The next step in Biden’s effort to lower drug prices

https://www.axios.com/2022/10/21/bidens-effort-lower-drug-prices

The next phase of the Biden administration’s bid to curb rising drug costs is in the hands of an under-the-radar federal office called the Center for Medicare and Medicaid Innovation (CMMI).

Driving the news: The center will publish a report within three months on how it can use new payment and delivery models to lower drug costs and boost access to treatments for beneficiaries of the two government health programs, per a recent executive order from President Biden.

Zoom in: CMMI was created through the Affordable Care Act to experiment with new ways of paying for and delivering health care.

  • Pilot programs typically last for years. Participation is usually voluntary, but the center can require provider involvement in some cases.
  • CMMI programs can become permanent fixtures of Medicare and Medicaid —  if they’re found to save money or improve care quality.

Be smart: The expectation is the center will tackle the prices health providers pay for Medicare drugs like infusions or injectables. Under the Inflation Reduction Act, the government can’t negotiate prices for these drugs until 2028.

  • Experimenting with price negotiation or payments based on patients’ health outcomes could help regulators learn best practices before that start date.
  • The center may also look for ways to incorporate drug pricing reforms into its existing projects and across different federal payers, said David Ault, a lawyer at Ropes & Gray and a former CMMI employee.

Refining policies from recent congressional action on Medicare prescription drug pricing could also be on the agenda.

  • The center could test alternative versions of the $2,000 annual cap on out-of-pocket costs for Medicare prescription drugs, for example.
  • Incorporating a monthly spending limit “could avoid having people pay everything in one month, after which all of their treatments are free,” Stacie Dusetzina, a health policy professor at Vanderbilt University Medical Center, wrote in an email.

Flashback: CMMI has tried to tackle drug prices under previous administrations, with mixed success.

  • Both the Obama and Trump administrations failed to implement experiments meant to lower health providers’ Medicare drug costs. But 106 health plan sponsors currently participate in a center program that gives seniors access to lower-cost insulin.

Reality check: It could take some time to get new drug pricing experiments up and running.

  • Programs typically take a year and a half to two years to be approved and implemented, so any new drug pricing model likely wouldn’t start until at least 2024, Ault said.

Don’t forget: The Centers for Medicare and Medicaid Services, the center’s parent, will continue its own work on drug pricing as it implements policies from the Inflation Reduction Act.

  • Congress also hasn’t tapped out of the discussion. Lawmakers seem keen to continue talking about insulin costs and pharmacy benefit manager practices, Rachel Sachs, a law professor at Washington University in St. Louis, told Axios.

Zoom out: Expect to see more from CMMI in the next couple years, on drug pricing reforms and other federal health care policy issues.

  • “You oftentimes see the innovation center being very active in the last few years of administration, trying to take ideas or concepts … far enough along that they’re in place, should there be a change in political party,” Ault said.

House expected to vote to pass healthcare and climate reform bill, sending it to President Biden for signature

https://mailchi.mp/11f2d4aad100/the-weekly-gist-august-12-2022?e=d1e747d2d8

The $740B Inflation Reduction Act (IRA) includes significant reforms for Medicare’s drug benefits, including capping seniors’ out-of-pocket drug spending at $2,000 per year, and insulin at $35 per month. Medicare plans to fund these provisions by requiring rebates from manufacturers who increase drug prices faster than inflation, and through negotiating prices for a limited number of costly drugs. Drug prices are consistently a top issue for voters, but seniors won’t see most of these benefits until 2025 or beyond, well after this year’s midterms and the 2024 general election. 

The Gist: While this package allows Democrats to deliver on their campaign promise to allow Medicare to negotiate drug prices, the scope is more limited than previous proposals. Over the next decade, Medicare will only be able to negotiate prices for 20 drugs that lack competitors and have been on the market for several years.

Still, because much Medicare drug spending is concentrated on a few high-cost drugs, the Congressional Budget Office projects the bill will reduce Medicare spending by $100B over ten years. However, these negotiated rates and price caps don’t apply to the broader commercial market, and some experts are concerned this will lead manufacturers to raise prices on those consumers—creating yet another element of the cost-shifting which has been the hallmark of our nation’s healthcare system. 

