pnhpf3a

Comparative Effectiveness of Generic and Brand-Name Statins on Patient Outcomes: A Cohort Study

By Joshua J. Gagne, PharmD, ScD; Niteesh K. Choudhry, MD, PhD; Aaron S. Kesselheim, MD, JD, MPH; Jennifer M. Polinski, ScD, MPH; David Hutchins, MBA, MHSA; Olga S. Matlin, PhD; Troyen A. Brennan, MD; Jerry Avorn, MD; and William H. Shrank, MD, MSHS
Annals of Internal Medicine, September 16, 2014

Background: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them.

Objective: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes.

Design: Observational, propensity score–matched, new-user cohort study.

Setting: Linked electronic data from medical and pharmacy claims.

Participants: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008.

Intervention: Initiation of a generic or brand-name statin.

Measurements: Adherence to statin therapy (measured as the pro- portion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated.

Results: A total of 90 111 patients who initiated a statin during the study was identified; 83 731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P < 0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was -1.53 events per 100 person-years (CI, -2.69 to -0.19 events per 100 person-years).

Limitation: Results may not be generalizable to other populations with different incomes or drug benefit structures.

Conclusion: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome.

Primary Funding Source: Teva Pharmaceuticals.

From the Discussion:

In a head-to-head comparison, we found that patients initiating generic statins were more likely than those initiating brand-name statins to adhere to their prescribed treatment and had an 8% lower rate of a composite end point of cardiovascular events and death. Generic drug use has been widely recognized to reduce patient out-of-pocket costs and payer spending. Most persons in the United States are enrolled in prescription drug insurance programs with tiered benefits that require higher copayments for brand-name prescriptions than bioequivalent generic versions. Among patients in our study, the mean copayment for the index statin prescription was $10 for generic drug recipients and $48 for brand-name drug recipients. Our finding that adherence is greater with generic statins than with brand-name statins is therefore not surprising and is consistent with other studies that have shown a direct relation between higher copayments and lower adherence.

http://annals.org/article.aspx?articleid=1905128

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Comment:

By Philip Verhoef, MD

This study further dispels the notion that more skin in the game leads to better outcomes.

The researchers prospectively examined 90,111 patients who received a new prescription for statin therapy and divided them into receiving generic (83,731 patients) versus name-brand (6380 patients) for the 3 statins that were generic at that time. They used propensity scores to “match” patients since they weren’t able to properly randomize patients to generic versus name-brand. They then measured adherence and outcomes and found the following:

• 77% adherence in patients receiving generics versus 71% adherence in patients receiving name brand
• 8% reduction in the rate of pooled clinical outcomes (stroke, acute coronary syndrome or all cause mortality) for patients receiving generics
• They note that the out of pocket costs to fill the generic was 10 dollars and the branded was 48 dollars

They basically conclude that patients who have to pay more for their medications are less likely to be adherent, and that the difference in clinical outcomes occurred as a direct result of the increased cost, leading to poorer adherence and consequently more strokes/ACS/death.

There’s lots in here:

• Generics work
• Generics are cheaper
• Relatively small differences in adherence can lead to substantial clinical outcomes (ie, perhaps we should focus on improving adherence to prescribed therapies)

But I think that the biggest take-home is that if patients have to pay more for medications, they will not take them and then they will die. Ergo, shifting costs to patients leads to more death.

Philip Verhoef, MD, PhD is Clinical Instructor of Medicine at The University of Chicago Medicine, a member of the PNHP Advisory Board, and co-president for PNHP-Illinois.

Vermont ends single payer bid: Feds now left to confront the issue

By John E. McDonough
CommonWealth, December 23, 2014

Many American dislike the Affordable Care Act not because it goes too far but because it does not go far enough.  About 24 percent of Americans believe the ACA should be expanded, and by that, many mean a Medicare-for-All single payer financing scheme that takes insurance companies out of the equation.

Since the ACA is nothing like single payer, for four years now, the candle in the window for single payer advocates has stood in the governor’s office in the Vermont State House.  Gov. Peter Shumlin got elected in 2010 promising to bring a single payer health financing scheme to Vermont, and various people in his administration have been hard at work figuring how to make it happen.  Last Wednesday, though, Shumlin snuffed out the candle, admitting that he couldn’t make the numbers work.

