Monthly Archives: February 2021

The U.S. Court of Appeals for the Fourth Circuit sided with a Black man and against two Virginia cops Thursday in what the plaintiff argued had been a driving while Black arrest.

George Wingate III had been driving on Jefferson Davis Highway in April 2017 when he experienced car trouble. Wingate is a mechanic who kept tools in the trunk of his car; he pulled to the side of the road, popped the hood, and began to work on his car, using the overhead streetlamp for lighting. Two Stafford County deputies saw Wingates disabled vehicle, and pulled in behind Wingate, ostensibly to render assistance.

The officers helpfulness, however, would be short-lived. Wingate walked over to the officers, greeted them, and explained that hed been trying to resolve his car trouble while en route to his girlfriends house. Deputy Scott Fulford reacted by demanding identification from Wingate, then activating his mic and calling for backup when Wingate questioned why he was being asked to show ID.

Fulford continued to demand ID from Wingate, explaining that Wingate was required to comply. Wingate refused, and asked multiple times whether he was being detained. The two engaged in the following exchange:

FULFORD: Youre not detained.

WINGATE: Am I free to go?

FULFORD: No.

WINGATE: Am I being detained? If Im not being detained, then Im free to go.

FULFORD: Youre not free to go until you identify yourself to me.

A second officer, Dimas Pinzon, arrived on the scene, and he told Wingate that there had been, a lot of catalytic converter thefts in [the] area. That officer also remarked, Its kind of weird, its 2 oclock in the morning, and youre out here on the side of the road in the same area where the businesses have all been hit. Wingate saidand subsequent investigation confirmedthat he hadnt committed any theft. Bodycam video of the exchange can be viewed here.

Stafford County Ordinance 177(c) says it is a crime to refuse an officers request for identification if the surrounding circumstances are such as to indicate to a reasonable man that the public safety requires such identification.

The officers prepared to handcuff Wingate, but Wingate ran across the street. One officer then pointed his Taser at Wingate, threw him to the ground, handcuffed him, and placed him in the back of the patrol car. Wingate was arrested and his car was searched.

Wingate brought a civil rights claim against the officers, and challenged the constitutionality of the Stafford ordinance. The district court sided with the police, granting summary judgment in the case. The Fourth Circuit reversed, and found in Wingates favor.

Chief Circuit Judge Roger Gregory (a Bill Clinton appointee) wrote for a unanimous three-judge panel of the Fourth Circuit, which also included Circuit Judge Paul V. Niemeyer (a George H.W. Bush appointee), and Circuit JudgeJulius N. Richardson (a Donald Trump appointee).

The court held that Fulfords statements constituted unambiguous restraint on Mr. Wingates liberty, thereby triggering protections under the Fourth Amendment. Accordingly, the officer would have required reasonable suspicion to act as he didand the facts at hand werent nearly enough.

Judge Gregory dismissed the officers arguments out of hand, writing, the notion that the driver of a broken-down vehicle creates suspicion of criminal activity by approaching the officer trying to render him aid, put candidly, defies reason.

Although we generally defer to officers claimed training and experience, we withhold that deference when failing to do so would erode necessary safeguards against arbitrary and boundless police prejudgments, Gregory continued. That is the case here.

The court went on to deny the officers qualified immunity for Wingates Fourth Amendment claim against them. The court ruled separately on Wingates claims for wrongful arrest under the Virginia statute. Holding that because Wingates right was not clearly established at the time of his arrest, the officers are entitled to qualified immunity on that claim. The case, now remanded for further proceedings, will now move toward trial or settlement.

Attorneys for the parties could not immediately be reached for comment.

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Link:
Court Rules in Favor of Man Who Said He Was Arrested for Driving While Black: Cops Acted with Arbitrary and Boundless Prejudgment - Law & Crime

Metro Health issues fourth amended health directive related to school systems

CONTACT: For members of the media, please contact:covid19media@sanantonio.gov

Laura Mayes, City of San Antonio (210) 207-1337Michelle Vigil, City of San Antonio (210) 207-8172

For questions from the general public, please contact:COVID-19@sanantonio.govCOVID-19 Hotline (210) 207-5779

SAN ANTONIO (February 2, 2021) Today, San Antonio's Local Health Authority, Dr. Junda Woo, issued a fourth amendment to the current health directive related to our local school systems. The revised health directive, either virtual or hybrid learning are options in Red Zone, but the directive stresses the importance of restricting other gatherings instead when community COVID levels are high. The directive adds links to new tools and FAQ's provided by the Centers for Disease Control and Prevention (CDC), highlights the fact that contact sports are still not recommended in the Red Zone, and removes specific pod sizes while sharing CDC templates for classroom layouts.

