Medicare for All Emerges as Early Policy Test for 2020 Democrats

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Senator Elizabeth Warren spoke at length this week about her vision for improving the American health care system, like strengthening the Affordable Care Act and making prescription drugs more affordable. Twice, though, she ignored a question posed to her: Would she support eliminating private health insurance in favor of a single-payer system?

“Affordable health care for every American” is her goal, Ms. Warren said on Bloomberg Television, and there are “different ways we can get there.”

To put it another way: I am not walking into that political trap.

Ms. Warren of Massachusetts and three other liberal presidential candidates support a Medicare for All bill, which would create a single-payer health plan run by the government and increase federal spending by at least $2.5 trillion a year, according to several estimates. But Ms. Warren’s determination to sidestep an essential but deeply controversial issue at the heart of the single-payer model — would people lose the choices offered by private insurance? — illustrated one of the thorniest dilemmas for several Democrats as the 2020 primary gets underway.

Their activist base, inspired by Senator Bernie Sanders of Vermont, believes that the party should unabashedly pursue universal health care, ending private insurance entirely. But polls indicate that the broader electorate, particularly the moderate- and high-income voters who propelled the party’s sweeping suburban gains in the midterms, is uneasy about this “Medicare for all” approach in which many would lose their current insurance options and pay higher taxes.

Senator Kamala Harris of California drew immediate attacks from Republicans this week by taking on the issue that Ms. Warren dodged. Ms. Harris breezily acknowledged in a CNN town hall forum that she would “eliminate all of that,” referring to ending private insurance in a country where almost 60 percent of the population receives coverage through an employer.

Her remark triggered an intraparty debate about an issue that until now had been largely theoretical: A decade after Democrats pushed through the most significant expansion of health care since the Great Society, should they build incrementally on the Affordable Care Act or scrap the insurance sector entirely and create a European-style public program?

Four Democratic presidential candidates — Ms. Harris, Ms. Warren, Senator Kirsten Gillibrand of New York and Senator Cory Booker of New Jersey — are among the co-sponsors of Mr. Sanders’s Medicare for All bill, which would replace the Affordable Care Act with a single government health plan for all Americans. Medicare is the federal program providing health coverage to people 65 and older.

The concept of Medicare for all has become popular with Democrats: 81 percent support it, according to a recent Kaiser poll. Yet voter opposition to surrendering the insurance they are used to led to a backlash over President Barack Obama’s repeated promise that “if you like your plan, you can keep your plan” after it proved false for several million people under his health law. Many Democrats are keenly aware of that backlash, and the 2020 presidential race will be the first where many of the party’s leading candidates will have to explain and defend the meaning of Medicare for all.

For now, as Ms. Warren demonstrated, many candidates do not want to wrestle publicly with the details. After Ms. Harris’s comment, her aides hastened to add that she would also support less sweeping changes to health care; like most other candidates, Ms. Harris declined an interview request. And by Friday, Mr. Booker, hours after announcing his presidential bid, sought to curtail the matter by offering a brisk “no” when asked if he supported eliminating private coverage.

Yet there is one likely 2020 contender who is thrilled to discuss Medicare for all.

Mr. Sanders, in an interview, did not mince words: The only role for private insurance in the system he envisioned would be “cosmetic surgery, you want to get your nose fixed.”

“Every candidate will make his or her own decisions,” Mr. Sanders said, but “if I look at polling and 70 percent of the people support Medicare for All, if a very significant percentage of people think the rich, the very rich, should start paying their fair share of taxes, I think I’d be pretty dumb not to develop policies that capture what the American people want.”

But Michael R. Bloomberg, the former New York City mayor who is considering a 2020 bid on a centrist Democratic platform, said it would be folly to even consider a single-payer system. “To replace the entire private system where companies provide health care for their employees would bankrupt us for a very long time,” Mr. Bloomberg told reporters in New Hampshire on Tuesday.

The Congressional Budget Office has not scored Mr. Sanders’s Medicare for All bill, but a study last year by the Mercatus Center of George Mason University predicted it would increase federal spending by at least $32.6 trillion over the first decade. The cost could be even greater, the study says, if the bill overestimated the projected savings on administrative and drug costs, as well as payments to health care providers.

