Merle M. DeLancey Jr. and Ryan C. Craig*
Over the past couple of months, there have been two important developments that could affect a lender’s decision whether to finance real estate transactions involving entities and individuals in the healthcare field.
Advisory Opinion No. 19-05 (Purchasing Real Estate from an Excluded Party)
In September 2019, the Department of Health and Human Services Office of Inspector General (“HHS OIG” or “OIG”) issued an advisory opinion regarding the proposed purchase of real estate from a company owned and managed, in part, by an excluded individual. The Proposed Arrangement involved a community health center that receives Federal grant funding and owns and operates community health centers enrolled in the Medicare program (“Health Center”). The Health Center sought to purchase the real estate on which one of its community health centers is located. The Company from which the Health Center sought to purchase the property is owned and managed, in part, by an individual who was excluded from participation in all Federal healthcare programs by HHS OIG (“Excluded Person”). Continue reading “Real Estate Financing in the Healthcare Space: Keep Your Eye on the Ball”
Justin A. Chiarodo and Robyn N. Burrows
As part of a recent wave of supply chain requirements, Section 889 of the 2019 National Defense Authorization Act (“NDAA”) imposed major new limitations on the use of certain Chinese telecommunications products and services in federal procurement, and recent implementing regulations mandate a range of compliance actions relating to the ban. This blog post provides practical guidance on the new rules and five compliance tips.
Ban against Procuring “Covered Telecommunications Equipment or Services”
The Department of Defense (“DoD”), General Services Administration (“GSA”), and National Aeronautics and Space Administration (“NASA”) recently released an interim rule implementing the first part of Section 889. This ban, which became effective August 13, 2019, sweeps broadly by prohibiting agencies from procuring the following “covered telecommunications equipment or services”:
- Telecommunications equipment produced by Huawei and ZTE Corporation;
- Video surveillance and telecommunications equipment used for public safety, surveillance of “critical infrastructure,” or national security purposes and produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company;
- Telecommunications or video surveillance services provided by such entities for any purpose; or
- Telecommunications or video surveillance equipment produced or provided by an entity that the Secretary of Defense determines is owned or controlled by, or otherwise connected to, the government of the People’s Republic of China.
The ban includes all affiliates and subsidiaries of the listed companies. Continue reading “5 Tips for Complying with New Section 889 Supply Chain Regulations”
Michael J. Slattery
We discussed in a previous blog post how the current state of the law at the U.S Government Accountability Office (“GAO”) and within the Federal Circuit limits offerors’ ability to effectively challenge agency corrective action. See Is There No Balm in Gilead? The Federal Circuit’s Decision in Dell Federal Systems L.P. v. United States Reinforces Contractors’ Dwindling Options to Effectively Challenge Agency Corrective Action. Specifically, we demonstrated that GAO has adopted a highly deferential, “hands off” position with regard to agency corrective action, holding that “the details of a corrective action are within the sound discretion and judgment of the contracting agency.” Northrop Grumman Tech. Servs., Inc., B-404636.11, June 15, 2011, 2011 CPD ¶ 121 at 3. Under governing GAO case law, agencies have discretion to decide the scope of corrective action, including whether discussions will be held, the breadth of such discussions, which offerors shall be included in the corrective action, and the scope of permitted revisions to proposals. Deloitte Consulting, LLP, B-412125.6, Nov. 28, 2016, 2016 U.S. Comp. Gen. LEXIS 348 at *1, *11 (citing Computer Assocs. Int’l., B-292077.2, Sept. 4, 2003, 2003 CPD ¶ 157 at 5). Indeed, GAO will not disturb an agency’s proposed corrective action so long as the corrective action is deemed reasonable—that is, so long as the corrective action is “appropriate to remedy the flaw which the agency believes exists in its procurement process.” Onésimus Def., LLC, B-41123.3, B-41123.4, July 24, 2015, 2015 CPD ¶ 224 at 5. Continue reading “Evaluations That Prompt Corrective Action Must Be Documented”
Merle M. DeLancey Jr.
