Tag: White House

Federal Agencies Announce Investments and Resources to Advance National Biotechnology and Biomanufacturing Initiative

As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal departments and agencies, with funding of more than $2 billion, will take the following actions:

  • Leverage biotechnology for strengthened supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (API), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with a more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of biobased materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage the estimated one billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.
  • Expand domestic biomanufacturing: DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. According to the fact sheet, this support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals.
  • Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy by advancing regional biotechnology and biomanufacturing programs.
  • Bring bioproducts to market: DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale-up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
  • Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
  • Drive regulatory innovation to increase access to products of biotechnology: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
  • Advance measurements and standards for the bioeconomy: DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
  • Reduce risk through investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.
  • Facilitate data sharing to advance the bioeconomy: Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

A recording of the White House summit is available online.

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

For more environmental, energy, and resources legal news, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

The directive bolstered efforts already underway by the Biden Administration. A week before the E.O. was signed, HHS Secretary Xavier Becerra directed the HHS Office for Civil Rights (OCR) to take steps to ensure privacy protections for patients who receive, and providers who furnish, reproductive health care services, including abortions.[3] The following day, OCR issued two guidance documents to carry out this order, which are described below.

Although the guidance issued by OCR clarifies the privacy protections as they exist under current law post-Dobbs, it does not offer patients or providers new or strengthened privacy rights. Indeed, the guidance illustrates the limitations of HIPAA regarding protection of health information of individuals related to abortion services.

A.  HHS Actions to Safeguard PHI Post-Dobbs

Following Secretary Becerra’s press announcement, OCR issued two new guidance documents outlining (1) when the HIPAA Privacy Rule may prevent the unconsented disclosure of reproductive health-related information; and (2) best practices for consumers to protect sensitive health information collected by personal cell phones, tablets, and apps.

(1) HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care

In the “Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe,”[4] OCR addresses three existing exceptions in the HIPAA Privacy Rule to the disclosure of PHI without an individual’s authorization and provides examples of how those exceptions may be applied post-Dobbs.

The three exceptions discussed in the OCR guidance are the exceptions for disclosures required by law,[5]  for purposes of law enforcement,[6] or to avert a serious threat to health or safety.[7]

While the OCR guidance reiterates that the Privacy Rule permits, “but does not require” disclosure of PHI in each of these exceptions,[8] this offers limited protection that relies on the choice of providers whether to disclose or not disclose the information. Although these exceptions are highlighted as “protections,” they expressly permit the disclosure of protected health information. Further, while true that the HIPAA Privacy Rule itself may not compel disclosure (but merely permits disclosure), the guidance fails to mention that in many situations in which these exceptions apply, the provider will have other legal authority (such as state law) mandating the disclosure and thus, a refusal to disclose the PHI may be unlawful based on a law other than HIPAA.

Two of the exceptions discussed in the guidance – the required by law exception and the law enforcement exception – both only apply in the first place when valid legal authority is requiring disclosure. In these situations, the fact that HIPAA does not compel disclosure is of no relevance. Certainly, when there is not valid legal authority requiring disclosure of PHI, then HIPAA prohibits disclosure, as noted as in the OCR guidance.  However, in states with restrictive abortion laws, the state legal authorities are likely to be designed to require disclosure – which HIPAA does not prevent.

For instance, if a health care provider receives a valid subpoena from a Texas court that is ordering the disclosure of PHI as part of a case against an individual suspected of aiding and abetting an abortion, in violation of Texas’ S.B. 8, then that provider could be held in contempt of court for failing to comply with the subpoena, despite the fact that HIPAA does not compel disclosure.[9] For more examples on when a covered entity may be required to disclose PHI, please see EBG’s prior blog: The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe.[10]

Notably, the OCR guidance does provide a new interpretation of the application of the exception for disclosures to avert a serious threat to health or safety. Under this exception, covered entities may disclose PHI, consistent with applicable law and standards of ethical conduct, if the covered entity, in good faith, believes the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. OCR states that it would be inconsistent with professional standards of ethical conduct to make such a disclosure of PHI to law enforcement or others regarding an individual’s interest, intent, or prior experience with reproductive health care. Thus, in the guidance, OCR takes the position that if a patient in a state where abortion is prohibited informs a health care provider of the patient’s intent to seek an abortion that would be legal in another state, this would not fall into the exception for disclosures to avert a serious threat to health or safety.  Covered entities should be aware of OCR’s position and understand that presumably OCR would view any such disclosure as a HIPAA violation.

(2) Protecting the Privacy and Security of Individuals’ Health Information When Using Personal Cell Phones or Tablets

OCR also issued guidance on how individuals can best protect their PHI on their own personal devices. HIPAA does not generally protect the privacy or security of health information when it is accessed through or stored on personal cell phones or tablets. Rather, HIPAA only applies when PHI is created, received, maintained, or transmitted by covered entities and business associates. As a result, it is not unlawful under HIPAA for information collected by devices or apps – including data pertaining to reproductive healthcare – to be disclosed without consumer’s knowledge.[11]

In an effort to clarify HIPAA’s limitation to protect such information, OCR issued guidance to protect consumer sensitive information stored in personal devices and apps.[12] This includes step-by-step guidance on how to control data collection on their location, and how to securely dispose old devices.[13]

Further, some states have taken steps to fill the legal gaps to varying degrees of success. For example, California’s Confidentiality of Medical Information Act (“CMIA”) extends to “any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information.”[14] As applied, a direct-to-consumer period tracker app provided by a technology company, for example, would fall under the CMIA’s data privacy protections, but not under HIPAA. Regardless, gaps remain as the CMIA does not protect against a Texas prosecutor subpoenaing information from the direct-to-consumer app. Conversely, Connecticut’s new reproductive health privacy law,[15] does prevent a Connecticut covered entity from disclosing reproductive health information based on a subpoena, but Connecticut’s law does not apply to non-covered entities, such as a period tracker app. Therefore, even the U.S.’s most protective state privacy laws do not fill in all of the privacy gaps.