The pharmaceutical industry also claims that this “government price setting” will hamper drug development (although there is limited to no evidence to support this proposition), signaling that they will likely spend the next several years trying to influence the rulemaking process as the new law is implemented.

7 healthcare takeaways from Senate Democrats’ newly passed $739B landmark bill

With a 51-50 vote, Senate Democrats passed a sweeping $739 billion bill Aug. 7 that furthers some of the largest changes to healthcare in years.

Titled the Inflation Reduction Act, the bill touches energy, tax reform and healthcare. The House is expected to take it up Aug. 12, with Democrats aiming to approve it and send it to President Joe Biden’s desk.  

Here are seven healthcare takeaways from the 755-page bill

Drug pricing

1. For the first time, Medicare would be allowed to negotiate the price of prescription medicines with manufacturers. Negotiation powers will apply to the price of a limited number of drugs that incrementally increases over the next seven years. Ten drugs will be eligible for negotiations beginning in 2026; eligibility expands to 15 drugs in 2027 and 20 by 2029

2. The HHS secretary will provide manufacturers of selected drugs with a written initial offer that contains HHS’ proposal for the maximum fair price of the drug and reasoning used to calculate that offer. Manufacturers will have 30 days to either accept HHS’ offer or propose a counteroffer.  

3. Members of Medicare Part D prescription drug plan would see their out-of-pocket costs for prescription drugs capped at $2,000 per year, with the option to break that amount into monthly payments, beginning in 2025.

4. Democrats lost on a provision to place a $35 cap on insulin for Americans covered by private health plans. The provision to cap insulin at $35 dollars for Medicare enrollees passed by a of 57-43. 

5. Drug companies will be required to rebate back price differences to Medicare if they raise prices higher than the rate of inflation, coined an “inflation rebate.”

6. The legislation makes all vaccines covered under Medicare Part D free to beneficiaries with no deductibles, co-insurance or cost-sharing, starting in 2023. 

Tax subsidies 

7. The legislation extends the Affordable Care Act’s federal health insurance subsidies, now set to expire at the end of the year, through 2025. Democrats say the extension will prevent an estimated 3.4 million Americans from losing health coverage.

Democrats reach deal on healthcare and climate bill

https://mailchi.mp/ff342c47fa9e/the-weekly-gist-july-22-13699925?e=d1e747d2d8

Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) surprised everyone Wednesday night by announcing they reached a deal on a legislation package called the Inflation Reduction Act of 2022. The deal is a revival of portions of President Biden’s “Build Back Better” plan, more narrowly scoped to meet the demands of Sen. Manchin.

On the healthcare front, the bill would allow Medicare to negotiate prices for certain prescription drugs starting in 2026, and limit seniors’ annual out-of-pocket spending on Part D prescriptions to $2,000. It also includes $64B to extend the enhanced tax credits for Affordable Care Act exchange plans through 2025, avoiding health plan rate increases for millions of Americans. 

The Gist: While several Senate Democrats have announced support for the legislation, the party can’t afford any holdouts given its razor-thin majority. If all Democrats get on board, this legislation will fulfill the party’s longtime promise to lower prescription drug prices. But it stops well short of other major healthcare measures being discussed last year, including expanding Medicare coverage to include dental, vision, and hearing coverage, and closing the so-called Medicaid coverage gap. 

Current state of President Biden’s healthcare policy agenda

https://mailchi.mp/30feb0b31ba0/the-weekly-gist-july-15-2022?e=d1e747d2d8

With a closely divided Congress, President Biden has leaned heavily on regulatory actions to advance his healthcare priorities. With the midterm elections fast approaching, the graphic above assesses the impact of those actions, and outlines which legislative components Democrats may still try to pass before November.

From the start, the administration has signaled the importance of promoting competition in healthcare markets, and has devoted more scrutiny to hospital mergers—while leaving most attempts at vertical integration unchallenged. Through Medicaid waivers, it has worked to expand insurance coverage, rolling back Trump-era work requirements, expanding postpartum coverage, and encouraging states to experiment with public option plans on the Affordable Care Act (ACA) exchanges.

