Forty Years of Winning Friends and Influencing People

https://www.chcf.org/blog/forty-years-of-winning-friends-and-influencing-people/

An interview with former US Representative Henry Waxman of California.

Of the more than 12,000 Americans who have served in Congress since it convened in 1789, few have had careers as fruitful as Henry Waxman’s. Representing west Los Angeles and its surrounding areas for 40 years, Waxman, 78, left a remarkable imprint on US health policy. His manifold accomplishments were capped by the passage of the Affordable Care Act (ACA) in 2010. A son of south-central Los Angeles, he worked at his father’s grocery store, earned a law degree at the University of California, Los Angeles, and in 1968 won a seat in the State Assembly. He was elected to the US House in 1974 in an era when bipartisanship was ordinary and health care had yet to become an overwhelming economic and political force in American life. Waxman was known in Congress for his persistence at wearing down opposition. Republican Senator Alan Simpson of Wyoming famously called him “tougher than a boiled owl” after negotiating the landmark Clean Air Act amendments of 1990. Waxman led efforts to ban smoking in public places and to require nutrition labels on food products. I talked with him recently about his experiences, the future of health policy, and the changing language of health reform. The transcript has been lightly edited for length and clarity.

Q: In 1974, when Los Angeles voters first sent you to Washington, health policy wasn’t the ticket to political influence. You are a lawyer, not a doctor. What drew you to health care?

A: When I was first elected to the California State Assembly in 1968, I believed that if I specialized in a policy area I would have more impact than if I tried to be an expert on everything. Health policy fit my district in Los Angeles, and I could see that government needed to be involved in a whole range of decisions, from health care services to biomedical research to public health. I was chairman of the Assembly Committee on Health. I was elected to Congress in 1974 in a Democratic wave election. I wanted to get on a health policy committee, which was Energy and Commerce. Democrats picked up so many seats and there were so many committee vacancies that year that it was easy to claim one, and I got on that committee. Within four years there was a vacancy for chair of the health and environment subcommittee, and I stepped up to that. It gave me a lot more impact.

Q: What role do you think health care will play in the upcoming elections?

A: If the Democrats do as well as I expect and hope, it will be more because of what Trump was doing in the health area than anything else. Even though people value health care services and insurance, the idea that the president and the GOP wanted to take away health insurance and reduce benefits for people who needed it — that was something they didn’t expect and were angry about.

Q: Is it feasible to provide health coverage to everyone?

A: I have always felt we needed access to universal health coverage. It wasn’t until we got the ACA under Obama that we were able to narrow the gap of the uninsured — those who couldn’t get insurance through their jobs, who weren’t eligible for Medicare and Medicaid, who had preexisting conditions, or who couldn’t afford the premiums. The ACA helped people have access to an individual health policy by eliminating insurance company discrimination and giving a subsidy to those who couldn’t afford coverage. It wasn’t a perfect bill, but it was important. The idea that Republicans would come along and bring back preexisting conditions as a reason to deny people coverage is what drove enough GOP senators to stop the GOP repeal bill from going forward last year. We’ll see what they do by way of executive orders or through the courts to try to frustrate people’s ability to buy insurance.

The Republican ACA repeal bill last year was a real shock because they also wanted to repeal the Medicaid program and allow states to cut funds for people in nursing homes, people with disabilities, and low-income patients who rely so heavily on that program. And they had proposals to hurt Medicare that House Speaker Paul Ryan had been advancing. The American people do not want to deny others insurance coverage and access to health services.

Q: Bipartisanship has gone out of style. Can it be revived?

A: It doesn’t look very likely now, but I built my legislative career on the idea that there could be bipartisan consensus to move forward on legislation. All the big bills had bipartisan support. The only bill that got through on a strictly partisan basis was the Obamacare legislation, and I regretted that. The Republicans just wanted to denigrate it and scare people into believing the ACA would provide for death panels, hurt people, take away their insurance, and keep them from getting access to care. None of that was true.

Q: A growing number of Democrats want to establish a single-payer health care system for the state. Do you agree with them?

