Biden Says He Wants to Go Big On Health Care. But He Left Major Reforms Out of His Latest Plan

U.S. President Joe Biden speaks during a joint session of Congress at the U.S. Capitol in Washington, D.C., U.S., on Wednesday, April 28, 2021.

Source: Time, by Abigail Abrams

During President Joe Biden’s speech to Congress on Wednesday, he called for an ambitious health agenda that would allow the federal government to negotiate prescription drug prices, expand Medicare coverage, build on the Affordable Care Act and lower deductibles. All of these ideas would transform the way Americans pay for health care—but most of them are not actually in the legislative plan the President has put forward.

“Let’s give Medicare the power to save hundreds of billions of dollars by negotiating lower drug prescription prices. And, by the way, that won’t just help people on Medicare. It will lower prescription drug costs for everyone,” Biden said. “We’ve talked about it long enough. Democrats and Republicans, let’s get it done this year.”

Despite his strong rhetoric, Biden’s American Families Plan, also unveiled on Wednesday, does not include the proposals to cut prescription drug costs or lower the Medicare eligibility age, which congressional Democrats had pressured him to include in recent weeks. His $4 trillion package comprised of the American Families Plan and the American Jobs Plan has been praised by progressives as a huge investment in the country’s economy and social safety net. But the omission of these larger health care policies has raised questions for progressives about the President’s commitment to the ideas in the face of opposition from Republicans, moderate Democrats and pharmaceutical companies.

“While [lowering drug prices and expanding Medicare] is a focused priority of Congress, it’s clear it’s not as much so for the White House,” says Alex Lawson, executive director of Social Security Works, which supports the drug pricing and Medicare reforms.

Biden’s plan does include $200 billion to make permanent the increased premium subsidies for people who buy health coverage on the Affordable Care Act (ACA) marketplace, which were passed in the American Rescue Plan earlier this year. The expanded subsidies mean that millions of Americans are eligible for cheaper or free health coverage. But the Congressional Budget Office has estimated that the subsidies will get just 1.3 million uninsured people to buy coverage over two years, a small portion of the total uninsured. “In terms of federal dollars, subsidizing private insurance is the most expensive way you can go about getting people covered. Whereas doing it through a public option or Medicaid or Medicare is much lower cost on a per person basis,” says Cynthia Cox, a vice president at the nonpartisan Kaiser Family Foundation.

That is a main reason why many congressional Democrats have been pushing Biden to do more than shore up the ACA. Vermont Sen. Bernie Sanders and 16 other Senators sent a letter to Biden on April 25 calling for the President to address drug pricing, lower the Medicare eligibility age, cap out-of-pocket expenses for Medicare and expand Medicare benefits to cover hearing, dental and vision care. Another group of more than 80 House members, including progressives like Washington Rep. Pramila Jayapal and moderates like Rep. Conor Lamb of Pennsylvania and Rep. Jared Golden of Maine, wrote a similar letter advocating for the government to negotiate drug prices and expand Medicare.

A new set of analyses from the Kaiser Family Foundation this week indicate that lowering the Medicare eligibility age from 65 to 60 or even lower could bring down U.S. health spending overall. The foundation’s first analysis showed that when people turn 65, their health care spending drops significantly from the period between age 60 to 64 despite the fact that most people use more health care as they age. The reason? Medicare pays lower prices for health care services than private insurers. Employers also benefit. The foundation’s second analysis showed that if people ages 60-64 were no longer enrolled in employer-sponsored insurance, the cost for employer plans could drop by 15%. Even if Medicare expanded to include dental, vision and hearing coverage as Sanders and some Democrats want, Kaiser Family Foundation’s Cox says health spending could still drop.

Polling has shown that both of these policies are popular, even among Republican voters. And congressional Democrats say that is especially true after the COVID-19 pandemic disproportionately affected older Americans. But by far the most popular item that Democrats are pushing is the proposal to allow the U.S. government to negotiate with manufacturers over drug prices—something that most other developed countries already do. A new government study commissioned by Sanders and released this week shows that the U.S. pays two to four times more for prescription drugs than other wealthy countries, adding to the evidence supporting the Democrats’ position.

Even though these policies are popular among voters, the political reality for Biden is more difficult. Republicans oppose most of Biden’s spending on the social safety net, so the legislation will likely need to pass through the budget reconciliation process, which would allow Democrats to push it through along party lines. But with an evenly-divided Senate, they can’t afford to lose any votes. The ACA subsidies that Biden has included in his plan face no opposition from Democrats or the health insurance industry, but both the drug pricing reform and Medicare changes will face intense pushback from pharmaceutical companies, hospitals and medical providers, as well as more moderate Democrats.

Health care has been a winning topic for Democrats in recent election cycles and bringing down drug prices could be particularly helpful ahead of the next midterms, says Robert Blendon, a Harvard professor of health policy and political analysis who studies public opinion about health care. If Biden isn’t prioritizing that, “it must be because there’s one or two votes in the Senate who have an interest that’s more worried about the pharmaceutical industry than what it’s going to look like in the 2022 election,” he says.