The Centers for Medicare and Medicaid Services (CMS) has continued the steady march toward value programs, revising the Direct Contracting model to factor in health equity. Despite these incremental moves, Medicare Advantage (MA) remains the focus of long-term efforts to control Medicare spending, and MA programs have seen payments boosts year-over-year.

Meanwhile, the fate of President Biden’s signature healthcare campaign promises remains in the hands of an intransigent Congress. Senate Democrats are currently trying to negotiate a deal on a bill allowing Medicare drug negotiations and extending ACA subsidies, an important provision to protect millions from receiving premium hike notices just weeks before Election Day.  

Democrats Should Talk About Costs, Not Fairness, to Sell Drug Pricing to Voters

https://view.newsletters.time.com/?qs=ea318fe40822a16d35fd05551e26f48182b6d89aa3b6000b896a9ff2546a39caab4656832bb3a0c5bda16bcd6517859e00eba11282e80813fd45887b2c2398c865b7cca1f30f6315a7a3fb7a1b05cde6

Democrats Should Talk About Costs, Not Fairness, to Sell Drug Pricing to  Voters | Time

Here in Washington, the conversation about politics is often framed as a spectrum, a straight line with poles at the end that are hard-wired opposites. Team Blue to the left and Team Red to the right. But in reality, the chatter might more accurately be framed as a loop, with the far ends bending back on themselves like a lasso. Eventually, the far-right voices and the far-left voices meet at the weird spot where Rand Paul supporters find common ground with The Squad.

It’s often at the knot between the two ends of that scale that we find some of the loudest voices on any given issue: foreign aid, vaccine mandates, the surveillance state. Right now, as Congress is considering a massive spending package on roads and bridges, pre-K and paid family leave, lawmakers have been debating a point on which political opponents agree: drug prices are too high.

Drug pricing is one of those rare sweet spots where it seems everyone in Washington can agree that consumers are getting a raw deal. The motives behind that sentiment differ, of course: liberals want to make medical care more accessible and to curb the power of big pharma, and conservatives see drug prices divorced from pure capitalism. But everyone can rally around the end goal. No one gets excited to tuck away pennies on the paycheck to control acid reflux or prevent migraines.

The package under consideration tries to fix drug costs by ending the ban on feds negotiating with pharmaceutical companies. In a deal hashed out among Democrats, Medicare would be allowed to negotiate directly with drug companies on the prices of the 10 most expensive drugs by 2025. That number would double to 20 drugs three years later. Only established drugs that have been on the market at least nine years in most cases would be eligible, giving pharmaceutical companies almost a decade of unrestricted profitability. (Start-up biotech companies would be exempted from the process under the guise of giving newcomer innovators a leg-up.)

For individuals on private insurance, their drug costs would be tied to inflation, meaning no spiking costs if a drug becomes popular. Seniors, meanwhile, would have a $2,000 cap on what they’d be responsible for at the pharmacy.

Democrats have been working for years to make drug companies the enemy. In the current environment of woke capitalism, they’re an easy target for lawmakers in Washington to come after. Drugs, after all, aren’t luxury goods. They’re necessary. And for the government to give them a pass in ways few other industries enjoy, that just seems wrong to the far-left wing of the Democratic Party that has flirted with elements of socialism.

It turns out, maybe that messaging isn’t working. New polling, provided exclusively to TIME from centrist think tank Third Way, suggests the way the conversation is framed matters more than you’d think. In a poll of 1,000 likely voters in September, costs were their biggest hangup about the healthcare system, regardless of political identity. Almost 40% of respondents cited healthcare costs as the biggest flaw in the system.

What didn’t seem to bother people much? Fairness. That’s right. The spot where the far-right and the far-left tines of the political fork meet is usually seen as an objection to a system rigged against the consumers. But a meager 18% of respondents to the Third Way poll say profits were what’s wrong with the system. Grievance isn’t the most grievous of problems.

And if you dig a little deeper, you find other reasons Democrats might want to reconsider how they talk about drug prices in the twin infrastructure plans parked in Congress. In fact, there’s a 12-point gap in two competing reasons to address healthcare; lowering costs draws the support of 72% of respondents while making things fair wins backing from 60%.

