HealthCare Roundtable e-News – March 16, 2021

Upcoming Webinar Alert

“The First 100 Days: New Congress, New Administration and Public Sector Purchasers”

The Public Sector HealthCare Roundtable will host its next webinar on Wednesday, March 31st at 3:00pm EDT, to closely examine the federal policy activities of the new 117th Congress, the Biden Administration, and discuss priorities for public sector purchasers. Following the passage of the American Rescue Plan Act of 2021, a number of important issues to public sector purchasers will be considered in the coming months, including drug pricing, issues related to Medicare Advantage, Medicare eligibility, and a range of other reform proposals such as the “public option”. Join us to hear about the current state-of-play in Washington, D.C., and engage in a discussion on issues critical to you, our members.

Registration is now open for this webinar at the following link:

After registering, you will receive a confirmation email containing information about joining the meeting.

Biden Directs States to Make All Adults Eligible For COVID-19 Vaccine by May 1

On the first anniversary of the COVID-19 shutdown in the United States and after signing into law the American Rescue Plan, President Joe Biden gave his first primetime address offering reflections from the and announcements regarding the country’s vaccination efforts. According to the president, his administration is directing states to make all adults, ages 18 and older, eligible for the vaccine by May 1st of this year.

To ease the process and make more vaccines available, the administration will also look to increase the number of vaccinators and vaccination sites, make it easier for people to find a vaccine site, and expand screening testing in schools and congregate settings. The effort is part of the president’s plan to bring the country closer to “normal” before the Fourth of July. One administration official said the plan “reflects our success working with the vaccine manufacturers to increase supply and secure doses for all adult Americans, as well as our efforts to significantly increase the pace of shots in arms.” (InsideHealthPolicy)

One of the key obstacles of vaccine roll-out has been the lack of support and booking resources for elderly Americans who don’t have the means or resources to book their vaccinations online once they became eligible. While many states began adding individuals 65 and older to their 1A and 1B phases, older Americans who don’t have access to the internet or family to help them book online appointments have largely been neglected. Biden announced that his administration would launch a website by May to help individuals find nearby vaccination sites and make vaccines available at more than 20,000 pharmacies across the United States.

Former FDA Officials Suggest the Agency Become Independent of HHS, Report Directly to White House

Former FDA Chiefs Scott Gottlieb and Margaret Hamburg are calling for structural changes that make the FDA an independent agency, affecting everything from who the agency reports to and how policymaking and regulations review will take place. Currently, the FDA reports to HHS, which the former officials argue slows down regulations and offers a vehicle for stakeholders to lobby HHS to change FDA decisions.

Experts say the FDA could be structured similarly to the Federal Communications Commission or Federal Trade Commission, reporting directly to the White House or working directly with the White House through the Domestic Policy Council. Hamburg argued that making the agency independent could help protect it from political and ideological interference, and could help it be nimbler and swifter in its decision-making. (InsideHealthPolicy)

“The work of the FDA is so specialized, there were very few circumstances where HHS was providing value on our rulemaking or our policy…If [people] didn’t get recourse with FDA, they would go and try to lobby HHS and try to stop things at that level. It really, more often than not, stymied policymaking. I didn’t see it adding a lot of value over successive administrations. And it wasn’t people-specific; it was just institutional and structural,” Gottlieb said.

Other former FDA officials have argued the case for keeping FDA within HHS, suggesting that the agency would still be subject to political interference even as an independent agency. Gerald Masoudi, former FDA Chief Counsel and partner at Covington & Burling, said there are several agencies within HHS that FDA interacts with on a regular basis, including the Centers for Disease Control and Prevention, the Surgeon General and CMS, and he said that having those functions under one source of common leadership is important. Hamburg countered the argument, saying those relationships with other HHS agencies can complicate FDA’s decision-making process.

Advocates Push for Larger Government Role in Drug Manufacturing and Price Setting Amidst Successful Pandemic Partnership

After a successful partnership was formed between the federal government and drug manufacturers during the pandemic, lobbying groups are now pushing for more government participation in drug and vaccine development. In the U.S., rapid COVID-19 vaccine development with the help of government funding has sparked conversations about taxpayers playing a greater role in development and price setting, which has traditionally been left to private investors.

While lobbying groups haven’t received much feedback on the proposal, industry experts argue the push for government partnerships could help regulate drug costs for consumers. Manufacturers have long argued that high drug prices are needed to entice private investors to back drug research and development, but Sarah Emond, executive vice president and chief operating officer for the Institute for Clinical and Economic Review, said that COVID-19 vaccines demonstrate that partnerships between the government and private industry can work well in some circumstances. (InsideHealthPolicy)

“There are other paths to incentivizing the type of innovation that we all want that involves that type of partnership, and then we can have a grown-up conversation about what’s the fair price,” said Emond, who spoke at a policy conference sponsored by America’s Health Insurance Plans last week. Emond also suggested that if society wants to be able to afford those drugs, it needs to stop overpaying for drugs that offer little value. (InsideHealthPolicy)

Francis Collins, director of the National Institutes of Health, has said that he wants the agency and the drug industry to maintain their partnership that was formed during the pandemic, which helped to coordinate research on vaccines and drugs to treat the coronavirus. Congress also directed NIH to help speed the development of COVID-19 diagnostics, and Collins said that the method of the federal government serving as an investor could be applied to other industries. (InsideHealthPolicy)

Starting April 1, Consumers Must Return to for New ACA Credits Under American Rescue Plan

Last Friday, HHS officials announced that consumers who reside in states using will need to return to the site to access tax credits starting April 1. The American Rescue Plan, which was signed into law by President Biden last week, includes an expansion of credits available under the Affordable Care Act and other changes to help lower health care costs for millions.

Under the American Rescue Plan, the expansion of tax credits comes for people earning up to 400% of the federal poverty level (FPL) and extends tax credits to anyone above 400% FPL by limiting the premium contribution to 8.5% of income. While administration officials said they do not have any models predicting how many people might enroll due to the new benefits and offered no estimates, the provision will last through 2022. More than 206,000 individuals have already signed up for coverage in the first two weeks of the special enrollment period, which kicked off in February. (InsideHealthPolicy)

The new subsidies under the American Rescue Plan will help address racial disparities by expanding coverage to historically uninsured communities. As of now, consumers will need to revisit the exchange to get the additional premium tax credit. Officials have also emphasized that consumers who do not get the subsidies in advance can still collect them during tax season the following year.

HHS has already committed $50 million in funds to outreach and marketing campaigns for the SEP, using all resources available to make sure Americans are aware of the enrollment period and additional benefits. Administration officials say that an outreach campaign could be launched by the end of the month, the 11-year anniversary of the ACA. (InsideHealthPolicy)