Health Law Advisor

HRSA’s “Audit Reporting Requirement Attestations” arrived in inboxes on Friday, March 22, 2024, and require a response by Friday, April 5, 2024.  The government is under pressure to show that the money distributed under the CARES Act and the American Rescue Plan was used responsibly.  These notices are frustrating and frightening, and a two-week turnaround may seem a bit callous, but the situation could certainly be worse—the government could have simply demanded a return of the funds.  If an organization expended more than $750,000 in a single fiscal year and does not comply ...

Use of telehealth services has surged since the COVID-19 pandemic; however, this increase in use does not come without limitations. Telehealth providers are subject to regulations, which differ by state, that govern various aspects of providing services via telemedicine, including what types of health care providers can provide telehealth services, what services can be provided via telehealth, and where providers must be located in order to provide telehealth services to a patient. A requirement consistent across most states is that providers engaging in telehealth services ...

On March 22, 2023, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) updated its Frequently Asked Questions (“FAQs”), drafting 13  FAQs aimed at easing the transition from COVID-era flexibilities to the end of the Public Health Emergency (“PHE”) on May 11, 2023. These FAQs arrive on the tail of OIG’s March 10, 2023 COVID-19 Public Health Emergency policy statement, which announced that the expiration of the PHE in May also marks the end of flexibilities extended during the crisis.  The updated FAQs offer a glimpse into how OIG investigations and enforcement might play out after the end of the PHE.  These FAQs address subjects including “General Questions Regarding Certain Fraud and Abuse Authorities,” the “Application of Certain Fraud and Abuse Authorities to Certain Types of Arrangements,” and “Compliance Considerations.”  

The vast majority of the principles articulated in the updated FAQs will undoubtedly be familiar to many.  Generally speaking, the updated FAQs restate or clarify longstanding OIG policy.  The updated FAQs are more than reiteration, however; they offer condensed policy and explanation in a single location, and demonstrate that for the most part, investigations and enforcement may return to the pre-PHE status quo. 

On April 11, 2023, U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced its plan for termination of the existing notifications of enforcement discretion related to the expiration of the COVID-19 public health emergency (PHE) on May 11, 2023. 

In this episode of the Diagnosing Health Care Podcast:  In conjunction with the national COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services and other federal agencies have issued waivers and other declarations with the goal of giving providers flexibility in order to render services during the PHE. 

How should stakeholders prepare for the end of the PHE on May 11, 2023?

Interest in and acceptance of telehealth services continues to grow. Recent events, like the COVID-19 pandemic and the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women's Health Organization, have put more pressure than ever on federal and state legislators to promote access to telehealth services.

However, the greater use of telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while staying compliant with applicable laws.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. We are pleased to release our latest compilation of state telehealth laws, regulations, and policies within the mental/behavioral health practice disciplines.

In this episode of the Diagnosing Health Care Podcast:  While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up.

What can businesses do to prevent or mitigate potential civil and criminal charges in this area?

In this episode of the Diagnosing Health Care Podcast:  For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19 impacted these efforts?

Hear from special guest Will Chang, Chief Legal Officer of UpStream.

In two recent memoranda, the Centers for Medicare and Medicaid Services (CMS) made changes to previously issued survey guidance related to COVID-19 vaccination issues.

In this episode of the Diagnosing Health Care Podcast:  What challenges are providers likely to face as the Occupational Safety and Health Administration (OSHA) prepares its permanent COVID-19 standard for health care workers?

Attorneys Denise Dadika, Bob O’Hara, and Tim Murphy review the provisions of OSHA’s temporary COVID-19 standard for health care workers and what’s expected to change under the permanent rules. They also discuss how the agency’s current enforcement push is impacting health care providers.

On April 20, 2022, the Department of Justice (DOJ) announced a nationwide coordinated enforcement action targeting COVID-19-related fraud involving charges against 21 individuals across nine federal districts, and over $149 million in alleged false claims submitted to federal programs.[1]

This marks the first significant DOJ enforcement action since Attorney General Merrick Garland named Associate Deputy Attorney General Kevin Chambers as the Director for COVID-19 Fraud Enforcement on March 10, an appointment President Biden previewed in his State of the Union address on March 1.

On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities.  The amount of blanket waivers ending is notable; while there have been terminations of waivers previously, these were usually limited to a single waiver.

CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” CMS reported that findings from onsite surveys at these facilities “revealed significant concerns with resident care that are unrelated to infection control.” Accordingly, CMS is acting to remove certain operational flexibilities not directly related to infection control.

In this episode of the Diagnosing Health Care Podcast:  The Supreme Court recently upheld the Centers for Medicare and Medicaid Services (CMS) vaccine mandate, which requires recipients of federal Medicare and Medicaid funding to ensure that employees, including third- party contractors, are vaccinated against COVID-19. The Court’s decision has clear implications for owners of health care facilities and their contractors with active construction work in 2022 and beyond.

On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.

On February 1, 2022, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2021.^[1]

With collections amounting to $5.6 billion, FY 2021 marks DOJ’s largest annual total FCA recovery since FY 2014, and more than twice the $2.3 billion received in FY 2020. FY 2021 was also a record-shattering year for DOJ as it relates to health care fraud enforcement; over $5 billion (90% of the total) was obtained from cases pursued against individuals and entities in the health care and life sciences industries.

Interest in, and acceptance of, telehealth services continues to grow. Federal and state legislators are under pressure to codify the flexibilities granted in response to the COVID-19 pandemic that increased access to telehealth services. Meanwhile, increased use of telehealth has put a much greater focus on the potential for fraudulent behavior and increased enforcement activity as a result. Telehealth providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while at the same time ...

On May 26, 2021, the Department of Justice (“DOJ”) announced a coordinated law enforcement action against 14 telehealth executives, physicians, marketers, and healthcare business owners for their alleged fraudulent COVID-19 related Medicare claims resulting in over $143 million in false billing.[1] This coordinated effort highlights the increased scrutiny telehealth providers are facing as rapid expansion efforts due to COVID-19 shape industry standards.

Since the outset of the COVID-19 pandemic, the DOJ has prioritized identifying and prosecuting COVID-19 ...

On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.[1]

Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.”[2]  The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation.  “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others.

In this episode of the Diagnosing Health Care Podcast:  The vaccine passport has been a major topic of discussion as businesses and governments consider how to balance privacy and safety through the rollout of the COVID-19 vaccine. Epstein Becker Green attorneys Patricia Wagner, Alaap Shah, and Jessika Tuazon discuss the privacy and security concerns companies must weigh as they consider developing or implementing vaccine passports, such as the collection and use of an individual's personal health information. As state governments and the private sector take the ...

On April 8, 2021, the U.S. Department of Justice (“DOJ”) announced the first charges brought in connection with alleged fraud on the Accelerated and Advance Payment Program, administered by the Centers for Medicare & Medicaid Services (“CMS”).[1]  According to the indictment, Francis Joseph, M.D., a Colorado physician, has been charged with misappropriating nearly $300,000 from three different COVID-19 relief programs: the Accelerated and Advance Payment Program, the Provider Relief Fund, and the Paycheck Protection Program.[2]

Accelerated and Advance Payment Program

The Accelerated and Advance Payment Program is intended to provide emergency funds by way of expedited payments to health care providers and suppliers when there is a disruption in claims submission or claims processing.  While CMS has historically utilized this program to provide targeted relief in response to national emergencies or natural disasters affecting certain portions of the country, the program was expanded in March 2020 to apply to a broader group of Medicare Part A providers and Part B suppliers nationwide due to the financial impact of COVID-19.[3]

According to the indictment, Dr. Joseph allegedly submitted an Advance Payment Request Form for a medical practice of which he had relinquished control, and then transferred approximately $92,000 from the medical practice’s operating account to a personal bank account (approximately $87,000 of that amount was paid by the Medicare Administrative Contractor as an advance payment the previous day).

