Archives: Health Care Contracting

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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

HRSA Proposes Calculation of 340B Ceiling Prices, Implementation of Manufacturer Civil Monetary Penalties

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a proposed rule to clarify how manufacturers should calculate the ceiling price for covered outpatient drugs under the 340B program, and to provide for civil monetary penalties (CMPs) on manufacturers that “knowingly and intentionally” overcharge 340B covered entities.[1]  The ceiling price provisions are … Continue Reading

Efforts to Define Recruitment Fees Move Forward as Newly-Revised Human Trafficking Rule Goes into Effect

Late last week the House Foreign Affairs Committee approved H.R. 400, which would require the Department of State and the United States Agency for International Development (USAID) to propose a definition of recruitment fees within 180 days of the statute’s enactment.  H.R. 400 explains that “contractors sometimes employ foreign workers who are citizens neither of … Continue Reading

New Human Trafficking Rule Imposes Compliance Obligations on All Government Contractors and Subcontractors Starting March 2015

On January 29, 2015, the Federal Acquisition Regulation (“FAR”) Council published the long-awaited  final rule (“the Final Rule”) implementing Executive Order 13627 and title XVII of the National Defense Authorization Act of 2013, significantly augmenting existing human trafficking-related prohibitions for Federal contractors and subcontractors.  The Final Rule is similar to the previously summarized proposed rule.… Continue Reading

President Signs Act Authorizing $5.4 Billion in Emergency Funding to Combat Ebola

Yesterday, President Barack Obama signed into law a $1.1 trillion appropriations act that allocates approximately $5.4 billion in emergency funding to support the U.S. Government’s response to the Ebola outbreak in West Africa.  Although this funding falls short of the Administration’s initial $6.18 billion request—approximately $1.54 billion of which was to be allocated to a … Continue Reading

HHS Issues PREP Act Declaration Covering Ebola Vaccines

The U.S. Department of Health and Human Services (“HHS”) published a declaration today under the Public Readiness and Emergency Preparedness (“PREP”) Act covering activities relating to three Ebola vaccine candidates that are currently in development.  The declaration went into effect on December 3, 2014 and extends liability protection to manufacturers, distributors, program planners, and qualified … Continue Reading

Changes Ahead for TRICARE Managed Care Support Program?

In a move that signals the start of the acquisition cycle for the DOD’s largest purchased care contract, the Defense Health Agency (“DHA”) has released a draft RFP for the next generation of TRICARE Managed Care Support (“MCS”) contracts.  The TRICARE program, which provides health care services to nearly 10 million servicemembers and their families across … Continue Reading

Department of Health and Human Services Announces It Will Issue 340B Guidance and Targeted Rules in Place of Omnibus 340B Rule

On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew a proposed rule (known as the “340B mega-reg”) intended to establish comprehensive 340B Drug Pricing Program requirements for participating covered entities and manufacturers.  The rule was originally expected to publish for notice and comment in June 2014, and was expected to address key … Continue Reading

Defense Threat Reduction Agency Seeks “Near-Term” Solutions to Ebola Outbreak

The Defense Threat Reduction Agency (“DTRA”) issued a broad agency announcement (“BAA”) at the end of last week seeking “near-term” solutions that can be developed in time to assist with the current (Zaire) Ebola virus outbreak in West Africa.  Expanding on the BAA under which the U.S. Department of Health and Human Services (“HHS”) is … Continue Reading

Government Looking to Existing Procurement Vehicles to Stem Ebola Threat

As the U.S. government works to address the threat posed by the Ebola virus, one tool available to the Department of Health and Human Services (HHS) in this effort is a broad agency announcement (BAA) originally issued in 2009 as a means of accelerating the development of vaccines, therapeutics, and diagnostics to prevent and treat … Continue Reading

PhRMA Filed Suit Today Seeking to Invalidate the 340B Orphan Drug Exclusion Interpretative Rule

Today, Pharmaceutical Research and Manufacturers of America (“PhRMA”) filed a suit seeking to invalidate the 340B Orphan Drug Exclusion Interpretative Rule.  The same Health Resources and Services Administration (“HRSA”) policy in the “interpretive rule” was previously set forth in substance as a final regulation that was struck down by the U.S. District Court for the District of Columbia, about which we previously reported … Continue Reading

FDA Adopts Core NIST Framework in Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration recently became one of a number of federal agencies to adopt the National Institute of Standards and Technology’s (“NIST”) core cybersecurity framework.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  The final guidance sets forth … Continue Reading

HRSA Updates the Self-Disclosure Process for 340B Noncompliance

Earlier this month, HRSA set forth steps that providers should follow to make a “self-disclosure” when a “material breach” of 340B compliance has occurred.  HRSA noted that it is “working to standardize the self-disclosure process, and highlight best practices to assist covered entities in this effort.” During the annual covered entity recertification process, the 340B entity’s … Continue Reading

DoD Recently Released its Finalized RFP for its Healthcare Management System Modernization

On August 25, 2013, the Department of Defense (“DoD”) released its finalized solicitation to vendors who are interested in contending for the nearly $11 billion contract to provide an off-the-shelf electronic health record (EHR) software solution aimed at modernizing the DoD’s aging in-house systems, as well as the program support to foster interoperability with the … Continue Reading

Court of Federal Claims Stays Decision Requiring Commercial Item Contractor to Comply with Non-Commercial Practices

Contractors supplying commercial products and services to the U.S. Government under the Federal Supply Schedule (“FSS”) or General Services Administration (“GSA”) Schedules program may be required to comply with non-commercial requirements. Until recently, it was thought that rules in Part 12 of the Federal Acquisition Regulation (“FAR”) applicable to commercial item purchases—rules that restricted agencies … Continue Reading

Judge Requires PhRMA To Initiate New 340B Orphan Drug Lawsuit to Challenge Interpretive Rule

A Washington, D.C., federal judge has declined requests from Pharmaceutical Research and Manufacturers of America(“PhRMA”) to invalidate a new interpretive rule applicable to orphan drugs in the 340B drug discount program, saying the trade group must file a new complaint in order to proceed. Last week, the D.C. District Court ruled that PhRMA must bring … Continue Reading
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