Category: Health Care Law

Price Gouging and Deceptive Advertising Practices Amidst COVID-19 Pandemic

The Federal Trade Commission, the Food and Drug Administration and state Attorneys General have bumped the protection of consumers in the midst of the COVID-19 crisis to the top of their respective lists, including, but not limited to, price gouging and unsubstantiated product efficacy claims.  The U.S. Department of Justice has also issued a broad mandate regarding criminal enforcement of deceptive, fraudulent and predatory practices.

 State Attorneys General

State Attorney General have actively been policing the advertising of claims related to products that purport to cure, treat or prevent COVID-19.  This includes both express and implied claims (e.g., immunity-based claims).

Currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products to treat or cure.

By way of example, a group of thirty-two state attorneys general recently sent letters to executives at prominent online retailers, urging them to help police price gouging.  Additionally, the New York Attorney General has asked GoDaddy and other online registrars to halt and de-list domain names used for Coronavirus-related scams and fake remedies designed to unlawfully and fraudulently profit off consumers’ fears around the coronavirus disease.

The NY AG has also recently contacted Craigslist.com, calling on the company to immediately remove posts that attempt to price gouge users, or otherwise purport to sell items that provide “immunity” to the coronavirus or allow individuals to test for the disease.  For example, the AG’s letter referred to posts that promoted an “immunity pack,” a fake coronavirus testing kit, and face masks that are not even proven to provide coronavirus-related protection.  The AG also asked Craigslist to remove an advertisement for a bottle of Purell that was priced at over $200.

Price gouging on disinfectant products is also a priority.

State AGs and other federal agencies are actively investigating potential price gouging violations, filing enforcement lawsuits, issuing civil investigative demands (CIDs), and serving cease-and-desist warnings.  The NYC Department of Consumer and Worker Protection (DCWP) – formerly the New York City Department of Consumer Affairs (DCA) – has also been policing local business that it believes are selling necessary products (e.g., cleaning products, diagnostic products and services, disinfectants [wipes, liquids, sprays], face masks, gloves, hand sanitizers, medicines, paper towels, rubbing alcohol, soap, tissues and basic food supplies).

The State of New York’s price gouging statute prohibits the sale of goods and services necessary for the health, safety and welfare of consumers at unconscionably excessive prices during any abnormal disruption of the market.  During any abnormal disruption of the market for consumer goods and services vital and necessary for the health, safety and welfare of consumers, no party within the chain of distribution of such consumer goods or services or both shall sell or offer to sell any such goods or services or both for an amount which represents an unconscionably excessive price.

In the State of New York, whether a price is unconscionably excessive is a question of law for the court.  The court’s determination that a violation has occurred shall be based on any of the following factors:  (i) that the amount of the excess in price is unconscionably extreme;  or (ii) that there was an exercise of unfair leverage or unconscionable means;  or (iii) a combination of both factors in subparagraphs (i) and (ii).

Proof that a violation of has occurred can include, for example, evidence that:  (i) the amount charged represents a gross disparity between the price of the goods or services which were the subject of the transaction and their value measured by the price at which such consumer goods or services were sold or offered for sale by the defendant in the usual course of business immediately prior to the onset of the abnormal disruption of the market; or (ii) the amount charged grossly exceeded the price at which the same or similar goods or services were readily obtainable by other consumers in the trade area.  A defendant may be able to rebut such evidence by establishing that additional costs not within its control were imposed on the defendant for the goods or services.

Where a violation is alleged to have occurred, the AG may seek an injunctions, civil penalties and restitution.

Under the Rules of the City of New York, stores are prohibited from selling items that have been declared in short supply at excessively increased prices.  NYC has recently issued an emergency rule prohibiting price increases above 10% on various products necessary to combat the coronavirus.  New York State has now proposed legislation concerning medical supplies that includes a presumption that a price exceeding 10% of its price immediately prior to a public health emergency is to be considered unconscionably excessive.

Other states also utilize percentage-drive formulas when assessing excessive or unconscionable price increases, such as, without limitation, Arkansas, Florida, Michigan, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia, and Wisconsin.  Some states impose liability upon manufacturers and distributors.  Some states also impose civil fines and penalties for violations, in addition to potential criminal liability.

Any entity charged with price gouging during a public health emergency would be entitled to rebut an alleged violation of this new law with evidence that the additional costs not within the control of the defendant were imposed on the defendant for the consumer medical supplies.

FTC and FDA

The Federal Trade Commission and the Food and Drug Administration recently announced that it has issued joint warning letters to companies that allegedly had been disseminating unsubstantiated product advertising claims related to the coronavirus.  The letters cite efficacy claims that are not supported by competent and reliable scientific evidence, as well as issues relating to unapproved and misbranded drugs.

On March 26, 2020, FTC lawyer and Chairman Joe Simons issued a statement setting forth the agency’s enforcement efforts to protect consumers from unfair and deceptive commercial practices and to educate the public.  The FTC “will not tolerate businesses seeking to take advantage of consumers’ concerns and fears regarding coronavirus disease, exigent circumstances, or financial distress,” FTC lawyer Simons stated.