Alongside OCR’s guidance, the Federal Trade Commission (FTC) published a blog post warning companies with access to confidential consumer information to consider FTC’s enforcement powers under Section 5 of the FTC Act, as well as the Safeguards Rule, the Health Breach Notification Rule, and the Children’s Online Privacy Protection Rule.[16] Consistent with OCR’s guidance, the FTC’s blog post reiterates the Biden Administration’s goal of protecting reproductive health data post-Dobbs, but does not go so far as to create new privacy protections relative to current law.

B.  Despite the Biden Administration’s Guidance, Questions Remain Regarding the Future of Reproductive Health Privacy Protections Post-Dobbs

Through E.O. 14076, Secretary Becerra’s press conference, OCR’s guidance, and the FTC’s blog, the Biden Administration is signaling that it intends to use the full force of its authorities – including those vested by HIPAA – to protect patient privacy in the wake of Roe.

However, it remains unclear how this messaging will translate to affirmative executive actions, and how successful such executive actions would be. How far is the executive branch willing to push reproductive rights? Would more aggressive executive actions be upheld by a Supreme Court that just struck down decades of precedent permitting access to abortion? Will the Biden Administration’s executive actions persist if the administration changes in the next Presidential election?

Attorneys at Epstein Becker & Green are well-positioned to assist covered entities, business associates, and other companies holding sensitive reproductive health data understand how to navigate HIPAA’s exemptions and interactions with emerging guidance, regulations, and statutes at both the state and Federal levels.

Ada Peters, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Washington, DC office and Jack Ferdman, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Boston office, contributed to the preparation of this post. 

[1] 87 Fed. Reg. 42053 (Jul. 8, 2022), https://bit.ly/3b4N4rp.

[2] Id.

[3] HHS, Remarks by Secretary Xavier Becerra at the Press Conference in Response to President Biden’s Directive following Overturning of Roe v. Wade (June 28, 2022), https://bit.ly/3zzGYsf.

[4] HHS, Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe (June 29, 2022),  https://bit.ly/3PE2rWK.

[5] 45 CFR 164.512(a)(1)

[6] 45 CFR 164.512(f)(1)

[7] 45 CFR 164.512(j)

[8] Id.

[9] See Texas S.B. 8; e.g., Fed. R. Civ. Pro. R.37 (outlining available sanctions associated with the failure to make disclosures or to cooperate in discovery in Federal courts), https://bit.ly/3BjX4I2.

[10] EBG Health Law Advisor, The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe (June 17, 2022), https://bit.ly/3oPDegl.

[11] A 2019 Kaiser Family Foundation survey concluded that almost one third of female respondents used a smartphone app to monitor their menstrual cycles and other reproductive health data. Kaiser Family Foundation, Health Apps and Information Survey (Sept. 2019), https://bit.ly/3PC9Gyt.

[12] HHS, Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone1 or Tablet (last visited Jul. 26, 2022), https://bit.ly/3S2MNWs.

[13] Id.

[14] Cal. Civ. Code § 56.10, Effective Jan. 1, 2022, https://bit.ly/3J5iDxM.

[15] 2022 Conn. Legis. Serv. P.A. 22-19 § 2 (S.B. 5414), Effective July 1, 2022, https://bit.ly/3zwn95c.

[16] FTC, Location, Health, and Other Sensitive Information: FTC Committed To Fully Enforcing the Law Against Illegal Use and Sharing of Highly Sensitive Data (July 11, 2022), https://bit.ly/3BjrzNV.

Article By Alaap B. Shah, Allen R. Killworth, Marylana Saadeh Helou, and Devon Minnick of Epstein Becker & Green, P.C.

For more privacy-related legal news, click here to visit the National Law Review.

©2022 Epstein Becker & Green, P.C. All rights reserved.

Auto Industry Picks up Capitol Hill Advocacy on Reports of Resurgence of Biden’s Build Back Better (BBB) Proposal

Last week, General Motors Chair and CEO Marry Barra, Toyota Motor North America President and CEO Ted Ogawa, Ford Motor Company CEO James Farley, and Stellantis CEO Carlos Taveres sent a letter to Senate Democratic Leader Chuck Schumer, Senate Republican Leader Mitch McConnell, House Speaker Nancy Pelosi, and House Minority Leader Kevin McCarthy revamping the industry’s advocacy for the inclusion of certain production tax credits ahead of a possible budget reconciliation package.

This letter comes on the heels of recent reports on Capitol Hill that the lynchpin to the Senate passing a budget reconciliation package, Senator Joe Manchin (D-WV), has had multiple in person conversations with Senate Democrat Leader Chuck Schumer regarding a legislative path forward on the proposal.

The letter specifically advocated for the inclusion in any final BBB proposal of House-passed legislation, authored by Congressman Dan Kildee (D-MI-05) and Senator Debbie Stabenow (D-MI) which would extend and build on current tax credits for EVs. Specifically, the provision would make consumers eligible for a $7,500 credit for eligible EV purchases for the first five years and an additional $4,500 credit if the EV is manufactured by a unionized facility, and an additional $500 credit if the EV uses an American made battery. In addition, the proposal would amend the current credit authority to make the credits refundable and transferrable at the time of purchase rather than consumers having to claim the credit on their tax return. Finally, the proposal would bar consumers making over $400,000 from eligibility and creates EV price limits to preclude luxury EVs from eligibility.

While this provision enjoys broad Democrat support in the Senate, Senator Manchin, foreign automakers and Tesla have publicly criticized the $4,500 bonus for union made vehicles.