At risk levels in the Red Zone. Preventing transmission in K-12 settings requires reducing transmission in the community through policies such as restrictions on indoor dining. COVID testing should be offered to at least 25% of on-campus staff once a week, and class sizes should be smaller than in the Yellow Zone, with rigorous cohorting. In-person instruction prioritizes pre-kindergarten through elementary school students, special needs students, the most severely at-risk students, and students who lack access to resources. Building and room occupancy should be contingent on adequate ventilation and ability to create 6-foot distancing. Close contacts must be quarantined for 14 days.

Metro Health's weekly school risk level, which includes varying levels of virus prevention tactics and guidance within its Red, Yellow and Green Zones, can be found here.

For more information please visit http://www.covid19.sanantonio.gov

FOUR WAYS TO SIGN UP FOR COVID-19 ALERTS

Public service announcements on social distancing, prevention and testing are available here.

Documents to download

Health Directive Related to Schools Amended v16 Feb 2

This press release was produced by the City of San Antonio. The views expressed here are the author's own.

Excerpt from:
San Antonio: Metro Health Issues Fourth Amended Health Directive Related To School Systems - Patch.com

A significant privacy bill will be on Congress's agenda during the next two years, with privacy-focused Democrats holding thin majorities in both the House and the Senate.

While privacy legislation will take a back seat early this year because of the COVID-19 pandemic, lawmakers and privacy experts expect to see a significant push for legislation that would give consumers more control over how companies share their data, particularly over the internet.

Sen. Maria Cantwell, a Washington Democrat, introduced privacy legislation in late 2019. She will take over as chairwoman of the Senate Commerce, Science, and Transportation Committee, where privacy bills are debated. Her 2019 Consumer Online Privacy Rights Act would have given consumers the ability to prohibit companies from sharing their data with third parties. It would have required companies that hold personal data to check for security vulnerabilities and take preventive measures to protect that data.

Sen. Ron Wyden, an Oregon Democrat, plans to introduce two privacy bills, a spokesperson said. Wyden's Mind Your Own Business Act would create a national do-not-track list and allow for huge fines and, in some cases, prison terms for privacy violations. The Fourth Amendment is Not for Sale Act would prohibit government agencies, including law enforcement agencies, from purchasing personal information from data brokers.

Wyden's spokesperson said the senator plans to work closely with Cantwell to get privacy legislation passed.

With states passing privacy legislation and the European Union's General Data Protection Regulation in effect, privacy legislation in Congress will likely focus on the right for consumers to opt out of their information getting sold. They will also have the right to know what data is collected and the right for their data to be removed from company databases, said Cameron Call, a technical operations manager at Network Security Associates, an information technology services and regulatory compliance vendor.

Still, some of these regulations could have a significant impact on the technology industry, Call told the Washington Examiner. A lot of free online services "make their revenue on the data collected about you," he said. "If this gets taken away, how will they monetize? Will it mean more services will require a monthly subscription?"

It's also unclear whether United States consumers will pay attention if websites and companies are required to tell them what personal data they collect, he added. Because of the EU's GDPR, many websites now deliver a notice that they collect cookies. If web users get even more pop-ups, "will people actually read them?" he asked.

With California and other states passing privacy regulations, federal law seems likely, said Michael Williams, a partner at Clym, a data privacy law compliance platform. Many business leaders have pushed for a national law to avoid compliance with multiple state laws.

"To date, the U.S. has abdicated any true responsibility regarding federal data privacy regulation, and as such, many states have taken it upon themselves to enact or consider data privacy regulations for their residents," he told the Washington Examiner.

However, federal law may instead create baseline privacy regulations that states can build on, he added.

