Exploring the next phase of U.S. health reform

[This article was published on the website of the Harvard Chan School of Public Health in connection with an executive training program — Preparing for What’s Next in U.S. Health Reform — that I’m running May 31-June 2.]

by Lisa D. Ellis

These are uncertain times in American health care. The Republican Congress and President Trump have vowed to repeal and replace the Patient Protection and Affordable Care Act (ACA), commonly called Obamacare. They recently unveiled the American Health Care Act, the replacement plan, which has met with substantial resistance from all parts of the political spectrum. The current political and policy environment has left many health care leaders and other stakeholders wondering what to expect and how best to position their organizations for the next phase of health care reform.

The Potential Effects of Proposed Changes

House Republicans recently introduced legislation intended to create a new health plan, retaining some provisions of Obamacare and eliminating or scaling back others. While the exact details may continue to change in the coming weeks as the bill moves through Congress, there are some specific themes that can be expected in the final version that becomes law, according to John E. McDonough, DrPH, MPA, Program Director of Preparing for What’s Next in U.S. Health Reform and Director of the Center for Executive and Continuing Professional Education at the Harvard T.H. Chan School of Public Health. McDonough, who served as a Senior Advisor on National Health Reform to the U.S. Senate Committee on Health, Education, Labor, and Pensions, explains that there are two major components of the ACA that will be affected by whatever legislation is passed. These are access and value.

Two Main Themes: Access and Value

The first area, access, refers to insurance coverage for uninsured and underinsured Americans. While a significant impact of the ACA was that it expanded its Medicaid offerings to states to cover vulnerable residents, a number of Americans are now at risk of losing this support under whatever new plan is ultimately passed.

There are two major components of the ACA that will be affected by whatever legislation is passed. These are access and value.

“Many, many individuals have gotten health insurance coverage from ACA and [some of them] are quite concerned about whether they will still have coverage in three months, six months, or a year,” McDonough says.

The second area, value, refers to a focus started by the ACA to improve the quality, efficiency, and effectiveness of medical care in the United States. “The evidence shows Americans get care from our medical system that is not as high quality as we have a right to expect because of high costs,” McDonough says. The ACA established a number of initiatives to address this fact, including creating Accountable Care Organizations (ACOs), providing bundled payment plans, and imposing penalties on hospitals with very high rates of readmissions and hospital-acquired infections.

These types of efforts, which are part of a broader push to transform the health care delivery system to ensure a greater focus on value, are receiving widespread support from both Republicans and Democrats, which means that they should continue, and even grow, under any new health care law, McDonough stresses.

“There seems to be a growing sense in the health care community that [the move to value-based payment and population health management] pushed forward under ACA should continue and expand,” McDonough says, adding that this is one piece of good news in the sea of uncertainty that exists.

Preparing for New Developments

Ashish Jha, MD, MPH, Professor of International Health and Health Policy at the Harvard T.H. Chan School of Public Health, Director of the Harvard Global Health Institute, and a practicing general internist at the VA, agrees with this assessment. “The journey we began with ACA to move to value-based health care is going to continue,” he says. “But what form it will take, how we will do it, and how much is voluntary verses mandatory” remain to be seen moving forward.

He points out that this means that professionals need to know the range of options in order to be prepared for whatever way the field goes. “They need to ask, ‘What is the range and how do I prepare, so I will be in good shape?’’’ he explains.

Trends to Watch

Jha, who is also faculty on Preparing for What’s Next in U.S. Health Reform, points to a number of other changes also started under the ACA that, regardless of the final health plan passed, will continue to affect organizations over the next few years. For instance, people today are responsible for a growing portion of their own health care costs. This changes the way that organizations collect their money, meaning organizations need to find new ways of operating.

There will be many moral and ethical dilemmas for organizations as access shrinks and many patients lose coverage under the new plan.

“I think health care leaders are very used to a world where they provide services to patients and get paid by insurers, or the government/Medicare or Medicaid. But now they’re waking up to a new model where they are getting a larger chunk from patients. They’re not used to collecting money from patients themselves and that will change their relationships,” Jha says.

With customers footing more of the bill, they now have higher expectations from providers. “The customer is changing, and what will customers want in return now that they’re writing the check? That becomes a really important issue for providers to focus on. It’s part of patient-centered care. Now patients are in the driver’s seat,” he stresses.

