Archives: Health Care Contracting

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OFCCP Promulgates Final Rule Eliminating Its Authority Over TRICARE Providers

On July 2, 2020, the Department of Labor’s Office of Federal Contract Compliance Programs (“OFCCP”) promulgated a final rule resolving long-standing uncertainty regarding its enforcement authority over health care providers participating in TRICARE, a federal program that provides health care to service members, veterans, and their families.[1] The rule officially removes OFCCP’s regulatory authority over … Continue Reading

Emergency Contracting During COVID-19: A Guide to FAR Part 18

The government’s response to the coronavirus pandemic implicates a host of authorities of interest to contractors, from those under the Stafford Act to its recently invoked Defense Production Act powers.  The government has another critical, and perhaps under-examined, set of tools at its disposal to meet the demands of the pandemic:  FAR Part 18, “Emergency … Continue Reading

Defense Production Act Anti-Hoarding Provisions Invoked for Coronavirus

The Department of Health and Human Services published a notice on March 30, 2020 — effective March 25, 2020 — designating certain COVID-19-related personal protective equipment (“PPE”) and materials as “scarce” or “threatened” materials subject to the Defense Production Act’s (“DPA”) anti-hoarding provisions.  As a result of this notice, the DPA now prohibits the accumulation … Continue Reading

The Defense Production Act and the Coronavirus Executive Order: Key Considerations

Following up on our post earlier this week giving a general overview of the Defense Production Act of 1950 (“DPA”), 50 U.S.C. §§4501 et seq., this post comments on President Trump’s March 18, 2020 Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “COVID-19 E.O.”) and … Continue Reading

A Coronavirus Contractor’s Guide to the Defense Production Act

As a followup to our recent post on the implications of the PREP Act for government contractors working to respond to the COVID-19 outbreak, this post will provide an overview of the Defense Production Act—including its key powers that the federal Government might invoke to counter the pandemic.… Continue Reading

A Coronavirus Contractor’s Guide to the PREP Act

We’ve covered several topics already this week on the U.S. Government’s varied responses to the COVID-19 outbreak and how these responses will affect contractors that do business with the government, including BARDA’s EZ-BAA for COVID-19 diagnostics, mission-essential services during the outbreak, and how excusable delay provisions may help federal contractors affected by the outbreak.  But … Continue Reading

Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development

In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global … Continue Reading

Tenth Circuit Provides New Material on FCA’s Materiality Standard

Earlier this month, the United States Court of Appeals for the Tenth Circuit issued a decision that provided further clarity on the False Claims Act’s standard for materiality.  The decision, United States ex rel. Janssen v. Lawrence Memorial Hospital, further demonstrated that materiality should be viewed through the eyes of the government customer rather than … Continue Reading

U.S. Government Seeks Industry Solutions in Novel Coronavirus Response

As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than … Continue Reading

OFCCP Proposes Rule Removing TRICARE Health Care Providers from Its Regulatory Authority

On November 6, 2019, the Department of Labor’s Office of Federal Contract Compliance Programs (“OFCCP”) issued a Notice of Proposed Rulemaking (“NPRM”) aimed at resolving what OFCCP describes as a “decade of confusion.”[1] At issue is a long-standing question concerning the scope of OFCCP’s enforcement authority over health care providers participating in TRICARE, a federal … Continue Reading

White House Seeks Input from Biotech Stakeholders on Bioeconomy

Last week, the White House Office of Science and Technology Policy (“OSTP”) issued a request for information (“RFI”) to learn how the Government can more effectively “support scientific discovery, the development of technological advances, and increase the impact of a vibrant bioeconomy on the Nation’s vitality and our citizens’ lives.” 84 Fed. Reg. 47561 (Sep. … Continue Reading

The 340B Ceiling Price and CMP Rule . . . Changes on the Horizon?