A: A lot of people mistake the phrase “single payer” with universal health coverage. While I share the passion of people who want to cover everybody, single payer is not a panacea. My goal is universal health coverage. The Republican attempt last year to repeal the ACA and send 32 million Americans into the ranks of the uninsured was an albatross around their necks.

But the Democrats could turn this winning issue into a loser if some make a single-payer bill such as Medicare for All into a litmus test. I cosponsored single-payer legislation in Congress with Senator Ted Kennedy, and I always sought to bring the nation closer to universal coverage. I authored laws to bring Medicaid to more children and to establish the Children’s Health Insurance Program, and I led the fight to enact the ACA. These bills were very important. If we passed something like a single-payer bill, which would be extremely hard to do, we would be passing up opportunities to make progress. A lot of people who want a Medicare for All bill don’t realize that those of us on Medicare have to pay for supplemental insurance, because Medicare doesn’t cover everything. Medicare doesn’t generally cover certain services like nursing home care, so to get help you have to impoverish yourself to qualify for Medicaid.

One organization is sending out letters telling voters to support a single-payer bill and you won’t have to pay anything anymore. We can’t afford something like that. Democrats can embrace a boundless vision for a health care future without being trapped by a rigid model of how to get there. We should increase the number of people with comprehensive health insurance and focus on lowering costs. People with Medicare don’t want to give it up. People have health insurance on the job.

I would rather expand on what we have and build it out to cover everybody.

People don’t seem to remember that Democrats could barely muster the votes for the ACA when we had 60 votes in the Senate and a 255–179 majority in the House. Even if we recapture Congress and the presidency, I don’t think we would get a Medicare for All bill passed. It would require such a high tax increase that people would be absolutely shocked.

Q: What would be the national impact of California adopting a universal coverage plan?

A: Californian progress would be a model for the rest of the country, and we would be doing what’s right for the people of California who don’t have access to coverage. I think California is a trendsetter — for good and for bad. Proposition 13 and term limits started in California and spread to other states, and I think they have been a disservice. We’ve also done a lot of good things in California, and the rest of the country follows those things as well.

People who try to marginalize California do so at their own risk. People around the country look at California as a leader. California embraced the ACA, expanded Medicaid, and has been moving forward on making sure our public health care system is reforming itself to represent the needs for population health care and to ensure that uninsured low-income patients get access to decent, good-quality health care.

Q: More states are adopting work requirements in Medicaid. Do you think that will become the standard nationwide?

A: Work requirements are inconsistent with the Medicaid law. We’re talking about making people go to work to get health care when they’re sick. I just don’t think it makes sense. The courts may throw it out, and if not, at some point there will be a reaction against it, and it will be repealed by a future Congress.

Q: Some see parallels between the conduct of tobacco companies and opioid makers. Do you think “Big Pharma” will be held to account like “Big Tobacco?”

A: In the difficult fight against big tobacco, one of the lessons we learned was that even an extremely powerful group like the tobacco industry could be beaten if you keep pushing back. Even though there was overwhelming public support for regulation of tobacco, it took until 2009 before we could enact tobacco regulation by giving the Food and Drug Administration (FDA) authority to act. In the meantime, there were lawsuits by states to recover money they spent under Medicaid programs to cope with the harm from smoking. With opioids, there will be more and more lawsuits against distributors and manufacturers whose actions resulted in deaths of people from opioid addiction. Congress now is grappling with many bills to help people who are addicted, to prevent addiction from spreading further, and to restrict the ability to get the drug product. I’m optimistic we can come to terms with this crisis.

Q: What have you been doing since retiring from Congress?

A: I wanted to stay in the DC area near my son, Michael Waxman, and his family. He had a traditional public relations firm and he asked me to join him. In the health area, we represent Planned Parenthood in California, public hospitals in California, community health centers at the national level, and hospitals that get 340b drug discounts because they serve many low-income patients. We have foundation grants to work on problems of high pharmaceutical prices, and foundation grants to have a program to make sure women know about the whole range of health services available to them for free under the ACA. I enjoy working with my son and pursuing causes I would have pursued as a member of Congress.