The FTC has also issued a press release calling attention to business-to-business scams that seek to exploit companies’ concerns about COVID-19, and sent letters to VoIP service providers and other companies warning them that “assisting and facilitating” illegal telemarketing or robocalls related to the coronavirus or COVID-19 pandemic is against the law.

“It’s never good business for VoIP providers and others to help telemarketers make illegal robocalls that scam people,” said FTC attorney Andrew Smith, Bureau of Consumer Protection Director.  “But it’s especially bad when your company is helping telemarketers exploiting fears about the coronavirus to spread disinformation and perpetrate scams,” Smith stated.

Department of Justice

The U.S. DoJ has issued a broad mandate with respect coronavirus-related fraud, price gouging and product hoarding.  In fact, it recently filed a number of federal criminal actions to combat fraud and other offenses related to the coronavirus pandemic.

Two of the actions were filed in California.  One involving allegations that an individual solicited investments in a company he claimed would be used to market pills that would prevent coronavirus infections, as well as market an injectable cure for those who had already contracted the virus.  The other, involving allegations that an individual mislabeled drugs that were purported to be a miracle cure for COVID-19.

Another two actions were filed in New Jersey.  One involving charges of violating the federal Anti-Kickback Statute and conspiracy to commit health care fraud.  The other, involving allegations of assault resulting from an individual who represented to have tested positive for COVID-19 that coughed on FBI agents, lied to them about his accumulation and sale of surgical masks, medical gowns and other medical supplies, and selling supplies to doctors and nurses at inflated prices.           .

The DoJ also recently filed a civil wire fraud lawsuit in a Texas federal district court against a website (coronavirusmedicalkit.com) that was purportedly offering access to bogus World Health Organization vaccines.

Digital marketers, consumer-facing businesses and others in the supply chain should consider consulting with experienced FTC defense counsel to avoid unsupported efficacy claims and inadvertently charging unlawful prices for goods and services necessary for the health, safety and welfare of consumers.

© 2020 Hinch Newman LLP

For more on FTC COVID-Actions, see the National Law Review Coronavirus News section.

CMS Waives Certain Penalties Classes of the Stark Law

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced it will waive certain penalties classes of violations of the Physician Self-Referral Law, known as the Stark Law. The affected penalties are those listed under Section 1877(g) of the Social Security Act (42 U.S.C. 1877). These blanket waivers are effective retroactively to March 1, 2020.

The Stark Law is a strict liability statute generally prohibiting a physician from making referrals of Medicare- and Medicaid-designated health services to an entity with which the physician or an immediate family member has a financial relationship. Typically, if such a relationship exists between a physician and an entity, then the arrangement must satisfy an express Stark Law exception for the physician to bill for the referred services.

The blanket waivers temporarily allow payments and referrals between physicians and covered entities if the relationship falls into one of the express categories during the COVID-19 pandemic, even if such an arrangement would otherwise not meet a Stark Law exception. The blanket waivers apply to payments and referrals between an entity covered under the Stark Law and (1) a physician, (2) the physician’s organization defined under 42 C.F.R. 411.354(c) or (3) the physician’s immediate family member.

The blanket waivers must relate to one of the explicitly defined COVID-19 purposes and meet the following conditions:

  1. The providers are acting in good faith to provide care in response to the COVID-19 pandemic.
  2. The financial relationship or referral is protected by one of CMS’s 18 permitted relationships (discussed below).
  3. The government does not determine that the financial relationship creates fraud and abuse concerns.

Defined COVID-19 Purposes

To apply, the blanket waivers must be related to COVID-19 purposes. Such purposes include:

  • “Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19;
  • Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States;
  • Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or
  • Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.”

Those wishing to use the blanket waivers need not provide advance notice to or receive approval from CMS. Those who rely on a blanket waiver, however, must retain records relating to its use, and the records must be available for the U.S. Department of Health and Human Services to review upon request.

The Blanket Waivers

The blanket waivers do not suspend the entire Stark Law. Rather, they apply only to 18 expressly enumerated relationships. These relationships can be divided into two classes: those that address payments and those that address referrals.

Allowed Payments

  1. Personally Performed Services: Remuneration paid by an entity to a physician above or below the fair market value (FMV) for the physician’s personally performed services to the entity is permitted.
  2. Office Space and Equipment Rental Payments: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for rental of office space or equipment is permitted by the waivers. Rental payments exceeding FMV are not covered.
  3. Purchase of Items or Services: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for the purchased items or services, including use of the entity’s premises, is permitted by the purchase waivers. The purpose of these waivers is to permit parties to rapidly source critical items or services without overpaying for the service.
  4. Additional Incidental Benefits to Medical Staff: Remuneration from a hospital to a physician in the form of medical staff incidental benefits that exceed the $36-per-item limit set forth in 42 CFR § 411.357(m)(5) is protected. This waiver permits a hospital to offer a range of benefits to its medical staff members to facilitate participation in the health care workforce, such as childcare services or clean clothing for the physician while at the hospital.
  5. Nonmonetary Compensation: Remuneration from an entity to a physician in the form of nonmonetary compensation that exceeds the $423 annual limit set forth in 42 CFR § 411.357(k)(1) is permitted. Similar to the medical staff benefit waiver, this waiver allows an entity to provide additional services that would otherwise exceed the limits established by the regulations to facilitate participation in the health care workforce during the COVID-19 pandemic. Currently, it is unclear how this waiver will be assessed when the blanket waiver period ends because the public emergency declaration caused by the COVID-19 pandemic is terminated. More guidance from CMS on the application of this waiver may be issued.
  6. Low-Interest or Interest-Free Loans: Remuneration among individuals and entities in the healthcare industry in the form of a loan, with an interest rate below FMV or on terms that are unavailable from another independent lender, is allowed. Essentially, CMS is attempting to increase cash liquidity within the health care industry to mitigate potential cash flow problems among health care workers and providers during the COVID-19 pandemic.