Democrats can still fight to add the drug pricing proposal and Medicare changes into the spending package once it gets to Congress. Sanders told reporters on Tuesday that the provisions would be in the legislation “if I have anything to say about it,” while Senate Finance Committee Chair Ron Wyden of Oregon said he would “look at every possible vehicle” to get drug pricing done. House Energy and Commerce Committee Chair Frank Pallone of New Jersey said drug pricing would be one of his top priorities as the plan makes its way through the House.

House Democrats passed their signature drug pricing legislation, known as H.R. 3, back in 2019, and the bill was recently reintroduced and has a hearing scheduled in Pallone’s committee. Advocates believe that lawmakers can negotiate to put measures like this into the American Families Plan. “We have a container that can fit what we want in there,” said Lawson of Social Security Works.

Still, Biden’s speech Wednesday hinted at how difficult these big health care changes can be. “We know how to do this. The last president had that as an objective,” he said, referencing former President Donald Trump’s failed push to lower prescription drug prices.

Now Biden has left it up to Democratic lawmakers to get their own colleagues on board and make the changes happen.

Work In Progress: Price Transparency Efforts Need To Go Further

Work in progress: Price transparency efforts need to go further |  BenefitsPRO

Source: BenefitsPRO, by Scott Wooldridge

Efforts to increase health care price transparency are moving forward, but problems remain with the current reforms, raising questions on whether additional steps are needed, a new Rand Corporation study has found.

The report, “Barriers to Price and Quality Transparency in Health Care Markets,” noted that recent legislative and regulatory efforts to increase transparency are being implemented: a 2018 federal rule requires hospitals to release price data, another 2019 rule requires disclosure of standard health care charges in a machine-readable format. Hospitals, health systems, and insurers are generally complying with these rules, but the information can be confusing and difficult to access in a consumer-friendly way.

More data, but not more clarity?

The study noted that hospitals, providers, and pharmaceutical companies negotiate with payers such as governmental bodies or commercial insurers. Payments for Medicare and Medicaid services tend to be lower, and among commercial payers prices are generally higher in areas with a higher concentration of providers.

Recent federal efforts to increase price transparency have resulted in more data being released; states are also attempting to increase transparency through state All-Payer Claims Databases (APCDs).

But such efforts still have a way to go, the Rand analysis said. One major problem is that releasing data on charges or negotiated prices does not actually reflect what consumers would pay for services out of pocket (OOP). The complexity of health plans, the various options available to consumers, and the lack of standardization in what providers charge for services, all contribute to a system where the data can be overwhelming, and means of interpreting the data are not available to the average consumer.

In on example, the Rand study notes, “OOP price transparency would be difficult to convey accurately, because any tool would need to know not only negotiated prices between plans and providers but also the specific plan benefit design information of each consumer’s insurance plan and where the consumer falls in their benefit (for example, whether the deductible has been met).”

This level of complexity threatens to undermine the usefulness of the transparency efforts now underway. Because of this, the Rand analysts list a number of additional steps that they recommend to improve both transparency and usefulness of the data to consumers.

Recommended improvements

The report recommends a number of changes, including:

Improvement of transparency tools for consumers.

The study said an increased emphasis on OOP price transparency would be more relevant to consumers. In addition, measurements such as the current Care Compare tools (which provide quality information on providers) should include more detail and do more to link quality and price data.

Require more disclosure on contracts and data.

This would include requiring data from self-funded health plans. Self-funded plans have ERISA exemptions allowing them to avoid disclosure to APCDs. The report suggests setting up a federal APCD, although it acknowledges this would be a big task. In addition, many insurer-provider contracts currently do not allow negotiated prices to disclosed. Legislation requiring disclosure of these prices would give consumers more useful information.

Promote tools such as APCDs.

The analysts said that states that have not yet established APCDs should do so, and those that have them should make sure that online price and quality tools have the depth and clarity of information needed by consumers.

“The barriers to consumer price and quality transparency identified through this work generally represented limitations of existing tools,” the study concluded. “Efforts to achieve price and quality transparency have the potential to allow consumers to make better-informed decisions about their health care.”

Biden Prodded to ‘Go Big’ on Drug Pricing

Biden Administration's Methodical Approach To Drug Price ReformSource: Bloomberg Government, by Brandon Lee

Democrats are urging the White House to include their health policy ideas in the next phase of President Joe Biden’s infrastructure push, with hopes of gaining an edge over colleagues with competing plans.

Congressional leaders, top senators, and rank-and-file Democrats say they’ve put in calls or made trips to the White House this week plugging legislation to broaden health insurance, expand Medicare, or lower drug prices. But Biden has kept quiet on whether he intends to include health care as part of the next phase of his infrastructure plan, which has left some lawmakers fearful it’s being left out.