Additional Electric Vehicle Infrastructure funding that could be included in the bill include:

  • Electric Vehicle Supply Equipment Rebate Program –$2 billion for eligible entities for covered expenses associated with EV supplies including grounding conductors, attachment plugs and other fittings, electrical equipment, batteries, among other things;
  • Electric Vehicle Charging Equity Program – $1 billion to provide technical assistance, education and outreach, or grants for projects that increase deployment and accessibility of EV supply equipment in underserved or disadvantaged communities;
  • General Services Administration Clean Vehicle Fleet program – $5 billion for GSA for the procurement of EVs and related infrastructure for the Federal Fleet (excluding USPS and DOD vehicles);
  • United States Postal Service Clean Vehicle Fleet and Facility Maintenance – $3 billion for the USPS to purchase electric delivery vehicles and $4 billion for the purchase of related infrastructure; and
  • District of Columbia Clean Vehicle Fleet – $10 million for the District of Columbia for the procurement of EVs and related infrastructure.

While it is unclear what would be in a final BBB deal or if it would have the votes to pass the House and the Senate, industry representatives are descending on Capitol Hill to push for critical funding and tax provisions that could have significant benefits to their respective industries, especially those provisions that could lower costs for producers and consumers in the current economic climate.

Article By William Ball of Foley & Lardner LLP

For more utilities and transportation legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

President Biden’s FY 2023 Budget Request Would Strengthen TSCA and Tackle PFAS Pollution

On March 28, 2022, the Biden Administration submitted to Congress President Biden’s budget for fiscal year (FY) 2023. According to the U.S. Environmental Protection Agency’s (EPA) March 28, 2022, press release, the budget makes critical investments, including:

  • Strengthening EPA’s Commitment and Ability to Implement Toxic Substances Control Act (TSCA) Successfully: The budget provides $124 million and 449 full time equivalents (FTE) for TSCA efforts “to deliver on the promises made to the American people by the bipartisan Lautenberg Act.” According to the budget, “[t]hese resources will support EPA-initiated chemical risk evaluations and protective regulations in accordance with statutory timelines.”
  • Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: PFAS are a group of man-made chemicals that threaten the health and safety of communities across the United States. As part of the President’s commitment to tackling PFAS pollution, the budget provides approximately $126 million in FY 2023 for EPA to increase its understanding of human health and ecological effects of PFAS, restrict uses to prevent PFAS from entering the air, land, and water, and remediate PFAS that have been released into the environment. EPA states that it will continue to act on its PFAS Strategic Roadmap to safeguard communities from PFAS contamination.

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

For more environmental legal news, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

Surprise! The No Surprises Act Changes Again

The No Surprises Act (Act), which became effective Jan. 1, 2022, is the latest health care law passed with the best of intent: to create consumer protection from unexpected out-of-network medical bills and to create a federal independent dispute resolution (IDR) process to resolve payment disputes between payers and out-of-network providers. Unfortunately, the Act, especially the U.S. Department of Health and Human Services’ (HHS) implementation of the IDR process, also creates a new administrative burden for health care providers. Providers and medical associations filed lawsuits in multiple jurisdictions to challenge HHS’ implementation of the IDR process and the constitutionality of the Act before it was even in effect.

On Feb. 24, 2022, the United States District Court for the Eastern District of Texas granted the Texas Medical Association’s Motion for Summary Judgement to vacate select IDR requirements. The Court found that HHS’ interim final rule’s IDR process, intended to resolve payment disputes regarding reimbursement for out-of-network emergency services and out-of-network services provided at in-network facilities, was contrary to the clear language of the Act[1] (Rule).

In general, the Act[2] requires health insurance payers (Insurers) to reimburse providers for certain out-of-network services at a statutorily calculated “out-of-network rate.”[3] Where an All-Payer Model Agreement or specified state law does not exist, to set such a rate, an Insurer must issue an initial out-of-network rate decision and pay such amount to the providers within 30 days after the out-of-network claim is submitted.[4] If the provider disagrees with the Insurer’s proposed out-of-network reimbursement rate, the provider has a 30-day window to negotiate a different payment rate with the Insurer.[5] If these negotiations fail, the parties can proceed to the IDR process.[6]

Congress adopted a baseball-style arbitration model for the Act’s IDR process. The Insurer and provider each submit a proposed out-of-network rate with limited supporting evidence. The arbitrator picks one of the offers while taking into account specified considerations, including the “qualified payment amount,” the provider’s training, experience, quality, and outcomes measurements, the provider’s market share, the patient’s acuity, the provider’s teaching status, case mix, and scope of services, and the provider’s/Insurer’s good-faith attempts to enter into a network agreement.[7] The “qualifying payment amount” (QPA), is designed to represent the median rate the Insurer would pay for the item or service if it were provided by an in-network provider.[8]

The Rule requires the IDR arbitrator to select the proposed payment amount that is closest to the QPA unless “the certified IDR entity [arbitrator] determines that credible information submitted by either party … clearly demonstrates that the [QPA] is materially different[9] from the appropriate out-of-network rate.”[10] This is a clear departure from the analysis set forth in the Act.

The Texas Medical Association challenged the Rule under the Administrative Procedures Act (APA), arguing that the Departments exceeded their authority by giving “outsized weight” to one statutory factor over the others specified by Congress, and that the Departments failed to comply with the APA’s notice and comments requirements in promulgating the Rule. In turn, the Departments argued that the plaintiffs did not have standing to bring the claims.

After dispensing with defendant’s standing arguments, the Eastern District of Texas Court ruled in favor of the plaintiff’s Motion for Summary Judgment and determined that “the Act unambiguously establishes the framework for deciding payment disputes and concludes that the Rule conflicts with the statutory text.” Under the Act, the arbitrators (or certified IDR entities) “shall consider … the qualifying payment amounts” and the provider’s level of training, experience, and quality outcomes, the market share held by the provider, the patient’s acuity, the provider’s teaching status, case mix, and scope of services, and the demonstrated good faith efforts of both parties in entering into a network agreement.”[11] The Act did not specify that any one factor should be considered the “primary” or “most important” factor. The Rule, in contrast, requires arbitrators to “select the offer closest to the [QPA]” unless “credible” information, including information supporting the “additional factors,” “clearly demonstrates that the [QPA] is materially different from the appropriate out-of-network rate.”[12] The Departments characterized the other factors as “permissible additional factors” that may be considered only when appropriate.[13] The Court found that the Department’s Rule was inconsistent with the Act and that since Congress had spoken clearly on the factors to be considered in the arbitration process, the Department’s interpretation of the Act was not appropriate and had exceeded the Department’s authority.[14]

Following the Court’s decision, the Departments issued a memorandum on Feb. 28, 2022, clarifying the Act’s requirements for providers and Insurers. The memo specifically noted that the Court’s decision would not, in their opinion, affect the patient-provider dispute resolution process.[15] The Departments also stated they would withdraw any guidance inconsistent with the Court’s Opinion, provide additional training for interested parties, and keep the IDR process portal open to resolve disputes. The Departments also will be considering further rulemaking to address the IDR process.