So what is single payer’s future?  Like all good Democrats, I harken to the words of my late boss, Sen. Kennedy: “…the work goes on, the cause endures, the hope still lives, and the dream shall never die.”

Today, in the United States, we have three-plus mega-health insurance programs in Medicare, Medicaid, and the new ACA subsidy/exchange structure.  Medicare is actually two programs when you count Medicare Advantage.  Medicaid is nearing 70 million covered lives.  And as employer coverage continues its 25 year plummet, the ACA subsidized exchange world is going to grow in size and importance. 

It may take 5, 10, 15 years, or even longer – but at some point, some Republicans and Democrats will propose federal health insurance consolidation.  The illogic and wastefulness of running these enormous, siloed health insurance behemoths will become clear – that will be the backdoor start and momentum will grow.

The Vermont failure, I believe with regret, signals the end of serious efforts to achieve single payer at the state level.  It’s too big a lift, economically and politically.  Shumlin inadvertently blew out the candle.

At the federal level, I do expect it – but through the backdoor, not the front, and no time soon.

John McDonough is a professor at the Harvard School of Public Health and the author of Inside National Health Reform.

http://www.commonwealthmagazine.org/Voices/Perspective/Online-Perspectives-2014/Fall/028-Vermont-ends-single-payer-bid.aspx

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Comment:

By Don McCanne, MD

John McDonough is one of the nation’s most astute observers of health care reform. We can take solace in his prediction that the entire nation will eventually achieve single payer reform, while regretting that it will be a slow process.

For those who differ, prove him wrong.

Vermont’s Single Payer Washout

The Wall Street Journal, December 22, 2014

Last week, in a reversal that deserves more attention, Democratic Governor Peter Shumlin announced that Vermont would no longer create America’s first statewide single-payer health system.

Single payer is the polite term for socialized medicine and the ultimate goal of the political left.

At least the Governor deserves credit for admitting failure. His ideological comrades are rarely dissuaded by the prospect of economic damage, as ObamaCare proves. But Mr. Shumlin has succeeded in making Vermont a national model: By admitting that single payer will make health care both more expensive and less efficient, he has shown other states what not to do.

http://www.wsj.com/articles/vermonts-single-payer-washout-1419293404

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H.202, Bill as Passed by the House and Senate, 2011

“An act relating to a single-payer and unified health system”

changed to

“An act relating to a universal and unified health system”

(H.202 is a 213 page bill. The first 135 pages were deleted and the remaining pages are a rewrite of the entire bill.)

Sec.2(a)(6):

The director, in collaboration with the agency of human services, shall obtain waivers, exemptions, agreements, legislation, or a combination thereof to ensure that, to the extent possible under federal law, all federal payments provided within the state for health services are paid directly to Green Mountain Care. Green Mountain Care shall assume responsibility for the benefits and services previously paid for by the federal programs, including Medicaid, Medicare, and, after implementation, the Vermont health benefit exchange.

http://www.leg.state.vt.us/docs/2012/bills/Passed/H-202.pdf

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Comment:

By Don McCanne, MD

As was fully expected, the conservative and libertarian pundits are inundating the Internet and other media vehicles with celebratory commentaries on the theme that Vermont Gov. Peter Shumlin’s withdrawal of his single payer proposal is proof that single payer is more expensive and less efficient than other health care financing systems. The Wall Street Journal editorial excerpt above is selected as a leading example of these right-wing responses. The problem with these comments is that H.202, the Vermont reform legislation, IS NOT A SINGLE PAYER PROPOSAL.

Even many single payer supporters have it wrong. They claim that Gov. Shumlin gave up for political reasons, and, if he had persevered, he would have been successful in establishing the first state-level single payer system in the U.S. Again, the problem is that H.202, the Vermont reform legislation, IS NOT A SINGLE PAYER PROPOSAL.