“I’ve talked with folks at the White House and I know other colleagues have as well because we’d love very much to see something on Medicare” in a new Biden infrastructure proposal, Sen. Debbie Stabenow (D-Mich.) told reporters.

The next piece of Biden’s massive infrastructure and economic proposal, called the American FamiliesPlan, isn’t expected to include boosting health coverage or reduce prescription drug costs, The New York Times reported yesterday. White House press secretary, Jen Psaki, didn’t mentioning any health care policies while outlining what would be included in that plan.

Sens. Stabenow, Tammy Baldwin (D-Wis.) and Sherrod Brown (D-Ohio) introduced a bill this week that would let Americans beginning at age 50 buy into Medicare. Stabenow said the White House hasn’t indicated if Biden would support their measure.

Their measure shares the same goal as Sen. Bernie Sanders’s (I-Vt.) drive to expand Medicare eligibility broadly to Americans starting at age 55. Rep. Pramila Jayapal (D-Wash.), who helped to lead a unity task force between progressive Democrats like herself and the Biden team, said she’s also pushing to include a Medicare expansion.

In addition, House leaders yesterday reintroduced their signature drug-pricing measure that would direct the government to negotiate with drugmakers for lower prices on certain drugs, hoping it will become part of the infrastructure plan. “Lowering health costs and prescription drug prices will be a top priority for House Democrats to be included in the American Families Plan,” Speaker Nancy Pelosi (D-Calif.) said. Alex Ruoff has more.

Drug Pricing Group to Launch Ads: A drug pricing group will launch ads in response to the report that Biden’s next plan will exclude drug cost reduction initiatives, Alex Ruoff reports. The Patients for Affordable Drugs Now is launching ads to run on broadcast and cable news in the Washington D.C. TV market, and on multiple digital platforms, Alex Ruoff reports. The campaign launches today with a new ad highlighting Biden’s promise to allow Medicare to negotiate for lower prices. It will also include patient mobilization and other activities.

Over-The-Counter COVID-19 Rapid Tests To Be Sent To Major Pharmacies This Week

Over-the-counter COVID-19 rapid tests to be sent to major pharmacies this  week - ABC NewsSource: ABC News, by Sasha Pezenik and Ivan Pereira

Store shelves at pharmacies across the county will soon be filled with affordable, quick, at-home coronavirus test kits.

The Food and Drug Administration gave an Emergency Use Authorization for BinaxNOW at the end of March. The test can be used on children as young as 2 when samples are collected by an adult and for all people 15 or older.

Users can take the test even if they don’t show symptoms and get results within 15 minutes, according to Abbott.

The company says it will manufacture tens of millions of BinaxNOW Self Tests per month and can further scale capacity based on demand.

Abbott said they will work with retailers to prioritize distribution to areas of the country where the virus is surging as additional supply comes online.

“Over the past year, Abbott has developed high-quality rapid testing and invested in U.S. facilities to scale up manufacturing so we could bring affordable testing to Americans on a mass scale,” Robert B. Ford, the president and CEO of Abbott said in a statement.

A spokesperson from Abbott told ABC News the company can produce tens of millions of kits a month. There are other over-the-counter rapid antigen tests available, like one from Ellume, out in the market.

Dr. Michael Mina, an assistant professor of epidemiology at Harvard T.H. Chan School of Public Health, said there will likely be a large demand for over-the-counter tests.

“At the moment, however, at 50 million per month split across over the counter and bulk sales to schools, businesses and other congregate settings, it is unclear what the availability of these tests will be over the coming weeks and months,” Mina told ABC News.

He commended Abbott for indicating they will increase their supply based on the market demands.

“It is a major advance over what has been available,” Mina said of BinaxNOW.

California To Cross Key Vaccination Milestone Next Week, Triggering Broader Reopening Across State

California To Cross Vaccination Milestone Next Week, Trigger Reopening –  Deadline

Source: Deadline, by Tom Tapp

The announced relaxation of Covid-19 guidelines across California on Friday is likely the prelude to a much wider reopening.

For weeks, Governor Gavin Newsom has been reminding residents that the state tied the loosening of restrictions to vaccine equity. That is: The faster the most underserved communities in the state are vaccinated, the faster the authorities will allow everyone else to relax restrictions.

Weeks ago, the governor ordered 40% of the state’s vaccine supply set aside for underserved communities. He also laid out two key thresholds that would trigger broader reopenings: First when vaccinations in the lowest economic quartile reach 2 million and second when the same population receives 4 million doses. California crossed 2 million vaccinations in that quartile on on March 12. Just 3 weeks later, the state is on the brink of crossing the 4 million threshold.

Newsom told San Diego officials on Friday that he anticipates “four million next week.” As he spoke, the state was reporting 3,730,000 vaccinations in the lowest economic quartile of residents. See chart below. Given that the number of vaccinations administered among this group topped 100,000 in the past 24 hours, it’s a safe bet that the state will cross four million very shortly.