Provider Relief Fund

The Provider Relief Fund is a $178 billion measure appropriated under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act that offers aid to providers who were financially impacted by COVID-19 and treatment and other assistance to individuals suffering from COVID-19.

The indictment marks the second time that DOJ has brought charges related to misuse of Provider Relief Fund distributions (DOJ announced the first charges in February 2021 against a home health provider).  According to the indictment, Dr. Joseph’s former medical practice met the criteria for a Provider Relief Fund distribution of $31,782, but Dr. Joseph allegedly transferred those funds from the medical practice’s operating account to a personal bank account.

In this episode of the Diagnosing Health Care Podcast: Since the start of the COVID-19 pandemic, many jurisdictions have enacted protections from COVID-19-related liability claims through legislation and executive orders. These liability shields, however, may give health care businesses a false sense of security and offer little protection when it comes to employment claims.

Epstein Becker Green attorneys Denise Merna Dadika, Gregory Keating, and Elena Quattrone discuss the unintended liability consequences health care employers must consider as they ...

On April 29, 2021, the Federal Communications Commission (FCC) will begin accepting applications for the second round of its COVID-19 Telehealth Program (the “Program”). However, the application filing window will only be open for a very short seven day period and will close on May 6, 2021. To give all applicants an equal opportunity to have their applications reviewed, the FCC announced that all applications filed during this period will be reviewed once the application filing window has closed.

Initially, in March 2020, Congress appropriated $200 million for the first round of the COVID-19 Telehealth Program funding under the CARES Act. An additional $249.95 million was provided to the FCC in December 2020, under the Consolidated Appropriations Act (CAA), to helping address inequities in access to health care service. The COVID-19 Telehealth Program was designed to help health care providers purchase telecommunications equipment, broadband connectivity, and other devices necessary for providing telehealth services to rural, low-income and underserved populations.

The Program is limited to nonprofit and public health care providers (47 U.S.C. § 254(h)(7)(B)) that fall within the following categories:

1. Post-secondary educational institutions offering health care instruction, teaching hospitals, and medical schools;
2. Community health centers or health centers providing health care to migrants;
3. Local health departments or agencies;
4. Community mental health centers;
5. Not-for-profit hospitals;
6. Rural health clinics;
7. Skilled nursing facilities; or
8. Consortia of health care providers consisting of one or more entities falling into one of the first seven categories.

On March 26, 2021, the U.S. Department of Justice (“DOJ”) reported on the agency’s heightened criminal and civil enforcement activities in connection with COVID-19-related fraud.[1]  As of that date, DOJ had publicly charged 474 defendants with criminal offenses in connection with COVID-19-related schemes across 56 federal districts to recover more than $569 million in U.S. government funds.

The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a federal law, enacted on March 29, 2020, designed to provide emergency financial assistance to the millions of Americans who are suffering the economic effects caused by the COVID-19 pandemic.  The CARES Act provides relief through a number of different programs, including the Paycheck Protection Program (“PPP”), Economic Injury Disaster Loans (“EIDL”), the Provider Relief Fund, and Unemployment Insurance (“UI”).[2]  With the promulgation of these programs, DOJ has ramped up efforts in identifying and investigating fraud to protect the integrity of the $2.2 trillion in taxpayer funds appropriated under the CARES Act.

Criminal Enforcement Activities

The majority of fraud cases brought by DOJ have originated in the Criminal Division’s Fraud Section, accounting for at least 120 defendants charged with PPP fraud.[3]  The PPP allows qualifying small businesses and other organizations to receive loans with a maturity of two years and an interest rate of 1 percent.  PPP loan proceeds must be used by businesses for payroll costs, interest on mortgages, rent, and utilities.  Most of these defendants are facing charges for allegedly misappropriating loan payments for prohibited purposes, such as luxury purchases, while another significant portion are charged in connection with allegedly inflating payroll expenses in order to obtain larger PPP loans.[4]

DOJ also announced that it has seized over $580 million in fraudulent application proceeds in connection with the EIDL program, which is designed to provide loans to small businesses and agricultural and nonprofit entities.  DOJ’s primary concerns with respect to this program have related to fraudulent applications for EIDL advances and loans on behalf of shell or nonexistent businesses.

In response to a rise in UI fraud schemes, DOJ has established the National Unemployment Insurance Fraud Task Force to investigate domestic and international organized crime groups targeting unemployment funds through the use of identity theft.  Since the start of the pandemic, over 140 defendants have been publicly charged with federal offenses related to UI fraud.[5]

At the end of March, Florida joined the roster of states that have erected legal shields for health care providers against COVID-19-oriented liability claims. Concerned about uncertainty surrounding the emergency measures taken in response to COVID-19 and the effects that lawsuits could have on the economic recovery and the ability of health care providers to remain focused on serving the needs of their communities, the Florida Legislature passed CS/SB 72 on March 29, 2021.  Governor Ron DeSantis signed CS/SB 72 into law as Laws of Florida 2021-1.  This law creates two new statutory provisions - section 768.38 and section 768.381, Florida Statutes – effective on passage.

What Are the Liability Protections?

Section 768.381, Florida Statutes provides protection for health care providers regarding COVID-19-related claims, as follows:

• Complaints alleging claims subject to the law must be pled with particularity, or will be dismissed. This is a higher pleading standard than typically required for a civil complaint, and requires a greater degree of specificity.
• Plaintiffs must prove gross negligence or intentional misconduct. This is a higher standard than ordinary negligence or professional malpractice.
• Health care providers are provided with several affirmative defenses which, if proven, preclude liability. These defenses primarily relate to a provider’s substantial compliance with government-issued standards regarding COVID-19, infectious disease generally in the absence of standards specifically applicable to COVID-19 or the inability to comply with applicable standards in light of medical supply shortages.
• There is a one-year statute of limitations on COVID-19-related claims against health care providers, which is substantially shorter than that for simple and medical negligence claims. When this statute starts to run depends on whether the claim arises out of the transmission, diagnosis, or treatment of COVID-19, or from other circumstances such as a delayed or canceled procedure. Actions for COVID-19 related claims that accrued before the law’s effective date must commence within one year of the effective date.

New from the Diagnosing Health Care Podcast:  The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other essential supplies. Epstein Becker Green attorneys Neil Di Spirito, Constance Wilkinson, and Bonnie Odom discuss the administration's reliance on the DPA as it continues to operationalize its pandemic response, and the challenges these actions are likely to present for medical product suppliers.

The Illinois Coalition to Protect Telehealth, a coalition of more than thirty Illinois healthcare providers and patient advocates, announced its support for a bill that would, among other things, establish payment parity for telehealth services and permanently eliminate geographic and facility restrictions beyond the COVID-19 pandemic. Like many states, Illinois issued an executive order at the outset of the pandemic temporarily lifting longstanding barriers to consumer access to telehealth via commercial health plans and Medicaid.[1]  The executive order expanded the definition of telehealth services, loosened geographical restrictions on physician licensing requirements, and barred private insurers from charging copays and deductibles for in-network telehealth visits.