Posted above is a link to H.202. During the legislative process, the bill was renamed, deleting “single-payer” from its title. If you check the document at the link, you will see that the original bill was red-lined out, and the bill was entirely rewritten. All references to “single-payer” were removed.

The crucial phrase in the except above regarding waivers and agreements is “to the extent possible under federal law.” It was known at the time the revisions were being made that Sec 1332 ACA waivers, Sec 1115 Medicaid waivers, the narrowly defined Medicare demonstration waivers, and the ERISA limitations on employer-sponsored plans were so limited that it would be impossible to establish a bona fide single payer system through unilateral state action alone, nor through a cooperative effort with the Obama administration. Comprehensive federal legislation would have been required, and that clearly was not forthcoming from this or the next Congress. Legislating a wish list does not equate with clearing all of the hurdles that only Congress can effectuate.

The reason that this message is being reemphasized again today is that there has not been a loud enough voice in unison emphatically rejecting the claim that Vermont’s experience is proof that single payer cannot work. Single payer never had a chance, considering the inertia in Congress. This was not a single payer failure. Do not remain silent when that claim is made. Single payer has been proven to work well in many other nations.

Medicaid Payments and Access to Care

By Sara Rosenbaum, J.D.
The New England Journal of Medicine, December 18, 2014

With more than 66 million beneficiaries, Medicaid is the United States’ largest insurer, and its impact on health insurance coverage, access to care, and the health of the poor has been substantial. But historically, Medicaid has faced a major challenge — a relatively low rate of physician participation. In its March 2011 report to Congress, the Medicaid and CHIP (Children’s Health Insurance Program) Payment and Access Commission (MACPAC, Congress’s Medicaid advisory panel) pointed out that the Medicaid population disproportionately resides in medically underserved communities with serious shortages of primary care providers and that the problem of isolation is confounded by low physician-participation rates.

Extensive research suggests that many factors contribute to low physician participation: complex program requirements, payment delays, and concerns about managing the care of patients with high levels of health and social risk. But research also shows that low fees play a key role and that substantial payment increases may be needed to alter physicians’ behavior. In a study conducted for the Kaiser Family Foundation, the Urban Institute estimated that in 2012, Medicaid physician fees averaged about 66% of Medicare payments and that the Medicaid–Medicare pay disparity was widening.

For good reason, primary care tends to be the first area of focus in any discussion of access in Medicaid. With a pronounced and growing shortage of primary care professionals — a shortage that’s estimated to reach 30,000 by 2015 — depressed Medicaid participation among available physicians is a major cause for concern. In the case of primary care, mitigation strategies exist. Safety-net providers such as community health centers play a vital role in reducing the access gap in the communities they serve.

Specialty care arguably presents the more serious Medicaid access problem, especially since there is no obvious mitigation strategy for it comparable to that offered by community health centers. The Commonwealth Fund reports that low payment rates are the principal cause of reduced specialist participation.

Among the hot-button issues that define the tense federal–state Medicaid relationship, no issue has historically been hotter than access to care, because of fierce state resistance to federal oversight of provider payment. This tension has led Congress to gradually strip most provider-payment provisions out of the Medicaid statute. But one basic legal principle remains: the so-called equal-access provision, which specifies that as a condition of federal funding, states’ Medicaid provider payments must be “sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”

The Department of Health and Human Services (HHS), however, has never implemented this provision through regulations.

Under the Affordable Care Act, Congress funded a 2-year pay increase for Medicaid primary care services in order to boost primary care payment rates to Medicare levels. In its Kaiser study, the Urban Institute estimated that the pay bump would increase fees by 73%. But the increase, which took effect in 2013, expires at the end of 2014, with no renewal in sight. News reports suggest that nearly all states plan to roll back primary care payments to 2012 levels, despite anecdotal evidence reported by some states of increases in provider participation.