The divide between Mr. Sanders, a democratic socialist, and Mr. Bloomberg, a Republican-turned-independent-turned-Democrat, reflects the large chasm in a party that has been reshaped by President Trump.

The president’s hard-line nationalism has simultaneously nudged Democrats to the left, emboldening them to pursue unambiguously liberal policies, and drawn independents and moderate Republicans to the party because they cannot abide his incendiary conduct and demagogy on race. These dueling forces have created a growing but ungainly coalition that shares contempt for Mr. Trump but is less unified on policy matters like health care.

And these divisions extend to what is wisest politically.

Liberals argue that the only way to drive up turnout among unlikely voters or win back some of the voters uneasy with Hillary Clinton’s ties to corporate interests is to pursue a bold agenda and elevate issues like Medicare for all.

“Those who run on incremental changes are not the ones who are going to get people excited and get people to turn out,” said Representative Pramila Jayapal of Washington, the co-chair of the Congressional Progressive Caucus.

And by preserving their options, Democrats risk alienating liberal primary voters, some of whom consider support for Medicare for all a litmus test.

“The center is not a good place to be on these policies anymore,” said Mary O’Connor, 61, a substitute teacher and horse farmer in Middleburg, Va., who wants a single-payer system. “I’ll be watching extremely closely, and I will most likely jump on board and volunteer for whoever it is that’s going to be the most forceful for this.”

But moderates believe that most Democratic primary voters are more fixated on defeating Mr. Trump than applying litmus tests — and that terminating employer-sponsored insurance would only frighten the sort of general election voters who are eager to cast out Mr. Trump but do not want to wholly remake the country’s health care system.

“Most of the freshmen who helped take back the House got elected on: ‘We’re going to protect your health insurance even if you have a pre-existing condition,’ not ‘We’re going to take this whole system and throw it out the window,’” said Kenneth Baer, a Democratic strategist.

While polling does show that Medicare for all — a buzz phrase that has lately been applied to everything from single-payer health care to programs that would allow some or all Americans to buy into Medicare or Medicaid — has broad public support, attitudes swing significantly depending on not just the details, but respondents’ age and income.

On the House side, a bill similar in scope to Mr. Sanders’s is under revision and will soon be reintroduced with Ms. Jayapal as the main sponsor. Other Democrats have introduced less expansive “Medicare buy-in” bills, which would preserve the current system but would give certain Americans under 65 the option of paying for Medicare or a new “public option” plan. Another bill would give every state the option of letting residents buy into Medicaid, the government health program for poor Americans.

The buy-in programs would generally cover between 60 and 80 percent of people’s medical costs and would require much less federal spending because enrollees would still pay premiums and not everyone would be eligible. Some proponents, like Senator Jeff Merkley, Democrat of Oregon, have described them as a steppingstone on the way to a full single-payer system; some of the Democrats running for president are co-sponsoring these “Medicare for more” bills as well as Mr. Sanders’s.

Mr. Sanders has suggested options to raise the money needed for his plan, such as a new 7.5 percent payroll tax and a wealth tax on the top 0.1 percent of earners. He has also predicted several trillion dollars in savings over 10 years from eliminating the tax exclusion that employers get on what they pay toward their workers’ insurance premiums, and other tax breaks.

But Robert Blendon, a health policy professor at Harvard who studies public opinion, said it would be wise not to delve into financing details for now.

“The reason it failed in Vermont and Colorado was taxes,” Professor Blendon said, referring to recent efforts to move to a near-universal health care system in those states, which flopped resoundingly because they would have required major tax increases. “But Democratic primary voters will not go deep into asking how these plans will work. What they will say is, ‘Show me you have a principle that health care is a human right.’”

The general election will be a different story, Professor Blendon added. If Ms. Harris were to become the Democratic nominee and keep embracing the idea of ending private coverage, he argued, “she’s going to have terrible problems.”