Another issue worth paying attention to on the value side of the equation is that participation in some Medicare bundled payment programs will be voluntary for now, but is ultimately expected to become mandatory in the not-too-distant future. This raises some interesting questions for organizations, as they grapple with whether to use the voluntary program to get acclimated. Organizations that don’t participate now could end up having a lot of catching up to do in the future, which could “have very serious consequences three to five years down the road,” Jha says.

Issues to Watch

On the access side of things, Jha points out that there will also be many moral and ethical dilemmas for organizations as access shrinks and many patients lose coverage under the new plan. Five years ago, many people were uninsured and had no contact with the health care system. “Now, these people have been covered and have become part of the organizations [that serve them]. They have developed relationships with their doctors, so it’s a big difference now when they lose coverage,” he says. “Are organizations really going to walk away from these patients? [And if not], how will health systems manage the financial debt they will incur to care for the uninsured?”

Another important trend that will impact many health organizations moving forward revolves around consolidation. “Doctors are being bought out by big hospitals. We have no idea how the Trump Administration will feel about that. Consolidation is a strategy that provider organizations have used to survive, getting bigger. But that gravy train for providers is coming to an end. Now, with more people uninsured, and more focus on value, there are broader market issues around consolidation and integration that will be challenging for providers,” Jha says.

Other Trends Worth Following

Other trends that will continue to impact organizations include the growing push for providers to use interconnected Electronic Health Records (EHR). This is an important tool to help track and achieve key benchmarks of value-based care and improve coordination among providers for increased efficiency and better outcomes. “While everyone thinks this is a good thing, and most organizations have made the leap into EHRs, people, especially frontline doctors and nurses, are very frustrated with these systems.  How organizations will manage the transition between simply adopting the EHR and using it in ways that lead to meaningfully better care is the challenge ahead,” Jha says.

In addition, Jha says that the Trump Administration’s tougher restrictions on immigration may have a real effect on health systems that needs to be addressed up front. “Twenty-five percent of doctors in our country are foreign medical graduates, as are a large population of our nurses and other health professionals,” he says. “As immigration gets tighter, there’s a question as to whether we will have a harder time attracting the best and brightest in the world. So health care will have a hard time building their ranks” in the future. With an aging population, this means that health systems may have challenges creating a good workforce to care for them.

The Importance of Staying Up-to-Date

With so many fluctuations expected in how the health care system will do business in the coming months and years, both Jha and McDonough say that it is crucial for health care leaders to stay abreast of the latest developments as they progress.

One of the most important things is for health care leaders to stay in touch with what is happening out there and pay attention to the coverage in the media.

“One of the most important things is for health care leaders to stay in touch with what is happening out there and pay attention to the coverage in the media,” McDonough says. “If you work in a hospital, [you will need to] follow the national organizations, such as the American Hospital Association, and stay alert to the opinions of experts as to what might happen,” he says. But that alone will not be enough, says Jha. Understanding the nuances of policy changes will be critical for leaders to stay on top of the shifting requirements—and opportunities—that exist in the current environment so they can strategically position their organizations for success.


Harvard T.H. Chan School of Public Health offers Preparing for What’s Next in U.S. Health Reform, which offers key lessons involving health reform from the nation’s leading policy experts under the new federal administration. To learn more about this opportunity, click here.

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24 Million May Lose Health Insurance to Pay for Tax Cuts for Wealthy Americans

[This commentary, “GOP Cuts Are Moral Challenge for America,” was published on Commonwealth Magazine’s website on March 14.]

THE BIG NEWS IS, of course, Monday’s “score” from the Congressional Budget Office detailing that the House Republican bill to repeal and replace the Affordable Care Act/Obamacare will result in 14 million Americans losing health insurance by 2018 and 24 million by 2026.

Before that, something else caught my eye from the Bangor Daily News. It’s a blog post from a woman named Crystal Sands who writes about how the ACA enabled her and her young family to take a chance and find a new life as farmers. Her post, “The ACA makes a simpler farming life possible for our family,” says this:

“I’m a writer, an online professor, a farmer, a wife, and a mom. None of these jobs offer health insurance for me and my family, so our family purchases our health insurance through the Affordable Care Act. We work hard, but we try to work differently. If you read my blog, you know we’re learning to grow and raise our own food, and our health insurance through the ACA makes this possible.

“The ACA has helped me to become a better mom, a better wife, a better teacher because I am not so overworked, and it has made it so I can learn to be a farmer. I’m also just a better person. I’m not sick and overworked. I’m more patient and more kind and more helpful to everyone. And this is my story. There’s so much potential here to make lives better. There are many people, including many farmers, who depend on the ACA. I hope we don’t lose sight of that.

