Administration Issues Executive Order Tying Medicare Drug Costs to International Prices

Merle M. DeLancey Jr.

On Sunday, while everyone was watching the return of NFL football, the Administration was busy fulfilling a promise it made in July to lower drug prices paid by the United States and Medicare beneficiaries by tying pricing to certain foreign countries.

In July, the Administration issued three Executive Orders concerning drug pricing and access to critical therapies. At that time, the Administration also announced that, unless the pharmaceutical industry proposed a plan that would decrease prices paid by Medicare Part B by August 24, the Administration would move forward with its own plan. Apparently, no agreement with the industry was reached because on Sunday the Administration announced its own plan.

In what is being called the “Most Favored Nations” Executive Order, the Administration is re-starting its efforts to reduce the prices the United States pays for drugs under Medicare Parts B and D. The Order uses the “most-favored-nation price” as the benchmark for prices to be paid by the United States. Most-favored-nation price is defined as the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a comparable member country of the Organisation for Economic Co-operation and Development (“OECD”).

Perhaps most surprising is the increased scope of the Order. The Order goes beyond what was proposed in July by seeking to link not only Medicare Part B drug prices but also Medicare Part D prices to lower prices paid by other countries. With respect to both Medicare Parts, the Department of Health and Human Services’ (“HHS”) “payment model” is to test whether poor clinical outcomes improve as a result of patients paying lower prices—no more than the most-favored-nation prices—for certain high-cost pharmaceuticals and biologics.

While the Order makes for a snappy sound bite, any potential benefits of lower drug prices will not be seen anytime soon. First, HHS will need to complete its rulemaking, which could have its own challenges. For example, in November 2018, HHS published an Advance Notice of Proposed Rulemaking (“ANPR”) proposing to implement an international reference pricing payment model for use by Medicare and Medicaid. Ultimately, nothing became of the ANPR. Even then, implementation of the contemplated programs is precarious. Industry opposition to the Order has been palpable and any HHS plan will likely face legal challenges that could substantially delay implementation.

Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye

Merle M. DeLancey Jr. and John M. Clerici 

On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry.[1] The impact of the EO may be far greater than currently anticipated. It is well-considered, well drafted, and structured in a way that is likely to survive if there is a change in Administration. The EO will have a greater and immediate impact on Medical Counter Measures (“MCMs”) for chemical, biological, radiological, and nuclear threats, and emerging infectious diseases than on Essential Medicines. The inclusion of Critical Inputs (i.e., active pharmaceutical ingredients (“API”)) and starting materials potentially makes the impact far reaching, especially when coupled with the significant funding from the federal government to support onshoring efforts as a result of the COVID-19 pandemic. Continue reading “Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye”

Recent and Possible Executive Orders on Drug Pricing: What You Need to Know

Merle M. DeLancey Jr.

On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce the prices Medicare Part B pays for drugs based upon international prices, unless the pharmaceutical industry implements measures in the next 30 days. Leaving politics and rhetoric aside, below are the key facts regarding the Executive Orders.

First Executive Order: Access to Affordable Life-Saving Medications

The Order: Click here to view the Order.

Effective Date:  July 24, 2020

Purpose: Requires Federally Qualified Health Centers (“FQHCs”) to pass on the discounted prices they pay for insulin and epinephrine to low income patients. FQHCs are federally funded, community-based health care providers serving low income patients and underserved areas. Under the Health and Human Services’ (“HHS”) 340B Drug Discount Program, drug manufacturers charge FQHCs statutorily discounted prices, sometimes as low as $0.01, for drugs including insulin and epinephrine. But FQHCs are not required to pass on the discounted prices to their patients. This Executive Order requires FQHCs to make insulin and epinephrine available to their patients at the price paid by the FQHC. The FQHC is permitted to charge a minimal administration fee. Continue reading “Recent and Possible Executive Orders on Drug Pricing: What You Need to Know”

Tricare Providers Are Not Federal Subcontractors

Merle M. DeLancey, Jr.

The Office of Federal Contract Compliance Programs (“OFCCP”) ended a long-running controversy by issuing a final rule stating that healthcare providers participating in the TRICARE military healthcare program are not federal subcontractors. TRICARE provides healthcare benefits to uniformed service members, retirees, and their families. In its final rule, the OFCCP, which enforces anti-discrimination laws as to government contractors, states that it does not have authority to enforce regulatory obligations in Executive Order 11246, Section 503 of the Rehabilitation Act of 1973, and the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, including affirmative action obligations, with respect to TRICARE providers.