The difficulty for Democrats, added Ezekiel Emanuel, a former Obama health care adviser, is that many voters look at the health care system the same way they view politics. “They say Congress is terrible but I like my congressman,” as Mr. Emanuel put it.

According to the Gallup poll, 70 percent of Americans with private insurance rate their coverage as “excellent” or “good;” 85 percent say the same about the medical care they receive. The Kaiser poll found that the percentage of Americans who support a national health plan drops by 19 percentage points when people hear that it would eliminate insurance companies or that it would require Americans to pay more in taxes.

Among those who make over $90,000 a year — the sort of voters in the House districts that several Democrats captured in the midterms — those surveyed in the Kaiser poll were particularly wary of an all-government system: 64 percent in this income group said they would oppose a Medicare for all plan that terminated private insurance.

“My constituents are tired of bumper sticker debates about complex issues,” said Representative Lizzie Pannill Fletcher of Texas, a freshman from an affluent Houston district. “We don’t want ideologues in charge.”

In Vermont, where former Gov. Peter Shumlin shelved his ambitious plan for a single-payer system in 2014 after conceding it would require “enormous” new taxes, advocates for universal health care are now resigned to a more incremental approach.

Dr. Deb Richter, a primary care doctor who helped lead the state’s single-payer movement, said that while the Democratic field is “going to have to face the T word,” being upfront about the required tax increases, she now thinks phasing in a government-run system is a better approach.

“There’s ways of doing this that don’t have to happen all at once,” she said, pointing to a push in Vermont to start with universal government coverage for primary care only. “But you need to talk about the end goal: We are aiming for Medicare for all, and this is a way of getting it done.”

 

 

 

Bipartisan Senate Budget Deal Boosts Health Programs

Bipartisan Senate Budget Deal Boosts Health Programs

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In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a two-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including two years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” said Senate Minority Leader Chuck Schumer (D-N.Y.) on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional four-year extension of the Children’s Health Insurance Program (CHIP), which builds on the six years approved by Congress last month.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs — some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall — a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions — meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for five years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” said Lori Freeman, CEO of advocacy group the Association of Maternal & Child Health Programs, in an emailed statement. “States, home visitors and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next two years for the National Health Service Corps and another $363 million over two years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.

 

Among Those Who Want to Lower Drug Prices, Cacophony, Not Consensus

https://www.statnews.com/2018/01/26/lobbying-drug-prices-health-care/

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Everyone seems to want lower drug prices. 5 reasons why that hasn’t happened.

Of all his campaign promises, President Trump’s vow to bring down drug prices was perhaps the most popular.

An assortment of interest groups spoke out loudly and passionately on the need for action, from hospitals to doctors to insurers to generic drug makers to patients themselves.

And in many ways, they seem to have the clout, and resources, to counter drug makers’ slick ad campaigns and lobbying firepower. Last year, the American Medical Association, America’s Health Insurance Plans, and the American Hospital Association together spent more than $45 million lobbying Congress, almost twice what the drug makers’ group, PhRMA, spent in the same time period.

Instead, congressional efforts to lower drug prices are at a total standstill. In interviews with STAT, lobbyists, lawmakers, and congressional staffers, Republicans and Democrats alike, said the most powerful health industry players conspicuously disagree about exactly how to move forward. Every group pushes its own priorities and strategies — a cacophony that makes it unlikely that crushing drug prices will change any time soon.

“They all say, ‘Yes, we should [lower drug prices], and someone else is responsible for it,’” Sen. Patty Murray of Washington, the top Democrat on the Senate Health, Education, Labor, and Pensions Committee, told STAT. “Everybody needs to come to the table and say what can my industry do, what can pharma do. … That will be how we solve this.”

Solving it, however, seems a stretch when just addressing it has gone nowhere. Despite President Trump’s insistence, on the campaign trail and in office, that he will lower drug prices, there has been no major federal effort to do so in the first year of his administration.

The disarray was on full display at a recent congressional hearing, when representatives from nearly every major trade group with any stake in the country’s drug prices — AMA, AHIP, and AHA included — spent almost an hour and a half testifying without more than a cursory discussion of how Congress could fix the problem. When they finally did talk solutions, outside of buzzy phrases like “increase transparency,” almost none of their answers matched.