And now, CBO’s Cost Estimate of the American Health Care Act. Bottom line — $894 billion in tax cuts financed by $1.2 trillion in cuts to Medicaid and to subsidies/tax credits for private health insurance. Those cuts will produce an increase in numbers of uninsured Americans of 14 million by 2018, 21 million by 2020, and 24 million by 2026. Of the 24 million, 14 million will lose Medicaid and 10 million will lose private coverage, employer-sponsored and individual. Continue reading

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House Republicans Show Their Hand on ACA — and It’s Not Good

[This February 26 2017 commentary was published on the Commonwealth Magazine website.]

LATE LAST WEEK, Politico released a leaked 105-page draft bill defining the House Republican plan to repeal/replace/repair/re-whatever the Affordable Care Act/Obamacare. The draft legislation was dated February 10, so likely it’s already out of date, though it is the best indication yet of their rapidly evolving intentions and fits with many of their prior recent proposals. So a big GOP move is getting close, and it’s not good. What’s important?

First, the ACA’s generous coverage expansion (for many, not all) through Medicaid expansion and private insurance subsidies would be drastically curtailed, leaving most of the 22 million who got either form of coverage without an affordable option.

repeal-replace-720

Second, not only is the ACA Medicaid expansion repealed by 2019 (11 million people and counting), the plan would replace current Medicaid financing with a “per capita cap” by 2019, shrinking funding by hundreds of billions, perhaps more, over 10 years. Continue reading

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“It has saved my life.” Voices from Ohio on Medicaid Expansion

[This commentary was first published on February 15 on the Commonwealth Magazine website:]

OHIO IS ONE of 31 states that expanded Medicaid as permitted by the Affordable Care Act/Obamacare for nearly all low-income citizens. The state’s Republican governor, former presidential candidate John Kasich, has been among the most vocal proponents of the expansion on the Republican side and has taken a lot of grief for it from ACA opponents.

In early January, the state released an evaluation of the impact of the expansion, “Ohio Medicaid Group VIII Assessment: A Report to the Ohio General Assembly“. (Group VIII is the legal name for the ACA Medicaid expansion population.)

ohio-medicaid

The report has a host of quotes from interviews with individuals who benefited from the expansion, and I include a selection of these quotes below, along with a section from the report’s overall summary. This is what Medicaid expansion has meant to real Americans:

“It gives me peace of mind knowing that I don’t have to pay for the medical insurance, and it saves me money being able to afford food and utilities and everyday things you need in life.”

“It’s been a blessing and I thank God that I have Medicaid because I no longer have large payments and I can get my Medicaid medicines.”

“More freedom. Less worries. I was an addict for 3 years before getting Medicaid. Because of Medicaid I’m not an addict.” Continue reading

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Welcome Back to the Medical Underwriting Circle of Hell

[This commentary was posted today (2-15-2017) at RealClearHealth.]

All leading Republicans who are committed to repealing all or key parts of the Affordable Care Act (ACA) also emphasize their commitment to maintaining the law’s most popular part: banning pre-existing condition exclusions and medical underwriting by preserving the ACA’s (also known as Obamacare) policy of “guaranteed issue.” But the fine print in Republican proposals betrays that commitment, including legislation filed on January 26 by House Energy and Commerce Committee Chairman Greg Walden (R-OR) threatening health security for tens of millions of Americans.

Medical underwriting is the insurance industry practice of issuing and pricing health insurance based on an individual’s current or prior medical condition. Insurers use medical underwriting and pre-existing condition exclusions to avoid covering anyone who might cost them money. The Walden bill, called the “Preexisting Conditions Protection and Continuous Coverage Incentive Act,” pretends to continue the ACA’s ban on medical underwriting, but would, in reality, do the opposite.What are pre-existing conditions that can prevent you from obtaining coverage?

What are pre-existing conditions that can prevent you from obtaining coverage? Here is a list of hundreds that are used to exclude or limit health insurance: acne, cancer, domestic violence, leukemia, pregnancy, sleep apnea, and much more. Continue reading

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Vive la ACA Resistance!

[This commentary was published on the Commonwealth Magazine website last week.  If you are supportive of what the Affordable Care Act has achieved and want to help defend it — the time is NOW.  Please go to: http://protectmycare.org/ to learn how you can help, now. Everyone.  Please.]

