PPACA Care Provisions: Hospital-Acquired Infections

The Patient Protection and Affordable Care Act penalizes hospitals by reducing payments for treatment of hospital-acquired infections and imposes monetary penalties of hospitals with the worst HAI rates. The severity of this problem is covered in my previous posts below. In the US 1.7 million HAIs occur per year, killing 99,000 people. This is more people than are killed yearly by car accidents, breast cancer and AIDS combined. The annual cost of these infections is $35-45 billion.

Hospital-Acquired Infections September 1, 2010
Hospital-Acquired Infections October 6, 2010
Hospital-Acquired Infections July 11, 2011
Hospital Hazards September 1, 2011 (section on HAIs)

Shortage of injectable tromethamine

The American Society of Health-Care Pharmacists reports a shortage of injectable tromethamine. Hospira, the sole US-approved manufacturer, cites unspecificed manufacturing delays as the reason for the shortage. The blood becomes too acid because of the acid-citrate-dextrose anticoagulant used during cardiac bypass surgery. THAM, aka tromethamine, is used to make it less acid before restoring normal circulation. When someone goes into cardiac arrest, their blood almost always becomes too acid, and tromethamine is used in this instance as well.

Shortage of injectable dobutamine

The American Society of Health-System Pharmacists reports a shortage of injectable dobutamine. This drug increases the force with which the heart muscle contracts, making it possible for the heart to pump more blood without having to increase the rate at which it contracts. In other words, your pulse stays the same. WARNING: This is true for about 90% of the people given dobutamine. The other 10% may have both increased heart rate and blood pressure. Since dobutamine works on beta-receptors in the muscle, it is ineffective if you have recently taken a beta-blocker.

This is yet another shortage caused by Ben Venue's voluntary closure of its manufacturing facility, where it manufactured this drug on contract for Bedford Laboratories. There are two remaining manufacturers - Hospira cites unspecified manufacturing delays and Baxter does not give a reason for its shortage.

Dobutamine is used after heart surgery to help the heart recover, and is also given to people with heart failure to help keep blood flowing as well as possible.

PPACA Care Provisions: Quality Measurements

The PPACA required that the results of the National Quality Strategy be measured by ten outcome measurements each for acute and chronic care diseases and for preventive and primary care. Health and Human Services has contracted with the non-profit National Quality Forum for these measurements. There are currently 598 endorsed quality measures on the NQF website.

Taking the first item on the list, asthma assessment, the American Medical Association-Physician Consortium for Performance Improvement (AMA-PCPI) was put in charge of this quality measurement and produced a standard that was adopted in 2009 and is currently undergoing maintenance. The measurement is published by the HHS Agency for Healthcare Research and Quality (AHRQ). For a layperson, a quality asthma assessment consists of at least two office visits in a calendar year by a person 5-40 years of age, at which daytime and night-time asthma symptoms are recorded, quantitative measurements of the person's ability to get air into and out of their lungs are made, asthma attacks are recorded, asthma's effects on the person's quality of life are determined, short-term and long-term drugs are evaluated, along with whether the drugs are actually being bought and used as instructed. Doctor-patient communication  and patient satisfaction are reported by National Asthma Education and Prevention Program/National Heart, Lung, and Blood Institute (NAEPP/NHLBI) guidelines.

PPACA Care Provisions: The National Quality Strategy

Having heard about the individual mandate and other insurance provisions of the Patient Protection and Affordable Care Act ad nauseum, I decided to use the Scribd document below as a basis for expanding on the care provisions of the law.

The PPACA mandates an annual report on the development and implementation of a national strategy to improve health care quality. The report is here and the executive summary is reproduced below.

Executive Summary  

The Affordable Care Act seeks to increase access to high-quality, affordable health care for all Americans. To that end, the law requires the Secretary of the Department of Health and Human Services (HHS) to establish a National Strategy for Quality Improvement in Health Care (the National Quality Strategy) that sets priorities to guide this effort and includes a strategic plan for how to achieve it. This report describes the initial Strategy and plan for implementation.