So why can’t the broader health care industry agree on how to make drugs more affordable? Here are five factors.

1. Health care lobbyists are stuck playing defense.

When it comes to drug pricing, hospitals, insurers, and PBMs in particular have spent the last year fending off congressional inquiries into their own business practices — leaving little time to go on the offensive.

Meanwhile PhRMA has alternately pointed at hospitals, insurers, and PBMs as the profiteers in the current system.

It’s “lobbying 101, to muddy the waters,” according to Rep. Peter Welch (D-Vt.). And in the complicated world of drug pricing, it’s an effective strategy.

Drug makers’ efforts to vilify PBMs and to demand more transparency about their role in the supply chain are well-documented. The Washington Post earlier this year called pharma’s tactics against those players an effort to “start an industry war.”

They’ve opened a similar front against insurers, ramping up rhetoric and backing new patient groups that decry how higher deductibles and copays mean steeper costs for consumers, even when list prices don’t change much.

And they’ve accused hospitals of marking up the price of drugs and pocketing the difference, both in general and specifically as part of a push to overhaul the hot-button 340B drug discount program.

“That disarray you talk about, it’s not accidental,” Welch said. “The flames of that are fanned by pharma, [which] is doing everything they can to create confusion about what’s the right remedy,” he said.

The problem, according to Walid Gellad, who leads the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing, “is that every part of the industry says things that are correct. It is correct that one of the reasons patients are feeling such high prices is because they have to pay coinsurance and big deductibles,” Gellad said, noting that pharma’s concerns with the PBMs and hospitals had some validity, too. “And it’s true that pharma sets the list prices high. They do do that.”

PhRMA spokesman Robby Zirkelbach also said there was a reason for lawmakers’ interest in so many players: the validity of the concerns. He pointed to data that showed slowing growth of prescription drug prices and increasing copays and deductibles.

“There’s no wonder that people are continuing to dig into this issue, and what they’re realizing is that to really be able to address the drug pricing concerns that people have raised, you’ve got to address some of the misaligned incentives in the system,” he said. “This is a complicated system, and we’ve got to look at how money flows across the system.”

And the tactic has successfully diverted lawmakers’ attention. Republicans in both chambers of Congress have held hearings in the past year looking at the “supply chain” that goes into the cost of drugs — broadening their spotlight from the companies that set the price to the other actors that can impact it. And lawmakers on both sides of the aisle say they want to better examine the vast array of players before they make any sudden policy moves.

“There are some that zero in on just one piece of the cost curve, so what I’m trying to do on the committee is look methodically at every piece,” Rep. Greg Walden, the Oregon Republican who chairs the influential Energy and Commerce Committee, told STAT. “We’re going to look at PBMs, we’re going to look at hospital costs, we’re going to look at what insurance costs. We’re going to look top to bottom.”

2. Congress isn’t jumping to act.

Beyond hearings, Congress hasn’t actually shown great appetite to tackle drug pricing. And that lethargy can dampen lobbyists’ enthusiasm to throw their weight and resources behind a given campaign or piece of legislation.

One physician lobbyist called it a “chicken and the egg” problem, wondering whether it would be Congress or the industries to first signal their motivation to act.

Case in point: the so-called CREATES Act. It’s one of the few pieces of drug price legislation that has the support of hospitals, insurers, doctors and a whole host of other groups and companies. But it’s languishing on Congress’s to-do list.

The bill, like its counterpart, the Fast Generics Act, takes aim at what supporters call delay tactics that drug makers use to keep generic competitors off the market. The legislation would give generic manufacturers that are legitimately seeking product samples the right to sue the drug makers if they refuse to hand over those samples.

It’s a small but meaningful change — the Congressional Budget Office has estimated that the legislation could save Medicare, Medicaid, and other federal government health programs more than $3 billion over 10 years.

And industry has been pushing the legislation, albeit without the same urgency that’s animated other priorities. Together, many of the trade associations — along with some three dozen other groups and companies, including Walmart, CVS, and AARP — formed a coalition, the so-called Campaign for Sustainable Rx Pricing, to push the bill. They hired a handful of lobbyists who are largely focused on the issue, too, to the tune of $440,000 over 2017.

