Mostrando las entradas con la etiqueta Massachusetts. Mostrar todas las entradas
Mostrando las entradas con la etiqueta Massachusetts. Mostrar todas las entradas

07 mayo, 2013

Controlling Health Care Spending — The Massachusetts Experiment

Composition of Massachusetts Residents Newly C...
Composition of Massachusetts Residents Newly Covered under Chapter 58 (as of 1/1/08) (Photo credit: Wikipedia)
As debate rages on about implementation of the Affordable Care Act (ACA), national attention is once again focused on Massachusetts, which instituted a similar comprehensive health care reform package in 2006. After expanding health insurance coverage to almost 98% of the state population, Massachusetts is now struggling to control increasing health care costs that threaten the continued viability of its reforms. This second phase of health care reform presents entirely new challenges. Whereas expanding coverage has popular appeal, cost control does not. Whereas expanding coverage injects additional dollars into the health care system, cost control does the opposite. Whereas expanding coverage can be relatively simple, cost control is difficult. Yet despite these obstacles, Massachusetts forges ahead, with a combination of public and private efforts at payment reform on an unprecedented scale.
Massachusetts spent more than $61 billion on health care in 2009, a figure that places it among the highest-spending states in the country.1 In the past 5 years, growth in health care spending has consistently exceeded economic growth, resulting in challenges both for lawmakers dealing with a constrained state budget and individuals required to purchase coverage privately. In fiscal year 2012, health care will consume 54% of the state's budget, up from 49% in fiscal year 2009, with the bulk going toward Mass Health (Medicaid) and individual subsidies for purchasing health insurance. For individuals, monthly premiums for a minimal (“bronze”) plan purchased through the Commonwealth Choice connector (the state insurance exchange) increased from about $175 in 2007 to $275 in 2012 (a 57% increase), despite slowed growth in overall health care spending since the start of the recession in 2008.
To address these concerns, Governor Deval Patrick convened the Massachusetts Special Commission on the Health Care Payment System, which voted unanimously in July 2009 to recommend that the state transition from a fee-for-service to a global payment system within 5 years. The commission also encouraged providers to band together into accountable care organizations (ACOs) — organizations of providers held jointly accountable for spending and quality of care for a defined population of patients. Meanwhile, the Health Care Quality and Cost Council, created by the 2006 coverage-expansion law, issued its Roadmap to Cost Containment in 2009; in it the council argued strongly for global payment and systemwide redesign to lower spending.2Recognizing that price and volume together account for spending, the Office of the Attorney General and the Division of Health Care Finance and Policy embarked on a landmark effort to document the substantial price variations in the state — illustrating, in several influential reports, the role of providers' market power in determining the prices charged to commercial insurers.3
These activities culminated in a comprehensive payment and delivery reform bill released by Governor Patrick in February 2011. The bill proposes migrating into global payment arrangements most state employees and Medicaid enrollees, groups that together include about 25% of Massachusetts residents.4 It also encourages but does not require providers to form ACOs — with the state providing oversight of market power and price transparency — and includes provisions for malpractice reform favored by physicians. The bill also grants the commissioner of insurance the authority to strike down increases in insurance premiums that result from excessive increases in underlying provider-payment rates. The appropriateness of increases in provider-payment rates will depend on how they compare with growth in the Massachusetts gross state product (the state-level equivalent of the national gross domestic product) and the growth of total medical expenses in the providers' particular region. Combined with global payment, this authority to indirectly regulate providers' prices would be among the strongest policy tools available for cost control. Since the bill's release, state legislators have been drafting their own proposals, and both public and closed-door debates have intensified. The legislative outcome remains unclear.
While the state aggressively pursues its agenda, innovations in the private sector have arguably taken the lead. Most notably, Blue Cross Blue Shield of Massachusetts, the largest commercial insurer in Massachusetts, launched the Alternative Quality Contract (AQC) — based on global payment with shared savings and shared risk, as well as pay-for-performance incentives — with seven provider organizations in 2009. Since then, the AQC has been extended to cover more than a dozen provider organizations and more than 600,000 enrollees. Encouraged by provider organizations and the AQC, Harvard Pilgrim Health Care and Tufts Health Plan, the state's other major insurers, have also negotiated global payment contracts with their provider networks, which will probably push the number of enrollees in commercial insurance plans that have global payment arrangements to more than 1 million.
Finally, and perhaps most important, the Center for Medicare and Medicaid Innovation launched its Pioneer ACO program in January 2012 with 32 advanced provider organizations around the country. Among them are 5 large organizations in eastern Massachusetts (Atrius Health, Beth Israel Deaconess Physician Organization, Mount Auburn Cambridge Independent Practice Association, Partners Healthcare, and Steward Health Care System), which will together care for approximately 150,000 Medicare beneficiaries (roughly 75% of Medicare beneficiaries in the Boston area) under their Pioneer contracts. Additional provider organizations in the state will probably join the Medicare Shared Savings ACO Program later this year.
These synergistic efforts by public and private payers have resulted in a watershed moment in Massachusetts health care. By our estimates, if the Group Insurance Commission, which purchases insurance for state employees, and Medicaid follow Medicare and commercial payers into global payment, substantially more than half of residents of eastern Massachusetts would be cared for by providers working under risk-based contracts. Primary care physicians will have the opportunity and responsibility to steer resource utilization for their organizations, and providers in all specialties will have strong incentives to better coordinate care, improve quality, and intensify their focus on patient-centered care. Referral patterns and the movements of patients from one provider system to another will probably change considerably. Similarly, with strong incentives to reduce spending, provider organizations will probably take an active role in identifying and discouraging the use of low-value services. Opportunities will be ripe for designing incentives within organizations directed at individual physicians as well as teams of providers.5
Yet immense challenges loom. Because enrollees in preferred-provider organizations and most employees of self-insured firms remain largely outside of global payment arrangements, the fee-for-service system retains a substantial role. With global payment expected to constrain spending for a growing proportion of patients, undesirable spillover effects, such as cost shifting onto the fee-for-service population, may occur. At a macro level, Massachusetts relies heavily on specialty-driven tertiary care delivery systems not only for its health care but also for jobs and the education of thousands of physicians-in-training each year. Indeed, health care is an engine of the Massachusetts economy. A crucial question is whether lawmakers will gain the stakeholder support needed to embrace cost control and tackle the roots and drivers of Massachusetts health care spending, given that unintended consequences for the labor market and the broader economy may lie downstream.
No matter the outcome, this wholesale Massachusetts experiment should offer invaluable lessons for other state and federal cost-control efforts, particularly as the ACA is implemented. One lesson is already resoundingly clear: the growth of health care spending threatens the sustainability of every other public service, from education, to public health, to infrastructure, to defense. Indeed, health care spending is the most important determinant of our growing national debt. In a society of limited resources, the imperative for cost control now comes from outside health care. Payment reform may well be a reasonable beginning, but fundamental reform of the delivery system is needed if we are to truly succeed.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1201261) was published on April 11, 2012, at NEJM.org.