On August 15, 2019, the Defense Health Agency (“DHA”) and Defense Logistics Agency (“DLA”) agreed upon a joint approach to healthcare logistics. Under the Memorandum of Agreement (“MOA”), DLA will be responsible for materiel acquisitions, while DHA will take the lead on medical services acquisitions. The MOA clarifies the agencies’ complementary roles and responsibilities and avoids duplication of effort. The MOA covers all aspects of medical logistics support provided by DLA to DHA, and DHA’s consideration for that support in performance areas including pharmaceuticals, medical-surgical supplies, healthcare technology equipment, cataloging, and Class VIII surge and sustainment materiel required by the services to meet the demands of the national military support strategy.
The uninformed might question the need for DHA and DLA to formally enter into a MOA. After all, DHA and DLA are both under the Department of Defense (‘DoD”) umbrella. Why is an agreement required to coordinate the two agencies’ efforts? Why wasn’t such coordination and avoidance of duplication of effort simply ordered by DoD senior command? Good questions perhaps, but the MOA was necessary to ensure the agencies stay in their respective lanes. Continue reading “Defense Health Agency and Defense Logistics Agency Memorandum of Agreement: A Good First Step, but What about Coordination with the Department of Veterans Affairs?”
Merle M. DeLancey Jr.
On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action Plan identifies two pathways for the importation of drugs.
Pathway 1 allows states, wholesalers, and pharmacists to submit plans to HHS for demonstration projects, which test and measure the effect of potential program changes, that allow for the importation of certain drugs from Canada. Importing drugs from Canada is not a new concept. In 2003, Congress gave the Secretary of HHS the authority to permit drug importation from Canada. To implement a drug importation plan, however, the Secretary was required to certify to Congress that the importation program poses “no additional risk to public health and safety” and the program will result in a “significant” reduction in costs of products to American consumers. No HHS Secretary has ever made such a certification to Congress. Implementation of importation plans under Pathway 1 will most likely take considerable time. HHS intends to implement Pathway 1 through a formal Rulemaking process with Notice and Comment. Then, importation plans will need HHS approval before going “live.” Continue reading “Will HHS’s Safe Importation Action Plan Affect How the Federal Government Purchases Drugs?”
Merle M. DeLancey Jr. and Michael Joseph Montalbano
In May 2018, the Government Accountability Office (“GAO”) implemented a $350 filing fee for bid protests. There are differences of opinion regarding why GAO implemented the fee. GAO publicly states that the fee was implemented to cover the costs of its new Electronic Protest Docket System (“EPDS”). Many, however, believe the fee was implemented to deter the filing of frivolous protests. Regardless, there “may” be an unintended consequence of the protest filing fee—an increase in agency-level protests. Recently, several agency contracting officers have stated that they are handling more agency protests, and, in their opinion, it is a direct result of GAO’s protest filing fee. As a result, contractors should understand and be prepared to mitigate the risk of agency protests to protect their contracts and position themselves for new ones.
Pros and Cons of Agency Protests Continue reading “Agency Protests: An Emerging Tool and Potential Threat for Contractors”
Robyn N. Burrows
The Supreme Court in Food Marketing Institute v. Argus Leader Media, No. 18-481 (U.S. June 24, 2019) recently relaxed the standard for withholding confidential information under Exemption 4 of the Freedom of Information Act (“FOIA”)—a major win for contractors that regularly submit sensitive business information to the government.
Exemption 4 protects from disclosure trade secrets and commercial or financial information that is privileged or confidential. For the past 45 years, courts have been guided by the stringent “competitive harm” test first enunciated in National Parks & Conservation Association v. Morton, 498 F.2d 765 (D.C. Cir. 1974). This test allowed an agency to withhold information as “confidential” only if disclosure would (1) impair the government’s ability to obtain necessary information in the future, or (2) cause substantial harm to the competitive position of the person from whom the information was obtained. Many businesses objected to this test as overly burdensome and causing confusion about the showing required to establish substantial competitive harm. Continue reading “The Supreme Court Expands the Meaning of “Confidential” Information under FOIA Exemption 4”