But as one supporter put it, “it’s kind of telling that it has to be such an egregious abuse for everyone to coalesce.”

So far, drug makers have blocked attempts to include the measure in the 21st Century Cures Act that passed in 2016 or in last year’s reauthorization of FDA user-fee agreements, a priority for the drug industry. They say the bill will weaken protections for patients and spur “meritless, wasteful litigation.”

Supporters were nonetheless optimistic about the path forward for the bill. Several lobbyists backing the effort, along with staffers in both the House and Senate, told STAT there is momentum on Capitol Hill to include the measure in an upcoming spending package since it could help offset some other spending.

3. Each industry has very different priorities, even when they do agree.

Even when they do agree — as on CREATES, for example — health industry lobbyists don’t always prioritize the same issues. Some may have spent 2017 more focused on the repeal and replace of the Affordable Care Act than drug pricing. Others might have they used their meetings with lawmakers to defend a tax credit. Or perhaps some argue for other, more important drug pricing policies that need to be tackled first.

“When you work with these other groups, they rank [policy proposals] differently. There are certain things they want first. So it’s not only about finding solutions you can agree on, but about which ones you want to do first,” one patient advocate told STAT.

Drug makers, on the other hand? Pricing is their primary concern.

Other groups “have their own fish to fry, their own priorities,” said David Mitchell, the founder of the patient group Patients for Affordable Drugs. For drug companies, “it’s their number one issue: drug pricing. All the rest of them have their own number one issues, and drug prices aren’t it.”

4. All the major players have a stake in the status quo.  

Academics had another easy explanation for the lack of consensus — and the lack of concerted effort — from health care industry groups that profess an interest in lowering drug prices. They all profit from the current system.

Hospitals are paying more for drugs for patients admitted to the hospital, but on the flip side, at least some facilities are profiting from reimbursements for drugs in outpatient settings and in their own specialty pharmacies, according to Peter Bach, the director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes. PBMs also earn bigger rebates if the list prices are higher. And doctors, too, make more money under Medicare rules if they administer a more expensive drug to a given patient.

“People are paying these bills and the pie is getting bigger. Everyone’s arguing about where the knife comes in and cuts the slices of pie,” he said. “Everybody thinks everybody else is getting an unfair share.”

Gellad agreed.

“Everyone is making a lot of money. No one’s gone broke. So they don’t want to change things,” he said. “And that’s why the industry is not going to all agree to do something [on drug prices], because they’d all have to agree to lose money. Why would anyone agree to do that?”

5. There’s no silver bullet.

It’s not as if there’s one easy solution, ripe for the picking, if only groups could agree on it, several trade association officials told STAT. The piecemeal approach — getting behind policies like CREATES and then turning to other, smaller issues — may be the best way to approach the issue, they argued.

Similarly, lawmakers said there’s no one fix.

“The reason you haven’t seen all of the groups coalesce around one proposal — it’s not really clear what the solution is at this point because it’s such an opaque process,” Rep. Diana DeGette (D-Colo.) told STAT. “It’s hard to see what one solution there would be.”

Mitchell, along with a spokesman for the Association of Accessible Medicines, which represents generic manufacturers, also pointed to growing consensus behind smaller, targeted policies that would keep branded drug manufacturers from “gaming the system” — policies like CREATES and other changes to the patent system that could garner broader support. They each noted, too, that newly confirmed Health and Human Services Secretary Alex Azar, himself a former drug company executive, had voiced support for those changes during confirmation hearings.

They also preached patience. Bach, a former senior adviser to the Centers for Medicare and Medicaid Services, likened the push to the decades of jockeying between various environmental groups over fossil fuel regulation.

“Environmental regulation is a classic example of this,” Bach said. “You have this broad array of interested parties that would like to see movement, but the flavor of the movement they want, the ranking of their priorities, it’s not ‘one and only,’ even if it’s top [priority] — against a highly concentrated entity that specifically has a single agenda counter to it, with deep influence. That is a very hard row to hoe.”