“This is kitchen table economics and it’s not a morality play,” says Jim Kessler, a co-founder of Third Way and its policy chief who is advising the Hill on messaging on the twin bills. “Those are winning messages, especially on healthcare. You’re going to keep the exact same system, but you’re going to get some help with costs.”

In other words, the chatter in the purple knot might feel most fulsome when talking about justice and weeding out the super-rich exploiters of capitalism. But, really, people just want to hold onto their cash. Protections against healthcare bankruptcy are super popular, suggesting the fear of losing everything to a hospital visit is real. Capitalism may well be exploitative but it’s tough to argue that a few extra bucks in the bank can make falling asleep easier at the end of the day.

So as Congress gets ready to move forward with drug prices in its infrastructure talks, lawmakers can find some comfort that the whole of the political spectrum agrees costs need to come down. And they don’t really care if it’s done in a fair way — as long as their savings doesn’t take a hit every 90 days.

Deal to Lower Prescription Drug Prices

https://thehill.com/policy/healthcare/579660-schumer-announces-deal-to-lower-prescription-drug-prices

Texas Drug Prices Reduced By New Bill To Lower Prescription Prices

Democratic lawmakers have reached a deal on legislation to lower prescription drug prices to be included in President Biden‘s social spending package, Senate Majority Leader Charles Schumer (D-N.Y.) announced Tuesday.  

The agreement is less far-reaching than earlier Democratic proposals, but still represents progress on an issue the party has campaigned on for years.  

The agreement would allow Medicare to negotiate drug prices in limited instances, prevent drug companies from raising prices faster than inflation and cap out-of-pocket costs for seniors on Medicare at $2,000 per year.

Democrats scaled back their earlier sweeping measure because of concerns from a handful of moderates that it would have harmed innovation from drug companies to develop new treatments. Sen. Kyrsten Sinema (D-Ariz.), as well as Reps. Scott Peters (D-Calif.) and Kurt Schrader (D-Ore.) were among those moderates and helped lead negotiations with leadership over the compromise measure.

“It’s not everything we all wanted, many of us would have wanted to go much further, but it’s a big step in helping the American people deal with the price of drugs,” Schumer told reporters.

Sinema said in a statement that she supported the agreement. “The Senator welcomes a new agreement on a historic, transformative Medicare drug negotiation plan that will reduce out-of-pocket costs for seniors – ensuring drug prices cannot rise faster than inflation – save taxpayer dollars, and protect innovation to ensure Arizonans and Americans continue to have access to life-saving medications, and new cures and therapeutics,” Sinema’s office said.

One of the key compromises leading to a deal was limiting the scope of Medicare’s ability to negotiate lower drug prices, which has long been a signature Democratic proposal. Lawmakers agreed to limit Medicare’s ability to negotiate to older drugs that no longer have “exclusivity,” meaning the period when they are protected from competition. Earlier versions of Democrats’ bills would have allowed negotiation for newer drugs too.

A draft measure that circulated to lobbyists in recent days would allow negotiation for 10 drugs starting in 2025 and 30 drugs starting in 2028. Full details of the final measure have not yet been released.

Drug pricing, most Medicare expansions are out of Biden’s economic bill

https://www.washingtonpost.com/politics/2021/10/28/drug-pricing-most-medicare-expansions-are-out-biden-economic-bill/

The FDA could greenlight a vaccine for kids as soon as Friday and more workers now have vaccine mandates. But first: 

Democrats are ditching progressives’ health priorities in their economic bill

The White House says Democrats have clinched a deal. 

The $1.75 trillion framework for Biden’s massive social spending bill temporarily funds several of the party’s health care ambitions. But it includes big misses on health care, such as significantly paring back progressives’ goal of adding new benefits to Medicare — instead including only coverage for hearing services — and excluding Democrats’ plan aimed at lowering the sky-high prices of prescription drugs. 

Will all Democrats get on board? Senior administration officials projected confidence that they would, and characterized the framework as the biggest expansion of health care in a decade. Yet, it includes major defeats for the party’s more liberal members, who have been reticent to draw red lines on what they would or wouldn’t support.