A NEW REPUBLICAN-CONTROLLED Congress is in place. And for the sixth time, the Affordable Care Act (ACA) is facing extinction. Indeed, a gripping narrative history of the ACA/Obamacare could be written focused only on its numerous near-death experiences. Maybe the sixth time will be the curse, and maybe not. Let’s recall.

One, in January 2010, the loss of the 60th Democratic vote in the US Senate via the election of Republican Scott Brown to the seat formerly held by Massachusetts Sen. Edward Kennedy was almost universally assumed to be the end of the road for President Obama’s health reform agenda. He signed the ACA into law two months later.vive-la-resistance

Two, in June 2012, by a single vote, the US Supreme Court upheld the constitutionality of the ACA’s individual mandate and, by extension, the ACA. On the day of the decision, premature news accounts by CNN and Fox News erroneously reported that the court had overturned the law.

Three, in November 2012, thorough ACA repeal would have followed an electoral win by Republican Mitt Romney in that year’s presidential election, well before full implementation in 2014.

Four, between October-December 2013, catastrophic launches of the federal and state Health Exchange websites temporarily made the law a national laughingstock facing stillbirth at its most critical setup moment. The debacle was accompanied by a three-week October shutdown of the federal government in a final Republican spasm to prevent January 1, 2014, implementation.

Five, in June 2015, a second potentially fatal lawsuit that reached the US Supreme Court was laid aside by a 6-3 vote.

Six and lastly, the November 2016 federal elections represented the final life-threatening challenge.  An expected presidential victory by Democrat Hillary Clinton would have sealed the law’s lifespan at least until 2021. Instead, Republican Donald Trump’s victory now is leading many, once again, to predict the law’s effective demise this year.

Except, it ain’t necessarily so.  Here are three reasons why.

First, the Republicans’ ACA playbook is riddled with contradictions and dissent over their “repeal and delay” strategy.  Will delay last two, three, or four years? Once they repeal the law’s financing, how can they pay for even a minimal replacement? Will they do one replacement or a series of replacement bills? How can they keep private insurance companies from abandoning the individual insurance market in soon-to-be demolished health exchanges?  How will they keep preposterous promises that their still-unknown replacement will provide better coverage at lower cost for everyone who has been helped by the ACA? How will they keep Republican governors in line as they seek to slash Medicaid spending by approximately $1 trillion dollars over 10 years? These are just for starters.

For a devastating look at the contradictions in “repeal and delay,” see this week’s Health Affairs blog by conservative analysts Joseph Antos and James Capretta: “The Problems with ‘Repeal and Delay.’” “The most likely end result of ‘repeal and delay,’” they write, “would be less secure insurance for many Americans, procrastination by political leaders who will delay taking any proactive steps as long as possible, and ultimately no discernible movement toward a real marketplace for either insurance or medical services.”

Second, as Americans now focus on Republican non-plans and non-answers, public opinion is turning against them. Recent Kaiser Family Foundation polling shows that even Trump voters – who are far more chronically ill and needy than Clinton backers – support nearly all of the ACA’s essential building blocks except for the individual mandate, and oppose repeal without a replacement plan. As Noam Levey from the Los Angeles Times has shown, not a single nationally recognized patient or health care provider organization supports the Republican repeal agenda. Only the fringes of the Tea Party stand by their sides in this backward quest.

Third, while defenders of Republican drive to end coverage for between 22 to 30 million Americans are few and far between, broad resistance to the first major policy thrust of the Trump era is building.  A broad-based “Protect Your Care” coalition is spearheading national resistance, collaborating with President Obama and congressional Democrats and leading to a day of demonstrations across the nation on January 15. Hospitals, doctor and medical student groups, insurance companies, community health centers, and other health care stakeholders are making clear the damage now threatening the entire US health care system. Meanwhile, former Democratic congressional staffers have developed a blueprint for broad-based resistance to the Trump/Republican agenda, called “Indivisible.”

Republicans may win, though they will rue the day that they set in motion destabilization of the nation’s health care system. Around the globe, universal health coverage is now recognized not just as something governments do to be nice to their people, it is understood as an essential precondition for healthy societies and healthy economies. Over the past eight years, the United States has been moving forward to join the universal consensus of advanced nations, most of whom are far less affluent than the US.

Whether Republicans succeed or fail is not just up to them. It is now up to all Americans. Vive la ACA resistance!