So what will happen at 4 million? For one thing, counties will have a much easier time progressing through the state’s color-coded reopening tiers. Los Angeles County, for example, sits in the state’s Orange tier. Currently, its number of new cases per 100,000 residents would have to fall below 1 to move the county into the Yellow tier. L.A. currently sits at a 3.1 adjusted rate of cases per 100,000. Orange County is at 2.9 per 100,000. Once the number of lowest economic quartile vaccinations reaches 4 million, however, the threshold for Yellow becomes 2 new cases per 100,000 residents. See chart below. Both Orange and L.A. counties have a shot at making that number next week.

Movement into the Yellow tier doesn’t mean much for movie theaters, which would stay at 50% capacity. But it would allow theme parks such as Disneyland, Universal Studios Hollywood and Magic Mountain to increase capacity another 10%, to 35% total. Parks would also be allowed to increase indoor dining to 50% capacity and sell tickets at the gate.

The Yellow Tier could have benefits for larger concert, sports and theatrical venues, as well. While capacity is limited to 10% or 2,000 people, it increases to 50% if all guests are tested or show proof of full vaccination.

And what lies beyond the Yellow tier?

“Ultimately [we’ll be] getting to a green tier, which we’ll be talking a lot more about next week,” said Newsom on Friday.

Newest Nevada Vaccine Group Can Self-Report Health Condition

Newest Nevada vaccine group can self-report health condition - Las Vegas  Sun Newspaper

Source: Las Vegas Sun, by Associated Press

People age 55 and older can self-report to their pharmacist any underlying health conditions that make them eligible to receive COVID-19 vaccinations, Nevada health officials said.

As eligibility has broadened in the statewide coronavirus inoculation process, deaths from COVID-19 have fallen to an average of about four per day, state biostatistician Kyra Morgan told a statewide panel on Tuesday. Average deaths during the pandemic peaked at 40 per day in mid-January.

Morgan did not tie vaccinations to recent data showing fewer hospitalizations and deaths.

But “this is really about the best we’ve seen since the beginning of the pandemic,” she told Nevada COVID-19 Task Force members.

The panel is meeting this week with officials from Nevada’s 17 counties to plan a return of coronavirus response authority to local control on May 1.

Panel members on Monday cast efforts to reach people with underlying health conditions, disabilities and the homeless at retail pharmacies and supermarkets as an effort to get more shots in arms.

“We will see how the appointment scheduling goes this week,” said Candice McDaniel, state vaccination chief. “And then we’ll compare that with the supply that we hope to see for next week and then we’ll be able to gauge when we’ll be able to open it (further).”

“I really hope that people attest to what they truly have,” McDaniel said.

State health officials reported 346 new cases of COVID-19 on Tuesday, totaling 299,817 since March 2020. Fourteen new deaths reported since Monday brought the pandemic toll in Nevada to 5,135.

Test positivity continues to decrease in the state, to 5.5%. The measure of the number of people tested who receive a positive diagnosis peaked at 21.6% in January. The World Health Organization target is 5% or less for at least two weeks before easing restrictions meant to slow the spread of the virus.

More than 1 million doses of COVID-19 vaccine have been administered in Nevada, the federal Centers for Disease Control and Prevention reported Tuesday. The state’s weekly allocation of vaccines has risen to about 70,000, from 47,000 last month.

The state Department of Health and Human Services said 19.5% of Nevada’s population has received at least one dose of vaccine, and almost 11% have completed the process.

That compares with almost 22% of the U.S. population receiving at least one shot, according to the CDC, and 11.8% fully vaccinated.

About one-third of Nevada’s 3.1 million population is 50 and older, and the state Department of Health and Human Services estimates that about 290,000 people ages 55 to 64 have underlying conditions.

That age group joined a prioritization list that started in December with doctors and first responders and went on to add teachers, government and community support employees.

In northern Nevada, Washoe County health officials have focused on vaccinating frontline supply chain workers, including essential airport employees. Plans call for widening eligibility to transportation, warehouse workers and the trucking industry — one of the biggest categories in the Reno-Sparks area.

The eligibility list of underlying conditions covers a wide range of ailments including cancer; chronic heart, lung, kidney and liver diseases; diabetes; dementia; Down syndrome; and high blood pressure. It also includes people with compromised immune systems because of organ transplants, obesity, pregnancy, sickle cell disease and smoking.

Drugmakers Prepare For The Unusual: A Defeat In Washington

Drugmakers prepare for the unusual: A defeat in Washington

Source: Politico, by Susannah Luthi and Sarah Owermohle

The pharmaceutical industry is preparing to take a hit in Democrats’ next major legislative package — and the long-untouchable powerhouse is racing to contain the damage.

Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry, or potentially more, to help pay for a massive infrastructure bill they could try to pass along party lines this summer.