Now, House Bill 3498 seeks to make permanent some of those temporary waivers by aligning coverage and reimbursement for telehealth services with in-person care. If enacted, it would also establish that patients could no longer be required to use an exclusive panel of providers or professionals to receive telehealth services, nor would they be required to prove a hardship or access barrier in order to receive those services.  The bill does not include a provision that would permanently allow out-of-state physicians or health care providers to provide services in the state beyond the pandemic.[2]

In the Coalition’s announcement of support for this bill, it states that the use of telehealth over the last year has shown an increased adherence to patient care plans and improved chronic disease management.  “In recent surveys, over 70% of Illinois hospital respondents and 78% of community-based behavioral healthcare respondents reported that telehealth has helped drive a reduction in the rates at which patients missed appointments. Surveys of Illinois physicians, community health centers, and specialized mental health and substance use disorder treatment providers have also revealed similar dramatic reductions in missed appointments.”

On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest level since 2008 and almost $1 billion less than was recovered in 2019. The total recoveries in 2020 reflect the first of many anticipated resolutions of fraud enforcement actions in the COVID-19 world, and over 80% of all recoveries—amounting to almost $1.9 billion—came from the health care and life sciences industries.

HIGHEST NUMBER OF NEW FILINGS EVER REPORTED

Significantly, 2020 saw the largest number of new FCA matters initiated in a single year. The government initiated new FCA matters at its highest rate since 1994, with 250 new cases brought in 2020. Strikingly, the number of government-initiated cases against health care entities more than doubled from 2019 to 2020 and was at the highest level ever reported. Likewise, qui tam relators filed 672 new matters in FY 2020, an increase over FY 2019 and the fifth highest number of cases in reported history. Qui tam relators filed, on average, almost 13 new cases a week. Of the 672 qui tam cases filed, 68% were related to health care.

QUI TAM FILINGS CONTINUE TO BE THE DRIVER

Total recoveries from qui tam-initiated actions generated almost $1.7 billion. While the largest recoveries continue to come from cases where the government intervenes, cases pursued by relators post-declination generated more than $193 million in FY 2020, the fifth largest annual recovery in non-intervened cases since 1986. These cases continue to be rewarding for relators; over $309 million in relators’ share awards were paid in FY 2020, of which more than $261 million were paid in cases pursued against health care entities.

The Department of Justice (DOJ) announced on January 12, 2021, the first civil settlement to resolve allegations of fraud against the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.[1] SlideBelts Inc. and its president and CEO, Brigham Taylor, have agreed to pay the United States a combined $100,000 in damages and penalties for alleged violations of the False Claims Act (FCA) and the Financial Institutions Reform, Recovery, and Enforcement Act (FIRREA).[2]

The CARES Act was enacted in March 2020 to provide emergency financial assistance to individuals and businesses affected by the COVID-19 pandemic.[3] The CARES Act established the PPP, which provided $349 billion in forgivable loans to small businesses in order to assist in job retention and business expenses.[4] Since March 2020, Congress has authorized an additional $585 billion in PPP spending to be distributed under the Small Business Administration (SBA).

SlideBelts operates as an online retail company, and filed a petition for relief under Chapter 11 of the Bankruptcy Code in August 2019. Between April and June of 2020, while its petition was pending in the U.S. Bankruptcy Court for the Eastern District of California, SlideBelts and Taylor allegedly made false statements to federally insured financial institutions that the company was not involved in bankruptcy proceedings in order to influence the institutions to grant, and for SBA to guarantee, a PPP loan. SlideBelts received a loan for $350,000 based off of these purported false claims, which SlideBelts repaid in full to the PPP.

The government was able to recover damages and civil penalties from SlideBelts under the FCA for submitting alleged fraudulent claims for payment to the government and under the FIRREA for violations of federal criminal statutes that affect federally insured banks. This settlement is the end result of the first, but not the last, of many civil investigations and, ultimately, litigations relative to the CARES Act in the coming months and years under the FCA. In fact, during a June address to the Chamber of Commerce, Principal Deputy Attorney General Ethan Davis stated, “Going forward, the Civil Division will make it a priority to use the False Claims Act to combat fraud in the Paycheck Protection Program.”[5]

As the SBA prepares to issue a second round of PPP loans, the DOJ is likely to continue to use the FCA and the FIRREA to pursue entities receiving funds on the theory that those entities intend to exploit for their benefit these federal programs.[6]

As employers continue their efforts to safely bring employees back to the workplace, many have moved beyond initial pre-entry wellness checks or questionnaires and are considering technology solutions that monitor social distancing and conduct contact tracing in real-time. Along with introducing these enhanced capabilities, the question of the privacy and security of employee personally identifiable information (“PII”) and protected health information (“PHI”) continues to loom.

In order to isolate and contain the spread of COVID-19, one critical component of an ...

Recently, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), the agency enforcing the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, obtained two large breach-related settlements: one from a HIPAA Covered Entity and one from a HIPAA Business Associate.  These enforcement actions signal that despite COVID-19 related challenges, organizations continue to face rampant data breaches and ensuing HIPAA enforcement.

On September 25, 2020, OCR settled an investigation into a breach suffered by a large health insurer by obtaining the second-largest resolution payment in HIPAA enforcement history ($6.85 million).  This enforcement action resolved an investigation concerning potential violations of HIPAA Privacy and Security Rules related to a breach affecting the electronic protected health information (ePHI) of more than 10.4 million people.  The breach resulted from a phishing attack that introduced malware into the insurer’s IT systems and allowed unauthorized actors to gain access and remain undetected for nearly nine months.  Similarly on September 23, 2020, a business associate providing IT and health information management services to hospitals and physicians clinics entered a settlement ($2.3 million) with OCR for potential violations of HIPAA Privacy and Security Rules related to a breach affecting over 6 million people.  Essentially, these cyberattacks were advanced persistent threats that compromised the privacy and security of ePHI and PHI and revealed longstanding gaps in the companies’ cybersecurity controls.

On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of Annual Needs (“AAN”) for the List I Chemicals pseudoephedrine, ephedrine, and phenylpropanolamine. This marks the second year that DEA has issued APQs pursuant to Congress’s changes to the CSA via the SUPPORT Act.  After assessing the diversion rates for the five covered controlled substances, DEA reduced the quotas for four: oxycodone, hydrocodone, hydromorphone and fentanyl.

DEA recently increased the APQ to allow for the additional manufacture of certain controlled substances in response to the COVID-19 pandemic and the need to provide greater access to these medications for patients on ventilator treatment.  According to DEA, that increased demand has been factored into the proposed APQs for 2021.

Comments are due by October 1, 2020.  Because DEA’s APQs determine the amount of quota DEA can allocate to individual manufacturers in 2021, adversely impacted parties should file comments soon.

Background on APQs

The CSA requires the establishment of aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.  These aggregate quotas limit the quantities of these substances to be manufactured – and with respect to the listed chemicals, imported –  in the United States in a calendar year, to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.