The No Surprises Act continues to surprise us all with more adaptations. Enforcement of this new law remains uncertain in light of the numerous legal challenges, including at least one constitutionality challenge.

[1] Requirements Related to Surprise Billing: Part II, 86 Fed. Reg. 55,980 (Oct. 7, 2021).

[2] Consolidated Appropriations Act of 2021, Pub. L. No. 116-260, div. BB, tit. I, 134 Stat. 1182, 2758-2890 (2020).

[3] 300gg-111(a)(1)(C)(iv)(II) and (b)(1)(D).

[4] 300gg-111(a)(1)(C)(iv) and (b)(1)(C).

[5] 300gg-111(c)(1)(A).

[6] 300gg-111(c)(1)(B).

[7] 300gg-111(c)(5).

[8] 300gg-111(a)(3)(E)(i)(I)-(II).

[9] “Material difference” is defined as “a substantial likelihood that a reasonable person with the training and qualifications of a certified IDR entity making a payment determination would consider the submitted information significant in determining the out-of-network rate and would view the information as showing that the [QPA] is not the appropriate out-of-network rate. 149.510(a)(2)(viii).

[10] 45 C.F.R. 149.510(c)(4)(ii).

[11] 300gg-111(c)(5)(C)(i)-(ii).

[12] 45 C.F.R. 149.510(c)(4)(ii)(A).

[13] 86 Fed. Reg. 56,080.

[14] Because the Departments had exceeded their statutory authority, no Chevron deference was owed to their regulations. Chevron U.S.A. v. Natural Resources Defense Council, Inc., 468 U.S. 837 (1984).

[15] This is a separate dispute resolution process designed to address disputes between patients and providers when bills for uninsured and self-pay patients are inconsistent with the good faith estimate provided by the health care provider.

Article By Stacey A. Borowicz and Joseph D. Wheeler of Dinsmore & Shohl LLP

For more healthcare legal news, click here to visit the National Law Review.

© 2022 Dinsmore & Shohl LLP. All rights reserved.

Congress Grants Five Month Extension for Telehealth Flexibilities

On Tuesday, March 16, 2022, President Biden signed into law H.R. 2471, the Consolidated Appropriations Act, 2022 (“2022 CAA”). This new law includes several provisions that extend the Medicare telehealth waivers and flexibilities, implemented as a result of COVID-19 to facilitate access to care, for an additional 151 days after the end of the Public Health Emergency (“PHE”). This equates to about a five-month period.

The 2022 CAA extension captures most of the core PHE telehealth flexibilities authorized as part of Medicare’s pandemic response, including the following:

  • Geographic Restrictions and Originating Sites: During the extension, Medicare beneficiaries can continue to receive telehealth services from anywhere in the country, including their home. Medicare is permitting telehealth services to be provided to patients at any site within the United States, not just qualifying zip codes or locations (e.g. physician offices/facilities).
  • Eligible Practitioners: Occupational therapists, physical therapists, speech-language pathologists, and qualified audiologists will continue to be able to furnish and receive payment for telehealth services as eligible distant site practitioners during the extension period.
  • Mental Health:  In-person requirements for certain mental health services will continue to be waived through the 151-day extension period.
  • Audio-Only Telehealth Services: Medicare will continue to provide coverage and payment for most telehealth services furnished using audio-only technology. This includes professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000 by HCPCS Codes 99241-99275, 99201-99215, 90804-90809 and 90862) and any other services added to the telehealth list by the CMS Secretary for which CMS has not expressly required the use of real-time, interactive audio-visual equipment during the PHE.

Additionally, the 2022 CAA allocates $62,500,000 from the federal budget to be used for grants for telemedicine and distance learning services in rural areas. Such funds may be used to finance construction of facilities and systems providing telemedicine services and distance learning services in qualified “rural areas.”

Passage of the 2022 CAA is a substantial step in the right direction for stakeholders hoping to see permanent legislative change surrounding Medicare telehealth reimbursement.

Article By Joelle M. Wilson and Laura Little of Polsinelli PC

For more health law legal news, click here to visit the National Law Review.

© Polsinelli PC, Polsinelli LLP in California

Intellectual Property Consolidation in the Agriculture Industry

Ever since agencies around the world such as the USPTO, USDA, and Union for the Protection of New Varieties of Plants (UPOV) have started recognizing and enforcing intellectual property rights relating to plants, there has been a slow yet massive consolidation in global seed markets.  This article discusses a brief history of how intellectual property rights and lax antitrust enforcement in the seed industry created one of the largest industry consolidations and how the current Administration seems to be taking steps in the right direction.

Intellectual Property in the Agriculture Industry

In 1930, the United States began granting plant patents and the USPTO issued the first plant patent in 1931 for a rose.  The UPOV is an international organization that was founded in 1961 to acknowledge and make available exclusive property rights for breeders of new plant varieties in all member states to the UPOV Convention. The U.S. Plant Variety Protection Act (PVPA) was enacted by Congress in 1970 to encourage the development of new varieties and to make them available to the public.  The Plant Variety Protection Act established in the Department of Agriculture an office to be known as the Plant Variety Protection Office.  These regulations are all very important for the protection and continued innovation of certain varieties of crops and plants.  However, when genetically modified seeds were introduced in 1996, seed companies began to take advantage of these protections and began to invest heavily in amassing as many seed-related IP rights as they could.  As these companies have merged and acquired smaller businesses, they remove competition from the industry, harming farmers, families, and consumers.