A renewed debate over whether to allow the government to negotiate drug prices, which is strongly opposed by pharma and Republican lawmakers, could become a watershed moment for an industry that’s unaccustomed to losing — and survived the Trump era largely unscathed, even as the previous president found rare common ground with Democrats in bashing high drug prices. But those with knowledge of initial discussions told POLITICO that Democratic lawmakers appear intent on using their razor-thin congressional majorities to finally push through a drug pricing overhaul for at least one simple reason: It’s one of the few issues under consideration that would save money in a sprawling package expected to cost trillions.

“The huge difference between drug prices and literally everything else out there: Everything else costs money, and this one saves money,” said Alex Lawson, executive director of Social Security Works, whose group is in close contact with congressional staffers on drug pricing.

The long-running drug pricing debate, propelled by bipartisan voter anger over high medicine costs, had been stalled by the pandemic before it sprang back to life last week with two major developments: House Democrats began exploring whether to include negotiations in the forthcoming infrastructure package, and one of the pharmaceutical industry’s most vocal critics, Sen. Bernie Sanders (I-Vt.), abruptly scheduled the first hearing on drug prices in the new Congress for Tuesday.

The hearing announcement jolted some pharma lobbyists, who told POLITICO it signaled the industry could become the “piggy bank” for the infrastructure bill. It also underscored the challenge the industry faces in trying to use the pandemic to alter its perception from price-gougers to world-savers.

POLITICO spoke with more than a dozen industry lobbyists, Hill aides and advocates about revived talks over drug prices. Many of them requested anonymity to share sensitive discussions that are still in the early stages.

“Something is coming. We’re just not sure when,” said one drug industry lobbying source.

Democratic leaders are widely expected to advance the infrastructure package using a budget maneuver known as reconciliation, which would allow them to pass it with simple majorities in both chambers. That could let them tack on party priorities on health care, climate change and other policies that could otherwise fall victim to the Senate filibuster.

House Democratic leaders are still examining whether their negotiation bill, numbered H.R. 3 (116) in the previous Congress, would satisfy the complex requirements for reconciliation, which they recently used to deliver the $1.9 trillion Covid relief plan along party lines.

Some drug industry lobbyists told POLITICO they believe that enough Senate moderates may have reservations about the House bill and the way it would, for example, limit the maximum negotiated price to what’s paid for the drug in other developed countries. Those lobbyists also believe the industry’s hand has been strengthened by the rapid development of Covid-19 vaccines that can bring the pandemic under control.

“I think getting moderate Senate Democrats on board for H.R. 3 is going to be a challenge, and I think there’s a lot of salient points attacking that policy around cures and the investments in the Covid vaccines, which have been shown to be effective,” said one health care lobbyist who’s been closely tracking Capitol Hill talks.

President Joe Biden, who campaigned on drug pricing negotiations, hasn’t said yet whether the House’s negotiation measure should be included in the infrastructure package. An administration official pointed to the Biden campaign’s plan, which also called for limits on drugs’ launch prices and prices hikes.

House Democrats approved their negotiation bill in the previous Congress, but it never came up for a vote in the Senate, which at the time was controlled by Republicans. Senate Democrats haven’t indicated whether they support including the negotiation measure in the infrastructure package, but it would come with attractive savings: $456 billion over a decade, according to the Congressional Budget Office.

Democratic leaders aren’t yet saying much publicly about their strategy for drug pricing, which aides and lobbyists said were in early phases. A senior Democratic aide in a statement called negotiations a “top priority” for this Congress.

Drugmakers are also holding their fire. Brian Newell, spokesperson for drug lobbying giant PhRMA, said the group is “ready to work with policymakers” to lower what patients pay out of pocket for drugs and “protect access to medicines and preserve future innovation” — nodding to industry arguments that government negotiations would result in drugs being withheld from patients and shrunken investments in research and development.

Privately, some drug industry lobbyists said they hoped to nudge Democrats toward focusing on a separate — and narrower — drug pricing effort that came out of the Senate Finance Committee with some bipartisan support last Congress. The bill, from Chair Ron Wyden (D-Ore.) and then-Chair Chuck Grassley (R-Iowa), doesn’t authorize negotiations but aims to curb drug price hikes in Medicare and caps seniors’ out-of-pocket spending, as the House version would.

It’s not that the industry likes the measure — and many Republicans have compared its central provision targeting price increases to “price controls” that are anathema to conservative orthodoxy. But it would mean a significantly smaller dent to industry profits. The Medicare restrictions on price hikes would save the federal government about $50 billion, just a fraction of savings from the House’s negotiation bill.

Democratic leaders meanwhile will face pressure from the party’s progressive wing, who will push for the infrastructure bill to include their priorities after the $15 minimum wage was dropped from the recent stimulus package. Rep. Pramila Jayapal (D-Wash.), chair of the Congressional Progressive Caucus, has said any drug pricing legislation should be more aggressive than H.R. 3, which didn’t extend the price hike protections to private health insurance.

“The ultimate goal is that no American should pay more for their drugs than anyone else in any other country,” Jayapal said last month.