Allowed Referrals

  1. Referrals by Physician-Owner of a Hospital: Referrals by a physician-owner of a hospital that temporarily expands its facility capacity above the number of operating rooms, procedure rooms and beds for which the hospital was licensed on March 23, 2010 without prior application and approval of the expansion of facility capacity will temporarily not be prohibited by the Stark Law. (In the case of a hospital that did not have a provider agreement in effect as of March 23, 2010, but did have a provider agreement in effect on December 31, 2010, the effective date of such provider agreement applies.)
  2. Referrals by Physician-Owner of Ambulatory Surgical Centers that Temporarily Convert to Hospitals: Referrals by a physician-owner of a hospital that converted from a physician-owned ambulatory surgical center to a hospital on or after March 1, 2020 are permitted provided that:
  • The hospital does not satisfy one or more of the requirements of Section 1877(i)(1)(A) through (E) of the Act.
  • The hospital enrolled in Medicare as a hospital during the period of the public health emergency described in Section II.A of this blanket waiver document.
  • The hospital meets the Medicare conditions of participation and other requirements not waived by CMS during the period of the public health emergency described in section II.A of this blanket waiver document.
  • The hospital’s Medicare enrollment is not inconsistent with the Emergency Preparedness or Pandemic Plan of the state in which it is located.
  1. Referrals by Owners to a Home Health Agency: Referrals are now permitted by a physician of a Medicare beneficiary for the provision of designated health services to a home health agency (1) that does not qualify as a rural provider under 42 CFR 411.356(c)(1) and (2) in which the physician (or an immediate family member of the physician) has an ownership or investment interest.
  2. Referrals for Services at Locations Other than the Health Care Facility: Referrals are now permitted by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building” for purposes of 42 CFR 411.355(b)(2). Also, referrals by a physician in a group practice for medically necessary designated health services furnished by the group practice to a patient in his or her private home, an assisted living facility, or independent living facility where the referring physician’s principal medical practice does not consist of treating patients in their private homes will not violate the Stark Law.
  3. Referrals to Immediate Family Members in Rural Areas: Referrals are now permitted by a physician to an entity with which the physician’s immediate family member has a financial relationship if the patient who is referred resides in a rural area.
  4. Relaxing Compensation Arrangement Written Requirements: Stark Law compensation arrangement exceptions frequently require the arrangement to be in writing. However, referrals are now permitted by a physician to an entity that the physician (or an immediate family member of the physician) has a compensation arrangement that does not satisfy the writing requirements of an applicable exception but satisfies all other requirements of the applicable exception, unless that requirement is waived under one or more of the blanket waivers above.

CMS encourages providers to contact CMS with questions regarding the applicability of the blanket waivers. Providers should send any requests to 1877CallCenter@cms.hhs.gov and include the words “Request for 1877(g) Waiver” in the subject line. All requests should include the following minimum information:

  • the name and address of requesting entity
  • the name, phone number and email address of the person designated to represent the entity
  • the CMS Certification Number (CCN) or Taxpayer Identification Number (TIN) of the requesting entity; and
  • the nature of the request.

The contours and applications of these blanket waivers are complex and often require a nuanced understanding of how they are couched into the existing regulatory framework addressing the provision of health care services under the Social Security Act, the Stark Law, and a number of other statutes and regulations.

© 2020 Much Shelist, P.C.

For more on healthcare blanket waivers amidst COVID-19, see the National Law Review Coronavirus News section.

Physicians Face Regulatory Exposure for Prescribing COVID-19 Drugs Cited by President Trump

Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home.

In light of safety concerns for their family members, over the past few weeks, there have been reports claiming physicians throughout Ohio have prescribed chloroquine and hydroxychloroquine, frequently cited by President Donald Trump, to family members and friends. In some reported instances, prescriptions were issued even when such individuals did not exhibit signs or symptoms of the coronavirus.

In order to preserve the stockpile of medications for patients, on March 22, 2020, the Ohio Board of Pharmacy issued an emergency rule (OAC 4729-5-30.2) that prohibits a pharmacist from filling prescriptions for chloroquine or hydroxychloroquine without a valid COVID-19 diagnosis and positive test result.

On March 30, 2020, the Ohio Attorney General’s Office issued the following statement, which highlighted the Pharmacy Board’s new emergency rule and advised physicians to self-report to the State Medical Board of Ohio if they prescribed these medications improperly:

“It has come to my attention that physicians may be abusing their privilege to prescribe medications by writing prescriptions for chloroquine and hydroxychloroquine for themselves, their friends and their families without any legitimate medical need for the medication. As Attorney General, I am very concerned with these reports and will work vigorously with Ohio’s regulatory boards and agencies to address any illegal or prohibited conduct. I encourage anyone who has written a prescription of this type improperly to self-report to their respective regulatory authority.”