The National Quality Strategy will promote quality health care in which the needs of patients, families, and communities guide the actions of all those who deliver and pay for care. It will incorporate the evidence-based results of the latest research and scientific advances in clinical medicine, public health, and health care delivery. It will foster a delivery system that works better for clinicians and provider organizations—reducing their administrative burdens and helping them collaborate to improve care. It is guided by principles (available atwww.ahrq.gov/workingforquality) that were developed with input by stakeholders across the health care system, including Federal and State agencies, local communities, provider organizations, clinicians, patients, businesses, employers, and payers. Most importantly, the implementation of this Strategy will lead to a measurable improvement in outcomes of care, and in the overall health of the American people.

An update for 2012 is available here on the Agency for Healthcare Research and Quality website. Within the update, here is the FDA's section of the plan as an example of one of the eight agencies. There is a ninth section for agency leadership.

Priorities

Making care safer by reducing the harm caused in the delivery of care.

Safe Use Initiative. The Safe Use Initiative is an FDA Center for Drug Evaluation and Research nonregulatory program through which collaborative cross-health sector projects are created to better manage specific preventable drug risks and reduce preventable harm from FDA-regulated drugs. Adverse events from drug use are estimated to result in more than 4 million visits to emergency departments, doctors' offices, or other outpatient settings annually. Innovation and improvement of risk management approaches through collaborations between federal agencies and the broader health care community can reduce preventable drug harm through increased communication, engagement, and action across all sectors of public health and health care. The metrics will be based on the specific project's objectives and outcomes. FDA and interested collaborators will develop appropriate evaluation metrics to measure an approach's success.

The overall national goal is an improvement in way things turn out for someone who is receiving health care. This is commonly referred to as the outcome, and will be a topic of later posts. One of my earlier posts, Payments for Services, Payments for Outcomes has already touched on this topic.

Health Care Shalls in the Affordable Care Act

PPACA and The US Supreme Court

Next week will probably bring the Supreme Court decision on the Patient Protection and Affordable Care Act. At the time the court accepted the case, my somewhat informed prediction was that their decision would be 7-2 in favor. Lest you doubt my sanity, there were better informed people who predicted 8-1 in favor. My prediction may yet be vindicated if Chief Justice John Roberts takes the view that a partisan decision against the PPACA would reflect poorly on the court's reputation and his own.


The bulk of the media have reported the decision as if they were covering a horse race and made speculative inferences from the oral arguments. This type of coverage has, IMHO, affected the national polls and brought forth the question of how insulated the court's decision-making process might be from the partisan divide which is the national news topic.


Polls and pundits currently predict that the court will break away from past legal decisions supporting the individual mandate as being within the range of powers granted to the federal government, declaring only that part of the PPACA an unconstitutional extension of government power. If the media and poll majorities have correctly predicted this outcome, what of it? The individual mandate as written in the PPACA is unenforceable.


The comparison between Massachusetts' experience under Governor Romney and states such as my native Texas is made by Paul Starr in The New Republic.

The one state with a mandate hardly offers much guidance. Massachusetts now has near-universal coverage, but, even before its recent reforms, only about 10 percent of its population was uninsured. Romney’s program passed with overwhelming support from both Republicans and Democrats in the state legislature. Business, labor, and the health care industry all backed the law. And, when the mandate went into effect, the agency in charge of the program ran TV ads with stars from the Boston Red Sox saying it was time to get health insurance. In some states today, by contrast, the uninsured represent 20 percent or more of the population, and, instead of elite-led support for the health care legislation, there is elite-led opposition. Under those conditions, open defiance of the mandate will be respectable, and compliance with the mandate may be much lower than the official estimates assume.

Sarah Kliff made the comparison to Washington state's repeal of an insurance mandate in two Washington Post articles. A graphic representation of what happened to insurance companies in Washington state selling individual policies is presented by Aaron Carroll of The Incidental Economist.

Experimentation at the state level is one possible answer to a Supreme Court finding that the individual mandate is an unconstitutional extension of the power of the federal government. Charles Goozner presents options in his post at GoozNews, Why Reform Will Survive Mandate’s Fall.

Shortage of prednisolone tablets

The American Society of Health-System Pharmacists reports a shortage of prednisolone tablets. If you look at the link, however, only prednisone tablets are listed. They are not the same, the liver converts prednisone into prednisolone, which is the active form. If someone has a liver disease or insufficiency, they are given prednisolone for this reason.