 

 

 

A Supreme Court victory for lowering drug prices

http://thehill.com/opinion/judiciary/385326-why-scotus-ruling-in-oil-states-v-greenes-energy-group-is-a-win-for-working

A Supreme Court victory for lowering drug prices

A recent Supreme Court decision on patents — Oil States v. Greene’s Energy Group — marks an understated victory, with far-reaching consequences that will positively impact families and communities across America. This case has deep implications for basic economic fairness, with the judiciary recognizing the importance of keeping critical checks in systems that have become far too imbalanced.

In the national media, this case is being held up as a victory for Silicon Valley and the wealthy tech elites. Perhaps this makes sense: The decision handed down April 24 preserves a process for disputing and overturning unmerited patents, helping curb the glut of patent trolls polluting the industry. But this is not just a victory for the ensconced Palo Alto bubble — working families are silent winners of this week’s Supreme Court decision.

In 2011, Congress created within the U.S Patent Office a body called the Patent Trial and Appeal Board (PTAB). While the patent office examines and grants patents, which are akin to giving a monopoly power for a period of time for an invention, the PTAB serves as an appeal body when such rights are disputed. This week’s SCOTUS decision affirmed that the PTAB can continue its role in ensuring that monopoly rights given through a patent can be reversed.P

Why is this important for ordinary Americans? Abuse of the patent system is directly tied to skyrocketing drug prices.

Americans of all political stripes are united on one thing: Drug prices have spiraled out of control. One in 4 Americans cannot fill their prescriptions because they can’t afford them. Nineteen million Americans are forced to go overseas to buy their drugs because companies don’t price fairly. And pharmaceutical companies get away with their exorbitant pricing by abusing our patent system.

In order to maintain monopolies on life-saving treatments, pharmaceutical companies often file dozens of unmerited patents on their drugs, blocking the generic competition that lowers prices. For example, Celgene has applied for over 100 patents on just one cancer drug, Revlimid. As a result, Celgene will likely make an extra $45 billion while Americans should have been able to access cheaper alternative generic options years ago.

The PTAB can curb that abuse and help restore integrity to our patent system, stopping drug companies from holding a wrongly issued monopoly for years or even decades more. In fact, roughly half of the pharmaceutical patents challenged through the new PTAB reviews are found to be unmerited. This includes patents on expensive drugs: The blockbuster multiple sclerosis drug Copaxone, for example, is one drug the PTAB found to have been wrongly granted patents, thus allowing cheaper versions of the medicine to enter the market.

But more broadly, this Supreme Court decision offers a bit of respite and a rare moment of bipartisan consensus in an increasingly fractured America. The decision strikes at the heart of basic economic unfairness and the ways in which power has become concentrated in the hands of industries — like the pharmaceutical industry which works hard to lobby and advocate and influence to ensure that no checks and balances exist to curb their unfettered power. The Supreme Court upheld a basic mechanism to curb that power.

There is more work to be done. Congress must continue to improve upon the system it built in 2011. We must work to ensure our patent system rewards true invention and allows healthy competition, rather than encouraging frivolous patenting that rewards corporations at the expense of everyday Americans.

But the Oil States decision offers a glimmer of hope for patients and communities who are struggling to get medical treatment. This week’s Supreme Court decision makes it possible to believe that those families may have a shot at affording the medicines they so desperately need.

 

 

5 Key Healthcare Points From Trump’s State of the Union

http://www.healthleadersmedia.com/leadership/5-key-healthcare-points-trump%E2%80%99s-state-union?utm_source=edit&utm_medium=ENL&utm_campaign=HLM-Daily-SilverPop_02022018&spMailingID=12862476&spUserID=MTY3ODg4NTg1MzQ4S0&spJobID=1340163930&spReportId=MTM0MDE2MzkzMAS2#

Image result for state of the union

The president outlined healthcare accomplishments from his first year in office, addressing a closely watched issue for many Americans.

