HealthCare Roundtable e-News – July 21, 2021

Pelosi Backs Senate Budget Resolution, Offering House Support on Coverage Gap and Medicare Policies

Last week, Senate Majority Leader Chuck Schumer (D-NY) announced that he plans to push through a $1.2 trillion bipartisan infrastructure package and $3.5 trillion budget resolution ahead of the Senate’s next recess in August. The framework for the budget resolution includes nearly all of President Joe Biden’s American Families Plan bill, plus the addition of expanded Medicare coverage for hearing, vision and dental care, and is expected to pass on a party-line vote.

The bill was supported by House Speaker Nancy Pelosi (D-Calif.), who praised the inclusion of House priorities like closing the Medicaid gap, enhancing Medicare, and extending increased tax credits from the American Rescue Plan. In a letter sent to House members on July 14th, Pelosi said that every representative “can be proud of the priorities that this budget commits to – and every Member should know that we will fight to ensure that our priorities become law. Our House Committees stand ready to work with the Senate, as this topline agreement is turned into legislative text.” (InsideHealthPolicy)

Few details have been shared on how the Senate anticipates paying for the cost of the bill. One Senate senior Democratic aide said the deal will be offset in part by drug pricing reforms; however, Pelosi did not mention drug pricing legislation in her letter to House members. Pelosi has previously advocated for drug pricing reform as a potential pathway to pay for the infrastructure bill by letting the government negotiate drug prices and bargain with drugmakers in order to lower costs for the Medicare program.

HHS to Issue Harsher Penalty for Hospitals Not Following Price Transparency Guidance

The Biden administration announced this week a proposed rule to place harsher fines for hospitals that do not comply with guidance requiring them to publish the prices they charge patients. The maximum annual penalty proposed by CMS will increase from $109,500 to $2 million per hospital.

In 2019, then-President Donald Trump signed an executive order calling for increased hospital price transparency, arguing that the rule will allow patients to shop for lower-priced medical services and reduce overall healthcare costs. The announcement this week supports the Trump-era order and follows a directive from Biden given earlier this month calling on HHS and other federal agencies to support existing hospital price transparency rules. HHS Secretary Xavier Becerra said the proposed rule is “simply showing hospitals through stiffer penalties: Concealing the costs of services and procedures will not be tolerated by this administration.”

The Biden administration and health experts have argued that the guidance will lead to increased competition in the US healthcare system and likely drive prices down; however, some health experts have criticized the rule, saying that similar transparency efforts haven’t worked in the past. Hospitals and others in the industry have also argued that price disclosure will burden health systems that are still heavily battling the coronavirus, with increased transparency to likely also lead to increased confusion for patients.

Read the full guidance issued by HHS, here.

Senate Judiciary Subcommittee Revisits Bills Aimed at Curbing Anti-Competition Practices Across Pharma Industry

Last week, the Senate Judiciary subcommittee held a hearing to determine methods of boosting pharmaceutical competition via patent laws and allowing Medicare to negotiate drug prices. While some drug companies have argued the current antitrust laws already encourage competition and have enabled innovation, many patient advocate groups argue the rewriting of antitrust laws and passing of bills specifically targeted at the drug industry are necessary to prevent anti-competitive conduct.

Committee members assessed a package of bipartisan patent reform bills reintroduced earlier this year; the Preserve Access to Affordable Generics and Biosimilars Act, which would ban pay-for-delay agreements and make it difficult for drug makers to defend them in court; the Stop STALLING Act, which would penalize brand drug makers for using “sham” citizen petitions to delay competition; and the Affordable Prescriptions for Patients through Promoting Competition Act, which aims to prohibit the pharmaceutical industry practice of “product hopping.” (InsideHealthPolicy)

During the hearing, Michael Kades, director of markets and competition policy at the Washington Center for Equitable Growth, called out federal courts that so far have shown “an almost neurotic fear of over enforcement,” suggesting that many have “increased burdens on plaintiffs and narrowed the scope of antitrust law, which have raised inappropriate and unnecessary hurdles to antitrust enforcement, which allows any anticompetitive activity to escape condemnation.” (InsideHealthPolicy)

ICER Calls for Decrease in List Price of Alzheimer’s Treatment Drug, Aduhelm

On Monday, the Institute for Clinical and Economic Review’s expert panel determined that Biogen’s Alzheimer’s treatment drug Aduhelm (aducanumab) is not worth the $56,000 list price, citing that the cost set by the manufacturer has no net clinical benefit. The committee had previously shared in a draft report earlier this year that the data obtained from the drug’s trials was “insufficient” and that, until new evidence can be provided, the drug would be better off priced from $2,500 to $8,300.

The FDA approved the drug last month through an accelerated pathway that can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. The agency’s approval of Aduhelm led to several panel resignations and gave Biogen free rein over the roughly 6 million American Alzheimer’s patients living with the disease. The drug’s approval also led to a former advisor calling for an investigation into the agency’s approval of the treatment.

Committee members agreed that Aduhelm would either display no effect or a minor to major negative effect in helping patients achieve their life goals, adding to the quality of life for caregivers or adding to the societal goal of reducing health inequities. However, many patient and caregiver advocates argued that a minimal health benefit should not be a reason to deny patients access to a potential new treatment for the disease. (InsideHealthPolicy)

Biogen began running print and video ads to hype early awareness of cognitive symptoms, including a placement in the New York Times magazine and a Father’s Day ad in June, shortly after the drug was approved, featuring a former journalist struggling with early Alzheimer’s symptoms, such as the ability to recognize people. The manufacturer also announced a planned partnership with CVS Health to launch a program on brain health and highlighting the importance of screenings and disease education.

NACo Aims to Upgrade Counties’ Internet Access and Speed Through Leftover COVID-19 Relief Funds

While much of the COVID-19 relief funding given to counties over the course of the pandemic went towards health and medical needs, much of the funding has since gone towards social health needs like clean drinking water, food needs and rental assistance. In many areas, leftover funds are now also going towards the improvement of broadband availability and affordability. Since the pandemic has swept across the country, the National Association of Counties has taken issue with the Federal Communication Commission’s broadband map and their claims of internet speeds and availability that have so far proven to be inaccurate. The group has argued that speeds are significantly lower in practice, impacting the ability to do telehealth visits.

Gary Moore, NACo immediate past president and county judge from Burlington, KY, said once the pandemic hit, “the speeds were nowhere close enough.” Moore says the FCC connectivity maps were way off and that his county is prioritizing access to high-speed broadband for every resident in the next two to three years. (InsideHealthPolicy)

Since taking office, President Biden has expressed that improving health equity across the country is a priority for his administration. Earlier this year, administration official and COVID-19 Health Equity Task-Force Lead Marcella Nunez-Smith said health equity is “key to building systems that address social determinants of health.” During its five day conference earlier this month, NACo supported the administration’s efforts and highlighted how COVID-19 relief funds from the CARES Act and American Rescue Plan have helped counties improve broadband and address other social determinants of health, group president Larry Johnson told reporters. (InsideHealthPolicy)

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