Changes in Setting APQs Under The SUPPORT Act

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law October 24, 2018, provided significant changes to the process for setting APQs.  First, under the CSA, aggregate production quotas are established in terms of quantities of each basic class of controlled substance, and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.  However, the SUPPORT Act provides an exception to that general rule by giving the DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance.

Additionally, the SUPPORT Act changed the way the DEA establishes APQs with respect to five “covered controlled substances”: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.  Under the SUPPORT Act, when setting the APQ for any of the “covered controlled substances,” DEA must estimate the amount of diversion.  The SUPPORT Act requires DEA to make appropriate quota reductions “as determined by the [DEA] from the quota the [DEA] would have otherwise established had such diversion not been considered.”  Furthermore, when estimating the amount of diversion, the DEA must consider reliable “rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States,” and may take into consideration other sources of information the DEA determines reliable.

Estimating Diversion  

In accordance with this mandate under the SUPPORT Act, in setting the proposed APQs for 2021 DEA requested information from various agencies within the Department of Health and Human Services (“HHS"), including the U.S. Food and Drug Administration (“FDA”), Centers for Disease Control and Prevention (“CDC”), and the Centers for Medicare and Medicaid Services (“CMS”), regarding overdose deaths, overprescribing, and the public health impact of covered controlled substances.  DEA also solicited information from each state’s Prescription Drug Monitoring Program (“PDMP”), and any additional analysis of prescription data that would assist DEA in estimating diversion of covered controlled substances.

After soliciting input from these sources, DEA extracted data on drug theft and loss from its internal databases and seizure data by law enforcement nationwide.  DEA then calculated the estimated amount of diversion by multiplying the strength of the active pharmaceutical ingredient (“API”) listed for each finished dosage form by the total amount of units reported to estimate the metric weight in kilograms of the controlled substance being diverted.

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing ...

On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections ...

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.

The COVID-19 pandemic’s impact on the regulatory landscape of telehealth was the topic of a June 17, 2020 hearing before the Senate Health, Education, Labor & Pensions Committee.  As Chairman Lamar Alexander acknowledged during his opening statement, the health care sector and government “have been forced to cram 10 years’ worth of telehealth experience into just the past three months.” Indeed, this “cramming” has resulted in thirty-one temporary changes to telehealth policy at the federal level. Of these temporary changes, Chairman Alexander included the OCR enforcement discretion / HIPAA waiver as one of the three changes he considers most important. However, of the three changes the Chairman views as most important, he declined to include the enforcement discretion in the temporary changes he believes should be made permanent, and instead called upon his colleagues to consider whether to extend the HIPAA waiver.[1]

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.

The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing.[1]  As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products.  The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date.  The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.

Many manufacturers utilize their field sales representatives to deliver drug samples directly to, and collect written receipts from, prescribers at prescriber offices during sales calls. The COVID-19 crisis has disrupted field sales representatives’ ability to have face to face visits with prescribers, preventing them from delivering samples and collecting required receipts.  In addition, as a result of the crisis, many prescribers are providing telehealth services from their homes, impacting prescribers’ ability to receive, store and distribute samples at their offices.

On January 1, 2020 California Consumer Privacy Act (“CCPA”) largely came into effect, albeit with several last-minute modifications and a need to promulgate regulations.  As our colleagues have discussed previously here, CCPA joins other California laws safeguarding California residents’ privacy rights under the California Constitution.  Despite uncertainty around the final regulatory parameters of the law, CCPA grants the California Attorney General (AG) the authority to begin enforcement on July 1, 2020. Further, there have been no indications that such enforcement will be delayed.

Re-issued Proposed CCPA Regulations

After the California legislature passed several amendments to the CCPA in October 2019, the California AG has been working on proposed regulations.  The proposed regulations, initially introduced on October 12, 2019, went through three rounds of comment periods and were recently amended and reissued as the “Final Text of Regulations” on June 1, 2020.  These proposed regulations notably add new aspects and regulatory hurdles to CCPA implementation most notably: (i) increasing requirements for initial notices; and (ii) adding new requirements on the contents in business’s privacy policies.  These reissued proposed regulations were submitted to the California Office of Administrative Law (OAL) for review.  The OAL has thirty working days to review these regulations, plus an additional sixty calendar days under the California Governor’s Executive Order N-40-20 related to the COVID-19 pandemic, to review the regulations for procedural compliance with state law.

CCPA Proposed Regulatory Framework

The CCPA applies to any for-profit business that: (i) collects personal information on California residents; (ii) does business in the state of California; and (iii) satisfies one or more of the following thresholds: (a) has annual gross revenues in excess of $25,000,000; (b) alone or in combination, annually buys, receives for the business’s commercial purposes, sells, or shares for commercial purposes, alone or in combination, the personal information of 50,000 or more consumers, households, or devices; or (c) derives 50 percent or more of its annual revenues from selling consumers’ personal information.  Businesses that hit the thresholds will be covered even if they are located outside the state of California.

Notably, companies subject to CCPA must “at or before the point of collection” of personal information provide notice to consumers informing them of the categories of personal information the company collects and what purpose the information is used by the company.  In addition, CCPA requires businesses to post a clear and conspicuous link on their website that says "Do Not Sell My Personal Information" and then to enable consumers to opt-out of the sale of their data to third parties.  CCPA also establishes a wide-range of rights to consumers (as specified below).  Companies should be aware of the potential added cost of business in responding to these rights and ensure that they do not discriminate against any individual who exercises their rights under CCPA.

Just a few months ago, the idea of a virtual jury trial probably seemed inconceivable to most judges and lawyers.  Now, with the COVID-19 pandemic shuttering courthouses throughout the nation and most in-person proceedings suspended, many judges and attorneys are left wondering when and how civil jury trials will be able to safely resume.  We suspect that most prospective jurors will not be enthralled with the idea of sitting shoulder to shoulder in a jury box while the outbreak is still raging.  As litigators and the courts become comfortable with Zoom and other videoconferencing tools, it is apparent that we have the technology to hold virtual trials – the questions is should we?

The prospect of remote jury trials raises a host of serious issues ranging from how to overcome the constitutional hurdles to ensuring that witnesses, parties and jurors have access to high-speed internet so that they can participate in the first place.  Some potential solutions for accessibility concerns are having pre-wired government offices for those who lack access or distributing common technology (such as an iPad, with a cellular connection).  In addition to technology access, there will also be questions of whether a potential juror has access to a room where they can be alone and deliberate in private.

In a previous post, we discussed the appropriate use of the Provider Relief Funds authorized and appropriated by Congress under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. Within that post, we specifically discussed the limitation imposed on use of the Relief Funds for payment of salaries, a topic of great interest to many recipients. Under the Terms and Conditions, recipients are prohibited from using the funds for salaries in excess of the Senior Executive Service Executive Level II amount – an annual salary of $197,300 – or $16,441 a month. We noted that, although the Department of Health and Human Services (“HHS”) had not spoken to this requirement with respect to the Provider Relief Funds, HHS permits other HHS grant Recipients to pay individuals’ salaries in excess of the $197,300 limit with non-federal funds.[1] Also, HHS’ federal contract regulations similarly limit use of federal contract funds for salary costs to the Executive Level II amount, but allow for amounts in excess of that limit to be paid with non-federal funds.[2]

On March 23, 2020, Governor Phil Murphy signed Executive Order 109, which “limit[ed] non-essential adult elective surgery and invasive procedures, whether medical or dental, [in order to] assist in the management of vital healthcare resources during this public health emergency.” The purpose of EO 109 was to “limit[] exposure of healthcare providers, patients, and staff to COVID-19 and conserve[] critical resources such as ventilators, respirators, anesthesia machines, and Personal Protective Equipment (‘PPE’) [that] are essential to combatting the spread of the virus.” At the time EO 109 was executed, coronavirus cases were rapidly increasing within the State. On March 23rd, New Jersey had 2,844 coronavirus cases in all 21 counties, an increase of 935 over the previous day, and at least 27 people had died.