The impact of national privacy law will go beyond the tech sector, he said. Three of the highest five GDPR fines, for example, were imposed on companies outside the technology industry, with Swedish retail company H&M, British Airways, and Marriott International all receiving fines of over 20 million euros.

"In the modern economy, the flow of data informs operational decisions at every business, and companies of all shapes and sizes collect a massive amount of data, which, to this point, has gone unregulated in most areas of the U.S.," Williams said.

Still, some observers are less optimistic about a privacy bill passing. A major privacy bill seems unlikely unless the Senate eliminates the filibuster, said Kevin Coy, a partner and privacy group co-chairman with the Arnall Golden Gregory in Washington, D.C.

In some cases, Senate Republicans may block some comprehensive Democratic proposals, he noted.

"Privacy itself is not a partisan issue," he told the Washington Examiner. "However, some issues privacy legislation would need to address, such as whether the privacy legislation would preempt state law or whether there would be a private right of action for violations, are more likely to break down along partisan lines than many of the substantive requirements a major privacy law might include."

Read this article:
US lawmakers will push for new privacy regulations - Washington Examiner

By George Breen, Erica Bahnsen, and Daniel C. Fundakowski

Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.

Law360 (February 5, 2021, 6:17 PM EST) --

Qui tam relators filed 672 new cases in fiscal year 2020, an increase over fiscal year 2019 and the fifth highest number of cases in reported history, filing, on average, almost 13 new cases per week, 68% of which were related to the health care and life sciences industries.

More than $2.2 billion was recovered from settlements and judgments in fiscal year 2020, the lowest level since 2008, and almost $1 billion less thanfiscal year 2019. Notably, over 80% of recoveries, amounting to almost $1.9 billion, came from the health care and life sciences industries.

Health care-related recoveries focused on cases pursued against drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians.

The most significant recoveries again came from the pharmaceutical industry and involved allegations of improper patient copay amounts and illegal kickbacks. These recoveries include those related to the opioid crisis, which continues to be a point of emphasis for DOJ enforcement actions.

The circuit split on the FCA's required falsity standard for clinical judgments may be resolved by the high court.

While the FCA requires that claims be false or fraudulent, the statute does not define those terms, and a circuit split emerged in 2020 on the appropriate standard for proving falsity in the context of clinical judgments.

On Sept. 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued a key decision in U.S. v. AseraCare Inc. concerning the FCA's standard for proving falsity.[2]

The government alleged that AseraCare improperly billed Medicare for hospice benefits provided to individuals who were not properly certified as terminally ill. In adopting an objective falsehood standard, the Eleventh Circuit held that a "mere difference of reasonable opinion between physicians, without more," is insufficient to create a triable issue of fact regarding the FCA's falsity element.

Months after the Eleventh Circuit's AseraCare decision, the U.S. Court of Appeals for the Third Circuit, in U.S. v. Care Alternatives, expressly rejected the objective falsehood requirement.[3] In this factually similar Medicare hospice benefit case, the Third Circuit held that "a difference of medical opinion is enough evidence to create a triable dispute of fact regarding FCA falsity."[4]

The U.S. Court of Appeals for the Ninth Circuit later weighed in on FCA falsity in U.S. v. Gardens Regional Hospital and Medical Center Inc., where it considered whether an objective falsehood is required at the pleading stage to avoid dismissal.[5]

The relator alleged that the hospital falsely certified that patients' inpatient hospitalizations were medically necessary. In reversing the district court's decision that "subjective medical opinions ... cannot be proven to be objectively false," the Ninth Circuit held that the broad language of the FCA "does not distinguish between 'objective' and 'subjective' falsity or carve out an exception for clinical judgments and opinions."[6]

The practical effects of the circuit split and the differing standards are likely to become more apparent in 2021 as courts continue to apply them. Care Alternatives filed a certiorari petition on Sept. 16, 2020, so it remains possible that the U.S. Supreme Court could resolve the circuit split this year.[7]

Courts continue to grapple with materiality following Escobar.

The FCA requires that a false record or statement be material to the government's payment decision before liability can attach.

In accordance with the Supreme Court's 2016 decision in Universal Health Services Inc. v. Escobar, the touchstone of materiality is whether the government would have paid the claim in question if it had known of the defendant's noncompliance with an applicable law or regulation.[8] Throughout 2020, courts across the country continued to grapple with the FCA's materiality framework.