President Donald Trump delivered his first State of the Union address Tuesday night, highlighting policy goals while welcoming a “new American moment.”

Over the course of 90 minutes, Trump discussed several healthcare-related legislative achievements, including adjustments to the Affordable Care Act as well as new care accountability measures for the Department of Veterans Affairs (VA).

Below are five key takeaways from the president’s speech to Congress:

1. ‘The individual mandate is now gone.’

Trump touted the repeal of the individual mandate penalty, calling the eliminated provision “an especially cruel tax.”

The measure, which required Americans without health insurance to pay a fine, was removed as part of the tax reform bill passed late last year.

The penalty is $695 or 2.5% of an individual’s income, whichever amount is greater, and remains in effect for 2018. The elimination will take place next year.

Though Trump did not call for a renewed effort to repeal the ACA in its entirety, he said the Republican-controlled Congress successfully repealed “the core of disastrous Obamacare.”

2. No mention of upcoming funding deadline or community health centers.

Trump did not acknowledge the recent six-year extension granted to the Children’s Health Insurance Program (CHIP), which was part of the continuing resolution that reopened the government last week after a three-day shutdown.

There was also no mention of the February 8 deadline to pass another continuing resolution or pass an omnibus budget package. Such action would likely have to address the fate of over 10,000 community health center (CHC) sites across the country. Federal funding for CHCs lapsed on October 1, so they have been funded by temporary spending packages since then.

Despite the next deadline coming in little more than a week, Trump did not speak on the issue last night.

3. Will call for unity result in bipartisan solutions?

The president’s speech centered on a call for unity among Americans and members of Congress alike. Such bipartisanship will be important in order to avoid a second government shutdown in as many months and to address lingering healthcare policy concerns.

There are two bills in the Senate with bipartisan cosponsors seeking to stabilize the federal insurance exchange markets: Alexander-Murray and Collins-Nelson. Trump’s call for bipartisanship in the final crafting and debate over these measures will play a role in determining their road to passage.

Newly confirmed Health and Human Services Secretary Alex Azar applauded the speech in a statement released late Tuesday night.

“I commend President Trump for delivering a speech that celebrated the economic boom we have seen under his leadership, which has brought new opportunity and prosperity to the American people,” Azar said. “A healthier economy means a healthier America, and we look forward to more such success in the coming year, including through reforms to make healthcare more affordable and accessible for all Americans.”

4. Reduce price of prescription drugs, endorse “right to try.”

Continuing with a campaign promise to lower prescription drug costs, Trump said the FDA is following his administration’s lead to approve more generic drugs and medical devices.

“One of my greatest priorities is to reduce the price of prescription drugs,” Trump said. “In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

Trump also urged Congress to take up the issue of the “right to try,” a policy allowing terminally ill patients to access experimental treatments without having to leave the U.S.

“President Trump says reducing price of prescription drugs is one of his highest priorities,” tweeted Bob Doherty, senior vice president for government affairs and public policy at the American College of Physicians. “Doctors and patients certainly hope so and will be glad to do their part.”

5. Signed VA healthcare accountability bill into law.

Trump promised to ensure veterans have a choice in their healthcare decisions, after reports of substandard care at VA medical facilities surfaced in recent years.

In June, Trump signed the VA Accountability Act, which eased restrictions on removing employees who were accused of wrongdoing while also protecting whistleblowers.

The president said the VA has already fired more than 1,500 employees who “failed to give our veterans the care they deserve.”

VoteVets, a progressive veterans advocacy group, criticized Trump’s remarks Tuesday night. The organization highlighted the push by Republican lawmakers to cut $1.7 trillion from federal healthcare programs, which 1.75 million veterans rely on for coverage.

 

House GOP warming to ObamaCare fix

http://thehill.com/policy/healthcare/371738-house-gop-warming-to-obamacare-fix

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Key House Republicans are warming to a proposal aimed at bringing down ObamaCare premiums, raising the chances of legislative action this year to stabilize the health-care law.