Progressives could find new support from major employer groups that have historically been wary of price controls but are increasingly fed up with shouldering high health care costs. One of those groups, the Purchaser Business Group on Health, which represents large companies including Walmart and Boeing, said it’s in discussions to support a negotiation bill if it includes limits on price hikes for private health plans.

“We’re ready to play ball, and I think that having big employers on board could do a lot for Democrats on pushing back on the narrative the pharmaceutical industry is going to push is that this is bad for the economy and bad for business,” said Shawn Gremminger, the group’s director of health policy. “We think we could have a substantial role to play here.”

Wyden last week told reporters the House bill and his own are Democrats’ starting point for drug pricing legislation in this Congress. While he called the House measure’s negotiation provision “urgent business,” Wyden’s legislation is seen as more acceptable to Democratic moderates wary of negotiations.

In a Senate split 50-50, the threat of a single defection from a Democratic moderate could force the party to narrow its drug pricing ambitions.

Drug lobbyists sees a potential ally in Democratic Sen. Kyrsten Sinema, the Arizona moderate who has shown a willingness to break with her party. She tallied $121,000 in campaign donations from drugmakers and pharmaceutical lobbying groups during the 2020 election cycle, more than double what she received the previous two-year cycle when she was on the ballot, according to an analysis by Kaiser Health News. Her office did not return a request for comment.

Sen. Joe Manchin (D-W.Va.), who’s emerged as a power broker for moderates, has co-sponsored legislation that would allow Medicare to negotiate prices. However, he hasn’t indicated whether he would support including drug price negotiations in the infrastructure package.

Fauci Says Vaccine Supply Will Be “Dramatically Increased” In Weeks Ahead

Dr. Fauci confident in federal government's response to coronavirus  pandemic - ABC News

Source: CBS News, by Melissa Quinn

Dr. Anthony Fauci, chief medical adviser to President Biden, said Sunday that the number of vaccine doses available will sharply rise in the coming weeks following federal approval of a third coronavirus vaccine.

“We need to gradually pull back [on restrictions] as we get more people vaccinated, and that is happening every single day, more and more people, and particularly as we get more doses, which are going to be dramatically increased as we get into April and May,” Fauci said on “Face the Nation” of scaling back mitigation measures.

The Food and Drug Administration has now authorized three COVID-19 vaccines for emergency use, with the most recent, Johnson & Johnson’s single-dose shot, receiving the green light last week.

The U.S. is now administering at least 2 million shots each day, and 87.9 million doses have been given, according to the Centers for Disease Control and Prevention (CDC). Mr. Biden has predicted that by the end of May, there will be enough vaccine supply to cover all adults, while Fauci said high school students likely will be able to receive their vaccines by the fall term and elementary school students by the first quarter of 2022.

Fauci said that as the vaccine supply increases, the federal government will “have to put a big push to get it into people’s arms.”

“But by that time, we’re going to be doing much, much better,” he said. “We’re going to have community vaccine centers, vaccine in pharmacies.”

While the number of new coronavirus cases in the U.S. has sharply declined over the last few weeks, public health officials warn the nation has hit a plateau of between 60,000 and 70,000 new infections per day, which Fauci said is “not an acceptable level.”

That leveling-off comes as some states like Texas and Mississippi have begun to lift mask mandates and loosen other restrictions designed to mitigate the spread of the coronavirus against the guidance of federal public health officials.

Fauci said the nation is “going in the right direction,” but stressed that mitigation measures should be rolled back slowly and carefully as more Americans are inoculated.

“Don’t turn that switch on and off because it really would be risky to have yet again another surge, which we do not want to happen because we’re plateauing at quite a high level,” he said.

While the number of Americans who have received their shots continues to grow, the Biden administration has yet to release guidance on activities for those who have been fully vaccinated.

But Fauci said those guidelines from the CDC should come out “imminently,” within the next few days.

“Every day that goes by that we keep the lid on things will get better and better because we’re putting now at 2 million vaccinations into the arms of individuals each day, and as the days and weeks go by, you have more and more protection, not only of individuals, but of the community,” he said. “So we’re going in the right direction. We just need to hang in there a bit longer.”

California Counties Don’t Want Centralized Vaccine Program Run by Blue Shield

Source: NBC Los Angeles, by Associated Press

Counties across California are increasingly asking to opt out of the state’s centralized vaccination program run by Blue Shield, further complicating Gov. Gavin Newsom’s plan to smooth out what has been a confusing and disjointed rollout of coronavirus vaccines.

None of the state’s 58 counties have signed contracts with the insurance giant even as the state moved ahead with plans to bring 10 counties in the inland sections of central and Southern California under Blue Shield oversight beginning this week, the Los Angeles Times reported Saturday.

“The hesitations and uncertainties span urban, suburban and rural parts of the state,” said Sarah Dukett, legislative advocate for the Rural County Representatives of California. “It’s not always the case that everyone is in the same boat. I hope the state is listening to that, but they really seem to be full steam ahead.”