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Want Drug Pricing Regulation? Why Not AMNOG?

[This article was posted on December 29th 2016 on the Health Affairs blog.  It was co-written with Dr. Karl Lauterbach, the Deputy Leader of the Social Democratic Party in the German Bundestag, and Dr. Elizabeth Seeley of the Harvard Chan School of Public Health.] 

Donald Trump and Hillary Clinton agreed on almost nothing during the 2016 presidential campaign — but they did agree that the U.S. needs to address unaffordable prescription drug prices. And the public also supports this idea. A survey released in October 2016 showed that 64 percent of voters, including 52 percent of Republicans, believe that the federal government should place a “limit on how much pharmaceutical companies can increase prescription drug prices.”germanparliament

Further, 73 percent of all voters (68 percent of Republicans) concur that the federal government should be able to negotiate with drug companies to lower Medicare drug prices for seniors. While the November 8 federal election results have dampened prospects for policy change along these lines, does anyone believe that this issue now will disappear? We think not.

The German Model for Regulating Drug Prices

If political will emerges to tackle this issue, is there a realistic and politically savvy model to use? On what basis would drug purchasers and drug makers negotiate? How would the value of new prescription drugs be determined? And how would genuine scientific innovation be encouraged and rewarded, and not stymied?

We suggest that a superior model to accomplish these goals now exists and can be found in Germany’s drug pricing regulatory system that has performed admirably since 2011. Called AMNOG (the Act to Reorganize Pharmaceuticals Market in the Statutory Health Insurance System or Arzneimittelmarktneuordnungsgesetz), the system has noteworthy advantages in that it:

  • Rewards innovative drugs that provide genuine breakthrough clinical benefits;
  • Provides immediate access to new drugs by allowing marketing, sale, and full reimbursement in the first year, during which time the drug’s clinical benefits are assessed;
  • Uses non-governmental, non-profit organizations for review and decision making, with the pharmaceutical manufacturers bearing much of the costs;
  • Makes decisions based on clear empirical evidence of clinical benefit to patients;
  • Determines prices only after—and based on—a determination of clinical benefits, and through negotiations involving drug companies and key system stakeholders, not government bureaucrats;
  • Avoids controversial tools such as Quality Adjusted Life Years (QALY) that place a monetary value on each additional year of life;
  • Ensures full transparency in all key processes and steps.

Historically, as with the U.S., Germany has had a reputation for high drug prices. Prior to AMNOG, drug prices in Germany were 26 percent higher than average drug prices in the European Union. Since AMNOG’s 2011 launch, by August 2016, 146 new drugs have been assessed. Of the newly assessed drugs, 63 percent were determined to have an additional benefit, though half of those only for select patient groups. In 2015 alone, Germany achieved savings of $1 billion on new drug spending, with discounts averaging 21 percent in this market segment.

If the U.S. cares to examine other national models, AMNOG should top the list. Because of AMNOG, the average annual growth rate in public pharmaceuticals expenditure per capita between 2009 to 2013 in Germany was -0.7 percent, as compared with +2.7 percent in the US. In a recent international comparison of health benefits assessments of pharmaceuticals, Germany showed more rigorous appraisals of new drugs than other countries in the survey.

How the AMNOG process works

First, once a new drug has been demonstrated as safe and efficacious by the European Medicines Agency (the European Union’s equivalent to the U.S. Food & Drug Administration) or by the German Federal Institute for Drugs & Medical Devices, the drug maker may introduce the product into the German market at any initial price of its choosing, fully reimbursed by all German insurance plans for the first 12 months.

Second, during those 12 months, the Federal Joint Committee (G-BA), a non-governmental body of payer, provider, and patient representatives, with authority over coverage decisions for all German payers, commissions a clinical comparative effectiveness review by a non-governmental and non-profit research body known as the Institute of Quality and Efficiency in Healthcare (IQWiG). IQWiG assembles, evaluates, and reports all evidence of a new drug’s clinical effectiveness and benefits compared with standard treatment and/or existing drugs, including data on benefits for different demographic groups. Drug makers must submit all their relevant data in a “Benefit Dossier,” and will face sanctions for withheld information. Results are subject to an expert hearing published and used to inform both doctors and patients.