In U.S. v. Lawrence Memorial Hospital, the relator alleged that the hospital fabricated patient arrival times associated with certain Centers for Medicare & Medicaid Services pay-for-reporting and pay-for-performance programs.[9]

A key issue in the case was from whose perspective materiality should be judged; the relator argued that materiality should be judged based on the likely impact of the noncompliance on a reasonable person (an objective standard).

In affirming the district court's opinion that the alleged false claims were not material, the U.S. Court of Appeals for the Tenth Circuit held that the proper focus in determining materiality is on the actual reaction of the recipient of the false claim, not on a reasonable person.

Applying that standard, the Tenth Circuit held that CMS' inaction and continued payment of claims, even after CMS was made aware of the alleged noncompliance six years earlier, suggests immateriality.[10] The Supreme Court denied the relator's certiorari petition on Oct. 5, 2020.

In U.S. v. Salus Rehabilitation LLC, the Eleventh Circuit reinstated an $85 million jury verdict over $255 million after trebling and penalties on Medicare claims that the district court initially set aside after a month-long jury trial where the judge found that the relator "failed to introduce evidence of materiality and scienter at trial."[11]

The case involved allegations that the nursing home operators artificially inflated Medicare patients' resource utilization group scores by upcoding and ramping to yield increased Medicare payments.[12]

The Eleventh Circuit dismissed the district court's conclusion that the relator's allegations amounted to a handful of paperwork defects, and found that the upcoding and ramping allegations were a "simple and direct theory of fraud" with "plain and obvious materiality [that] went to the heart of the SNFs' ability to obtain reimbursement from Medicare."[13]

Given the Supreme Court's apparent reluctance to take up materiality again in the near term every certiorari petition on materiality since Escobar has been denied district courts will continue to be where the key decisions as to how FCA materiality, and the scope of what can be enforced with the FCA, will be made.

Agencies and courts continue contemplating ramifications of the "substantive legal requirement" concept following the Supreme Court's Allina decision.

On June 3, 2019, the Supreme Court in Azar v. Allina Health Services held that any Medicare issuance that establishes or changes a substantive legal standard governing Medicare eligibility, benefits or payments for services must go through notice-and-comment rulemaking to be valid.[14]

Since that decision, district courts and agencies have acknowledged Allina's broad impact on FCA litigation, albeit reaching different conclusions on the actual effects as applied in specific instances.

For example, in Agendia Inc. v. Azar and Polansky v. Executive Health Resources Inc., the U.S. District Courts for the Central District of California and the Eastern District of Pennsylvania have thrown out cases on summary judgment where the guidance at issue constituted a substantial legal standard that was not promulgated through notice-and-comment rulemaking. Both decisions are on appeal.[15]

The U.S. District Court for the Northern District of Mississippi, in denying the defendants' motion to dismiss in U.S. v. Mitias Orthopaedics, noted that while it had some skepticism about whether FCA actions would necessarily be subject to Allina, it expressly did "not rule out the possibility that it will eventually agree with [defendants'] interpretation of Allina in this case."[16]

On Dec. 7, 2020, the U.S. Department of Health and Human Services issued its good guidance practices final rule, which limits HHS' ability to issue and rely upon subregulatory guidance documents in enforcement actions, investigations, and audits, including actions relating to coverage and reimbursement for items and services under Medicare and other federal health care programs, and establishes a petition process to challenge guidance.[17]

The effect was swift: On Jan. 8, 2021, HHS released its first formal response to a petition submitted pursuant to the good guidance practices final rule's petition process.[18] HHS agreed to withdraw certain guidance documents that DaVita Inc. challenged as unlawful, as CMS determined that "they impose binding new obligations that are not reflected in duly enacted statutes or regulations lawfully promulgated under them."[19]

Given recent judicial and agency action, there may be new avenues both to challenge and, potentially seek early resolution of FCA cases or investigations premised on allegations of noncompliance with subregulatory guidance not lawfully promulgated. We expect to see additional challenges play out in 2021.

Courts continue scrutinizing the DOJ's discretion to dismiss qui tam claims following the Granston memorandum.