The state is in the process of switching over to a vaccine appointment and delivery system administered by Blue Shield that is expected to be completed by March 31. The decision announced in February to outsource functions to Blue Shield that had previously been managed by public officials at the state and local levels was intended to ensure vaccines are distributed equitably and reach low-income communities disproportionately affected by the pandemic.

Last week, San Joaquin County Board of Supervisors requested looking into opting out of what they called a “tremendous bureaucratic system” that would be implemented under Blue Shield.

In a March 2 letter to Newsom, leaders of the Los Angeles County Board of Supervisors asked to exempted from Blue Shield’s oversight, saying the insurer’s officials “have not demonstrated they have adequate understanding of the unique needs and features of Los Angeles County, its diverse population, and where our residents go for health care.”

Ventura County made a similar request, but state and Blue Shield officials said opting out was not allowed, said Barry Zimmerman, chief deputy director for the county’s Health Care Agency.

Blue Shield officials told the state’s Community Vaccine Advisory Committee on Friday that contracts with counties were being finalized, although no timeline was provided. It’s unclear how a potential impasse with counties would affect vaccine distribution in those areas.

One of the counties’ main concern is a requirement in the Blue Shield contract that all vaccine providers use the state’s vaccine sign-up system, called My Turn. County officials have complained that the the system is riddled with flaws, some of which prevented counties from reserving appointments for targeted populations.

My Turn also requires vaccine providers to enter data twice: once in their own systems for billing and record-keeping, and a second time into the state’s new system. State officials said an interface between the two systems is scheduled to be completed in two weeks.

California announced Friday that it had surpassed 10 million vaccinations, with 1.67 million doses administered in the last seven days. It’s too early to attribute that uptick to changes under Blue Shield, a spokesperson for the California Department of Public Health said.

Counties are continuing to receive vaccine, despite the contract hang-ups. Erika Conner, a spokeswoman for Blue Shield, said vaccine providers who were already receiving doses before the new contract are continuing to receive them during the transition period.

“Our aim is to enhance the state network to support the state’s goal to increase its capacity and be able to administer 4 million doses a week — and we are well on our way to meeting that milestone,” Conner said in a statement.

Biden To Announce ‘Historic Partnership’: Merck Will Help Make Johnson & Johnson Coronavirus Vaccine, Officials Say

Johnson & Johnson coronavirus vaccine FAQ: What you need to know - The  Washington Post

Source: The Washington Post, by Laurie McGinley and Christopher Rowland

President Biden will announce Tuesday that pharmaceutical giant Merck will help make Johnson & Johnson’s single-shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials.

The officials, who spoke on the condition of anonymity to discuss a matter that has not been announced, said they began scouring the country for additional manufacturing capacity after they realized in the first days of the administration that Johnson & Johnson had fallen behind in vaccine production. They soon sought to broker a deal with Merck, one of the world’s largest vaccine makers, which had failed to develop its own coronavirus vaccine.

Under the arrangement, Merck will dedicate two facilities in the United States to Johnson & Johnson’s shots. One will provide “fill-finish” services, the last stage of the production process during which the vaccine substance is placed in vials and packaged for distribution. The other will make the vaccine, and has the potential to vastly increase supply, perhaps even doubling what Johnson & Johnson could make on its own, the officials said.

“It’s a historic partnership,” said one of the officials, adding that the companies “recognize this is a wartime effort.” He praised their sense of “corporate citizenship.”

The officials declined to provide details about how Merck’s involvement will affect the projected supply of the Johnson & Johnson vaccine and the timetable for distributing it. It could easily take two months to get the “fill-finish” plant ready and a few more months to equip the other facility to make the vaccine, according to a person familiar with the process who spoke on the condition of anonymity because he was not authorized to discuss the issue.

The Biden administration’s efforts to ramp up production of the Johnson & Johnson vaccine suggest that it sees the vaccine playing a bigger role in addressing the challenges ahead, such as the eventual need for children’s vaccines and possibly for boosters to counter virus variants, said a person familiar with the situation who spoke on the condition of anonymity because he was not authorized to discuss it. Johnson & Johnson is conducting a trial of a two-shot vaccine regimen, with the doses given two months apart; results are not expected until at least May.

Johnson & Johnson did not respond to a request for comment. Merck did not comment on the deal but said it “remains steadfast in our commitment to contribute to the global response to the pandemic.”

The administration officials indicated Biden would wield the powers of the Defense Production Act, a Korean War-era law, to give Merck priority in securing equipment it will need to upgrade its facilities for vaccine production, including the purchase of machinery, bags, tubing and filtration systems.

In teaming up with Merck, Johnson & Johnson has a partner with a century-long tradition of making vaccines. In the United States, Merck is the sole supplier of the combination childhood vaccine that protects against measles, mumps and rubella. It developed Gardasil, which protects against the human papillomavirus. And it won Food and Drug Administration approval for an Ebola vaccine in 2019.

