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18 Matching News Items
1.
Recent Developments in Pharmacy-Related Legislation and Regulations
Wiley Rein LLP
May 14, 2024
Wiley Rein LLP
May 14, 2024
"[GAO] published a report examining the regulation of pharmacy benefit managers (PBMs) in five states.... [HRSA] issued a final rule for the 340B Program's administrative dispute resolution process.... Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a quite ambitious draft legislative proposal to address prescription drug shortages.... [CMS] issued new draft guidance for the second cycle of negotiations for the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act of 2022."
2.
Proposed State and Federal PBM Legislation: Is There Reason for Action Now?
Wiley Rein LLP
May 1, 2024
Wiley Rein LLP
May 1, 2024
"[E]xposing PBMs' opaque business practices and imposing regulatory constraints will remain a top priority for regulators.... Even before a statutory or regulatory elimination of spread pricing, health plans should begin to consider now how this change could impact current and future PBM contracts ... [It] may be worthwhile to consider now the various channels for PBM profit available under your PBM contract, and whether you can begin to limit/narrow (or consider limiting/narrowing) those avenues for PBM remuneration that exceed the scope of 'bona fide service fees.' "
3.
Administration Looks at Harmonizing Cyber Regs Amidst Flurry of New Activity (PDF)
Wiley Rein LLP
Nov. 20, 2023
Wiley Rein LLP
Nov. 20, 2023
"[T]he authors discuss some of the Biden administration's recently issued cybersecurity rules and proposals and provide additional details about the Office of the National Cyber Director's [August 2023] request for information seeking comment on how to harmonize cybersecurity regulations.... The continued onslaught of new cybersecurity proposals and expectations create complex compliance burdens on organizations across a range of sectors, many of whom are already subject to various other cyber incident reporting and regulatory obligations."
4.
Senate Finance Committee Releases Framework for Pharmacy Benefit Manager Reform
Wiley Rein LLP
Apr. 27, 2023
Wiley Rein LLP
Apr. 27, 2023
"The framework identifies four 'key challenges' within the PBM industry requiring policy solutions: [1] a lack of transparency into financial flows and incentives that inform drug pricing, [2] barriers to pharmacy access, [3] 'behind-the scenes' practices that impede competition and drive up out-of-pocket costs, and [4] misaligned incentives resulting from the relation between PBM compensation and drug list prices.... The framework provides ... examples of legislative solutions under current Committee consideration."
5.
FTC Votes to Examine PBM Practices
Wiley Rein LLP
June 26, 2022
Wiley Rein LLP
June 26, 2022
"The Commission is particularly concerned that PBMs' efforts to realize maximum levels of manufacturer-paid rebates and fees (some or all of which are retained by the PBM) result in PBMs preferring higher cost, brand (i.e., patented) drug products on their formularies. The Commission is concerned that such PBM and manufacturer practices diminish the competitive market effect that lower-cost biosimilars and generic drugs would otherwise be having on overall drug pricing."
6.
DOL Issues Guidance on Coronavirus-Related Leave for Federal Service and Construction Contractors
Wiley Rein LLP
Aug. 9, 2020
Wiley Rein LLP
Aug. 9, 2020
"If a contractor pays cash instead of fringe benefits, they would not be required to pay the SCA H&W fringe benefit rate or the DBA fringe benefit rate for FFCRA leave. But contractors must maintain an employee's health insurance, if they had been providing it, throughout the employee's paid FFCRA leave. In addition, ... a [contractor will need] to provide H&W payments to an employee using existing paid vacation, sick leave or holiday hours under the SCA while concurrently using FFCRA expanded family and medical leave."
7.
OMB Releases Guidance on Implementing CARES Act Provision Permitting Reimbursement of Paid Leave for Government Contractors Related to COVID-19
Wiley Rein LLP
Apr. 20, 2020
Wiley Rein LLP
Apr. 20, 2020
"The memorandum sets forth several 'guiding principles' for agencies on the use of Section 3610, organized into two general categories ('Support contractor resiliency' and 'Exercise good stewardship') ... The memorandum also advises that contractors carry the burden of properly documenting their costs, including both the costs of paid leave and any other credits that the contractor has taken advantage of that may reduce reimbursement under Section 3610 (such as the Paycheck Protection Program)."
8.
Agencies Issue Guidance on CARES Act Reimbursement of Paid Leave for Government Contractors Related to COVID-19
Wiley Rein LLP
Apr. 13, 2020
Wiley Rein LLP
Apr. 13, 2020
"Section 3610 of the [CARES] Act authorizes agencies to reimburse contractors for the cost of paid leave incurred to keep contractor or subcontractor personnel in a 'ready state' to the extent that the personnel were [1] unable to access a government-approved facility, and [2] unable to telework because their jobs could not be performed remotely.... DOD issued a class deviation ... that provides a framework for contracting officers to authorize payment of paid leave (including sick leave) costs resulting from the COVID-19 crisis.... NASA issued a general FAQ document geared towards helping contractors understand the agency's response to COVID-19.... ODNI released a short memorandum emphasizing its desire for the Intelligence Community to apply Section 3610 'to the greatest extent possible.' "
9.
COVID-19 Questions: Does Your PBM Agreement Hold Answers?
Wiley Rein LLP
Mar. 12, 2020
Wiley Rein LLP
Mar. 12, 2020
"Health plans should reach out to their PBMs to coordinate and collaborate regarding the impacts of COVID-19 on delivery of pharmaceuticals to members, but not without first evaluating their PBM agreements. While no contract can anticipate every possible scenario, a well-drafted PBM agreement will anticipate and address certain key areas that may be helpful in managing your pharmaceutical benefit and PBM in the months ahead."
10.
Federal Sick Leave Health and Welfare Benefit Changes Bring Enhanced Compliance Challenges for Federal Service Contractors (PDF)
Wiley Rein LLP
Sept. 12, 2017
Wiley Rein LLP
Sept. 12, 2017
"[F]ederal service contractors need to closely manage ... [1] the application of differing H&W rates to service contracts and individual service employees; [2] the differing standards for incorporation of the federal sick leave obligations and the new [Service Contract Act (SCA)] fringe benefits levels; and [3] the impact of the new sick leave H&W level on potential price adjustments under the FAR price adjustment clause. This white paper discusses these challenges as well as strategies for managing these SCA compliance issues."
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