House GOP aides and lobbyists say that top House Republicans are interested in funding what is known as reinsurance. The money could be included in a coming bipartisan government funding deal or in another legislative vehicle.

Any action from Republicans to stabilize ObamaCare would be a major departure from the party’s long crusade against the law, but after having failed to repeal the Affordable Care Act last year, the discussion is shifting.

Rep. Ryan Costello (R-Pa.) is one of the leaders of the push in the House and is sponsoring a bill to provide ObamaCare stability funding in 2019 and 2020. He notes the relatively short-term nature of his measure.

“That reflects the political reality that we are not going to be doing some large, sweeping health-care bill in the next year,” said Costello, who faces a competitive reelection race this year.

“I am optimistic that it would be under serious consideration for inclusion in the omnibus,” he added.

Speaker Paul Ryan (R-Wis.) noted the possibility of action on an ObamaCare stability measure, particularly funding for reinsurance, at an event in Wisconsin in January, saying he thought there could be a “bipartisan opportunity” on the issue.

Action on the reinsurance payments is far from certain; conservative opposition to what some view as a bailout of ObamaCare insurers could stop the proposal in its tracks. But there is growing momentum for the idea, and Republicans said the proposal would likely be discussed more at the GOP retreat this week in West Virginia.

The push on reinsurance matches up with one of the ObamaCare bills that Sen. Susan Collins (R-Maine) has been pushing in the Senate.

Senate Majority Leader Mitch McConnell (R-Ky.) gave Collins a commitment to support a reinsurance bill as well as another stability measure from Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.) in exchange for Collins’s support for tax reform in December.

Opposition in the House has always been the major impediment to those measures moving forward. But it now appears some of that resistance is softening, at least on the reinsurance measure, now that Republicans have repealed ObamaCare’s individual mandate through the tax bill.

Importantly, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), whose panel has jurisdiction, is supporting the ObamaCare stabilization efforts and backs Costello’s bill.

“Chairman Walden is supportive of Rep. Costello’s efforts to help states repair their insurance markets that have been damaged by Obamacare,” an Energy and Commerce spokesperson wrote in an email. “Rep. Costello’s bill is a fair approach to granting states greater flexibility to help patients and lower costs.”

Rep. Cathy McMorris Rodgers (R-Wash.), the fourth-ranking Republican in House leadership, is also a co-sponsor of Costello’s stabilization bill.

While House conservatives have opposed propping up ObamaCare, Rep. Mark Meadows (R-N.C.) did not dismiss the payments out of hand on Tuesday.

“If it lowers premiums, I’m willing to listen to any ideas,” said Meadows, who is chairman of the House Freedom Caucus.

He warned that he did not want a proposal to be an “insurance bailout,” but noted that he has been talking to colleagues in the House and Senate about the issue.

Another obstacle for an ObamaCare fix is a dispute over abortion. Republicans are adamant that a stabilization measure must include restrictions on the new funding being used to cover abortion services, a notion that is problematic for Democrats.

Reinsurance funding is used to help insurers cover the costs of especially sick patients, which helps relieve pressure on premiums for the broader group of enrollees.

The other main stabilization measure, from Alexander and Murray, would fund ObamaCare payments that reimburse insurers for giving discounts to low-income enrollees, known as cost-sharing reductions (CSRs).

Republican sources say there is less momentum in the House for funding CSRs than there is for the reinsurance measure. But even some Democrats are now questioning whether funding CSRs still makes sense, given that through a quirk in the law, President Trump’s cancellation of the payments last year actually led to increased subsidies and lower premiums for many enrollees.

Rep. Phil Roe (R-Tenn.), for example, a leading House Republican on health-care issues as co-chairman of the GOP Doctors Caucus, said Tuesday that he feels negatively about the idea of funding CSRs but likes the idea of reinsurance.

Roe pushed back on the idea that the funding would be propping up ObamaCare, saying that the repeal of the individual mandate had changed the discussion because people no longer were forced to buy coverage.

Roe said he runs into people in his district paying more than $1,000 per month in premium costs.

“We’re going to have to do something,” he said.

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.