SOURCE INFORMATION

From the Department of Health Care Policy, Harvard Medical School (Z.S., B.E.L.); and the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center (B.E.L.) — both in Boston; and the National Bureau of Economic Research, Cambridge, MA (Z.S.).

REFERENCES

  1. 1
    Centers for Medicare and Medicaid Services. National health expenditure accounts (httphttp://s://www.cms.gov/NationalHealthExpendData).
  2. 2
    Massachusetts Health Care Quality and Cost Council. Roadmap to cost containment. October 21, 2009 (http://www.mass.gov/hqcc).
  3. 3
    Examination of health care cost trends and cost drivers: report for annual public hearing, June 22, 2011. Boston: Office of Attorney General Martha Coakley (http://www.mass.gov/ago/docs/healthcare/2011-hcctd.pdf).
  4. 4
    An act improving the quality of health care and controlling costs by reforming health systems and payments. Boston: Commonwealth of Massachusetts, 2011 (http://www.mass.gov/governor/docs/legislation/paymentreformlegislation.pdf).
  5. 5
    Landon BE. Keeping score under a global payment system. N Engl J Med 2012;366:393-395
    Full Text | Web of Science | Medline

30 octubre, 2012

Florida Suspends A Compounding Pharmacy


In the wake of the meningitis outbreak and controversy over compounding pharmacies, the Florida Department of Health late last week suspended a compounder in Boca Raton after determining the pharmacy had violated a number of statutes and rules. The move came following an inpsection earlier this month.