It’s a critical day. President Biden is heading to huddle privately with House Democrats this morning. House Speaker Nancy Pelosi announced plans for the chamber’s Rules Committee to hold a hearing, although legislative text hasn’t yet been released. And before leaving for his trip overseas, Biden will speak publicly about the path forward for his legislative agenda, per a White House official. 

Early this morning, senior administration officials spoke to reporters on the condition of anonymity to detail the framework. 

What’s in and what’s out

Prescription drug negotiation: OUT

Democrats campaigned on reducing prices of prescription drugs — and letting Medicare directly force lower prices is a key plank of that effort. But the party couldn’t overcome fierce divisions amid a lobbying storm.

  •  “At the end of the day, there are not yet enough votes to get something across the line to deliver what the American people need and expect on prescription drugs,” a senior administration official said. “We’re going to keep fighting to get this done and deliver lower drug prices.”

The House’s signature drug proposal faced resistance from a trio of House moderates who instead backed more limited drug negotiation. On the other side of the Capitol, Sen. Kyrsten Sinema had raised objections and other senators had concerns with a bill as sweeping as the one the House passed in 2019. The industry’s main trade group has been working furiously to keep the proposal out of Democrats’ economic package.

  • Of note: The framework includes fully repealing a Trump-era ban on prescription drug rebates as a way to offset the cost of the package. The administration anticipates that would save $145 billion.

Medicare expansion: mostly OUT

Sen. Bernie Sanders (I-Vt.) and the House Congressional Progressive Caucus have been bullish on two main health policies: allowing the federal government to negotiate drug prices, and using those savings to expand Medicare to cover dental, vision and hearing.

The framework only creates a new Medicare benefit for hearing. 

  • Rep. Pramila Jayapal (D-Wash.), the chair of the CPC, has repeatedly said her 96 members aren’t drawing red lines. But here’s how she characterized the CPC’s thoughts yesterday: “For a lot of members, it’s like what are we doing for seniors? How do we make sure we get some benefits for seniors in here?”
  • Sanders is the person to watch here. He’s long championed expanding Medicare, and has already come down on his ambitions for a wide-ranging $6 trillion bill.

Closing the Medicaid coverage gap: IN 

The framework extends coverage for 2.2 million adults in the dozen, mostly GOP-led states that have refused Obamacare’s Medicaid expansion. They’ll get tax credits to receive premium-free health coverage on the Obamacare health exchanges through 2025. 

Earlier this week, Manchin raised concerns with allowing the federal government to pay for health coverage for 2.2 million adults in the dozen, mostly GOP-led states refusing Obamacare’s Medicaid expansion. His own colleagues — such as Georgia Sens. Raphael Warnock and Jon Ossoff — lobbied heavily to change his mind.

Obamacare subsidies: IN

The framework would extend more generous financial help to Obamacare consumers through 2025, building on an effort that began in Biden’s coronavirus relief bill passed this spring. 

In-home care: IN 

Biden has pushed for a $400 billion investment in home care for seniors and the disabled. It’s been clear for weeks that his ask will be significantly pared back. Administration officials said funding for home and community-based services is included in the framework, but didn’t detail how much money would go toward the program helping keep seniors and those with disabilities out of institutional settings.   

Democrats’ risky health care play

https://www.axios.com/democrats-health-care-coverage-medicaid-affordable-care-act-4758a48b-fc65-4ca4-8c1e-888c882e759f.html

Some Democrats say it’s possible that pieces of their social policy agenda end up being enacted or extended for only a year or two, including major Affordable Care Act and Medicaid provisions.

Why it matters: Limited terms may be the only way Democrats can strike a deal within their budget. But the risk is that Republicans will be able to undo these temporary programs if they’re able to regain control of Congress through next year’s midterms.

  • There also aren’t many policy areas that Republicans are less excited about than the ACA and Medicaid expansion.

What they’re saying: Extending programs for only a year or two is a “possibility,” Senate Majority Whip Dick Durbin (D-Ill.) told Axios.

  • Extending enhanced ACA subsidies and closing the Medicaid coverage gap were measures that “we wanted … to be permanent,” said Sen. Ben Cardin D-Md.). “Clearly there’s a lot of pressure to get as much in as we can, [which] means shorter periods.”
  • “I think all of the programs are being considered for shorter periods. There are some that are of greater importance to get as long as possible,” Cardin added. He said it’s also possible that an extension of the child tax credit would also last only a year.