“We are making progress,” he added. “But we get there in fits and starts.”

Bipartisan Bill Would Increase Competition Among Drug Manufacturers and Lower Drug Prices

http://www.commonwealthfund.org/publications/blog/2018/jan/bipartisan-bill-drug-manufacturers-competition-prices?omnicid=EALERT1349313&mid=henrykotula@yahoo.com

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Congress is considering including bipartisan legislation that could expedite the availability of lower-priced generic drugs in its must-pass bill to fund the federal government in 2018. The legislation, called the CREATES Act, tackles one of the numerous problems driving high drug prices — brand-name drug manufacturers’ use of anticompetitive tactics to block access to generic drugs — that we describe in our report, Getting to the Root of High Prescription Drug Prices: Drivers and Potential Solutions. If passed, the CREATES Act, which has bipartisan support, would increase the development and availability of generic drugs by addressing anticompetitive behaviors of certain brand-name manufacturers that use limited distribution systems and congressionally mandated risk-mitigation programs as a way to delay generic drug development. And because the Act could save the federal government more than $3 billion over 10 years, it could help pay for other necessary federal spending, including funding for community health centers.

Purpose of the Bill

The Drug Price Competition and Patent Term Restoration Act of 1984 — commonly referred to as the Hatch-Waxman Act — created the generic drug market in order to balance incentives for innovation (i.e., extended patent terms and market exclusivity protections) with a system that ensures safe, therapeutically equivalent generic drugs are available at lower prices when patents and exclusivities expire. Before a generic drug can be approved by the Food and Drug Administration (FDA) it must demonstrate that it is bioequivalent to the brand-name drug it intends to compete against on the market.

The Food and Drug Administration Amendments Act of 2007 authorized the FDA, when there are safety concerns like increased toxicity or risk factors, to require manufacturers to adhere to a Risk Evaluation and Mitigation Strategy, or REMS. A REMS program can have four components: patient information, communication plan, elements to assure safe use (ETASU), and implementation system.

Some brand-name drug manufacturers have misused REMS programs to block generic drug manufacturer access in two different ways. First, a brand-name manufacturer may prevent a potential generic competitor from getting access to samples for bioequivalence testing by using the REMS program with ETASU to limit who can access or purchase the drug. More than half of drugs with REMS programs have limited distribution, which restricts access for generic manufacturers. Without access to samples of brand-name products, generic manufacturers cannot conduct bioequivalence testing, which is required for FDA approval of a generic.

Second, if a brand-name drug is subject to an FDA-mandated REMS, then the generic competitor drug is also.1  Shared REMS programs are generally required by statute to be implemented for the brand-name drug and the generic versions. Negotiations between manufacturers for a shared REMS program include confidentiality, product liability concerns, antitrust concerns, and access to a license for REMS program elements that are patented. Brand-name manufacturers can intentionally delay establishing a single, shared REMS program, which blocks the generic drug from the market. As of January 26, 2018, 10 of the 72 REMS programs were shared.

In addition to FDA-mandated REMS programs, manufacturers may voluntarily institute a REMS program or create a limited distribution system to control who may access their drug by allowing dispensing from a limited number of specialty pharmacies. For example, an investigation by the Senate Aging Committee found that Turing Pharmaceuticals put a limited distribution system into place in order to block competitors’ access to samples and significantly increase the drug price. (Daraprim was not subject to an FDA-mandated REMS program.) The anticompetitive behaviors associated with REMS programs and limited distribution systems are estimated to cost patients more than $5 billion each year.

Potential Impact

The CREATES Act would enable a generic manufacturer facing one of these delay tactics to bring an action in federal court for injunctive relief (i.e., to obtain the sample it needs, or to enter into court-supervised negotiations for a shared safety protocol). The CREATES Act would expedite legal review and change the burden from proving a violation of antitrust law to one in which the generic manufacturer would need to only prove that sufficient quantity of samples were being withheld by the brand-name manufacturer. In addition, the CREATES Act would permit the generic manufacturer to work with the FDA to establish its own REMS with ETASU that are comparable to the brand-name manufacturer’s REMS program.