Section 3730(c)(2)(A) of the FCA gives DOJ the express authority to seek dismissal of an FCA case, even over the relator's objection, if the relator is provided notice and an opportunity for a hearing.

While that authority has historically been exercised rarely, the DOJ increasingly moved to dismiss cases following release of the Jan. 10, 2018, memorandum authored by Deputy Assistant Attorney General Michael Granston that instructed the DOJ and U.S. Attorney's Office civil litigators to consider dismissal of qui tam actions under Section 3730(c)(2)(A) where it would be in the government's interest to do so, for example, to curb meritless claims, preserve government resources or safeguard classified information.

TheDOJ reported that, between Jan. 1, 2018, and Dec. 19, 2019, it sought dismissal of 45 FCA cases.[20] This was roughly the same amount of cases that the DOJ moved to dismiss in the 30 years preceding the Granston memorandum.[21]

However, courts remain divided on what standard to apply when the government exercises that statutory dismissal authority. The DOJ's efforts to dismiss qui tam cases have generally been analyzed under two standards: the U.S. Court of Appeals for the D.C. Circuit's Swift standard and the Ninth Circuit's Sequoia Orange standard.[22]

The Swift standard is the most deferential and provides the government with an unfettered right to dismiss qui tam cases. By contrast, the Sequoia Orange standard applies a rational relation standard that requires the government to show (1) a valid government purpose and (2) a rational relation between dismissal and accomplishment of the purpose before the court can grant the dismissal.

The U.S. Court of Appeals for the Seventh Circuit recently fashioned a new standard for evaluating Section 3730(c)(2)(A) dismissals. In U.S. v. UCB Inc., the DOJ declined to intervene and later sought to dismiss the case after its investigation found the claims lacked sufficient merit to justify the use of government resources. The district court denied the motion to dismiss, holding that the Sequoia Orange standard was not satisfied.[23]

On appeal, the Seventh Circuit declined to adopt Swift or Sequoia Orange, finding the "choice between the competing standards as a false one, based on a misunderstanding of the government's rights and obligations under the False Claims Act."

The Seventh Circuit ultimately held that the FCA requires the DOJ "to intervene as a party before exercising its right to dismiss under 3730(c)(2)(A)" and therefore construed DOJ's motion to dismiss also as a motion to intervene.

Finding that DOJ had intervened in the action, the Seventh Circuit looked to Federal Rule of Civil Procedure 41(a)(1)(A)(i), which provides that a plaintiff has an absolute right to dismiss an action without prejudice any time "before the opposing party serves either an answer or a motion for summary judgment," and the case was dispensed with on that basis.

While the Seventh Circuit's new standard arguably poses a higher bar than the Swift standard, the court's reasoning indicates that, as a practical matter, the DOJ should have a nearly unfettered right to intervene and dismiss pursuant to Rule 41(a)(1)(A)(i).

Just weeks prior to the Seventh Circuit's decision, the Ninth Circuit, in United States v. Academy Mortgage Corp., refused, on jurisdictional grounds, to invoke the collateral order doctrine to permit the DOJ to appeal the district court's denial of a motion to dismiss, permitting the case to proceed over the government's objection.[24]

On April 6, 2020, the court denied certiorari on this issue in U.S. v. JPMorgan Chase Bank, where the relator argued that the D.C. Circuit should have required the DOJ to show that the dismissal served a valid governmental purpose, i.e., adopt the Sequoia Orange standard.[25] It remains unclear whether the Supreme Court will weigh in on the circuit split in 2021.

Other expectations for 2021 include heightened CARES Act enforcement, increased scrutiny on telemedicine and clarifications to physician compensation rules.