The State Medical Board of Ohio is also on record stating that it takes allegations of inappropriate prescribing very seriously, and that it will be actively investigating complaints as they come in and working with the Ohio Attorney General on any necessary enforcement actions for bad prescribing.[i]

In addition to state regulators, the U.S. Attorney’s Office for the Northern and Southern Districts of Ohio have set up a COVID-19 Task Force. One of its responsibilities is to investigate and criminally prosecute physicians who have egregiously prescribed chloroquine and hydroxychloroquine to themselves, family members, or friends without a legitimate medical purpose. The Task Force is comprised of representatives of the United States Attorney’s Office, Ohio Attorney General’s Office, State Medical Board, and the Pharmacy Board.[ii]

Physicians who recently prescribed chloroquine and hydroxychloroquine and who are considering whether they should self-report to the Medical Board should first contact experienced legal counsel to determine the implications of a possible self-report, including the potentiality of license discipline and/or criminal charges.

[i] See:  https://clt945532.bmeurl.co/A27E486

[ii] See: https://www.dispatch.com/news/20200324/feds-yost-will-prosecute-doctors-who-abuse-power-with-personal-coronavirus-prescriptions

© 2020 Dinsmore & Shohl LLP. All rights reserved.

For more COVID-19 developments, see the dedicated National Law Review Coronavirus News page.

COVID-19 Update: Patent Rights in the COVID-19 Pandemic: How will Industries and Governments Respond?

As the world scrambles to address an ever-expanding wave of COVID-19 infections, new and urgent needs for medical supplies, diagnostics and treatments arise.  Shortages of such supplies are plaguing hospitals and care-givers, while doctors and nurses put their lives at risk in their desperate efforts to save COVID-19 patients.  Many of these vital supplies, however, are protected by valuable patent rights.  The essence behind patents rights is to exclude others from making, using, or selling a patented invention, except by authorization of the patent holder in carefully negotiated license agreements to ensure proper compensation for the efforts and costs invested in developing the patented invention.1  On the other hand, the U.S. government has rights to forcibly license a patented invention during times of need, in particular when there is a threat to public safety.2  Will the government resort to use of these available, yet rarely used, compulsory licensing provisions?  How patent owners are responding to the current COVID-19 pandemic is revealing that benevolence may, in some cases, have a place in commercial business without the government needing to exercise its compulsory licensing rights.

In the face of the COVID-19 pandemic, several large companies have come forward with offers to manufacture medical supplies such as masks and respirators.  Manufacturers, such as the auto makers General Motors, Ford and Tesla, are offering to repurpose production lines to help manufacture and increase the supply of ventilators and other much needed medical equipment.3  Fashion and cosmetic companies, such as Louis Vuitton, L’Oréal and Coty, are also pitching in and offering to re-allocate their resources to produce hand sanitizers, while fashion designers, like Christian Siriano and Brandon Maxwell, are offering to mobilize their teams to produce masks and hospital gowns.4  Even the beer company giant, ABInBev will use its facilities to manufacture and distribute hand sanitizer.5

On the patent front, the drug manufacturer AbbVie has taken a bold public health stance by suspending enforcement of its global patent rights on all formulations of the HIV medication, Kaletra (Aluvia) while the drug is being evaluated as a candidate to treat COVID-19 in several clinical trials.  AbbVie’s bold stance would allow generic versions of Kaletra to be made by others without fear of repercussion based on patent infringement.  This would allow countries to purchase generic versions of Kaletra, if it is found effective in treating COVID-19, and would help alleviate possible drug supply shortages.  AbbVie is the first drug-maker to take such a strong public health stance amid the COVID-19 pandemic.  However, whether AbbVie’s decision to suspend its patent rights to Kaletra is an act of pure benevolence, mounting public pressures, or because at least one clinical trial  already suggested Kaletra may not be effective in treating COVID-19, AbbVie’s strong public health stance is at the very least a comforting thought and may hopefully sway other drug-makers, like Gilead Sciences Inc. (“Gilead”), to do the same.

On the other end is the drug-maker Gilead who recently halted emergency access to its COVID-19 candidate drug, Remdesivir, except for pregnant women and children with severe symptoms.6  In suspending access to Remdesivir, Gilead issued a company statement7 on March 22, 2020 citing “overwhelming demand” and “exponential increase” in requests which “flooded [its] emergency treatment access system.”  However, Gilead’s restrictions to Remdesivir come on the heels of it being granted “orphan” drug status8 by the U.S. Food and Drug Administration (“FDA”) on February 23, 2020 and on the heels of a Chinese drug-maker, BrightGene Bio-Medical Technology (“BrightGene”),9 filing for patent protection in China for a combination drug therapy to treat COVID-19 using the active ingredients of Remdesivir.  The 1983 Orphan Drug Act10 allows a seven-year market exclusivity period for pharmaceutical companies developing treatments for a “rare disease” and also provides tax credits.  Gilead’s strategic move to obtain orphan drug status for Remdesivir blocks generic drug manufacturers from supplying the drug and thus further limiting access.

