HealthCare Roundtable e-News – January 16, 2020

Appeals Court Shares Concerns Over HHS Rule Requiring Drug Prices in TV Ads

On Monday (Jan. 13), a federal appeals court heard arguments regarding a Trump Administration final rule requiring drug companies to disclose the list prices of their drugs in television advertising. The judges shared concerns that the rule might ultimately lead to more consumer confusion than it would lower drug prices, while proponents of the rule argue that it would encourage patients to shop for better deals, potentially driving down prices, according to HHS’ attorney Ethan Davis.

“The problem is the cost of prescription drugs. I don’t see this as a solution to the problem,” said Judge Karen LeCraft Henderson, an appointee of former President George H.W. Bush. The list price “is not the price I’ll ever pay. Why is that not adding confusion?”

Drug manufacturers, including Merck, Eli Lily, and Amgen, have argued that HHS does not have the authority to implement the rule, noting that Congress has not passed a law directing HHS to require drug companies to disclose prices in advertising. The drugmakers’ attorney Richard Bress told the court that the rule could be “far more dangerous than helpful” if it takes effect.

Democrats Petition for Supreme Court to Expedite ACA Case

Last Friday (Jan. 10), GOP attorneys general and the US Department of Justice told the Supreme Court there’s no reason for a quick review of the Fifth Circuit decision, which found in 2018 the Affordable Care Act’s individual mandate to be illegal. Last year, the Supreme Court had punted the question of severability back to the same judge that previously said the entire law should be tossed, but House Democrats and state officials have signed a petition asking the Court to expedite and review the case.

“Given their position on the merits of the severability question, respondents’ insistence that this Court should not decide severability now betrays that their real objective is delay pure and simple,” the House Democrats told the high court. (InsideHealthPolicy)

The Attorneys general argued that the lower court should be allowed to do a more granular analysis, per the major Fifth Circuit order, and argued the case isn’t urgent enough to resolve because the initial lower court decision has not been made. The Trump administration is also encouraging the courts to wait and not take on the case this year, despite the President having promised to repeal the ACA during his 2016 election campaign.

Insurers Ask CMS to Consider Expanding Copay Accumulator Policy

Blue Cross Blue Shield Association and America’s Health Insurance Plans are recommending that the CMS consider updating its copay accumulators policy, per a November meeting the insurers had with the agency. The insurers asked the policy to be updated to let exchange plans exclude drugmakers’ copay coupons from counting toward enrollees’ out-of-pocket maximums for all drugs. The group also requested CMS make it easier to track financial assistance, particularly in the form of copay coupons, and to expand the policy to support insured patients receiving financial assistance to purchase a drug. (InsideHealthPolicy).

Members of the National Business Group on Health attended the meeting and shared concerns that restrictions to the program could negatively impact employers that already have copay accumulator programs in place. The group asked that CMS clarify its intentions on copay accumulators to help employers prepare for any substantial changes that would require months of planning.

While insurers have touted the copay accumulator proposal as a way to promote generics, the policy is controversial among patient advocates and has been banned in some states, including Virginia and West Virginia.

Supreme Court to Review 8th Circuit Decision on State Laws Regulating PBMs

The Supreme Court has agreed to hear a case that could determine whether states can regulate aspects of prescription drug reimbursement and require more regulation amongst pharmacy benefit managers (PBMs). The case could ultimately have implications for state efforts to lower drug prices as a result of limiting PBMs’ activities and would be a win for those who argue PBMs are inflating drug costs for patients. (InsideHealthPolicy).

Leslie Rutledge, Arkansas Attorney General, argued a Supreme Court review is needed to give guidance to states and the lower courts about “what regulations of the central players in prescription drug markets are and are not preempted by ERISA.” The states have argued that the court’s decision “invalidating Arkansas’s PBM statute has created confusion and uncertainty regarding states’ power to regulate these significant market participants.”

The Pharmaceutical Care Management Association (PCMA) has opposed the request for a review of the case, but the group said Friday it was confident the court would uphold the 8th Circuit’s decision. The group has argued that the states’ policies “eliminate flexibility for plan sponsors and create significant administrative inefficiencies.” (InsideHealthPolicy).