The Coronavirus Aid, Relief and Economic Security Act was signed into law by former President Donald Trump on March 27, 2020, and with $1.8 trillion in direct aid to individuals and businesses, comprises the largest stimulus package in U.S. history.[26]

Under the Trump administration, combating COVID-19-related fraud was a top priority for the DOJ and, while other enforcement priorities remain to be seen, the Biden administration will almost certainly continue to focus on COVID-19 enforcement.[27]

On Jan. 12, 2021, the DOJ announced the first civil settlement to resolve allegations of fraud relating to misuse of Paycheck Protection Program funds, and we expect to see an increase in these resolutions throughout 2021.[28]

We also expect increased government scrutiny on telemedicine. As part of the ongoing efforts to provide safe medical care during the COVID-19 pandemic, HHS issued an amended declaration under the 2005 Public Readiness and Emergency Preparedness Act to expand its COVID-19 emergency countermeasures to allow clinicians to engage in certain limited telemedicine activities in states other than those in which they are licensed.[29]

While telemedicine enforcement actions to date have focused largely on criminal kickback schemes, providers practicing pursuant to HHS' amended declaration should be aware of enhanced scrutiny and potential liability in 2021.

On Nov. 20, 2020, HHS released complementary rules to modernize and clarify the regulations that interpret the Physician Self-Referral Law, also known as the Stark Law, and the federal Anti-Kickback Statute as part of its Regulatory Sprint to Coordinated Care.[30] The rules reflect an attempt to create exceptions and safe harbors that refine the Stark Law's strict-liability-based civil penalties and the Anti-Kickback Statute's criminal penalties.

The stated goal of these reforms is to prevent certain nonabusive and beneficial arrangements from being subject to enforcement actions. While many components of the rules are, in large part, clarifications of existing rules, they may be used to interpret the provider compensation rules in existing FCA actions.

Conclusion

Looking back on 2020, while the DOJ's FCA recovery numbers were the lowest sincefiscal year 2008, the key takeaway is that the DOJ set a record for the most new FCA matters ever initiated in a single year and did so despite a global pandemic, closed courts and conducting investigations remotely.

If the government's heightened enforcement activity relating to prior economic crises and government stimulus programs is any indication, we can expect a surge in FCA cases and enforcement activity in 2021.

Erica Bahnsenis a member at the firm.

Daniel Fundakowskiis senior counsel at the firm.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] Department of Justice, Justice Department Recovers Over $2.2 Billion from False Claims Act Cases in Fiscal Year 2020, Jan. 14, 2021, available at https://www.justice.gov/opa/pr/justice-department-recovers-over-22-billion-false-claims-act-cases-fiscal-year-2020.

[2] 938 F.3d 1278 (11th Cir. 2019).

[3] 952 F.3d 89 (3rd Cir. 2020).

[4] Id. at 100.

[5] 953 F.3d 1108 (9th Cir. 2020).

[6] Id. at 1117.

[7] With that certiorari petition being distributed for conference on February 19, 2021, a denial could appear on the Supreme Court's orders list as early as February 22, 2021, or, if not relisted, the petition could be granted as soon as the following week.

[8] 136 S. Ct. 1989 (2016).

[9] 949 F.3d 533 (10th Cir. 2020).

[10] Id. at 542.

[11] 963 F.3d 1089, 1098 (11th Cir. 2020).

[12] As it relates to the Medicare claims, "upcoding" involved allegations of artificially inflating RUG codes and "ramping" involved artificial timing of spikes in patient treatment to coincide with Medicare's regularly scheduled assessment periods to maximize reimbursement going forward. The Eleventh Circuit affirmed the district court's findings on the relator's failure to prove materiality on the Medicaid claims.

[13] Id. at 1105.

[14] 139 S. Ct. 1804 (2019).

[15] Agendia, Inc. v. Azar, 420 F. Supp. 3d 985 (C.D. Cal. 2019) (pending appeal before the Ninth Circuit); Polansky v. Executive Health Resources, Inc., 422 F. Supp. 3d 916 (E.D. Pa. 2019) (pending appeal before the Third Circuit).

[16] 2021 WL 79615, at *11 (N.D. Miss. Jan. 11, 2021).

[17] Department of Health & Human Services, HHS Finalizes Good Guidance Practices Rule and Issues Advisory Opinion Regarding Compliance with Notice-and-Comment Obligations, Dec. 3, 2020, available at https://www.hhs.gov/about/news/2020/12/03/hhs-finalizes-good-guidance-practices-rule-issues-advisory-opinion-regarding-compliance-notice.html.

[18] Department of Health & Human Services, Good Guidance Petition Response 21-01, Jan. 8, 2021, available https://www.hhs.gov/sites/default/files/davita-petition-response-and-exhibit.pdf.