The big picture: Political, budgetary and practical factors are all at play as Democrats try to figure out what’s in and what’s out of their reconciliation bill.

  • But one giant consideration when it comes to the health care provisions — particularly the ACA and Medicaid ones — is that Republicans may not feel compelled to extend these programs should they gain power.
  • “I expect Republicans would be glad to take back the mantle of the child tax credit but Democrats should not fool themselves into thinking Republicans will feel any real pressure to extend these health care policies,” said Brendan Buck, a longtime aide to former Republican House Speaker Paul Ryan.

The other side: Republicans may encounter political pressures similar to the ones they did in 2017, when they struggled — and ultimately failed — to repeal and replace the ACA.

  • Declining to extend Democrat-enacted coverage policies in the next couple of years would be somewhat similar, in that the result would be millions of low-income people would lose their health coverage or see its cost skyrocket.
  • Also, most of the states that haven’t expanded Medicaid are ruby-red.
  • “Remember what happened with the Affordable Care Act — they said that they didn’t like these things, but then they couldn’t repeal them because they didn’t have another option,” said Sen. Tina Smith, (D-Minn.)

Yes, but: But inaction is different from voting to end a benefit, Buck said.

  • Some Democrats are skeptical, too.
  • “The modern Republican party isn’t for much other than the destruction of government. So the idea that Republicans are going to want to hold onto programs even if they benefit the middle class runs a bit contrary to the recent history of the party,” said Sen. Chris Murphy (D-Conn.).

The bottom line: At this point, Democrats will take any party-wide agreement they can get. And temporary health coverage expansions may have their upside.

  • “It’s an easy way to slim costs,” said one Democratic strategist, adding that it allows both Sen. Bernie Sanders (I-Vt.) and Sen. Joe Manchin (D-W.Va.) to claim victory.
  • “If I’m [Majority Leader] Chuck Schumer, I do it for a year and make Republicans vote on it in October,” right before the midterm elections, the strategist added.

Democrats’ prescription drug collapse

After campaigning on health care one election cycle after another, Democrats have put forward a social policy framework that does nothing to lower prescription drug prices, expands Medicare benefits to only include hearing coverage, and temporarily builds on the Affordable Care Act.

Why it matters: The framework may be the best the party can do with razor-thin vote margins in Congress. But some health care advocates say it’s unacceptable — and voters may not be thrilled either.

The big picture: Democrats can certainly claim some health care victories.

  • The framework would extend the enhanced ACA subsidies that the party enacted earlier this year, although only through 2025. This has been plenty of moderate Democrats’ primary health care goal.
  • The framework also makes ACA subsidies available to people in the Medicaid coverage gap in states that have chosen not to expand, another major priority for many Democrats. This would also last through 2025.

The other side: Progressives have a much tougher pill to swallow. And when it comes to drug prices, nearly the entire party has campaigned on lowering them.

  • Progressives, championed by Sen. Bernie Sanders, have been pushing for Medicare to cover dental and vision benefits, as well as hearing. And that’s a far cry from what they actually want, which is Medicare to be offered to more or all Americans.
  • Lowering drug costs and expanding Medicare benefits are also very popular with voters — particularly seniors, who vote in large numbers.

What they’re saying: “We are outraged that the initial framework does not lower prescription drug prices,” said AARP in a statement. “Americans are fed up with promises that have not been kept.”

  • “The president and Democratic leaders are on the record fiercely supporting drug price negotiations and Medicare dental benefits. These are wildly popular benefits that almost all families across this nation want. Unfortunately, this small number of intransigent Democrats, who are schilling for lobbyists and drug companies, are standing in the way,” Families USA wrote in a statement.

What we’re watching: What’s out today is just a framework, and some key Democrats are vowing to keep fighting.

  • Energy and Commerce Chairman Frank Pallone and Senate Finance Chairman Ron Wyden both told reporters that drug prices are still being discussed.
  • And plenty of other Democrats, especially those in vulnerable seats, may be very sensitive to the prospect of failing to follow through on the party’s commitment.