In the weeks that followed, New Jersey saw the surge in cases for which it was preparing. On April 4, the three-day average of new confirmed positive COVID-19 cases peaked at 4,064 cases, and by April 14th, there were 8,084 of COVID-related hospitalizations and a staggering 1,705 patients on ventilators. But since that time, thanks to social distancing and New Jersey’s ability to flatten the curve, these numbers have fallen drastically. By May 11th, the three-day average of new, positive cases had fallen to 1,572 new cases—a 61 percent decrease. Likewise, the three-day average of new hospitalizations had fallen to 4,277 patients—a 48 percent decrease.

In light of this decreased burden on the healthcare system, Governor Murphy signed Executive Order 145, which allows for elective surgeries to resume as of 5 am on May 26, 2020. EO 145 provides that elective surgeries and invasive procedures may proceed at both licensed healthcare facilities and in outpatient settings not licensed by the Department of Health (e.g., health care professional offices, clinics, and urgent care centers), subject to limitations and precautions set forth in policies to be issued by the Division of Consumer Affairs, in consultation with the Department of Health, by Monday, May 18, 2020. EO 145 further states that the Department of Health and/or the Division of Consumer Affairs may issue supplemental or amended policies concerning elective surgeries and elective invasive procedures on or after Monday, May 18, 2020.

To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[1], Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.[2]

As of May 7, 2020, HHS identified $50 billion for general distribution to Medicare providers. HHS distributed to Medicare providers the Relief Fund’s initial $45 billion tranche in April 2020, and is distributing the Relief Fund’s second $20 billion tranche. Also, HHS allocated Relief Funds to: hospitals in COVID-19 high impact areas ($10 billion); rural providers ($10 billion); Indian Health Services ($400 million), and skilled nursing facilities, dentists, and providers that take solely Medicaid (unidentified amounts).[3]

One of the many relief efforts contained in the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), signed into law on March 27^th, 2020, is a hiatus of sequestration as it applies to Medicare payments. Section 4408 of the CARES Act exempts Medicare from the effects of sequestration from May 1, 2020, through December 31, 2020.[1] It also postpones the sunset of sequestration as it applies to Medicare from the end of 2029 to the end of 2030.

As background, on January 2, 2013, “sequestration,” automatic spending cuts applicable to all categories of the Federal budget, went into effect. Sequestration included a 2.0% reduction in most Medicare spending, and as a result of its implementation, many providers experienced reductions in their reimbursement. In addition to traditional fee-for-service Medicare payments, some Medicare Advantage plans reduced reimbursement under their contracts with providers to reflect the effect of sequestration, effectively passing on to providers the reductions in premiums recovered by such plans due to sequestration. Even non-Medicare reimbursement was affected for many providers whose participation agreements with plans contained fee schedules based off of Medicare reimbursement.

While this suspension of sequestration is certainly good news for providers participating in traditional fee-for-service Medicare, and plans offering Medicare Advantage products, the effect the suspension will have on reimbursement for providers participating in Medicare Advantage or commercial lines of business which rely on Medicare rates is slightly less clear.

Certifications, Acknowledgments,
and Reports

The CARES Act[1], passed by Congress and signed into law on March 27, 2020, provides $100 billion for the Public Health and Social Services Emergency Fund (“Relief Fund”) to support eligible health care providers. Less than a month later, Congress passed the Payroll Protection Program and Health Care Act[2], providing an additional $75 billion to the Relief Fund, raising the total funds available to $175 billion. As of the end of April 2020, the Department of Health and Human Services (“HHS”) released to providers two tranches of Relief Funds totaling $50 billion.[3] HHS disbursed the first $30 billion tranche (“Tranche 1”) between April 10 and April 17, 2020. Currently, HHS is disbursing the second $20 billion tranche (“Tranche 2”). Because these are grant funds – not loans – repayment is not required. What HHS requires is that the Recipients attest to and follow the Relief Fund’s Terms and Conditions. Before we turn to the Terms and Conditions, it is important to understand HHS’ Relief Fund disbursement process.

Relief Fund Disbursement Process

HHS disbursed the Tranche 1 Relief Funds as well as some of the Tranche 2 Relief Funds directly to providers participating in Medicare Part A and Part B. (“the Recipients”). Other Recipients must apply for the Relief Funds through the HHS’ on-line portal. No matter how the Recipient received the funds, either through direct payments or through the on-line application, all Recipients must attest to HHS’ published Terms and Conditions through the HHS on-line portal within 45 days after receiving the Relief Funds. Each tranche requires a separate attestation. If the Recipient retains the funds for at least 30 days without contacting HHS regarding the funds’ remittance, HHS deems the Recipient to have accepted the Terms and Conditions discussed below. There are two important considerations in determining whether to accept these funds:

1. The Terms and Conditions for Tranche 2 Relief Funds differ in several respects from the Terms and Conditions for the Tranche 1 Relief Funds; and
2. The Terms and Conditions listed provisions are not exhaustive and Recipients must also comply “with any other relevant applicable statutes and regulations”.

As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. This announcement, made via the Agency’s FAQs on Diagnostic Testing for SARS-CoV-2 webpage, comes after weeks of FDA reporting that it has been working closely with manufacturers on such a test during the weekly Virtual Town Hall Meetings hosted by the Center for Devices and Radiological Health. FDA clarifies that the test is only authorized for home collection of specimens to be sent back to a laboratory for processing. FDA still has not authorized a COVID-19 test “to be completely used and processed at home.”

According to the Emergency Use Authorization (EUA) letter for the test, the new home collection method involves the use of a nasal swab, as opposed to a nasopharyngeal swab. Home collection is only permitted “when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.” Instructions for self-collection must be made available to individuals online or as part of the collection kit, and the kit must include materials allowing the patient to safely mail the specimen to an authorized laboratory. The letter states that the EUA will be in effect until there is a declaration that the circumstances justifying this authorization is terminated or revoked.

Our colleagues Eric Moran and Elena M. Quattrone, attorneys at Epstein Becker Green, co-authored an article in The New York Law Journal, titled “Federal Courts Set Out Preconditions for Prisoner Release Because of COVID-19 Risk” (registration required).

Following is an excerpt:

As the COVID-19 pandemic continues its spread throughout the nation, federal prisons are experiencing an unprecedented crisis due to its inability to implement social distancing, resulting in exponential increases in COVID-19 cases among inmates and prison staff. On April 14, the ...