There are many ways that companies protect intellectual property in the agricultural industry.  For example, companies file for utility patents to protect a wide variety of plant-related inventions, such as breeding methods, plant-based chemicals, plant parts, and plant products. Plant patents are unique to the United States and provide protection to any distinct and new variety of plant that has been asexually reproduced, other than a tuber-propagated plant or a plant found in an uncultivated state.  Plant Variety Protection certificates, which are similar to plant patents, provide certain exclusive rights to breeders of any new, distinct, uniform, and stable sexually or asexually reproduced or tuber-propagated plant varieties.  Other rights, known as Breeders’ Rights, exist in other countries outside the United States and are very similar to the Plant Variety Protection regulations.  These protections generally last for 20 years from the date of filing and, according to the World Intellectual Property Organization, the patent owner has the right to decide who may – or may not – use the patented invention for the period in which the invention is protected.

The Key Players in the Agriculture Industry

Monsanto was a multinational agricultural biotechnology corporation founded in 1901 and based in the United States.  In 1970, Monsanto scientist John Franz discovered that glyphosate was an herbicide and quickly patented it as such.  In 1974, Monsanto brought the patented glyphosate herbicide to the market using the tradename “Roundup.”  In 1996, Monsanto created the first genetically engineered (GE), glyphosate-resistant crop, causing Roundup-resistant soybeans to be planted commercially throughout the United States.  By 1998, glyphosate-resistant corn was available on the market, and Monsanto became the largest supplier of these new GE, “Roundup-Ready” seeds.  This was such a breakthrough in the agriculture industry that in 2003, Roundup-Ready seeds accounted for about 90% of the genetically modified seeds planted around the globe.

As with many industries, the agriculture industry has those companies that are at the top and those that are not.  The agriculture industry’s “Big Six” companies—Monsanto, DuPont, Syngenta, Dow, Bayer, and BASF—turned into the “Big Four”—ChemChina, Corteva, Bayer, and BASF— after a series of mergers and acquisitions that took place in the last decade with very little oversight from some of the antitrust authorities in the United States and around the world.  As a result of these mergers, the “Big Four” companies now control around 60% of the proprietary seed in the world market.

The Consolidation of the Seed Industry

Dr. Phil Howard from Michigan State University discussed the tremendous consolidation of the commercial seed industry in one of his first publications, 2009’s Visualizing Consolidation in the Global Seed Industry: 1996-2008.  Dr. Howard describes how the hybrid-seed corn industry of 1930, the enforcement of patent-like protections, and especially the commercialization of fully patent-protected transgenic, genetically engineered seeds in the mid-late 1990s triggered a wave of consolidation in the agricultural industry.  To make matters worse, when these companies consolidated and amassed massive intellectual property portfolios, it was not uncommon for seed rights to be bundled with other inputs to protect profits in other, agrochemical divisions.  For example, as Dr. Howard details in Visualizing Consolidation, in order to use Monsanto’s herbicide-tolerant transgenic seed, farmers are required to also use Monsanto’s proprietary glyphosate herbicide, rather than a generic herbicide.  Essentially, if you were buying Roundup-Ready seed, you were buying Roundup herbicide, and if you were using Roundup herbicide, it was probably a good idea to buy Roundup-Ready seed.  This type of competitive business practice is one that eventually creates a multitude of problems for smaller, independent businesses, breeders, and farmers.

Antitrust and Anti-Competition in America

Antitrust laws are not a new concept in American society.  Antitrust laws are statutes and regulations that are designed to promote the overall competition in the market by promoting free, open, and competitive markets.  Congress passed the first antitrust law in 1890 when it wrote the Sherman Act, which made it illegal for companies to enter into agreements to compete with one another, resulting in price fixing and monopoly power.  Several years later, in 1914, Congress passed the Clayton Act and Federal Trade Commission Act to protect American consumers by giving the Federal Trade Commission (FTC) and the Department of Justice (DOJ) the authority to oversee and review mergers and acquisitions that are likely to stifle competition.  Under the Hart-Scott-Rodino Act, the FTC and DOJ review most of the proposed transactions that affect commerce in the United States and either agency can take legal action to block deals that it believes would “substantially lessen competition.”

While these laws are all beneficial in theory, their implementation in the agricultural industry has been lacking to say the least.  According to a study in 2018, Bayer alone is estimated to control 35% of corn seed, 28% of soybean seed, and 70% of cottonseed in the global market!  Even more alarming may be the USDA’s 2014 report citing concerns that glyphosate-resistant crops have become ubiquitous with American agriculture with 93% of soybeans, 85% of corn, and 82% of cotton planted being genetically modified to be glyphosate-resistant.  The herbicides that are used to combat the weeds surrounding the crops, in many cases, are supplied by the same company that provides the seeds.

Promoting Competition in the Agriculture Industry

It has been almost a century since the first antitrust laws were enacted, and yet the problem of corporate consolidations remains in many industries across America.  On July 9, 2021, the Biden Administration signed an executive order aimed to promote competition within various industries in the United States.  The order includes 72 initiatives by more than a dozen federal agencies to promptly tackle some of the most pressing competition problems across our economy.  According to the Administration, this order is a “whole-of-government” approach to drive down prices for consumers, increase wages for workers, and facilitate innovation. This was a major step in the right direction to weaken the power that major businesses have obtained as a result of corporate consolidation in industries like healthcare, technology, transportation, and especially agriculture.

This Executive Order also established the White House Competition Council to drive forward the Administration’s whole-of-government effort to promote competition.  On September 10, 2021, the Competition Council held its inaugural meeting to discuss promoting pro-competitive policies and new ways of delivering concrete benefits to America’s consumers, workers, farmers, and small businesses.  During the meeting, the heads of the Department of Health and Human Services, the Department of Transportation, the Department of Justice, the United States Department of Agriculture, and the Federal Trade Commission briefed the council members on their efforts to implement the directives of the Executive Order.