Faced with payment rates that in some cases may be dangerously low, beneficiaries and providers have turned to litigation. A fundamental question, however, is whether providers and beneficiaries can go to court when provider payments may be too low to ensure appropriate access to care. In 2012, in Douglas v. Independent Living Center of Southern California, which involved a challenge to deep rate cuts enacted by California’s legislature, the Supreme Court deflected this question. Now, however, the issue is back; this term, the Court will hear Armstrong v. Exceptional Child Center, Inc., which again raises the question of whether beneficiaries and providers can protest low Medicaid payments in court. Douglas involved a rate cut; Armstrong, in contrast, involves a state’s refusal to pay properly. The situation here is one of a state’s failure to pay a provider an HHS-approved rate, with no HHS effort to enforce its own requirements.

Observers do not expect another deflection; in his Douglas dissent, Chief Justice John Roberts made clear his objection to court involvement in Medicaid-access cases, arguing that HHS — not the courts — should be the sole enforcement authority.

The Armstrong situation may be more serious than that in Douglas. Douglas involved an ongoing and active federal review, however slow it may have been. In Armstrong, the federal government has chosen to play no affirmative role whatsoever. 

There is a deeper issue here, of course: getting the federal government to do what it is supposed to do. That means issuing the long-delayed access regulations, providing technical assistance to states, and maintaining active and ongoing oversight of state program management. Medicaid beneficiaries deserve no less.

http://www.nejm.org/doi/full/10.1056/NEJMp1412488

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Comment:

By Don McCanne, MD

Medicaid has traditionally underpaid physicians for their health care services. That has resulted in low participation rates, especially by specialists, which, in turn, threatens health care access for Medicaid patients. The Medicaid statute requires that states’ Medicaid provider payments must be “sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.” Failure of our government to enforce this equal-access provision will now be heard by the Supreme Court.

The Affordable Care Act (ACA) greatly expanded eligibility for Medicaid, though the increase was not quite as large as anticipated because of the Supreme Court’s previous ruling allowing states to opt out of the expansion. Nevertheless, in an effort to ensure that enough physicians would participate at a level to assure adequate access for the new Medicaid enrollees, Congress included a temporary provision in ACA that would increase primary care payments to Medicare levels. Next week, that increase ends, and most states will revert to pre-ACA payment levels.

Most states are shifting their Medicaid patients into managed care organizations for the purpose of reducing their spending for this program. With the low payment rates, it is difficult to see how these organizations can afford to finance their patients’ care except by significantly reducing the frequency and intensity of services delivered. This is not a population that has been receiving an excess of health care services. Quite the contrary, they were already doing without services that they should have. These further reductions likely will be able to be measured by an increase in suffering and death.

Although Chief Justice Roberts has already indicated that he does not believe this is a matter for the courts, even if there is a ruling that the equal-access provision must be enforced, it is likely that only nominal adjustments will be made and that Medicaid will continue to be critically underfunded.

Instead of tweaking Medicaid, we need to enact an improved Medicare for all that would include implicitly an equal-access provision that applies to everyone.

Protesters demand action on single payer, condemn Shumlin’s reversal

By Morgan True
VTDigger.org, December 18, 2014

Protesters from across the state descended on Montpelier Thursday to voice their anger with Gov. Peter Shumlin’s decision to drop his pursuit of single payer health care. More than 60 people stood in front of the Statehouse chanting slogans and singing protest songs.

Deb Richter, a longtime single payer advocate who regularly attends the Green Mountain Care Board’s meetings, tried to convince protesters that Shumlin is not their enemy.

“He’s the only governor in the country who raised this issue and put it in the forefront,” she said.

She urged them to have patience, and said she’s still optimistic Vermont will be the first state to have public universal health care, but that goal may need to achieved in increments, as the governor indicated when he made his announcement Wednesday.

“This is like turning the Titanic,” she said, “Frankly, beating up on the governor I do not believe is really going to be helpful.”

Richter called on the protesters to take their message to the Legislature, which she said is now the most fertile ground for making progress on health reform.

http://vtdigger.org/2014/12/18/protesters-demand-action-single-payer-condemn-shumlins-betrayal/

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Comment:

By Don McCanne, MD

Deb Richter is right. The criticisms of Vermont Gov. Peter Shumlin are not only misdirected, many of them are based on the notion that he had all of the tools at hand to establish a single payer system in Vermont, but that he then decided not to move forward in response to political pressure. We should look carefully at the facts and then decide what approach we should now take to advance the single payer cause.