octubre 29, 2012 under Compound Pharmacy, Rejuvi Pharmaceuticals
In reaching its decision, the department cited problems with cleanliness, dispensing and compounding medications, and record keeping. A review of previous inspections also found that Rejuvi Pharmaceuticals had previously been notified of the violations, but failed to correct them, according to a statement.
The suspension, which will be followed by a hearing, is the latest fallout from the scandal surrounding the New England Compounding Center – which has been identified as the source of contaminated vials of injectable steroids traced to the meningitis outbreak – and the role of regulators in overseeing compounding pharmacies.
Since the outbreak emerged this month, there has been a mixture of confusion and outrage over the extent to which the FDA and state regulators are responsible for enforcing regulations, and whether the appropriate actions were taken. NECC, for instance, received an FDA warning letter in 2006 and Massachusetts regulators had received complaints.
Although debate remains over FDA powers and whether Congress should clarify agency authority with additional legislation, the FDA last Friday issued the results of an inspection of NECC that found the compounding pharmacy had serious problems keeping its facilities free of mold and bacteria, notably in so-called clean rooms used for production (see this).
Meanwhile, state regulators are facing mounting pressure to ensure that compounders are adhering to local laws, a development reflected in the suspension in Florida. The state has, so far, tallied 22 cases of meningitis, including three deaths, accoring to the state health department (read here).
And in Massachusetts, regulators closed yet another compounder. In addition to shuttering NECC and a related operation called Ameridose, which voluntarily closed earlier this month, Infusion was closed after inspectors last week found “significant issues” and “expressed concerns for the sterility of products,” according to Madeleine Biondolillo, director of the Bureau for Health Care Safety and Quality.
In addition, “there was an adjacent space set up for giving patients intravenous medications onsite. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations.” The pharmacy has now surrendered its license (here is the statement).
On a broader scale, the state is filing regulations to require compounding pharmacies in Masschusetts to submit frequent reports of production, volume and distribution of sterile, injectable medications. And a commission is being formed to examine best practices in other states and potential changes to state law or regulations.

08 febrero, 2012

Caffeine to inhale hits market

Source: Newsmap


CAMBRIDGE —  Move over, coffee and Red Bull. A Harvard professor thinks the next big thing will be people inhaling their caffeine from a lipstick-sized tube. Critics say the novel product is not without its risks. 

The product, called AeroShot, went on the market late last month in Massachusetts and New York, and is also available in France. A single unit costs $2.99 at convenience, mom-and-pop, liquor and online stores. 

Biomedical engineering professor David Edwards said AeroShot is safe and does not contain common additives, like taurine, used to amplify the caffeine effect in common energy drinks. Each grey-and-yellow plastic canister contains 100 milligrams of caffeine powder, about the amount in a large cup of coffee, plus B vitamins. 

But Democratic U.S. Sen. Charles Schumer of New York wants the U.S. Food and Drug Administration to review AeroShot, saying he fears it will be used as a club drug so that young people can drink until they drop. Schumer's national press secretary did not immediately respond to calls for comment. 

FDA spokeswoman Siobhan DeLancey declined to comment, saying the agency will respond directly to Schumer on the matter. 

Edwards said Schumer's comments are understandable in the context of developments over the last few years, when students looking for a quick and cheap buzz began consuming caffeine-packed alcoholic drinks they dubbed “blackout in a can” because of their potency. But he said AeroShot is not targeting anyone under 18 and it safely delivers caffeine into the mouth, just like coffee. 

“Even with coffee — if you look at the reaction in Europe to coffee when it first appeared — there was quite a bit of hysteria,” he said. “So anything new, there's always some knee-jerk reaction that makes us believe ‘Well, maybe it's not safe.' ” 

Once a user shoots a puff of calorie-free AeroShot into his or her mouth, the lemon-lime powder begins dissolving almost instantly. Each single-use container has up to six puffs. 

“The act of putting it in your mouth is the act of breathing — so it's sort of surprising and often people the first time they take the AeroShot, they laugh ... that it's kind of a funny way of putting food in your mouth,” said Edwards, who also came up with a breathable chocolate product a few years back. 

Dr. Lisa Ganjhu, a gastroenterologist and internal medicine doctor at New York-based St. Luke's-Roosevelt Hospital, said people need to be aware of how much caffeine they are ingesting. 

“You want those 10 cups of coffee, it will probably take you a couple hours to get through all that coffee with all that volume that you are drinking,” Ganjhu said. “With these inhale caffeine canisters you can get that in 10 of those little canisters — so you just puff away and you could be getting all of that within the hour.” 

Even the product packaging warns people not to consume more than three AeroShots per day. 

Northeastern University students who sampled the product recently gave it mixed reviews. 