Third, within six months of a drug’s market introduction, and with IQWiG’s report in hand, the G-BA determines the new drug’s added benefit over existing drugs or treatments, including information on benefits and risks for specific patient subpopulations. New drugs are rates 1-6:

  1. Major added benefit — sustained and substantial improvement not previously achieved by current therapies;
  2. Considerable added benefit — significant improvement over current therapies;
  3. Minor added benefit — moderate improvement;
  4. Added benefit present but not quantifiable;
  5. No added benefit proven;
  6. Lower benefit than current therapies.

A drug can receive differential rankings for varied patient subpopulations. In addition, the quality of the studies and data on which the classification is based is specified in three categories:

  1. Proof of benefit
  2. Indication of benefit
  3. Hint of benefit

The combination of benefit ratings and quality categories summarizes the extent and probability of additional benefits of drugs in patient groups.

Fourth, if the G-BA accepts the IQWiG recommendation and the new drug is ranked in any of categories 1-2-3, then the newly established clinical value rating sets the basis for negotiations between the drug maker and the National Association of Statutory Health Insurances, the organization of all public insurance providers in Germany. If parties cannot reach agreement, the matter is submitted to an arbitration panel for a decision based on other international prices.

Fifth, if a drug offers no additional value over a previously available drug, ranked in categories 4-5-6, then payers will reimburse only at prices currently paid for the older existing drugs or therapies. Drug companies can choose to sell their product at higher prices, though patients who want the newer and lower ranked drug must pay the difference out of their own pockets. Importantly, if a drug company charged an excessive rate for a lower ranked drug in the first year of availability, the extra revenues must be returned to payers. A drug company can opt for their drug to not be assessed, in which case the drug’s price is set through the German reference pricing system. Under the reference pricing system, a drug’s price is based on the price of other drugs in that therapeutic class, including lower priced generic alternatives.

Results and Implications for the United States

As mentioned, in 2015 alone, Germany achieved savings of $1 billion on new drugs, with discounts averaging 21 percent in this pharmaceutical market segment. This savings estimate does not include a calculation for drugs that were placed in categories 4-6, so full savings would be significantly larger. Rather than stifling innovation, in AMNOG’s first four and one half years, 124 new products had completed assessments and launches, and only 13 were withdrawn from consideration.

Though some American policymakers suggest that the U.S. has little to learn from other nations, Germany may be an exception. Unlike single payer systems in Canada and the United Kingdom, Germany has a private multi-payer system where more than 90 percent of the insurance market is managed by non-profit “sickness funds.” Public anger led to AMNOG’s establishment as drug prices began to skyrocket in the last decade, reaching a growth rate of over 6 percent by 2009. Growth rates in the U.S. were 12.2 percent in 2014 and 8.1 percent in 2015.

In the U.S., the Patient Centered Outcomes Research Institute (PCORI), established under the Affordable Care Act, was created to commission clinical-effectiveness research to provide evidence to support patient-centered care, evaluating drugs and medical therapies. Like PCORI, IQWiG in its early days chose research targets on its own initiative. Under AMNOG, IQWiG now systematically reports on all new drugs and also may assess the effectiveness of older ones, including medical devices, plus surgical and screening procedures. PCORI may be well positioned to review manufacturers’ comparative-effectiveness documents as IQWiG now does.

In the U.S. pharmaceutical industry and elsewhere, a growing movement among some drug makers proposes payment based on the “value” of their products rather than on arbitrary price setting. This new “pay-for-value” movement, of course, now extends far beyond the pharmaceutical sector through initiatives such as accountable care organizations, bundled payments, and hospital readmission penalties set in motion by the Affordable Care Act. AMNOG represents a scientific and evidence-based way to pay for drugs based on their value.

For sure, the AMNOG system faces challenges, as any new and complex policy would. At times, the G-BA has chosen comparator drugs about which manufacturers disagree, that have resulted in negative benefit ratings. Parties have disagreed about appropriate end points that manufacturers must include in disclosed studies, especially in domains such as oncology where surrogate endpoints may not reflect ultimate clinical outcomes. However, the G-BA works extensively with manufacturers up front during the assessment process to communicate their choice of comparators and endpoints, allowing manufacturers a hearing or appeals process in which they disagree or develop new data.

Germany’s AMNOG system is value and evidence-based, transparent, non-governmental, publicly managed, and innovation embracing. If the U.S. wants to create an evidence and value-based system to pay for prescription drugs, we could not start at a better place than emulating the AMNOG model.

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Five Affordable Care Act Questions for the GOP

[This commentary was published today on the website of Commonwealth Magazine.]

