigation of the claims being audited. This can uncover potential problems before the audit points them out, giving the healthcare provider the time it needs to prepare its next steps.

Providers who are not currently being audited can still benefit from an attorney’s guidance. Whether by drafting a compliance plan that will prepare the provider for an inevitable CERT audit or by conducting an internal investigation to see how well a current compliance plan is performing, a lawyer can make sure that the provider is ready for an audit at a moment’s notice.

Taking these preventative steps soon is important. CMS put the CERT audit program on halt for the coronavirus pandemic, but that temporary hold was rescinded on August 11, 2020. While the CMS has reduced the sample sizes that will be used for its 2021 and 2022 reports, it will likely go back to the original numbers after that. Healthcare providers should prepare for this increased regulatory oversight appropriately.

Article By Dr. Nick Oberheiden of Oberheiden P.C.

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