HealthCare Roundtable e-News – November 5, 2020

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Pharma Industry Likely to Be the Target For Reforms as Senate, Presidential Race Results Are Determined

While both President Trump and the Democratic nominee, former Vice President Joe Biden, have campaigned in support of lowering prescription drug costs, experts agree that it’s not just the presidential race that will significantly impact the pharmaceutical industry in the next four years. Analysts are noting that either party’s control of the Senate will have a direct impact as ballots continue to be counted across the country.

As Americans continue to experience record levels of unemployment and lost health coverage, the pressure on pharmaceutical pricing “will remain high regardless of who wins in November,” according to an S&P Global report. Other analysts agreed that regardless of the presidential outcome, the final Senate result will have a significant impact on determining the level of drug-pricing action.

According to analyst Geoffrey Porges, drugmakers’ power to set prices on new products is “paramount to continued investment in biopharma innovation and maintaining the viability of the industry.” Porges notes that while Biden has proposed an independent panel to recommend launch prices if he wins, but will likely face challenges from Republicans and those opposing in the Senate.

Up for consideration in 2021, however, are a few drug pricing reforms that would benefit drug makers. Legislators in both parties have advocated for capping seniors’ out-of-pocket drug costs and combining that cap with enabling drug companies to pay a greater share of drug costs in the catastrophic phase, which would help some companies and hurt others. (InsideHealthPolicy)

Key Governor Races in 2020 Election Highlight Medicaid Expansion as a Hot Topic

Election results continue to be determined across the country two days after Election Day, with key races being determined in states where Medicaid is in the spotlight. As of Wednesday, several nominees and incumbents either won or had clear leads in governors’ races where Medicaid was a important topic, including in Missouri, New Hampshire, North Carolina, Utah, and Oklahoma.

Several GOP winners, including Missouri Governor Mike Parson, had opposed Medicaid expansion going into the election, noting the process of expansion would be costly.

“I don’t think it’s a time to be expanding anything in the state of Missouri right now. I’m telling you we’re going to have challenges going into 2021 when it comes to meeting the budget with what we currently have,” Parson explained last month. But despite his opposition, Missouri voters approved Amendment 2, which expands Medicaid to low-income adults.

Other Governors, like Democrat Roy Cooper of North Carolina, have pressed for Medicaid expansion and will continue to do so in the new term. Cooper included Medicaid expansion in his fiscal 2021 budget proposal as well as a proposed expansion on a COVID-19 relief bill, but neither have moved to a vote, according to Kaiser Family Foundation’s Medicaid tracker. (InsideHealthPolicy)

HHS Proposes Rule Requiring Review of Department Rules Every Ten Years

As votes continue to be counted in determining the results of the 2020 presidential election, the Trump administration proposed a rule this week that would require HHS to review all of the department’s rules and regulations every 10 years, analyzing the necessity and efficiency of each and eliminating those rules that do not appear to have the appropriate impact. Regulations will expire if the Department does not review them in a timely manner.

“This proposal—the boldest and most significant regulatory reform effort ever undertaken by HHS—would sunset burdensome regulations unless their necessity is publicly demonstrated to the American people,” said HHS Chief of Staff Brian Harrison in a statement. The department commented that the proposed rule seeks to increase transparency, public participation, and democratic accountability, where the public will be able to submit comments on the impacts of regulations.

Some rules will be exempt from the review, including those rules jointly issued with other agencies, rules that cannot be legally rescinded, and rules issued with respect to military and foreign affairs. According to HHS, regulations that affect the regulations of other agencies will be reviewed in conjunction with those agencies.

Trump Administration Issues Rule Requiring Insurers to Share Negotiated Rates By 2022

Last Thursday (Oct. 29), HHS Secretary Alex Azar and CMS Administrator Seema Verma announced a final rule requiring private insurers to provide enrollees access to pricing and cost-sharing information. The rule aims to provide more transparency for consumers in allowing access to the negotiated rates for items and services between their provider and plan, as well as additional out-of-pocket costs.

“HHS believes this change will preserve the statutorily-required value that consumers receive for coverage under the MLR program, while encouraging issuers to offer new or different value-based plan designs that support competition and consumer engagement in the healthcare market,” the agency fact sheet stated. (InsideHealthPolicy)

Under the final rule, individuals who are uninsured or shopping for health insurance will also be able to review and compare prices for different healthcare items and services under health insurance coverage. According to HHS, pricing information on an initial list of 500 services will need to be available on such a tool by the start of 2023. To aid the effort, technology companies will be able to create additional price comparison tools and portals that will further incentivize competition and allow for research studies and data analysis into how healthcare prices are set.

Experts Expect Stronger Focus on Medicare Price Negotiation Over Drug Importation if Biden Wins

Policy experts are anticipating that a Biden presidency will likely result in the prioritization of allowing Medicare to negotiate cheaper drug prices over drug imports, depending on whether Republicans will hold their Senate majority. Experts suggest that if Congress is able to pass legislation allowing Medicare to negotiate cheaper drug prices under a Biden administration, then guidance on drug importation may no longer be necessary.

The FDA unveiled a final rule earlier this month permitting states and tribes to import drugs from Canada, following an executive order from President Trump in July of this year directing the agency to take actions to allow for the importation and re-importation by states, wholesalers, and pharmacies of Food and Drug Administration-approved drugs from Canada.

While President Trump has received pushback from drug makers and U.S. pharmacists who say they don’t want to be responsible for imported drugs, a recent Kaiser Family Foundation poll found that the majority of the public supports allowing Americans to buy prescription drugs from Canada, with 75% of Democrats, 75% of Republicans and 82% of independents favoring the idea.

States that have already begun working on importation plans include Vermont, Colorado, Maine, New Hampshire, and New Mexico. Florida is also working on a drug importation plan but has not been able to successfully attract a bidder for its contract to operate the program. (InsideHealthPolicy)