Controversy regarding the status of TRICARE providers as potential federal subcontractors began in 2007 when OFCCP first asserted its authority over an Orlando, Florida, hospital serving TRICARE beneficiaries. Years of litigation ensued. In 2011, Congress sought to resolve any confusion by including a provision in the National Defense Authorization Act for Fiscal Year 2012 barring the OFCCP from asserting jurisdiction over a healthcare provider based on TRICARE participation.

Notwithstanding Congress’ clear intent to foreclose OFCCP’s further assertions of jurisdiction based solely on TRICARE, the agency continued its enforcement efforts. Eventually, perhaps seeing the writing on the wall, in 2014, the agency implemented a five-year moratorium on enforcement actions against TRICARE providers. In 2018, OFCCP extended the moratorium an additional two years during which, in November 2019, the agency initiated a proposed rulemaking leading to its final rule issued earlier this month.

The OFCCP’s final rule makes clear, for now, that TRICARE providers are not required to comply with certain employment protections involving race, sex, and other characteristics, including implementing affirmative action plans. In the final rule, the agency states that even if it had authority over TRICARE providers, it would grant a national interest exception for the providers.

According to the agency, the final rule gives certainty to more than 87,000 healthcare providers regarding their legal obligations and aims to improve access to medical care for veterans and their families, increase cost savings for TRICARE providers, and allocate the agency’s limited resources more efficiently.

The final rule only applies to healthcare providers under the TRICARE program. To the extent a healthcare provider has a separate federal prime contract or subcontract, it is still subject to the agency’s rules and regulations. Thus, if you are a TRICARE provider, you can breathe a sigh of relief but you must remain vigilant regarding direct contracts with other federal agencies and, more importantly, scrutinize whether subcontracts involving federal healthcare programs, other than TRICARE, could nonetheless make you a federal subcontractor subject to OFCCP’s rules and regulations and other Federal Acquisition Regulations. Our previous guidance in this area can be found in our blog post, Who Is a Subcontractor under a Federal Government Contract? 

Veterans Affairs Granted Unprecedented Procurement Authority under P.L. 85-804

John M. Clerici and Merle M. DeLancey Jr.

On April 10, 2020, the President issued a Memorandum to the Secretary of the Department of Veterans Affairs (“DVA”) authorizing the exercise of authority under Public Law 85-804, 50 U.S.C. §§ 1431-35. (See Memorandum on Authorizing the Exercise of Authority under Public Law 85-804.) This is a significant action that contractors must understand and be prepared to use for their benefit.

P.L. 85-804’s expansive powers are rarely invoked, used only in unique circumstances that require “extraordinary contractual actions.” See FAR Part 50. President Obama relied on P.L. 85-804 in 2014 when he granted the Administrator of the United States Agency for International Development (“USAID”) the authority to indemnify companies from lawsuits related to contracts performed in Africa in support of USAID’s response to the Ebola outbreak. Because there are now other legal authorities the U.S. Government may use to offer liability protection in certain circumstances (e.g., the SAFETY Act of 2002; the PREP Act of 2005), conferring liability protection under P.L. 85-804 is uncommon. The use of the law to broadly expand the U.S. Government’s contracting powers is truly extraordinary. Continue reading “Veterans Affairs Granted Unprecedented Procurement Authority under P.L. 85-804”

A Federal Contractor’s Five-Part Guide to the CARES Act

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was signed into law. This massive $2.2 trillion economic package provides a host of opportunities and resources for all varieties of federal contractors—from those who need financial assistance through the coronavirus pandemic to those who can leverage their resources to assist the federal government in its response.

The five timely posts below discuss discrete portions of the CARES Act, how they might affect federal contractors, and what federal contractors can do to take advantages of the many programs and opportunities offered under the Act. Please contact us for assistance with any of these, or other components, of the Act.

1. The CARES Act Provides Much Needed Financial Relief for Small Businesses

Michael Joseph Montalbano
This article discusses the expanded $349 billion loan program set aside for small businesses under the CARES Act.

2. CARES Act § 3610: An Immediate Lifeline for Qualifying Federal Contactors Displaced by COVID-19

Michael J. Slattery
This article discusses § 3610 of the CARES Act, which provides funds that federal agencies can use to alleviate disruptions to federal contractors caused by the coronavirus pandemic.