Whichever is actually in short supply, there are now related shortages of hydrocortisone sodium succinate for injection, methylprednisolone acetate for injection, and dexamethasone sodium phosphate

DIRECTIVE TO PHYSICIANS AND FAMILY OR SURROGATES

I recently had the initial physical exam for Medicare. My doctor asked me if I had a physician's directive to add to my file, and I told him it was in progress. Today it is finished, along with a will, medical power of attorney and durable power of attorney. The doctor commented that I was the first person who had ever  said that these documents were in the works, much less that they were complete. Boomers, do you think you will live forever?

Shortage of injectable sargramostim

The American Society of Health-System Pharmacists reports a shortage of injectable sargramostim. This drug shortage affects people whose white blood cells have been reduced during cancer chemotherapy, or eliminated entirely during a bone marrow transplant. There is a human protein that stimulates the production of white blood cells, and sargramostim is a synthetic version. As a class these drugs are known as immunostimulators, in this case a granulocyte-macrophage colony stimulating factor (GM-CSF). The brand name of the drug is Leukine, and Genzyme does not give a reason for the shortage. It is easy to speculate that the shortage is related to the fact that Sanofi-Aventis will acquire the drug from Genzyme effective July 1, 2012. The Chemocare website has a more complete description of this drug.

Ready to Break "The Pledge"

Perhaps the influence of Grover Norquist, Americans for Tax Reform, and their Taxpayer Protection Pledge is waning. Republicans, the party of low taxes, stand ready to raise the income tax rate of the approximately half of American taxpaying units that pay none. Why is that? Well, low income households are not likely to contribute to any political cause. When your major contributors are the very rich, politicians are going to follow the money in every sense of the phrase. There is also a narrative about the greater worthiness of the people who pay taxes and produce jobs for other Americans. Bruce Bartlett has gathered a few quotes.

  Last year, Senator Orrin Hatch of Utah, the ranking Republican on the tax-writing Senate Finance Committee, declared that taxes on the rich should not be raised until the poor are taxed. “I think many taxpayers are skeptical that the answer to our fiscal problems is for them to sacrifice more, when almost half of all households are not paying any income taxes,” Mr. Hatch said.
  In April, Representative Eric Cantor of Virginia, the House majority leader, said it was “unfair” that 45 percent of people don’t pay any federal income taxes. Asked if he wanted to increase taxes on these people, he replied, “You’ve got to discuss that issue.”
  In May, Richard Mourdock, the Republican Senate nominee in Indiana, likened the current split between taxpayers and nontaxpayers to the pre-Civil War division of the nation between slave and free. Consciously using Abraham Lincoln’s famous “house divided” terminology from 1858, Mr. Mourdock said, “When 47 percent are paying no income taxes — they do pay Social Security, but they are not paying income taxes — and 53 percent are carrying the load, we are a house divided.”

The poor's free ride is over! To quote our own Governor Perry, "We're dismayed at the injustice that nearly half of all Americans don'e even pay any income tax."

Mr. Bartlett's article is worth reading in its entirety, and I also recommend James Kwak's piece in The Atlantic, The GOP's Bizarre, Disturbing Passion for Raising Taxes on the Poor

Shortage of injectable succinylcholine chloride

The American Society of Health-System Pharmacists reports a shortage of injectable succinylcholine chloride. The "Implications for Patient Care" make clear that serious errors may arise when substituting blocking agents due to this shortage. Anesthesiologists typically use this drug to relax the skeletal muscles to facilitate intubation, mechanical ventilation, and the surgical procedure itself. The drug may be administered once for short surgical procedures or multiple times for longer operations. The fact that the body breaks the drug down so quickly is a matter of safety for the patient and convenience for the surgical team. A longer-acting blocking agent will preferably be used for longer operations during the shortage, but then unfamiliarity with less commonly used drugs and their antidotes can lead to problems.

Shortage of benznidazole

The first-line treatment for Chagas disease is benznidazole. Originally thought to be effective only in the early stage of disease, it is now thought to be useful during the chronic asymptomatic phase, given medical supervision. Médecins Sans Frontières details the failure of the Brazilian Ministry of Health that is responsible for this shortage, and gives an update.