After more than eight years in the making, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Rule”) seems to be a rudderless ship on a shoreless sea. On Monday, the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking delaying the implementation date of the final … Continue Reading

Fourth Circuit Embraces Expansive View of Derivative Sovereign Immunity for Government Contractors

Last week, the Fourth Circuit Court of Appeals affirmed a lower court decision to dismiss a Telephone Consumer Protection Act (“TCPA”) lawsuit against General Dynamics Information Technology, Inc. (“GDIT”), on the basis that GDIT was immune from suit as a government contractor under what is known as the “Yearsley doctrine.”  Craig Cunningham v. GDIT, No. … Continue Reading

If Shulkin Didn’t Resign, Who Runs the VA Until a New Secretary Is Confirmed? A Vacancies Act Puzzle

Recent news reports have raised a substantial question about who has authority to run the Department of Veterans Affairs (“VA”) in the wake of Dr. David Shulkin’s departure from the agency.  According to the White House, Dr. Shulkin resigned.  Meanwhile, Dr. Shulkin himself has publicly insisted that he did not resign and was instead fired. … Continue Reading

Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs. HB 4005 also imposes new reporting requirements on health insurers and establishes a temporary task force charged with … Continue Reading

The Long-Standing TAA “Substantial Transformation” Standard for Drug Products is Challenged at the Court of International Trade

A generic pharmaceutical distributor, Acetris Health, LLC, has challenged the Final Determination of U.S. Customs and Border Protection (“Customs”) that Acetris’ generic prescription drug, Rosuvastatin Calcium Tablets (“Rosuvastatin”), is a product of India, the place where the active pharmaceutical ingredient (“API”) is produced.  If successful, the challenge in the U.S. Court of International Trade (“CIT”) … Continue Reading

California Law Aims to Scrutinize Drug Pricing

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state … Continue Reading

Sample Human Trafficking Compliance Plan Finally Released

This week, the Department of State (“State”), Verité, and other global NGOs, unveiled a sample human trafficking compliance plan and online resource to help contractors comply with the FAR’s anti-human trafficking rule (the “Rule”).  As we have previously summarized, the Rule requires contractors to implement a compliance plan for contracts exceeding $500,000 that are for … Continue Reading

Proposed Definition of “Recruitment Fees” Published

DoD, GSA, and NASA published a definition of “recruitment fees” for purposes of FAR 52.222-50 in today’s Federal Register.  As we have previously discussed, the anti-trafficking requirements in FAR 52.222-50 were amended almost a year and a half ago to prohibit contractors from charging employees recruitment fees, without defining such fees.  Subsequent efforts to define … Continue Reading

Human Trafficking Model Compliance Plan and Internet-Based Compliance Tools Set for Release this Month

The Department of State (“State”) recently announced the upcoming release of the model anti-human trafficking compliance plan. State and Verité, a global NGO, developed this highly-anticipated model compliance plan in response to the amendments to FAR 52.222-50, which require contractors to perform supply chain due diligence and implement a compliance plan for contracts exceeding $500,000 … Continue Reading

HRSA Seeks a Second Round of Comments on 340B Penny Pricing, New Drug Estimates, and Civil Monetary Penalties

On Monday, April 18th, the Health Resources and Services Administration (“HRSA”) and the Department of Health and Human Services (“HHS”) reopened the comment period for their proposed rule “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” (“Proposed Rule”).  Originally issued on June 17, 2015, the Proposed Rule sought to implement the … Continue Reading

Non-TAA-Compliant Covered Drugs Must be Offered to the VA in the Coming Weeks

The United States Department of Veterans Affairs (“VA”) recently announced a significant change in policy that will allow it to purchase drug products that were previously unavailable due to the Trade Agreements Act (“TAA”) because they were manufactured in countries with whom the United States does not have a procurement agreement in place.  The VA … Continue Reading

Zika Virus Complications Lead to Expected Government Partnership with Private Industry

Concerns about the spread of Zika virus and potential complications associated with infection may soon lead to new research and development opportunities for government contractors and grant recipients.  Similar to developments after the recent Ebola outbreak in West Africa, a need to better understand Zika’s characteristics and develop an effective countermeasure or vaccine has led both domestic and … Continue Reading

Ninth Circuit Narrows Application of the False Claims Act’s Public Disclosure and First to File Bars

United States ex rel. Hartpence v. Kinetic Concepts, Inc., No. 12-55396 (9th Cir. July 2015) is one of many recent decisions limiting a contractor’s ability to dismiss False Claims Act (“FCA”) lawsuits at an early stage of the litigation.  In Hartpence, the Ninth Circuit resurrected two FCA cases in one sweeping decision by interpreting the … Continue Reading
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