 3. CARES Act Grant Programs: Searching for Opportunity in the Coronavirus Relief Effort

Tjasse L. Fritz
This article discusses the wealth of grant programs available to federal contractors and other businesses under the CARES Act.

4. CARES Act: Significant Funds for Defense Department and Defense Contractors

Adam Proujansky
This article discusses the billions of dollars in loans, loan guarantees, and other financial assistance available through the Department of Defense to defense industry contractors.

5. New Contracting Authorities and Preferences Established under the CARES Act

Albert B. Krachman
This article discusses new contracting authorities delegated under the CARES Act as well as sole source opportunities available under the Act.

As COVID-19 issues permeate virtually all aspects of commerce nationally and internationally, we stand ready to help. Blank Rome’s Coronavirus (“COVID-19”) Task Force includes interdisciplinary resources across every business sector from insurance recovery to HR.

CARES Act Grant Programs: Searching for Opportunity in the Coronavirus Relief Effort

Tjasse L. Fritz

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act” or “the Act”) is a $2.2 trillion legislative package designed to stabilize the United States’ economy as the country deals with the novel coronavirus COVID-19. Included in the Act are a wealth of grant programs that may hold opportunities for companies able to position themselves appropriately during this crisis.

Of particular interest are grant programs related to healthcare, technology, and workforce sustainment, which include:

1. Entrepreneurial development grants

Section 1103 of the CARES Act provides a $240 million grant fund for development of programs to provide education, training, and advising to covered small business concerns. Training topics include:

    • How to apply for Small Business Administration (“SBA”) resources, including business resiliency programs;
    • COVID-19 transmission prevention practices; and
    • How to manage and practice teleworking.

An additional $25 million grant is available for development of a centralized information hub where these educational materials may be accessed. Continue reading “CARES Act Grant Programs: Searching for Opportunity in the Coronavirus Relief Effort”

VA Federal Supply Schedule Contracts and the Coronavirus

Merle M. DeLancey Jr.

In response to the coronavirus COVID-19 pandemic, the Department of Veterans Affairs (“VA”) has relaxed procurement rules and regulations to facilitate purchases from VA federal supply schedules (“FSS”). On March 20, 2020, the VA National Acquisition Center (“NAC”) informed all VA FSS holders that, based upon the President’s invocation of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”), state and local governments, territories, and tribes have full access to VA FSS contracts. See Presidential Declaration of National Emergency COVID-19 – State and Local Government Ordering Procedures.

Thus, even if a contractor did not elect to participate in Disaster Recovery Purchasing at the time of contract award, contractors are now permitted to accept any orders by state and local governments. However, whether to accept any state or local government order is voluntary not mandatory. Continue reading “VA Federal Supply Schedule Contracts and the Coronavirus”

After Acetris Decision, Trade Agreements Act Compliance Questions Abound: Contractors Need Guidance

Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger

The Federal Circuit’s recent decision in Acetris has left many contractors scratching their heads and asking questions. To recap, on February 10, 2020, the Federal Circuit held that, under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the Trade Agreements Act (“TAA”), a drug must be either “manufactured” in the United States or “substantially transformed” in the United States. (See Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade Agreements Act (Acetris Decision).) This is a stark change from the Government’s long-held position that manufacturing and substantial transformation were one in the same.

As a result of the Acetris decision, federal contractors seeking to comply with or maintain compliance with the TAA are facing many questions. Some of the more prominent questions are below. Continue reading “After Acetris Decision, Trade Agreements Act Compliance Questions Abound: Contractors Need Guidance”

Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade Agreements Act (Acetris Decision)

Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger

Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry. In Acetris, the Federal Circuit held that a generic drug manufactured in the United States complied with the Trade Agreements Act (“TAA”) and could be sold to the Department of Veterans Affairs. The court made this determination even though the drug’s active pharmaceutical ingredient (“API”) came from a non-designated country, India. In reaching its decision, the court broke away from longstanding Customs and Border Protection (“CBP”) precedent that the country where the API was produced dictated the location of “substantial transformation” and thus the country of origin for any resulting drug. The court held that under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the TAA, a drug must be either “manufactured” in the United States or “substantially transformed” in the United States—but not be both.

For years, generic drug manufacturers that manufacture drugs in the United States from API produced in India and China have been precluded from selling their drugs to the U.S. Government under the TAA. The Federal Circuit’s Acetris decision opens up the U.S. Government market for generic drugs manufactured in the U.S. from API produced in India and China.