But the company, which makes vaccines in North Carolina, Pennsylvania and elsewhere, encountered setbacks in its quest to develop a coronavirus vaccine. Merck announced Jan. 25 that it was halting work on two experimental shots for the virus. The vaccine did not stimulate enough antibodies in Phase 1 human clinical trials to justify continuing, the company said.

Johnson & Johnson has been searching the world for manufacturing sites where it could produce doses of its vaccine on a global scale. It has publicly disclosed more than half a dozen manufacturing sites on four continents that it said were winnowed from more than 100 possibilities.

“While the science and the biology, the chemistry is certainly challenging … the engineering feat of actually producing it is just as challenging, and we’ve been working very, very closely with partners around the world,” Johnson & Johnson CEO Alex Gorsky told CNBC on Monday.

Johnson & Johnson’s vaccine uses an adenovirus vaccine as a vector — a harmless cold virus that does not replicate in the body — to deliver DNA instructions into a healthy human cell. The cell uses the genetic instructions to create a replica of a coronavirus spike protein that triggers an immune response that can recognize — and respond to — the real thing. The U.S. government paid the company $2 billion for development and clinical trials and preorders at a price of $10 per dose just days after it received emergency authorization from federal regulators.

The FDA on Saturday authorized the Johnson & Johnson vaccine for use in those 18 and older. The company said it would immediately ship nearly 4 million doses in the United States, and a total of 20 million by the end of March, which is 17 million less than expected under its government contract. Its current schedule calls for a recovery from those delays, with the company saying it is on track to deliver 100 million doses by the end of June. A top company executive told Congress last week that it has a goal of manufacturing 1 billion doses worldwide by year’s end.

Most of Johnson & Johnson’s partners disclosed to date are contract manufacturing companies, but now it is moving to team with larger drug companies that have seen their own vaccine projects delayed or fizzled.

Sanofi — which had to reboot its clinical trials of a vaccine candidate after early stumbles — announced last week that it would help Johnson & Johnson with final production steps and bottling in vials in Europe. Projected capacity from a Sanofi plant in France is 12 million doses per month.

BioNTech, Pfizer’s German partner on its mRNA vaccine, also announced deals in January for rivals Sanofi and Novartis to fill and finish vaccine vials in Europe.

The manufacturing process is time-consuming: Johnson and Johnson ferments large batches of its vaccine in vats at a contract manufacturing facility in Baltimore operated by Emergent, as well as locations in the Netherlands and India. That brewing step takes two months.

Then, the vaccine needs to be put into its final formulation and packaged into vials for shipping, which takes another five to six weeks, including testing for purity. In the United States and Europe, that final “fill-finish” process for vaccines has created bottlenecks across the industry, as manufacturers have flooded the supply chain with demand to finish hundreds of millions of doses.

Johnson & Johnson has agreements for fill-finish work to be done by two companies in the United States: Grand River Aseptic, with plants in Michigan, and Catalent, at a plant in Indiana. Catalent also is performing fill-finish operations for Moderna, which is obligated to deliver 300 million doses of its mRNA vaccine to the government by the end of July.

In Italy, Catalent also is helping Johnson & Johnson and AstraZeneca manufacture their vaccines.

Moderna said on Feb. 16 that Catalent had suffered short-term delays on final production of Moderna’s vaccine, but that the disruptions would not affect monthly deliveries to the U.S. government. The Financial Times reported on Saturday that Catalent’s system for automatic visual inspection of Johnson & Johnson vials had broken down, forcing staff members to inspect vials manually.

Catalent said Tuesday that it had sufficient, dedicated capacity at its Bloomington, Ind., plant to handle the vaccine volume for both companies.

“Catalent is on track to deliver on our commitments for Johnson & Johnson covid-19 vaccine deliveries as soon as we are approved to begin shipments by the FDA, which we anticipate in the coming weeks. Catalent is also on schedule to meet our commitment to Moderna to produce 100 million doses by the end of March 2021,” company spokesman Chris Halling said in an email.

Merck’s help in making Johnson & Johnson’s vaccine probably will require it to examine its product lines and decide what can be delayed or shifted, said John Grabenstein, a consultant and former executive director of medical affairs for vaccines at Merck.

“The question is, where is the bottleneck? The filling machines and the packaging machines are often the rate-limiting step,” he said. From a technical standpoint, it’s not too hard for other companies to help out, he said.

“It’s not just a mechanical engineering problem. It’s what products might get displaced to do this extra work,” he said. “Is there idle equipment? Oftentimes, there isn’t.”

Merck continues working on a pair of coronavirus treatments. One is an antiviral pill it is developing with a small company called Ridgeback Bio. It purchased worldwide rights to the drug last year from Ridgeback and has entered a late-phase clinical trial in an ongoing collaboration.

The other experimental Merck drug is an anti-inflammatory protein that it received as part of the purchase last year of a smaller company, OncoImmune.

Last Updated 05/05/2021

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