Remdesivir has been previously used to treat the Ebola virus, Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), but these infections did not cause a sustained global crisis to earn Gilead a sizable or continued financial revenue stream and other more successful experimental therapies existed.11  If Remdesivir is found to be effective for combating COVID-19, a patent protecting such a use may stand to earn a high and continued stream of global revenue for the patent owner.  As new combination drug patents or method patents for new uses of known drugs may be separately patentable, repurposing Remdesivir as a combination drug patent or for treating COVID-19 may prove to be a blockbuster hit for its patent owner.  Thus, while Gilead has cited overwhelming demand as the reason to restrict access to Remdesivir, one can’t help but wonder whether patent rights and the associated commercial revenue are Gilead’s underlying concern.

Gilead is not the only patent holder invoking a protectionist stance and seemingly attempting to profit from the global pandemic through the patent system’s exclusionary principle.  Labrador Diagnostics LLC (“Labrador”)—a company backed by its major investor SoftBank and who bought patents from a failed blood-testing start-up called Theranos—recently filed a patent infringement lawsuit against BioFire Diagnostics (“BioFire”), a health start-up who launched three COVID-19 tests.12  Labrador also requested an injunction demanding BioFire to stop using the technology covered by the Theranos patents.13  However, since filing the lawsuit and seemingly after public backlash, Labrador issued a press release14 stating it would allow third parties to use its Theranos patents to develop COVID-19 tests with a royalty-free license, but that it is continuing its lawsuit against BioFire for activities over the past six years not related to COVID-19 testing.

Similarly, in Italy, a patent holder of a special respirator valve used in respiratory machines allegedly threatened a patent infringement lawsuit against two engineers who volunteered to use their 3-D printing technology to manufacture the patented valves for a hospital in Brescia, Italy without obtaining permission or a license from the patent holder.15  However, in a follow-up statement, both the patent holder and the two engineers stopped short of calling the communications a threat, and instead characterized them as merely a refusal of the patent holder to assist or collaborate with the engineers.16

While some patent owners are choosing to suspend their global patent rights and others are taking a more protectionist stance, the U.S. government also has the right to take action by forcing patent owners to grant compulsory licenses when there is a threat to public safety.  A compulsory license refers to the government’s authority to grant permission to a party seeking use of another’s patented invention without the consent of the patent owner, and is provided broadly by 28 U.S.C. § 1498.  Several multilateral international agreements also address compulsory patent licenses.17  Other U.S. laws also allow for compulsory licenses in certain circumstances.  For example, march-in rights is a provision of the Bayh-Dole Act of 1980 and is codified in 35 U.S.C. § 203.  March-in rights allow the federal government the right to grant patent licenses to other parties or take licenses for themselves if the patented invention was researched and developed with the help of federally funded dollars.18

March-in rights may be a perfectly poised vehicle for increasing access to COVID-19 related therapeutic drugs and vaccines.  To fight the global pandemic, the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services (“HHS”), has partnered with several drug manufacturers, including Johnson & Johnson, Sanofi and Regeneron Pharmaceuticals, to fund the development of treatments and vaccines for COVID-19.19  However, some members of Congress have expressed concern as to the affordability and access should such drugs be found safe and effective, especially since federal funds are being provided.

No U.S. federal agency has ever exercised its power to march-in and license patent rights to others.  For example, advocacy groups have long petitioned the National Institute of Health (“NIH”) to exercise march-in rights for HIV/AIDS related drugs, but have been rejected by the NIH contending that high drug prices are an insufficient reason to break a patent.  However, in the face of a global pandemic, “health or safety needs” may provide a strong basis for the exercise of march-in rights and grant of a compulsory license if more patent owners, like Gilead, take a protectionist patent stance.  On the other hand, if more companies like AbbVie take a more socially conscious approach, there may not be need for government intervention in terms of compulsory patent licenses.  Nevertheless, the availability of this measure may at least provide some comfort and may motivate companies to voluntary suspend their patent rights during this global public health emergency in order to avoid government march-in, or maybe as a pure act of benevolence showing that social responsibility has a place in commercial business.

1   See 35 U.S.C. § § 154, 271.

2   See, e.g., 28 U.S.C. § 1498(a), 35 U.S.C. § 203.

3   See https://www.usatoday.com/story/money/cars/2020/03/22/coronavirus-ventilator-shortage-gm-tesla-covid-19/2895190001/.

4   See https://wwd.com/fashion-news/fashion-scoops/fashion-designers-make-masks-hospital-gown-hand-sanitizer-to-fight-coronavirus-1203545006/.

5   See http://longisland.news12.com/story/41926769/anheuserbusch-to-make-hand-sanitizer-in-response-to-coronavirus-pandemic.

6   See Id.

7  https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials.

8   See https://www.ibtimes.com/coronavirus-treatment-gileads-potential-covid-19-treatment-labeled-orphan-drug-could-2945353.