SO, REPUBLICANS ARE planning a major blitz to repeal and delay/replace/collapse the Affordable Care Act/ACA/ObamaCare. I’ve got five questions to ask leaders of the Grand Old Party.

First, if your guarantees are honest that your replacement law will be better than the ACA, why not share real numbers?

President-elect Donald Trump, Speaker Paul Ryan, and Majority Leader Mitch McConnell have each promised that their ACA replacement will cover as many Americans as the ACA with higher quality and lower costs. Bully for that!

Here’s the problem. None of the plans you’ve produced, including the 2016 Reconciliation bill, Trump’s platform, Ryan’s Better Way, Health & Human Services Secretary designee Tom Price’s Empowering Patients First plan, or others from Republicans and conservatives, comes close. Except for this year’s reconciliation bill, none has been submitted to the Congressional Budget Office for a score. Reputable analysts peg the drop in insured lives between 20-30 million currently insured.wash-monu

Your message is “trust us.” Would businessman Trump take such a deal?

Second, when you promise to continue “guaranteed issue” of health insurance with no-pre-existing conditions or medical underwriting, why do you always fail to mention the fine print?

Trump, Ryan, and other Republicans’ statements are clear – any reform will maintain “guaranteed issue.” Yet your written plans tell another story – guaranteed issue will be kept only for persons who maintain “continuous coverage” (undefined). This means if you lose your insurance and have a coverage gap beyond the allowed time, you will be newly subject to medical underwriting and pre-existing condition exclusions for an unspecified period (forever?).

How many people might fall into this new medical underwriting Circle of Hell (CoH)? Start with 28-29 million currently uninsured, add the estimated 20-30 million increase because of Republican plans to eliminate income-based premium subsidies. We start at 48-58 million Americans, and the numbers will only grow as more fall into the medical underwriting CoH.

This is detailed in numerous replacement plans, including Ryan’s. Yet you never mention this life-important detail when talking with media who buy your line that you will continue the ACA’s elimination of pre-existing conditions for everyone. Untrue.

Third, what will you do about enormous losses for those dealing with substance abuse and mental health needs under your plans?

Most Americans don’t realize that the ACA is the biggest law ever in covering Americans for substance abuse and mental health services (aka: behavioral health). It’s true. ACA guaranteed issue means no one can be denied insurance because they had or have substance abuse/mental health problems. Bans on lifetime and annual benefit limits allows countless persons with expensive substance abuse or mental health disorders to keep covered.  Requiring insurers to cover 10 “essential health benefits” insures that nearly all Americans have behavioral health coverage (#5) PLUS prescription drugs (#6) to treat their disorders.

All Republican plans – Trump, Ryan, Price etc. – propose eliminating “essential health benefits.” They propose eroding guaranteed issue (see above) and canceling elimination of annual benefit limits. So, the ACA’s enormous advances for  mental health and substance abuse would become major losses under Republicans’ plans. I’m not sure you get this at all.  I am certain most Americans have zero idea of this and they will strongly object when they find out.

Fourth, why are you so mean to the nation’s hospitals? 

In crafting the ACA, America’s hospitals committed a mortal sin in Republicans’ eyes by making a deal with President Barack Obama and the US Senate. In exchange for Democrats’ commitment to get as close to universal coverage as politically possible, hospitals agreed to $155 billion in federal payment reductions between 2010-19 (now about $350 billion between 2016-2025). They did this to stop being the default caretakers of America’s uninsured.

Now Republicans plan to repeal the ACA’s new taxes on wealthy Americans, on drug, medical device, and health insurance companies, even on indoor tanning salons! And, they plan to leave in place the $350 billion in payment cuts to hospitals even as their policies will send as many as 30 million recently insured Americans back into the ranks of the uninsured and back to America’s emergency departments.

The American Hospital Association and the Federation of American Hospitals, who brokered the 2009 deal, wrote a letter on December 7 to Republicans: “…any repeal legislation … must include repeal of the reductions in payments for hospital services embedded in the ACA.” Sounds reasonable to me, but maybe not to others because if Congress sends the money back, it will raise Medicare’s costs for the next decade and beyond, resulting in premium increases for Medicare enrollees across the nation, and shortening the lifespan of the Medicare Hospital Trust Fund (now solvent through 2028) by years. Sad!  (Read this excellent Kaiser Health Policy Brief for more details on the impact of ACA repeal on Medicare.)

Fifth, why don’t you just fix the ACA exchanges instead of killing them?