[19] On December 3, 2020, the HHS Office of the General Counsel issued Advisory Opinion 20-05 to clarify how HHS will comply with Allina. While caveated as not binding on "HHS or the federal courts," the opinion states that "to the extent that guidance documents set forth Medicare policies or rules that are not closely tied to statutory or regulatory standards, the government generally cannot use violations of that guidance to inform the basis for any enforcement action, because under Allina, it was not validly issued."[19]

[20] See Department of Justice, Letter from DOJ Office of the Assistant Attorney General to Senator Chuck Grassley, Dec. 19, 2019, available at https://www.grassley.senate.gov/sites/default/files/2019-12-19%20DOJ%20to%20CEG%20%28FCA%20dismissals%29.pdf; see also Department of Justice, Remarks of Deputy Assistant Attorney General Michael D. Granston at the ABA Civil False Claims Act and Qui Tam Enforcement Institute, Dec. 2, 2020, available at https://www.justice.gov/opa/speech/remarks-deputy-assistant-attorney-general-michael-d-granston-aba-civil-false-claims-act (noting how DOJ "has filed motions to dismiss in approximately 50 qui tam actions" since DOJ's September 2018 update to the Justice Manual with the dismissal guidance outlined in the Granston memorandum).

[21] See Department of Justice, Principal Deputy Assistant Attorney General Ethan P. Davis Remarks on the False Claims Act at the U.S. Chamber of Commerce's Institute for Legal Reform, June 26, 2020, available at https://www.justice.gov/civil/speech/principal-deputy-assistant-attorney-general-ethan-p-davis-delivers-remarks-false-claims.

[22] Swift v. United States, 318 F.3d 250 (D.C. Cir. 2003); U.S. ex rel. Sequoia Orange Co. v Baird-Neece Packing Corp., 151 F.3d 1139 (9th Cir. 1998).

[23] 970 F.3d 835 (7th Cir. 2020).

[24] 968 F.3d 996 (9th Cir. 2020).

[25] 2019 WL 4566462 (D.C. Cir. Aug. 22, 2019), cert. denied 140 S.Ct. 2660 (Apr. 6, 2020).

[26] The CARES Act, Pub. L. No. 116-136 (2020).

[27] See, e.g., Press Release, Department of Justice, Combating CARES Act Fraud: Ensuring Economic Relief for Americans Through Law Enforcement Efforts, July 8, 2020, available at https://www.justice.gov/usao-edtx/pr/combating-cares-act-fraud-ensuring-economic-relief-americans-through-law-enforcement; Press Release, Department of Justice, Acting Assistant Attorney General Brian Rabbitt Delivers Remarks at the PPP Criminal Fraud Enforcement Action Press Conference, Sept. 10, 2020, available at https://www.justice.gov/opa/speech/acting-assistant-attorney-general-brian-rabbitt-delivers-remarks-ppp-criminal-fraud.

[28] Press Release, Department of Justice, Eastern District of California Obtains Nation's First Civil Settlement for Fraud on Cares Act Paycheck Protection Program, Jan. 13, 2021, available at https://www.justice.gov/usao-edca/pr/eastern-district-california-obtains-nation-s-first-civil-settlement-fraud-cares-act.

[29] Department of Health & Human Services, Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID19 and Republication of the Declaration, available at https://www.phe.gov/Preparedness/legal/prepact/Pages/4-PREP-Act.aspx; Department of Health & Human Services, HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth, available at https://www.hhs.gov/about/news/2020/12/03/hhs-amends-prep-act-declaration-including-expand-access-covid-19-countermeasures-telehealth.html.

[30] Centers for Medicare & Medicaid Services, "Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations," 85 FR 77492 (Dec. 2, 2020), available at https://www.federalregister.gov/documents/2020/12/02/2020-26140/medicare-program-modernizing-and-clarifying-the-physician-self-referral-regulations; Office of Inspector General, "Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements," 85 FR 77684 (Dec. 2, 2020), available at https://www.federalregister.gov/documents/2020/12/02/2020-26072/medicare-and-state-health-care-programs-fraud-and-abuse-revisions-to-safe-harbors-under-the.

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Key FCA Developments From 2020 And What To Expect Next - Law360