The Challenge of Facing the Consolidated Agriculture Industry

According to an October 20, 2021 report by Thomson Reuters, Tom Vilsack, the U.S. Secretary of Agriculture, said that the Biden Administration plans to take a hard look at the consolidation of the seed industry and figure out “why it’s structured the way it’s structured” and “whether these long patents make sense.”  The White House Competition Council is certainly faced with a difficult challenge to parse through both anti-competition law and intellectual property law.  For centuries these bodies of law have caused great debate.  One body of law restricts monopolization wherein the later grants monopolistic opportunities.

There is no doubt that any changes to the current seed industry scene would shake things up.  But what exactly would that look like?  Are we going to see the “Big-4” morph into another, new identity?  Are changes to the patent law system likely?  Whatever happens, the agriculture industry will likely pay close attention to the actions of the White House Competition Council over the next couple months.

Article By Reinier R. Smit of Summa PLLC

Copyright 2021 Summa PLLC All Rights Reserved

Biden Signs Largest Climate and Resiliency Infrastructure Bill in U.S. History

Today President Biden signed H.R. 3684, the “Infrastructure Investment and Jobs Act” (IIJA), into law after months of negotiations on both the bill itself and the still pending “Build Back Better Act”. These two measures encapsulate the Biden Administration’s legislative priorities, many of which were rolled out during the campaign. The U.S. Senate passed the IIJA on August 10 by a vote of 69-30. Last week, on November 5, the House of Representatives passed the measure by a vote of 228-206. The months long negotiations resulted in bipartisan support for the IIJA in both the House and Senate.

Broadly, the IIJA:

Provides Funding: The funds provided are appropriated dollars, allowing Executive Branch agencies to distribute funds without further legislative action. The funds provided are for both new and existing federal programs for surface transportation, energy infrastructure, transportation safety, transit, broadband, ports and waterways, airports, drinking water and wastewater. ​

Expedites Permitting: There are several new programs created to support transmission development and streamline the permitting of new energy infrastructure, such as electric transmission

Provides New Authorities and Creates New Programs: Various federal agencies are required to develop new programs and processes, all aimed at deploying clean energy or improving cybersecurity​.

The IIJA represents a monumental investment in all types of infrastructure. However, most significantly, it will provide the largest federal investment since the New Deal in the Nation’s infrastructure and in developing the tools to curb carbon emissions and harden infrastructure to increase resiliency against the current global challenge of climate change. The Department of Energy and other federal agencies will receive $65 billion for power and grid related programs, including grid infrastructure, resiliency investments, clean energy demonstration projects and cybersecurity. An additional $7.5 billion will be available for alternative fueling infrastructure for grants to build public fueling systems, including electric and hydrogen fuels, establish alternative fuel corridors, and find ways to recycle used electric vehicle batteries to be reused as energy storage devices.

In July, our team shared the details of the bill passed by the Senate Energy and Natural Resources Committee. As signed into law, this earlier summary still accurately reflects the details of the funding that will be provided.

Implementation and Timing of Funding: Agencies will now be tasked with standing-up new or expanding existing programs to award federal funds to eligible infrastructure projects. Agency offices will work over the coming weeks to establish grant program parameters, develop, and publish solicitations for applications, set timelines for awards and oversee implementation of awarded funds.

The IIJA included deadlines for some agency actions, requiring that programs be established in 60, 90, or 180 days. Note that many of the agency offices, particularly within the Department of Energy, remain functioning without political appointees. For instance, the Office of Electricity, which will be responsible for issuing $3 billion in grants through the Smart Grid Investment Matching Grant Program, is operating under an Acting Assistant Secretary until the Senate confirms the Biden Administration’s nominee for that post. There are no legal or political impediments to getting funding programs up and running without a political appointee heading any federal office, but political influence on the pace and timing for the process may be limited.

Certain programs will automatically send funds to states through existing formula funding programs. Formula grant programs are non-competitive awards based on a predetermined formula. These programs are sometimes referred to as state-administered programs and are found throughout the federal government. Examples include the Environmental Protection Agency’s Clean and Drinking Water State Revolving Loan program, and the Department of Transportation’s Formula Funds for Rural Areas, and Buses and Bus Facilities formula grants programs. Once the states have received their federal allocations they will then make those funds available through their existing award structure, which may be competitive or formula-based.

How Your Organization Can Apply for Federal Funding Opportunities: As agencies establish parameters for new programs or develop solicitations for existing programs, it is important to engage with the agencies in this process to ensure your project will meet agency program criteria for a funding award, and to ensure solicitations are designed to support your infrastructure projects. Our professionals have had significant success in assisting clients through these processes, and successfully assisted clients in the development of grant applications for awards under both Democratic and Republican Administrations. Contact any of our professionals to learn more about what grant programs your organization may be eligible for, how to engage with the agencies, as well as apply and partner with the federal government to ensure funding is awarded for your project.

What’s Next, Human Infrastructure: The IIJA represents only the provisions in the Biden agenda that were able to earn bipartisan support. The remainder of the President’s priorities are encapsulated in a Budget Reconciliation bill, H.R. 5376, the “Build Back Better Act”, (BBBA) developed by House and Senate Democrats and requiring only a 50-vote threshold in the Senate.

For months, the Build Back Better Act and IIJA and were linked in the legislative process by President Biden and House Speaker Nancy Pelosi (D-CA) who demanded that one not pass without the other. This approach resulted in a rift between the Democratic Party’s moderate and progressive members. While the final outcome for the IIJA resulted in bipartisan votes in both the House and Senate, passage only came after a deal was struck between moderates and progressives within the Democratic Caucus to decouple the IIJA and the “Build Back Better Act”.