• Remote Notarial Acts: In order to keep various business operations moving, the Governor signed A-3903/S-2336, which allows remote notarial acts during a public health emergency and state of emergency as declared by the Governor in Executive Order 103. There are certain exceptions relating to family law and documents governed by the Uniform Commercial Code. This law is effective immediately, but it will expire once Executive Order 103 is rescinded.
• Remote Operations for Non-Profits: In what many nonprofit organizations may see as a welcome move Governor Murphy signed S-2342/A-3915, which amends New Jersey’s nonprofit corporation law to allow nonprofits to conduct certain corporate meetings using remote communication during a state of emergency declared by the Governor. Specifically, a meeting by the members may occur to the extent the board of directors authorizes and adopts guidelines and procedures governing such a meeting. The law is effective as of signing, and may be a useful tool for nonprofit organizations during this pandemic.

On April 10, 2020, the U.S. Department of Health and Human Services (“HHS”) provided additional details regarding its plan to provide billions in relief to providers in an effort to off-set healthcare-related expenses resulting from the Coronavirus (“COVID-19”) outbreak.

Passed into law on March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, also called the “CARES Act”, provided $100 billion in funding for the Public Health and Social Services Emergency Fund (the “Fund”). The Fund is a pre-existing resource overseen by the Office of Financial Planning & Analysis within HHS. The $100 billion added via the CARES Act was made available to qualifying healthcare providers to reimburse them for “health care related expenses or lost revenues that are attributable to [COVID-19]”. The CARES Act stipulated that the $100 billion would be made available to public entities, Medicare or Medicaid enrolled suppliers and providers and other entities as may be further specified in regulations or guidance, provided that any such provider must “provide diagnoses, testing or care for individuals with possible or actual cases of COVID-19”. Monies received from the Fund may not be used to cover expenses that have already been reimbursed through other sources or that other sources are obligated to reimburse. Little other detail regarding the funding or mechanism for disbursal was provided in the CARES Act itself.

In a new issuance on its website, found here, HHS provided additional details on the program. HHS noted that $30 billion out of the appropriated $100 billion will be distributed immediately via direct deposit, starting April 10, 2020. Further, HHS clarified that the money is “payment” and not a loan, and thus will not need to be repaid. The initial $30 billion tranche is being made available only to providers that received Medicare fee-for-service payments in 2019. The payments are being distributed according to the Taxpayer Identification Number (TIN) of the billing organization.

Among the many concerns arising from rampant spread of COVID-19, are provider concerns regarding potential liability for care provided during the pandemic due to limited medical resources. Providers and policy makers have discussed such concerns particularly given the currently limited number of available ventilators and qualified technicians as compared to the numbers of patients who may need access to such equipment.[1] Congress and states have provided varying levels of liability protection, though such protections are themselves limited.

Under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), Congress provided liability protection to volunteer health care professionals providing health care services during the current public health emergency. [2] Specifically, the CARES Act exempts volunteer health care professionals from liability under federal or state law for any harm caused by an act or omission, unless the harm was caused by willful or criminal misconduct, gross negligence, reckless misconduct, conscious flagrant indifference, or under the influence of alcohol or intoxicating drugs, in providing health care services during the public health emergency with respect to the coronavirus. This provision preempts state or local laws that provide such volunteers with lesser protection from liability.

Notably, Congress chose not to extend liability protection to non-volunteer health care professionals, affording no wide-spread federal protection to those employed or contracted professionals treating patients during the emergency. Certain states, however, have extended liability protection to employed or contracted health care professionals through state orders. For example, Governor Cuomo of New York, through executive order, waived certain state laws to provide immunity from civil liability to certain health care professionals for any injury or death alleged to have been sustained directly as a result of an act or omission by such professional in providing medical services during the pandemic, unless such injury or death was caused by the professional’s gross negligence.[3]

On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18^th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:

Prioritize Safety of Clinical Trial Participants

• Ongoing Clinical Trials. Sponsors, investigators, and IRBs should work together to assess whether the participants’ safety is better served by continuing the study as is, discontinuing administration or use of the product, or by ending participation in the trial. The Guidance provides a number of key factors for consideration. FDA also recognizes that there may be an investigational product that is providing benefit to a trial participant, and the sponsor must decide whether to continue administration during the COVID-19 pandemic. This is a context-dependent choice, and sponsors should consider whether there are any reasonable alternative treatments available, the seriousness of the disease or condition, the risks involved in switching treatment, supply chain disruptions, and whether discontinuing administration would pose a substantial risk to the participant.
• New Clinical Trials. With respect to initiating a new clinical trial, other than one to investigate treatments or vaccines related to COVID-19 infection, FDA advises sponsors to consider the ability to effectively mitigate the risks of a trial in order to preserve safety of the participants and trial integrity. Any new trial must also be designed in a way to comply with the Federal and State public health measures implemented in response to COVID-19.

WHO: The Secretary of the Department of Health and Human Services (HHS)

WHAT: Issued nationwide “blanket waivers” of the federal Stark Law (Section 1877 of the Social Security Act) pursuant to his authority Section 1135 of the Social Security Act.

WHEN: Although issued on March 30, 2020, the waivers are retroactively effective as of March 1, 2020.

WHY: HHS is waiving sanctions under the Stark Law and its underlying regulations to ensure that: (1) sufficient health care items and services are available to meet the needs of individuals enrolled in federal healthcare programs, and (2) health care providers that furnish such items and services in good faith, but are unable to comply fully with the Stark Law’s requirements as a result of the consequences of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for noncompliance.

HOW: The waiver is available to protect financial relationships that satisfy two criteria: (1) the remuneration and referrals must be solely related to “COVID-19 Purposes”; and (2) the referrals and claims must be related to a defined set of financial relationships, as set forth below.

Numerous media reports concern the shortage of medical resources, personal protective equipment, and qualified professionals during the growing COVID-19 medical emergency.  As a result, providers may ultimately have to make choices regarding resource allocation among hospitalized patients suffering from COVID-19.  Disability rights and other advocacy groups have expressed concern about resource allocation from the point of view of how individuals with pre-existing disabilities and other individuals may have been treated in the past by the medical system.  While bioethicists may work to address the ethical issues involved with treating patients under conditions of resource scarcity, providers rightfully may worry about potential legal liability in distributing scarce resources among those in need.  While both the Trump Administration and Congress have acted to allay some of these worries, concerns remain for both individual practitioners and the facilities with which they work.

On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period.[1] Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.[2]

Separate from and in addition to the blanket waivers, the Secretary’s authority under Section 1135 also allows CMS to grant Section 1135 waivers to states that request CMS to temporarily waive compliance with certain statutes and regulations for its Medicaid programs during the time of the public health emergency. So far, many states have requested these additional flexibilities in order to focus their resources on combatting the outbreak and providing the best possible care to Medicaid enrollees in their states. CMS has been rapidly approving these Section 1135 waiver requests, but it is important to recognize that not all state requests are created equal with respect to utilizing telehealth / telemedicine services during the public health emergency. Based on a review of the publicly available state request letters, it is clear that some states have prioritized use of telehealth in order to respond to COVID-19, while other states have not, or have not yet requested similar flexibilities related to provision of telehealth services. Examples of states that have prioritized greater use of telehealth include:

• California: The state requested flexibility for telehealth and virtual communications to make it easier for providers to care for people in their homes. Specifically, California requested flexibility to allow telehealth and virtual/telephonic communications for covered State plan benefits, such as behavioral health treatment services, and waiver of face-to-face encounter requirements for Federally Qualified Health Centers and Rural Health Clinics, among others. The state also sought reimbursement of virtual communication and e-consults for certain providers. CMS approved this waiver request on March 23, 2020.
• Illinois: The Illinois Department of Healthcare and Family Services waiver request, approved on March 23, 2020 by CMS, sought flexibility of documentation requirements, including the lack of documentation of consent for a telehealth consult. Like several other states, Illinois also requested CMS to allow providers to use non-HIPAA compliant telehealth modes from readily available platforms, such as Facetime, WhatsApp, Skype, etc., to facilitate a telehealth visit or check-in at the location of the patient, including the patient’s home.