9   See https://time.com/5782633/covid-19-drug-remdesivir-china/.

10 Orphan Drug Act of 1983. Pub L. No. 97–414, 96 Stat. 2049.

11 See https://www.statnews.com/2020/03/16/remdesivir-surges-ahead-against-coronavirus/.

12 See https://www.theverge.com/2020/3/18/21185006/softbank-theranos-coronavirus-covid-lawsuit-patent-testing; see also, https://www.businessinsider.com/theranos-patents-fortress-labrador-diagnostics-lawsuit-biofire-coronavirus-tests-2020-3.

13 See Id.

14 See https://www.businesswire.com/news/home/20200316005955/en/.

15 See https://www.law360.com/articles/1255547/3d-printing-as-indirect-patent-infringement-amid-covid-19.

16 See https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-medical-3d-print-valves-treatments.

17 See Convention of Paris for the Protection of Industrial Property, 13 I.S.T. 25 (1962), Art. 5(A)(2) (“Paris Convention”); See Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, Art. 31. (“TRIPS Agreement”).

18 See 35 U.S.C. § 203.

19 See https://crsreports.congress.gov/product/pdf/LSB/LSB10422.

© Copyright 2020 Cadwalader, Wickersham & Taft LLP

NJDOBI Mandates Insurance Carriers to Reimburse Providers for Telemedicine and Telehealth Encounters During State of Emergency and Public Health Emergency

NJDOBI issued Bulletin 20-07 to mandate insurance carriers to reimburse providers for telemedicine and telehealth encounters.  This applies to: (1) all health insurance companies; all HMOs; all health service corporations and any other entity issuing health benefits plans in New Jersey.

The mandate requires the insurance carriers to do the following:

  1. Review their telemedicine and telehealth networks for adequacy and grant any requested in-plan exception for individuals to access out of health telehealth providers if network providers are unavailable.
  2. Encourage their network providers to utilize telemedicine or telehealth services wherever possible and clinically appropriate in order to minimize exposure of provider staff and other patients to those who may have the COVID-19 virus
  3. Update their policies to include reimbursement for telehealth services that are provided by a provider in any manner that is practicable, including, if appropriate, and clinically appropriate, by telephone.   The Bulletin suggests that this be done on the carrier’s website.  This would include instruction on the use of telephone-only communications to establish a physician-patient relationship and the expanded use of telehealth for the diagnosis, treatment, ordering of tests, and prescribing for all conditions. Carriers are required to update telehealth policies to include telephone only services within the definition of telehealth.
  4. Reimburse providers that deliver covered services to members via telemedicine or telehealth. Carriers may establish requirements for such telemedicine and/or telehealth services, and guidance issued by the Department, including documentation and recordkeeping, but such requirements may not be more restrictive than those for in-person services. Carriers are not permitted to impose any specific requirements on the technologies used to deliver telemedicine and/or telehealth services (including any limitations on audio-only or live video technologies) during the state of emergency and public health emergency declared pursuant to EO 103.
  5. Ensure that the rates of payment to in-network providers for services delivered via telemedicine or telehealth are not lower than the rates of payment established by the carrier for services delivered via traditional (i.e., in-person) methods, and carriers must notify providers of any instructions that are necessary to facilitate billing for such telehealth services.
  6. May not impose any restriction on the reimbursement for telehealth or telemedicine that requires that the provider who is delivering the services be licensed in a particular state, so long as the provider is in compliance with P.L. 2020, c.3 and c.4 and this guidance.
  7. May not impose prior authorization requirements on medically-necessary treatment that is delivered via telemedicine or telehealth.

See the entire text of Bulletin 20-07.

© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

CMS/HHS Issues FAQs on Essential Health Benefits and COVID-19

As the President issues a state of emergency in response to the Coronavirus (COVID-19) outbreak, the Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, issued frequently asked questions (FAQs) on COVID – 19 and essential health benefits (EHB) coverage through the individual and small group insurance markets.

These FAQs state first that EHB generally include coverage for the diagnosis and treatment of COVID-19. However, the exact coverage details and cost-sharing will depend upon the individual’s plan, and some plans may require preauthorization before these services are covered. Under current regulations, each state and the District of Columbia generally determines the EHB that plans in their locality must cover. Moreover, many states are encouraging, and some are requiring, insurance carriers to cover a variety of COVID-19 services, including testing and treatment, without cost-sharing or preauthorization.

The FAQs went on to say that medically necessary isolation and quarantine required by and under the supervision of a medical provider during hospital admission is generally covered as EHB. However, quarantine outside of a hospital setting, such as a home, is not a medical benefit, nor is it required as EHB.

Finally, the FAQs addressed the possibility of a future COVID-19 vaccine. Although not yet available, all vaccines are analyzed by the Advisory Committee on Immunization Practice of the Centers for Disease Control and Prevention, who will recommend whether the vaccine should be included as EHB without cost sharing and before any applicable deductible. Current guidance indicates that the process of evaluation and final implementation as an EHB can take over a year, but plans may voluntarily choose to cover a vaccine before that time. The FAQs also note that participants may use the plan’s drug exemptions process to request the vaccine be covered.

© 2007-2020 Hill Ward Henderson, All Rights Reserved

Options for Employers When Employees Cannot Work From Home

Despite many politicians and employers discussing the option for employees to work at home, there are millions of employees who simply cannot do that. Bartenders, restaurant servers, cashiers, and many others have no one to serve and nothing to ring up when they work at home.