Many of the protests state or imply that Vermont was on the cusp of implementing a single payer system, but the effort failed because Gov. Shumlin was not innovative enough in his financing proposal for the single payer system, and then elected to abandon it because of the tax burden on individuals and businesses.

What is wrong with this concept?  Well, many things, but the most important is that the model that the governor was trying to implement WAS NOT A SINGLE PAYER MODEL. Excuse the shouting, but everyone must understand that this was not a failure of the single payer model.

Very early it was clear that Vermont could not establish a single payer system without federal support. Even the Obama administration did not have the tools to grant the comprehensive “waivers” that would be required since the process for such waivers must be authorized by Congress. The available Sec 1115 Medicaid waivers, Sec 1332 ACA waivers, and the highly limited Medicare demonstration waivers are not nearly enough to assemble a single payer program. Also ERISA restrictions prevent the state from moving self-funded employer-sponsored health plans into a state system.

It became so obvious that the label, “single payer,” was removed from the legislation, H.202, and the bill was completely rewritten. The bill passed WAS NOT A SINGLE PAYER BILL. After negotiations with the Obama administration, it was clear that there was no way to transfer the control of Medicare to the state government. It was decided that Medicare had to be left out since there was no other option. Another dilemma was that Vermont could not force employers such as IBM into the program, yet the financing system for Green Mountain Care (the surviving entity that was not even close to being a single payer for Vermont) would require payroll taxes and income taxes. How could you require IBM and their employees to pay taxes into a state health care program when they are already paying into IBM’s health benefit program? There are a multitude of other problems that we won’t repeat here, but Vermont was never even close to establishing a single payer system.

When opponents of single payer use the failure in Vermont as proof that single payer cannot work, we must respond that VERMONT NEVER ENACTED A SINGLE PAYER BILL. The bill that was enacted was not much more than a variation on the Affordable Care Act. Although it did have the unique feature of attempting to consolidate private insurers into Green Mountain Care, it failed to provide processes to implement the great multitude of other beneficial features that would be required to make it a single payer system. Vermont’s effort WAS NOT A FAILURE OF THE SINGLE PAYER MODEL.

Gov. Shumlin was not to blame. The federal restrictions were simply overwhelming, making implementation of single payer impossible without major federal legislative action. Nevertheless, Gov. Shumlin continued with his efforts to move forward with implementing as many features of single payer as were possible in this political environment. Any objective analysis reveals that there were too few options at his disposal. Merely expanding our dysfunctional system results in increased health care spending. Innumerable studies have shown that expanding on our system increases spending while falling short of reform goals. Gov. Shumlin just proved that once again. This was not a failure of the single payer model; it was a failure of a model composed of flawed health policies found in our current financing system, as perpetuated by the Affordable Care Act. A true single payer system achieves all goals while slowing spending to sustainable levels.

So what do we do now? Once everyone finishes with their venting, it is imperative that we all pick up our pace in moving forward with single payer. There are many tasks at hand. The three most important you’ve heard repeatedly: education, education, education. The nation needs to have a better understanding of single payer (and I dare say that applies to some in our own camp as well). We need both federal and state legislation. States cannot do it without enabling federal legislation, but then states will need their own legislation to implement the single payer bill enacted by Congress. Until we have the requisite federal legislation, states should begin working on cleaning up our health care financing systems so that the eventual transition to single payer will flow more smoothly.

Many have said that we cannot do anything for the next two years because of the red tide in Congress. On the contrary, two years is almost too short of a time to intensify our education efforts, and begin building the political momentum for reform, ideally before the 2016 elections. We need to get working immediately.

The news from Vermont should not be a reason to walk. On the contrary, it provides us with a reality check on what we need to do.

By the way, did I say that this was not a failure of single payer, since it was never a single payer model in the first place?

(Note: There are many views being expressed now, and some of them are in conflict. The views here are mine and not the official views of PNHP. During this time, all opinions should be expressed, but awfulizing and obstruction of progress should be avoided at all costs. We need to sound off, regroup, and then move forward both individually and in unison in our quest for health care justice for all.)