A parable: Last summer, Alaska realized that premiums in its health exchange and individual health insurance market would be rising in 2017 by over 40 percent. In response, the Republican legislature established a state reinsurance pool to protect insurers against high losses; after passing the law, insurance companies dropped their premium increases to about 7 percent.

Some health insurance exchanges (i.e., California, New York, Massachusetts) are working well, and some are having high rate increase problems. These problems are fixable with sufficient political will to address them.  The problem is that Republican lawmakers don’t want fixes – they want repeal. In 2014, 2015, and 2016, exchange premium increases were below projections. In 2017, they have risen at high rates in most states because of the end of rate protections known as “risk corridors” and “reinsurance” as well as the underfunding of “risk adjustment” in the ACA. All of these “3Rs” are permanent features of the Medicare Part D prescription drug program that Republicans support there and despise in the ACA.

These exchange problems are fixable. Yet you refuse to support them and fix the problems because that would undermine your case for ACA repeal.

These are my top five questions right now. Any answers, my friends?

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Is “Dental Care for All” on the Horizon?

[This commentary, “Might Oral Health Be the Next Big Thing?” was published in the December 2016 edition of the Milbank Quarterly.  It was written back in September — pre-November 8th.  Just sayin’…]

Has the time come for a national movement in the United States to expand access to affordable and quality oral health services? A growing network is betting that the answer is yes. Let’s consider this nascent movement using the three ways that public health knowledge gets translated into public policy: the knowledge base, the social strategy, and political will.1

The Knowledge Base—What Do We Know?

The United States has problems with oral health. While most Americans’ oral health has improved markedly over 60 years, many millions are left behind and hurting. Societal improvements in science, technology, education, hygiene, community water fluoridation, and school-based services have not been broadly shared.2 Today, 130 million Americans, primarily adults, have no dental coverage. Many Americans with coverage find today’s health insurance cost-sharing requirements a prohibitive barrier to care. Medicare provides no dental coverage for 70% of its enrollees; 40% of them did not visit a dentist in 2014 and 60% have severe or moderate gum disease. Medicaid does cover dental services for low-income children but 17 million of them got no dental care in 2009. In most states, Medicaid covers no or little dental care for poor adults, while 47 million Americans live in areas where finding a dentist can be impossible.dental-diseases

Because of these access issues, 25% of adults over age 65 have lost all their teeth (edentulism). In 2009, US hospital emergency departments saw 850,000 visits for preventable dental pain. The avoidable disease called dental caries (or cavities) is 5 times more prevalent than asthma and affects 60% of children age 5 to 17. For those left behind, it’s a crisis. Oral health is an important part of US racial and ethnic health disparities.

Bad oral health results in pain, substandard nutrition, sleep loss, lost school time, work absence, worse jobs, and lowered self-esteem. Chronic oral infection is a proven risk factor for diabetes, osteoporosis, heart and lung disease, low birth weight, and if a dental abscess grows out of control, sepsis. Good oral health care improves overall health and decreases hospitalizations for conditions such as cerebral vascular disease and rheumatoid arthritis. The link between tobacco use and oral disease has been recognized since the US surgeon general’s 1964 report on smoking and health.3
Continue reading

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Both Sides Now on the ACA at AEI

On Friday, December 16 I participated in a panel on the future of U.S. health reform at the new headquarters of the American Enterprise Institute at 1789 Massachusetts Avenue in Washington DC (note the street address number).  There were two panels on the program called “What’s Next for Health Care?”

AEI’s Joe Antos and James Capretta were the session moderators.  Former Urban Institute Chief Bob Reischauer and I, respectively, were the ACA defenders on each of the two panels.

Feel welcome to watch the full session below — my panel starts about 1 hour into the 2 hour event which was also shown on CSPAN.

What I picked up from the session is lots of uncertainty on the Republican/ conservative side on how to proceed, both on process and substance.  Some of them are now suggesting the need for a 4-year transition, not 2 or 3 are previously discussed.  Repealing and replacing the ACA is not going to be easy for them.

Meanwhile, please check out this new column by Noam Levey in the LA Times: “Trump and the GOP are charging forward with ObamaCare repeal, but few are eager to follow.”   Levey could not identify “a single major organization representing patients, physicians, hospitals or others who work in the nation’s healthcare system (that) backs the GOP’s Obamacare strategy.”  Neither can I.

The Republicans’ ObamaCare death march is getting more interesting every day as we move closer to the cliff.

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