The Congressional Budget Office (CBO) has not officially scored the CREATES Act, but has estimated that similar legislation would save the federal government more than $3 billion over 10 years.2

Taking these steps to counter brand-name manufacturer tactics to delay generic competition could help address one of the factors driving high prescription drug prices. Such action also may serve as an important opening for further conversations on how we can regain the balance of incentives for drug innovation and competition that was established under the Hatch-Waxman Act.

 

The GOP is getting closer to passing its tax bill. Here’s what it could mean for health insurers

https://www.fiercehealthcare.com/payer/gop-tax-reform-bill-health-insurers-individual-mandate?mkt_tok=eyJpIjoiTTJFMk1XWm1aalV4WVRsayIsInQiOiJ2STJJYW85ZmhWc0tKakYzU2VlV05Ydk5NbVNpd1orNWt0anFYUW9GcDZkTDBMSmJlTGs0XC9tNDBIT3RmMDhzdmtFazBaTWpDYm9hMVplUjhSTElrSVgreHBJd3FLXC9YaHhzMXpPR2Y4MHVNRVJqcDVvMDVzOGdGQUNIMCtobDZtIn0%3D&mrkid=959610

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The House and Senate have agreed upon a unified tax overhaul bill, putting Republicans on the fast track to pass legislation that has significant implications for the health insurance industry.

For one, the compromise tax bill will repeal the Affordable Care Act’s individual mandate penalty, Senate Majority Leader Mitch McConnell said in a statement on Wednesday. To McConnell, axing the mandate will offer “relief to low- and middle-income Americans who have struggled under an unpopular and unworkable law.”

Health insurers and the healthcare industry at large have opposed removing the key ACA provision without a viable alternative to encourage healthy consumers to buy coverage, arguing that doing so will destabilize the individual markets. Indeed, the Congressional Budget Office has estimated that repealing the mandate would increase the number of uninsured people by 13 million over the next 10 years and hike individual market premiums by 10% during most years of that decade.

Yet while the individual mandate repeal is problematic for insurers that do business on the ACA exchanges, nearly all insurance companies stand to gain from the GOP tax bill overall, according to Leerink Partners analyst Ana Gupte, Ph.D. She estimates that insurers can capture about 10% to 15% of the potential 25% upside from the legislation, subject to regulatory constraints such as medical loss ratio rules and competitive pricing constraints.

Likely the biggest gain for insurers is the fact that, per the New York Times, the compromise bill sets the corporate tax rate at 21%—significantly lower than the current rate of 35%.

Though the House and Senate have ironed out the differences in their bills, the final version still must be approved by both chambers. GOP leaders have but two votes to spare in the Senate, and will likely have to include two bipartisan measures to shore up the ACA in Congress’ year-end spending bill to win the support of Sen. Susan Collins, R-Maine.

Collins said on Wednesday that Vice President Mike Pence assured her that those measures would make it into the spending bill, according to The Hill. Yet some House conservatives have expressed opposition to the bills, which would provide funding for cost-sharing reduction payments and state-based reinsurance programs, among other provisions.

Meanwhile, the results of the headline-grabbing Senate race in Alabama have put a major crimp in Republicans’ plans to retry repealing the ACA. Once Democrat Doug Jones officially takes his seat, the GOP will have an even slimmer majority in the Senate, where the defection of a handful of moderate Republicans was already enough to kill several repeal bills earlier this year.

 

Tax Bill Threatens Our Health and Our Democracy

http://www.chcf.org/articles/2017/12/tax-bill-threatens-our-democracy

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Earlier this month, the Senate passed legislation that would overhaul the tax code, make dramatic changes to federal health care policy, and undermine the budgets of Medicaid and Medicare, two pillars of the American health care system. The House and Senate are now trying to reconcile their two tax bills. Each passed the legislation on a party-line vote, with one Republican voting against the bill in the Senate.

Congress is now one step away from passing a tax bill that will have a profound effect on the health and well-being of Americans for a generation. No one should forget that, to get this close, the Senate rushed to approve a deeply unpopular proposal with little transparency and due diligence — and no bipartisanship. Left unchecked, these actions will harm millions of Americans — and American democracy itself.