Employers of such employees accordingly have a difficult decision to make when business is at an all-time low or they have been shut down. Most cannot afford to pay employees during this time period and hope employees will qualify for unemployment benefits. The question for these employers thus becomes–to fire, or not to fire.

This is where a work furlough comes into play. A work furlough is essentially a temporary layoff that qualifies for unemployment benefits.

Furloughs rose in popularity some years ago when businesses had to cut costs. Most employers knew employees who worked from paycheck to paycheck would suffer a financial hardship if the employees lost their jobs. Employers did not want to terminate employment. These employers wanted to minimize the negative impact, psychologically and monetarily, a termination brings, and the hard feelings an employee may carry following termination. Employers wanted employees who were already-trained to return to work at the end of a furlough, rather than having to start the hiring process from scratch.

Work furloughs generally have a set beginning and end date, similar to the 15-day shut-down ordered in many cities. The employer does not pay the employee during the furlough. Employees, however, generally qualify for unemployment compensation benefits.

Employers who want to maintain better relations should tell their employees to apply for unemployment benefits on the first day of the furlough. This ensures the employees will receive the maximum compensation possible. Even an employee who uses vacation time or personal time may qualify for unemployment benefits.

Usually there is a one week waiting period before an employee is eligible to receive any unemployment benefits. Many states have benevolently waived this one week waiting period for job losses suffered due to the pandemic. In these states, employees will receive benefits beginning “day 1.” The employee will receive compensation during the second week and any later weeks during which the employee is not working.

Any employee who files after the first week of the furlough must use the second furlough week as the waiting period. The employee, therefore, loses a week of unemployment compensation.

Even if the furlough period is only one week in length, employees should file for benefits. This helps the employee if the employer is forced to extend a furlough or put employees on furlough again later that same year. The one-week waiting period only applies to the first week when the employee did not work during the first furlough. The employee does not have to wait yet another week to receive benefits (compensation) during any furloughs that take place within 12 months of the first furlough.

While furloughs are an excellent option for employers to consider, any employer considering termination or a furlough must carefully consider all state and local laws; the state emergency declarations and laws issued, given the pandemic; and federal law, including any relief package or whether the number of employees furloughed triggers obligations under WARN.

© Polsinelli PC, Polsinelli LLP in California

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

Important Guidance for IRS Tax Filers

Due to the situation created by the coronavirus, we’ve been fielding questions from clients, co-workers and accountants about potential changes in the tax filing and tax payment deadlines, as well as other IRS administrative issues such as examinations, collection actions and payment plans.

Because the president declared a national emergency, the IRS has broad powers under statute to extend certain deadlines. The IRS also has broad administrative authority. As of the date and time of this email, there has been no official guidance issued on extending the April 15 deadline for the filing of income tax returns. However, statements made on March 17, 2020 by Secretary of Treasury Mnuchin suggest that the government will allow a 90-day deferral of tax payments to the IRS.

Under this program, individuals can defer up to $1 million of tax payments, and corporations can defer up to $10 million, with no penalties and interest for 90 days. This program does appear to require the filing of a tax return first in order to obtain the deferral. Many questions on this program remain, and Varnum’s tax team will provide updates as they evolve.

Out of an abundance of caution, individuals may want to file an extension (Form 4868) prior to the filing deadline. This is NOT an extension in time to pay. As such, the first quarter tax estimates are due April 15 as is any shortfall in the expected 2019 tax liability. Please note, with respect to the payment deferral program, the secretary has not clarified whether the extension form or the estimated tax payment voucher falls under the definition of “return” for the payment deferral program. Finally, there are some safe harbors for estimated tax payments that may apply. Check the IRS website or talk to a tax advisor.

Tax preparers should check with the IRS employee assigned to any matter for the case status, including document requests, etc. If your client is honoring an IRS levy on an employee at this time, those obligations are still in force unless notified otherwise by the IRS. Some deadlines such as filing a Tax Court Petition for relief are statutory in nature and still valid.

© 2020 Varnum LLP

More on tax laws or the coronavirus outbreak on the National Law Review.

Families First Coronavirus Response Act: Paid Leave now Required for Absences Related to the Coronavirus (COVID-19)

Early Saturday, March 14, 2020 the House of Representatives passed the Families First Coronavirus Response Act (the “Act”). The Senate is set to take this matter up on Monday, March 16, 2020 and President Trump stated that he will immediately sign the legislation. The Act has many facets to it including new temporary employer obligations relative to paid leaves of absence related to the Coronavirus (COVID-19) and expands employer obligations under the Federal Family and Medical Leave Law. Employers have time to prepare as the law will be effective 15 days after enactment (potentially as soon as March 31, 2020, if signed Monday). While there is much remaining to be analyzed under this new law, the following provides an initial overview so employers can begin preparations for compliance and education of the workforce.

Expansion of FMLA rights

First, the Act expands the pool of employees that qualify for federal FMLA leave. The Act will require employers with fewer than 500 employees1 (and all government employers) to provide employees who have been employed for at least 30 days with FMLA leave for Coronavirus reasons if:

  1. The employee is absent from work due to the employee’s physical presence jeopardizing the health of others due to exposure to the Coronavirus or due to the employee exhibiting symptoms of the virus;
  2. The employee will care for a family member who a health care provider or a public health authority determines has been exposed to the Coronavirus or who exhibits symptoms of the virus; or
  3. The employee is needed to care for a son or daughter under 18 because a school or a place of care (daycare) has been closed or the child care provider is not available.