House Speaker Nancy Pelosi has publicly said that the “Build Back Better Act” will be brought to the House Floor during the week of November 15. Senate Leadership has made no such promise for timely action. In addition, some House Democrats and some Senators have announced they want to see the details of budget scoring – what individual provisions will cost – from the Congressional Budget Office (CBO) and the Joint Tax Committee – before proceeding. Some limited data has begun to be released by the CBO but not any numbers covering many of the most complex and controversial programs. The schedule may be accelerated if Democrats and Republicans cannot come to an agreement to increase the debt ceiling, a must-pass measure that may need to be included in the Budget Reconciliation process. As negotiations continue, the content of the legislation passed by the House is expected to be altered significantly during Senate consideration. Should that be the case, the House will vote a second time on the measure as amended by the Senate.

Article By: Tracy Nagelbush Tolk and Tiffany Ganthier from Van Ness Feldman LLP

© 2021 Van Ness Feldman LLP

White House to Business: “Take Ransomware Crime Seriously”

As we come out of the COVID-19 pandemic, it appears that another type of infection is threatening business and ransomware continues to spread.

  • Colonial Pipeline
  • JBS (world’s largest meatpacking company)
  • Massachusetts Steamship Authority
  • Scripps Health
  • City of Tulsa

A roll call of entities suffering major ransomware attacks just in the few weeks.    After the Colonial Pipeline attack, President Biden issued an Executive Order establishing some baselines for cybersecurity with respect to government contracts and improving detection of cybersecurity incidents on federal government networks, among other things.   The White House has now issued a rare “wake-up call” to private business in the form of an open letter “to corporate executives and business leaders.”

Deputy National Security Advisor for Cyber and Emerging Technology Anne Neuberger wrote that while the Biden administration has placed an emphasis on resilience, the “private sector has a distinct and key responsibility.”

“All organizations must recognize that no company is safe from being targeted by ransomware, regardless of size or location.  But there are immediate steps you can take to protect yourself, as well as your customers and the broader economy.”   Neuberger continued that private companies that “view ransomware as a threat to their core business operations rather than a simple risk of data theft will react and recover more effectively.”

The letter encourages business to do what regular readers of this blog, or attendees at our webinar events, have heard for many years:  understand your business risk, convene leadership teams to discuss the ransomware threat, and review corporate security posture and business continuity plans.

Neuberger’s letter highlights best practices to help defend against ransomware attacks:

  • Implement the best practices from the President’s Cybersecurity Executive Order
    • Prevent Intrusion (Section 3 – multi-factor authentication)
    • Minimize impact of intrusion pre-detection (Section 3 – data encryption, zero-trust environment)
    • Detect and respond to intrusion (Section 6 – incident response playbook, Section 7 – endpoint detection and response, centralized threat-hunting, Section 8 – logging)
    • Learning (and disseminating) lessons from intrusion
  • Backup your data, system images, and configurations, and keep the backups offline
  • Regularly test your data resiliency
  • Update and patch systems promptly
  • Test your incident response plan (do you have one?)
  • Check your security team’s work using a third party pen tester
  • Segment your networks

In April, the Federal Trade Commission published a Business Blog post entitled “Corporate boards:  don’t underestimate your role in data security oversight”   This piece, combined with today’s open letter from the White House, should be mandatory reading for board members.   The need for proactive and preventative measures increases by the day.   We can assist with a wide range of activities, including:

  • Cyber Risk Assessment/Management
  • Employee Training
  • Incident Response Planning
  • Disaster Recovery/Resiliency Planning
  • Cyber Liability Insurance Placement

©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Cynthia J. Larose of Mintz
For more articles on cybersecurity, visit the NLRCommunications, Media & Internet section.

The Impeachment Process: Politics, Procedure and Next Steps

The US House of Representatives is set to vote this week on impeaching President Donald Trump, and the impeachment vote is expected to pass.  This will set the stage for the next step in the impeachment process;  the third-ever Senate impeachment trial.

We thought this would be a good time to recap the steps in the impeachment process to better understand, procedurally, how the impeachment case against President Trump reached this point, and what is expected next.  Also, we wanted to dig into some of the issues which have been brought up as problematic by the Republican minority in the House related to the impeachment process and the structure of the House hearings.

Jeffrey S. Robbins, a litigation partner at the Boston offices of Saul Ewing Arnstein & Lehr LLP, served as Chief Counsel for the Minority (the Democrats) for the United States Senate Permanent Subcommittee on Investigations, and Deputy Chief Counsel for the Minority for the Senate Governmental Affairs Committee during its 1997 investigation into allegations of fundraising improprieties by the Clinton-Gore Administration during the 1996 presidential campaign.  Mr. Robbins was kind enough to share his expertise on past congressional investigations to help sort through some of the procedural issues raised and help us understand if the process, so far, has proceeded in a usual manner.

NLR: Impeachment is a three-step process, beginning with an investigation in the house and then a vote on articles of impeachment, then a trial in the Senate. What kind of evidence is the House looking for during the investigation stage prior to voting on articles of impeachment?

Robbins: The House committees are looking for the strongest quantum of evidence possible that the President engaged in conduct which amounts to an identifiable “crime,” since a conservative reading of the Constitution holds that some form of crime, at least, is necessary for impeachment.

House Republicans have complained about the limited access to closed-door House impeachment investigation and depositions leading up to the House’s impeachment vote should all be public and the transcripts should be released. Access to the House’s investigative hearings has been limited to members of the three House committees involved– Foreign Affairs, Intelligence and Oversight, and Reform which have a majority of Democratic House Members but Republican committee members can participate in the investigation and question the parties being deposed. Intelligence Committee Chairman Adam Schiff, D-Calif., said private sessions are needed to prevent witnesses from hearing each other, the same protocol used by prosecutors in criminal investigations.  House Minority Leader Kevin McCarthy, R-Calif., called Schiff a liar and a partisan leading a witch hunt and that the venerable Intelligence Committee has become the partisan Impeachment Committee.

NLR: How much of the House’s investigation needs to be in the form of public hearings?