Even though the legislation has been framed as a tax bill, it is very much a health care bill. The Senate bill would eliminate the Affordable Care Act’s individual health insurance mandate, which would lead to the destabilization of the individual health insurance market. The Congressional Budget Office (CBO) projects that this change alone would increase individual premiums by 10% a year and cause as many as 13 million Americans to join the ranks of the uninsured by the end of the next decade. In California, the uninsured population would grow by 1.7 million people. Congress may still pass separate legislation to restore some stability to the individual market, but the leading proposals are too modest to prevent much damage.

Seismic Impact

On its own, the language in the tax bills would trigger a major earthquake in the health care system, and the aftershocks of this tax bill would be just as dangerous. By eliminating more than $1 trillion of federal revenue, the administration and congressional leaders are manufacturing a budget crisis that would likely lead to automatic cuts to Medicare under federal rules. The CBO, which examined the House bill, has estimated that those cuts could be around $25 billion a year. Republican leaders have also indicated they intend to use the revenue shortfall that they are engineering with this tax bill to seek deep cuts in safety-net programs, starting with Medicaid.

This isn’t merely about what the legislation will do to health care, because it also would exacerbate inequality and worsen health disparities in this country. Under both the House and Senate bills, low- and middle-income families would pay more in taxes and have a harder time paying not just for health care, but also for food, housing, child care, education, and other basic needs. When people struggle so much to make ends meet, they suffer more from illness and die younger. And if inequality keeps getting worse, it will undermine the economic, social, and political stability upon which our nation depends.

The burden on Californians would be particularly heavy. Our families would no longer be able to deduct what they pay in state and local taxes on their federal tax returns. This change alone would take more than $112 billion a year out of the pockets of hardworking Californians — more than any other state. The fact that Californians would be paying more in federal taxes would inevitably put new pressure on our state and municipal governments to reduce their taxes. Under that scenario, it is not hard to imagine a new wave of painful state and local budget cuts.

The irony is that California actually has the power to stop this runaway train. If the entire California congressional delegation worked together to protect their constituents, and if they were united and strong, they could prevent many — if not all — of the worst provisions in the tax bills from becoming law.

This moment is a test of leadership. Nothing less than the health of our people — and our democracy — are at stake.

AARP: Congress must prevent ‘sudden cut’ to Medicare in 2018

http://thehill.com/policy/healthcare/363825-aarp-congress-must-prevent-sudden-cut-to-medicare-in-2018

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The AARP is urging House and Senate leaders to waive congressional rules so the Republican tax bill doesn’t trigger deep cuts to Medicare.

If Republicans pass their tax bill, which would add an estimated $1 trillion to the federal deficit, congressional “pay-as-you-go” rules would require an immediate $150 billion in mandatory spending cuts to offset the impact.

“The sudden cut to Medicare provider funding in 2018 would have an immediate and lasting impact, including fewer providers participating in Medicare and reduced access to care for Medicare beneficiaries,” AARP said in a letter sent to congressional leaders Thursday.

Under the bill, according to the Congressional Budget Office, Medicare would be faced with a $25 billion cut in fiscal 2018.

But Senate Majority Leader Mitch McConnell (R-Ky.) and Speaker Paul Ryan (R-Wis.) have promised the cuts won’t happen.

In a joint statement sent just ahead of the Senate vote on the tax bill last week, Ryan and McConnell said there is “no reason to believe that Congress would not act again to prevent a sequester, and we will work to ensure these spending cuts are prevented.”

Lawmakers have voted numerous times in the past to waive the rule, and even House conservatives have said they’ll likely support a waiver once the tax bill passes.

“I can’t imagine any scenario where there’s not a waiver for PAYGO,” House Freedom Caucus Chairman Mark Meadows (R-N.C.) said Wednesday. “It’s using a hammer when maybe a scalpel would do.”

But in the Senate at least, Republicans will need the support of Democrats to waive the rules. So far, they have been reluctant to offer it.