The definition of “family” in the application of the above requirements is expanded to include family members who are senior citizens, grandparents, grandchildren, next of kin of the employee or is a son or daughter with special needs. The definition of “spouse” also includes domestic partners, as defined under the law.

The rights and remedies available to an employee under the federal FMLA remain the same. Therefore, we recommend that employers review existing procedures and forms utilized to determine FMLA eligibility and update those materials to recognize the Act’s broadened scope.2

Enhanced Right to Paid Time Off

The Act also mandates that employers provide “Emergency Paid Sick Leave.” This benefit is available to employees to:

  1. Self-isolate because of a Coronavirus diagnosis;
  2. Obtain medical diagnosis or care if the employee is experiencing the symptoms of the Coronavirus;
  3. Comply with an order of a public official or Health Care Provider that physical presence at work would jeopardize the health of others due to the employee’s exposure to the Coronavirus or because the employee is exhibiting symptoms of the illness;
  4. Care for a family member of the employee due to the family member’s self-quarantining based upon exposure to the virus or because the family member is exhibiting symptoms and requires medical diagnosis or care; or
  5. Care for a child of the employee if a school or place of care has been closed or the care provider for the child is unavailable.

If an employee meets one or more of these qualifications, the Act provides that the employee is entitled to Emergency Paid Sick Leave. Specifically, full-time employees will have 80 hours of sick leave available to them and part-time employees will have their average hours of work over a 2-week period available as Paid Sick Leave. If the employee has variable hours of work each week, the employee’s average hours of work over the preceding 6 months will be used to determine the employee’s average hours per week. The sick leave benefit will be paid at the employee’s regular rate of pay for any absence due to the employee’s own treatment or quarantine. The sick leave benefit will be paid at two-thirds of the employee’s regular rate of pay for any absence to care for a family member or to provide child care due to school or daycare closure.

If an employee needs leave beyond the 2-weeks for Emergency Paid Sick Leave and continues to meet the requirements associated with the Act’s mandate for paid leave under the FMLA, the employee will be paid not less than two-thirds of the employee’s regular rate of pay (or minimum wage, if greater) for the regular hours of work missed, to the extent of the employee’s already-existing available FMLA leave. The changes to the FMLA under the Act will expire on December 31, 2020.

Finally, for employee absences associated with non-FMLA qualifying reasons (e.g., an employer’s decision to send an employee home because the employee is exhibiting flu-like symptoms), the employee may be eligible for Unemployment Insurance benefits beginning in the first week of absence. This provision will expire on December 31, 2020.

It is important to understand that the Act entitlement represents the “floor” of entitlement. In other words, employers will not enjoy a reduced obligation to provide Paid Sick Leave if it already offers Paid Sick Leave to employees. The Paid Sick Leave under the Act is in addition to what the employee may already be entitled to in employment. However, there will not be any carryover right for unused Sick Leave granted under the Act.

Again, it is important that employers revisit their protocol for determining eligibility for paid sick leave and prepare to implement the new mandate. Likewise, employers providing Paid Sick Leave and absence benefits should carefully log the wages paid related to compliance. As of now, the Act anticipates a tax credit available for sick leave wages paid to employees, subject to caps established under the law.

1 Exemptions for small employers (fewer than 50 employees) and certain emergency and healthcare workers continue to be discussed.
2 The DOL will be issuing a Notice related to the new requirements that must be posted along with other employment related Notices to employees.

©2020 von Briesen & Roper, s.c
For more on the developing Coronavirus situation, see the National Law Review dedicated Coronavirus News page.

U.S. Health & Human Services – Office of Civil Rights Issued Guidance Regarding HIPAA Privacy and Novel Coronavirus

The Office of Civil Rights (OCR) last month provided guidance and a reminder to HIPAA covered entities and their business associates regarding the sharing of patient health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule during an outbreak or emergency situation such as what we are all facing right now with the Novel Coronavirus (2019-nCoV) outbreak.

The OCR guidance focused on sharing patient information in several areas, including: treatment, public health activities, disclosures to family, friends, and others involved in an individual’s care, and disclosures to prevent a serious and imminent threat.

The HIPAA Privacy Rule allows a covered entity to disclose PHI to the Center for Disease Control (CDC) or to state or local health departments that are authorized to collect or receive such information, for the purpose of preventing disease and protecting public health.  This would include disclosure to the CDC, and/or state or local health departments, of PHI as needed to report prospective cases of patients exposed to or suspected or confirmed to have Novel Coronavirus.

The OCR message in the guidance document is clear and it emphasized the balance between protecting the privacy of patient PHI and the appropriate uses and disclosures of such information to protect the public health. For more information and resources, see the HHS interactive decision tool which provides assistance to covered entities to determine how the Privacy Rule applies to disclosures of PHI in emergency situations.

Copyright © 2020 Robinson & Cole LLP. All rights reserved.

For more on HIPAA regulation, see the National Law Review Health Law & Managed Care section.