A post on the Workforce Bulletin blog will be of interest to many of our readers: “The Race to Embrace Remote Online Notarization (“RON”) in Response to the COVID-19 Pandemic,” by attorney Theodora McCormick of Epstein Becker Green.

Following is an excerpt:

As employees are required to work remotely and practice social distancing due to the COVID-19 pandemic, the federal government and several state governments (including New York and New Jersey) are moving (New York more quickly than New Jersey) to enable remote online notarization and keep businesses operating.

Read ...

• Lease arrangements – Landlords may be willing to accept a temporary reduction in rent rather than risk losing a good, long-term tenant, and otherwise reliable income stream, altogether. This can usually be accomplished by a simple amendment to the lease agreement.
• Debt covenants – Companies that have credit facilities often are subject to debt covenants in favor of the lender that are tested periodically.  Typical debt covenants that could be violated in times of financial crises include minimum financial tests, or ratios, based on a company’s income, assets, working capital, net worth and equity.  Covenants that consist of operational milestones could be impacted as well.  It’s good practice for companies to approach their lenders and seek amendments (or temporary waivers) to their covenants before those covenants are tripped, rather than afterwards, when the company is in default.

The ongoing pandemic caused by the novel coronavirus has upended the American health care system in many ways. One of the many effects of COVID-19 will likely be substantial disruption in value-based payment arrangements between health plans and providers. Though this is an issue that is not on the top of providers or payors minds as the health care system prepares to respond to the crisis, there are some simple steps that providers can take now to avoid issues in the future.

Any iteration of value-based payments (“VBP”) is likely to be disrupted by COVID-19; be it shared savings, shared risk, or full risk arrangements. Quality targets and reporting deadlines are likely to be missed as providers move many routine and preventative services to telehealth services or suspend them entirely for the time being, as well as turn the bulk of their clinical focus to COVID-19. Under some VBP arrangements, providers may be ineligible for any savings due to their inability to meet “quality gates” (i.e., certain quality metric thresholds that must be met before any savings payments are made) in the current climate. Cost savings targets are likely to be missed or at least distorted as providers focus on building out their capabilities to address the pandemic. How will these sudden and substantial changes affect the parties participating in value-based arrangements?

CMS has already announced that it will amend its quality reporting requirements from the fourth quarter of 2019 through the end of the second quarter of 2020.[1] The announcement covers a variety of quality reporting requirements and payment programs with the stated purpose of alleviating reporting requirements and disregarding unrepresentative data created during the emergency. CMS has also stated that it intends to prorate any losses incurred by Medicare accountable care organizations (“ACOs”) in 2020 for the duration of the public health emergency (e.g., if the public health emergency lasts for six months, the annual losses an ACO incurs in 2020 would be halved). Many – including a bipartisan group of Senators – have argued that this approach is insufficient to truly address the pandemic-related costs incurred by ACOs.[1] CMS has also stated that it will disregard all costs associated with care related to COVID-19 when performing benchmark calculations.[2] States may make similar changes for VBP arrangements in Medicaid programs. How these government steps would flow down into VBP agreements between managed care plans and providers is not clear and requires analysis of the specific agreements.

Imagine these scenarios:

• Your company cannot perform a contract because of the COVID-19 pandemic.
• A vendor informs you that she cannot provide your company with necessary goods because of supply chain issues caused by a governmental emergency declaration.
• A subcontractor cannot perform because its employees are self-quarantining.

These are not hypotheticals. Scenarios like these are playing out around the country. The real-world impact of the COVID-19 pandemic is colliding with contractual requirements, and there is new attention to the legal doctrines of “impossibility,” “frustration of purpose,” “impracticability, and “force majeure.”

What do they mean? In a nutshell, traditional contract law says that an unforeseeable event occurring after the contract was formed can excuse contract performance, and determining whether an event was unforeseeable will depend heavily on the specific facts and the language of the contract.

Across the nation, authorities are scrambling to meet the new challenges posed by COVID-19. The United States Centers for Disease Control and Prevention (“CDC”) has recommended that individuals remain six feet apart in order to prevent the spread of COVID-19. On March 13, 2020, the White House proclaimed a national emergency and many State governments have ordered non-essential businesses to close, and residents to self-distance. However, these emergency measures conflict with the rules for personal service of process established by Federal Rule of Civil Procedure 4.

Personal service of process is among the oldest and commonest means by which a court can obtain personal jurisdiction over a defendant. F.R.C.P. 4(e) provides that personal service of process can be accomplished by handing the process papers to the defendant personally or leaving the papers with a responsible person at the defendant’s dwelling.

In most cases, personal service involves the physical act of handing papers from one person to another. The very act of accomplishing personal service therefore violates the CDC’s recommendation that individuals remain six feet apart. However, it can also run contrary to more stringent restrictions imposed by State governments.

In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated Guidance to all Governors urging them to take immediate action.  While the federal government, and some states, have admirably waived and relaxed many rules related to the provision of various types of benefits and services, including relaxed telehealth and privacy rules/enforcement, many necessary actions are within the authority of state governments ...

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.

During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home ...

On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic.  While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply.  FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.

Guidance Scope

Specifically, FDA will allow manufacturers of certain FDA-cleared ventilator/respiratory devices (as detailed in the table below) to make modifications to the indications, claims, functionality, or to the hardware, software, or materials of the device without making a new 510(k) submission to FDA, so long as the modification will not create undue risk in light of the public health emergency.  Such changes, which would normally require a new 510(k), could include a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

After U.S. Attorney General, William P. Barr[1] and the Federal Bureau of Investigation issued warnings this week regarding potential fraudulent schemes that are being perpetrated in the nation’s response to the COVID-19 pandemic, on Sunday, March 22, 2020, the U.S. Department of Justice (DOJ) filed its first enforcement action to shut down COVID-19-related fraud.  DOJ attorneys moved in federal court in Austin, Texas for a temporary restraining order against operators of a website, coronavirustestingkit.com, alleged to have engaged in a wire fraud scheme by offering consumers access to “free” World Health Organization (WHO) vaccine kits in exchange for a shipping charge, which required consumers to enter credit card information on the website.[2] The website stated that the kits “only” required water to administer the vaccine and provided testimonials from “recent users.” The government alleged that claims made on the website are false, as the WHO is not offering free vaccine kits and there is not yet a scientifically proven vaccine, and that the intent of the website is to gain access to consumer credit card information.

On March 16, 2020, U.S. Attorney General Barr directed in a memorandum to U.S. Attorneys that “[e]very U.S. Attorney's Office is thus hereby directed to prioritize the detection, investigation, and prosecution of all criminal conduct” related to the COVID-19 outbreak.[3] Attorney General Barr advised, “the pandemic is dangerous enough without wrongdoers seeking to profit from public panic,” and therefore, such criminal conduct will not be tolerated.

On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.

