221 pages. "This draft guidance [1] describes how CMS will implement the Negotiation Program for initial price applicability year 2028 (January 1, 2028 to December 31, 2028) ... [2] sets forth additional policies regarding manufacturer effectuation of the MFP in 2026, 2027, and 2028 ... [3] specifies the requirements that will be applicable to manufacturers of drugs that are selected for negotiation or renegotiation ... [4] includes information on the successor regulation exception to the IRA's formulary inclusion requirement for 2027 and 2028 ... [and] [5] describes the procedures that may be applicable to drug manufacturers, Medicare Part D plan sponsors, pharmacies, mail order services, and other dispensing entities that dispense drugs covered under Medicare Part D, in addition to ... providers of services and suppliers that furnish or administer drugs to individuals enrolled under Medicare Part B."  MORE >>

"The draft guidance includes new policies to incorporate drugs payable under Part B into the Negotiation Program for the first time and solicits comments on how to facilitate access to any negotiated MFPs for drugs payable under Part B. Additionally, the draft guidance outlines how CMS would choose for renegotiation certain drugs that were negotiated for initial price applicability years 2026 or 2027.... CMS is seeking comments on this draft guidance for drug selection and negotiation for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in 2026, 2027, and 2028."  MORE >>

"The order says [HHS] will establish a mechanism for patients to buy more drugs directly from manufacturers.... Pharmacy benefit managers have already been under regulatory pressure from the [FTC] ... The pharmaceutical industry has blamed them for high prices, saying the aftermarket discounts and fees add hidden costs to drug prices."  MORE >>

"This paper explores how to use enrollment data to surface insights and to design benefit programs and messaging aligned with company goals and employee priorities, including: [1] Key enrollment metrics to watch; [2] What metrics can reveal about employee benefits challenges and successes; [3] How to transform benefits enrollment data into actionable HR insights."  MORE >>

"The timesaving and usability benefits for both HR and employees are significant, but if there are implementation issues, your organization may face liabilities. A tremendous amount of data needs to be coordinated between HRIS, carrier, vendor and payroll teams and platforms. If these databases aren't correctly communicating or communicating incorrect data, your employees and their dependents may lose or receive the wrong coverage."  MORE >>

"Responsible use of AI can increase access to quality care, improve health outcomes, improve the consumer experience, and reduce administrative costs.... A consistent national approach to AI oversight would ensure protection for all American patients while minimizing additional administrative burdens and costs.... New legislation should not duplicate existing laws and instead should fill gaps in existing health data and consumer protection laws and regulations.... Policies should point to risk-based standards and confine any third-party evaluation requirements or government audits to 'high-risk' uses."  MORE >>

"[The] executive order to lower drug prices is largely an exercise in applying leverage, rather than actual policymaking -- and it may not amount to much ... The timeline for the administration to actually secure lower drug prices is slippery.... The order is almost certain to be challenged in court, just like a similar most favored nation policy for Medicare was during Trump's first term."  MORE >>