Robbins: There is no Constitutional requirement that impeachment hearings be public or private, but as a practical and a political matter, it is obvious that impeachment hearings need to be conducted in public; after all, building public support for impeachment is a sine qua non (an essential condition) of a vote to impeach, let alone a vote to convict. On the other hand, there is nothing remotely nefarious about what the Minority refers to as “closed door” depositions; Congressional investigations routinely utilize depositions, by definition closed to the public, as a device to ascertain which witnesses have relevant evidence and what that relevant evidence is, in order to assess the strength of a “case” and to more effectively organize any public hearings associated with the investigation.

Intelligence Committee Chairman Adam Schiff said private sessions are needed to prevent witnesses from hearing each other. House and Minority Leader Kevin McCarthy said “I can’t even go down there and read the transcript,” alleging that Republicans have not been allowed to cross-examine the hearing witnesses, which is not accurate.

The reality is that Republicans have participated in each deposition, but their role is limited by the Democratic committee majority. Both Republicans and the Democrats get equal time to ask questions.  Forty-seven Republicans from the Intelligence, Foreign Affairs, and Oversight Committees have been allowed to attend and participate in the depositions.

NLR: What actually goes on in Congressional hearings? What is the timeline between the hearings and the public testimony?

Robbins: From personal experience, I can tell you that the preparation to question witnesses in a Congressional investigation is an intense process, made all the more intense by the volume of material that has to be consumed in order to question effectively and by the shortage of time within which to consume it. Here, for example, there is a steady drumbeat of witnesses being called for deposition on only a few days’ notice to all concerned, and then only a week or so between the deposition and the public hearing. The process is made more intense by the fact that there are other staff lawyers, and Members, and communications experts, all of whom quite properly want to weigh in on the thrust of the questioning, the messaging of the questioning, and the like.

In the hearings, according to the Wall Street Journal, Adam Schiff opens with remarks and then invites a Republican counterpart to do the same.  Each party receives a block of time to ask questions, and a timekeeper keeps track and moves the proceedings along.  Rep. Mark Meadows (R., N.C.), told the Wall Street Journal that each party gets equal time.  “There is a clock, with a timekeeper,” he said.  Other Republicans, including Reps. Jim Jordan of Ohio and Scott Perry of Pennsylvania have been attending the hearings regularly.  Besides Mr. Schiff, Reps. Jamie Raskin of Maryland, Sean Patrick Maloney of New York, Eric Swalwell of California and Gerry Connolly of Virginia have been attending for the Democrats.  Eventually, the committee voted down party lines to advance the impeachment proceedings.

Complicating the evidence-gathering process is the lack of cooperation from the White House, including Trump administration officials defying subpoenas.  Per Adam Schiff, the White House isn’t cooperating and is defying several subpoenas, which Schiff predicted would be considered obstruction and additional evidence “of the wrongfulness of the President’s underlying misconduct.”  When the House Leadership unveiled the articles of impeachment on December 10, 2019, they first focused on the Trump’s pressuring of Ukraine to investigate Joe Biden before the 2020 election by delaying a White House meeting and $400 million in US Security Aid, but the second focused on the obstruction related to the investigation into his misconduct.

NLR: What are the consequences if a witness refuses to testify at a hearing, or otherwise ignores a subpoena? 

Robbins: Under law, there are to be consequences to refusal to testify or disobedience of a subpoena to produce documents, in particular, contempt findings that are appropriately enforced by federal courts.

Mr. Schiff, accused by House minority Whip Steve Scalise of “…trying to impeach a president of the United States… behind closed doors,” pointed out that the president’s former attorney, Michael Cohen, pled guilty to lying to Congress out of loyalty to the president, and was recently sentenced to three years in prison as a result. Still, the White House has consistently refused to cooperate with the inquiry, citing executive privilege as justification to keep those subpoenaed from actually appearing under oath. Citing executive privilege is a not-uncommon tactic to prevent disclosure of goings-on at the top end of the executive branch, but it doesn’t always work well for those using it, and the privilege itself remains a cloudy legal concept.

NLR: What privileges, if any, can a witness assert?

Robbins: With respect to privileges, there are, of course, the “Big Three”: the attorney-client privilege, the Executive Privilege, and the Fifth Amendment. When those privileges are invoked, as a practical matter they are beyond being challenged, except in extreme circumstances, and for the purpose of this impeachment proceeding, where the time constraints are what they are, if they are invoked their invocation will effectively block disclosure of evidence.

There have been many examples of witnesses invoking their Fifth Amendment rights to avoid answering questions in Congressional hearings.  One prominent example is the case of Lt. Colonel Oliver North in the hearings around the Iran-Contra affair during Ronald Reagan’s presidency.

NLR: If the House votes to ratify the articles of impeachment, the Senate will hold a trial.  Who acts as a prosecutor in this instance, and who acts for the defense?  How is that determined?

Robbins: Since the House is the indicting authority, it will choose who presents the case for removal to the Senate. It will in all likelihood be one or more members of the House.

By way of reference, for President Andrew Johnson’s impeachment trial in 1868, an impeachment committee was made up of seven members of Congress, led by Thaddeus Stevens.  President Bill Clinton’s impeachment featured a team of thirteen House Republicans from the Judiciary Committee.

NLR: Why does the Supreme Court get involved in impeachment proceedings, and what is their role?

Robbins: As for the role of the Supreme Court, it is the Chief Justice who presides over the trial, per the Constitution, and it is he who will be involved in those proceedings, and not the full Court—at least this has not occurred in our limited experience with impeachment.

While it may seem plain that the Supreme Court would have a larger role in the impeachment proceedings, that’s not truly the case. The chief justice is, of course, given the power to preside of the Senate trial by the Constitution as a part of the doctrine of separation of powers – as Justice Joseph Story argued – removing the Vice President from Senate leadership to uphold the trial’s impartiality. Should there be a conviction in the Senate, and the convicted president were to try and engage the highest court, SCOTUS has already found that the Senate’s impeachment procedures are nonjusticiable, because of Article I’s designation of the Senate as the “sole power to try all impeachments” (Nixon v United States, 1993).

Many thanks to Mr. Robbins for his time and for helping break down these complex issues during a complicated time.

Copyright ©2019 National Law Forum, LLC