The Guidance recognizes the impact COVID-19 may have on the conduct of ongoing clinical trials, including quarantines, site closures, travel limitations, interruptions to the supply chain, and other considerations should individuals involved in the studies become infected with COVID-19. FDA acknowledges that these factors may impact a sponsor’s ability to meet protocol-specified procedures, and that protocol modifications may be necessary and deviations unavoidable.

On March 17, 2020, the U.S. Food and Drug Administration (“FDA”) issued a Temporary Policy regarding preventive controls and food supplier verification audit requirements during the COVID-19 public health emergency. This guidance explains the current intent of FDA to not enforce onsite audit requirements in certain circumstances related to the impact of COVID-19. Such onsite audit requirements can be found in three important food regulations:

1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117);
2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507); and
3. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L).

The Agency has stated that this temporary guidance will become effective immediately, without comment from the public, due to the exigent circumstances surrounding this ongoing public health threat.

On March 17, 2020 the Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that it would “exercise its enforcement discretion and will waive any potential penalties for HIPAA violations” for health care providers who are serving patients using “everyday communications technologies.”  The OCR issued this guidance to ensure providers could make use of available technologies and communication apps in order to facilitate virtual visits with patients.

Specifically, the guidance provides (emphasis added):

A covered health care provider ...

While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth.

On March 6, 2020, President Donald Trump signed into law an $8.3 billion emergency coronavirus disease 2019 (“COVID-19”) response funding package. In addition to providing funding for the development of treatments and public health funding for prevention, preparedness, and response, the bill authorizes the U.S. Secretary of Health and Human Services, Alex Azar (referred to herein as the “Secretary”), to waive Medicare restrictions on the provision of services via telehealth during this public health emergency.

Greater utilization of telehealth during the COVID-19 outbreak will reduce providers’ and patients’ exposure to the virus in health care facilities. Telehealth is especially useful for mild cases of illness that can be managed at the patient’s home, thereby decreasing the volume of individuals seeking care in facilities. To further facilitate the increased utilization of telehealth, the Centers for Disease Control’s interim guidance for healthcare facilities notes that healthcare providers can communicate with patients by telephone if formal telehealth systems are not available. This allows providers to have greater flexibility when telehealth technology providers lack the bandwidth to accommodate this increase in telehealth utilization or are otherwise unavailable.

As the coronavirus spreads throughout the country, hospitals and other health care providers are finding themselves inundated with patients. Those providers who are in-network with payors have and will likely continue to experience difficulty in complying with certain provisions of their contracts. For instance, as payors are also experiencing an unexpected influx of telephone traffic, the wait time for various approvals, including, but not limited to, pre-authorizations are being delayed.

Providers are often contractually obligated to obtain pre-authorizations for certain procedures and services prior to rendering the care. Due to the increased telephone traffic and increased wait times on the payor end, these providers are now faced with a dilemma. A process that as of two weeks ago only took a matter of ten to fifteen minutes now can take up to an hour or more. This creates a serious dilemma for those providers who need to render care to their patients and comply with their contractual obligations to payors.

The Senate has spoken to this issue via the Families First Act which prohibits cost sharing and imposing prior authorizations for COVID-19 related testing under Medicare, CHIP, and individual and small/large self-funded group plans. See Division F-Health Provisions, § 6001, Coverage of Testing for COVID-19. While some payors have recognized and acknowledged the difficulties posed by COVID-19 and have made exceptions to the standard requirements, those exceptions have been limited. For example, the Blue Cross Blue Shield Association has indicated that its network of 36 BCBS companies will waive prior authorizations for diagnostic tests and covered services that are medically necessary for members diagnosed with COVID-19. Similarly, Wellmark and Anthem, Inc., have waived prior authorizations for covered services related to COVID-19. While these limited pre-authorization waivers are a start, they do not resolve the dilemma faced by those providers treating patients who are not suffering from COVID-19.

We hope that everyone is staying safe during the COVID-19 crisis. State health departments are, of course, doing what they can to facilitate management of transmission of COVID-19 by healthcare providers. Some recent actions by the New York Department of Health (“DOH”) to allow or promote telephonic and telehealth services include:

Telephonic Evaluation - Beginning with dates of service of March 13, Medicaid will reimburse telephonic evaluation and management services for established patients where face-to-face visits may not be recommended and it is medically ...

While the world continues to respond to the growing COVID-19 pandemic, the United States Congress recently passed legislation that provides for more than $8 billion in emergency funding to combat COVID-19. Part of this supplemental funding package, signed into law on March 6, 2020, includes the Telehealth Services During Certain Emergency Periods Act of 2020 (the “Act”),[1] which authorizes the Administration to loosen restrictions on telehealth in order to expand access to COVID-19 related telehealth services for Medicare beneficiaries—many of whom are especially vulnerable to this virus and in the event of future emergencies. On March 17, 2020, the Administration announced the implementation of this waiver with a retroactive effective date of March 6, 2020.

Our colleagues Anthony Argiropoulos and Sheila A. Woolson have a post on the Workforce Bulletin blog that will be of interest to our readers in the health care and life sciences industry: “Coronavirus Emergency Declarations Trigger Anti-Price Gouging Laws.”

Following is an excerpt:

The particulars of the laws vary with each state.  Some states set a percentage above which the merchant cannot increase the price.  Others simply state the price increase cannot be “unconscionable.”  Some laws apply to any party in the distribution chain, whereas others make allowances for ...

On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic.  The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19) cases.  As of March 12, 2020, nineteen states have declared a state of emergency to ensure there are resources to address the Coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020.  Given the prevalence of the Coronavirus in the U.S. and the growing numbers of cases globally, health care providers should take extra precaution with their patients, employees, and visitors.  As all public health communications are making clear, efforts to limit the spread of COVID-19 will not only prevent illness, but they will also reduce the pandemic’s potential to overwhelm critical health care resources.

This advisory provides guidance for health care providers in responding to the COVID-19 pandemic.  Our best practices for all employers can be found here and here, and all businesses should visit our Coronavirus Resource Center.

The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (the Act), signed by the President on Friday, March 6, provides $8.3 billion in much needed multi-year funds to battle the coronavirus public health crisis. While there are many important aspects of the Act, below we focus on the Act’s grants for construction, alteration, or renovation of non-federally owned facilities.

State and Local Level Preparedness and Response Capability - The Act allocates $3.1 billion to the Secretary of Health and Human Services (the Secretary) for the Public Health and ...

In a recent blog post, colleagues in our Employment, Labor & Workforce Management practice addressed the legal framework pertaining to coronavirus (COVID-19) risks in the workplace.  As the number of cases continues to the climb in the U.S., it is imperative that HIPAA covered entities and their business associates are aware of their privacy and security responsibilities in the midst of this public health emergency.  EBG provides this guidance on how to effectively respond to the coronavirus public health crisis while navigating patient privacy issues.

Congress is working to advance a strong emergency funding supplemental package, estimated to be between $2.5 billion and $8.5 billion, to fully address the scale and seriousness of the coronavirus (COVID-19) public health crisis. Working against a timeline to pass a funding package prior to the March 13, 2020, Congressional recess, the supplemental funding for the coronavirus emergency will result in new government contracts, grants, GSA schedule awards, as well as contract modifications. Because of the public health crisis, the government may also issue letter contracts under FAR Part 16.603, et seq., which allows the government to immediately contract for services or supplies with contract definitization at a later date.