“This tastes really good and I think it rocks,” student Zack Huang said after puffing onto a free sample before rushing to join a group of friends who were walking away from campus. 

Still, one student was not happy with the taste, echoing sentiment expressed online by some consumers. 

People elsewhere vowed they would never give up their morning coffee. 
“I want to brew it, I want to stir it and I want to drink it slowly as I absorb the caffeine,” said longtime coffee fan Mark Alexander. 

The makers of AeroShot appear to be aware of that sentiment, declaring that the product isn't about switching away from coffee, but rather making it easier for people with active lifestyles to get their caffeine fix. 

“AeroShot can be used in a variety of settings inconvenient for liquids, such as when you study in the library, board an airplane or get into the car for a long drive,” they say in the section dedicated to frequently asked questions on their website. “It's easy to take AeroShot with you when you go biking, skiing, curling, or any other activity that consumes energy.” 

AeroShot, manufactured in France and the flagship product of Cambridge-based Breathable Foods Inc., is the product of a conversation that Edwards had with celebrity French chef Thierry Marks over lunch in the summer of 2007. 

“We were discussing what interesting culinary art experiments we might do together and I had the idea that we might breathe foods since I've done a lot of work over the last 10 or 15 years on medical aerosols,” Edwards said. 

The first venture Edwards worked on with Harvard students was the breathable chocolate, called Le Whif. Now he's preparing to promote a product called Le Whaf, which involves putting food and drinks in futuristic-looking glass bowls and turning them into low-calorie clouds of flavor. 

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02 agosto, 2011

Massachusetts sues-jj-over-risperdal-marketing Sues J&J Over Risperdal Marketing

Ed Silverman
money-ben-franklinsYet another state has filed a lawsuit alleging that Johnson & Johnson illegally marketed its Risperdal antipsychotic to the detriment of its citizens. This time, Massachusetts alleges J&J promoted the drug to treat elderly dementia and various unapproved uses in children and adolescents. The state also claims J&J failed to disclose serious risks such as the possibility of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.
“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Massachusetts Attorney General Coakley says in astatement. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”
The state also charged the health care giant with making misleading and deceptive statements to prescribers about Risperdal safety, especially such side effects as weight gain and developing diabetes; paying docs to participate in “sham consulting programs” that were “thinly disguised” marketing programs touting unapproved uses; and targeting docs who rarely, if ever, prescribed Risperdal for FDA-approved uses which are schizophrenia and bipolar mood disorder (read the lawsuit here).
The lawsuit comes as J&J holds talks to to resolve a raft of litigation and investigations related to Risperdal marketing. Four months ago, J&J set aside an unspecified amount of money to be used to settle some of the litigation. The Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states have been probing off-label Risperdal marketing for years (see this).
Although reports have suggested J&J may wind up settling much of the litigation for $1 billion or so, the tab may be mounting. In June, a South Carolina judge that J&J must pay $327 million for deceptive Risperdal marketing, and last fall, a Louisiana jury ordered J&J to pay $257.7 million in damages for making misleading safety claims (read here), although $73 million in legal fees were later added. In explaining his decision, the South Carolina judge labeled J&J actions “detestable” (look here).
J&J has scored a couple of victories. A lawsuit brought by Pennsylvania officials, who charged J&J hid the risk of diabetes and misled state regulators into paying millions more than they should have for the medicine, was dismissed (see here). And two years ago, a West Virginia judge awarded $3.95 million, after finding J&J misled doctors about risks and benefits, although the state dropped its claim after J&J won an appeal. Nonetheless, the average loss has so far cost about $150 million (four state lawsuits) or roughly $300 million (when considering two actual defeats).
As we have noted previously, J&J will appeal the losses in Louisiana and South Carolina, and could possibly pay much less than the penalties awarded. By suggesting a global deal might total $1 billion or so, the health care giant may try to get the amounts reduced on a proportionate basis, and use the same argument in talks with any state that does not join a settlement. But if more states file lawsuits, the costs could rise. Perhaps the timing of the Massachusetts lawsuit is not a coincidence.
One looming case is scheduled to go to trial this November in Texas. And J&J potentially faces a much bigger liability in that Texas has a much larger population than Louisiana and South Carolina and, therefore, would encounter a heftier payout. This case, by the way, also involves statutory and common law fraud issues that were not raised in the other states. The focus is on the so-called TMAP program that was allegedly designed to boost Risperdal prescriptions by unduly influencing University of Texas professors and state officials to endorse the effort and promote it nationally (read here).