As per my earlier post, Chagas Disease and Typhus in Texas, the insect vectors for Chagas now extend north of the border. The cross-border legacy of poverty and neglected tropical diseases is presented in this PLoS article. along with these recommendations for Chagas disease.

Among the recommendations recently suggested for the control of Chagas disease in Texas is the need to make Chagas disease reportable (as it has been in Arizona and Massachusetts [30]), to carry out serological studies of human and canine populations, to monitor the extent of T. cruzi infection in rodents and other wild zoonotic reservoirs, and to undertake widespread testing of blood donors and other at-risk populations [30]. Similar programs of surveillance and transmission dynamics are also required for CL, dengue, and helminth infections [20]. Given the risks of Chagas disease (including congenital Chagas disease) in Mexico and the US, there is an urgent need to educate cardiologists, obstetricians, and other health care providers about the likelihood of this and other neglected infections of poverty [31].

The Instituto Carlos Slim de la Salud in Mexico City is at work on a vaccine, and Schering-Plough is presently recruiting for a phase II clinical trial of posaconazole for the asymptomatic chronic phase of the disease.

Extractive Economic Institutions, in a Song

Reference and recommended reading: Why Nations Fail: The Origins of Power, Prosperity, and Poverty, by Daron Acemoglu and James A. Robinson

Chagas Disease and Typhus in Texas

Believe or not in global warming as you will, but the Texas climate has changed and with it the geographic areas in which murine typhus (Rickettsia typhi) and Chagas disease (Trypanosoma cruzi) occur. Travis County just had its first ever typhus mortality, but the number of cases in Texas has been increasing as the disease has extended its range to the north in recent years. If infected fleas from rats and other animals bite a human, the human bite can be infected by the feces the insect leaves on the skin when the itching bite is scratched. YNN's recent report of a rat-infested home in central Austin and an inadequate number of city inspectors is discomfiting.

The geographic area in which Chagas occurs has extended northward into south Texas. Chagas is one of the neglected tropical diseases. It is unfamiliar to US doctors and is thus even less likely to be diagnosed in the early, readily treatable stage. Typically "kissing bugs" bite humans around the mouth and eyes and simultaneously leave their feces on the skin. The bites itch, and scratching infects the person with the trypanosome in the feces. The disease can also be transmitted from mother to child and by blood transfusion. Fleas from infected dogs and rats can also infect humans. There are life-threatening heart and gut problems in the late stage of the disease.

This University of Texas press release has a map of high-risk areas. Here is a picture of the bug and instructions on how to submit one for testing. Other names for the insect are triatomine bug, cone-nose bug, and vinchuca. It is called chinche in Spanish. The bugs submitted to the Texas state labs are being tested for the presence of the trypanosome. Bugs are also being gathered and tested for both Trypanosoma cruzi and the presence of human blood, meaning of course that an infected bug has bitten a human.

Which pledge? Is Norquist's influence waning?

Grover Norquist, President of Americans for Tax Reform, may have less influence on Republicans in office and seeking election. Rosalind S. Helderman reports some new information in the Washington Post, GOP showing small shifts on taxes. She writes of the Republican freshman mentioned in my post, Which Pledge? A Small Break in a United Front, She adds that candidates supported by the national party are also breaking ranks.

Of the 25 candidates this year promoted by the National Republican Congressional Committee as “Young Guns” and“Contenders” — the top rungs of a program that highlights promising candidates who are challenging Democrats or running in open seats — at least a third have indicated they do not plan to sign the pledge authored by anti-tax crusader Grover Norquist.

Two of the seven candidates promoted by the NRCC as the“Young Gun Vanguard” —candidates competing in open seats that are considered Republican-leaning — also have declined to sign.

None of these candidates are likely to vote for a tax increase, but they also don't want to be bound by "The Pledge" if they are offered a budget deal such as last year's for $1 in increased taxes per $10 in spending cuts.

Payments for Services, Payments for Outcomes

Fee-for-service is a payment model in which every test, procedure, office visit has a price. Since it is the predominant model in the US, it has driven and will continue to drive health care costs higher until it is abolished. Since the health care industry favors this payment model, all cost control attempts have failed. This model makes no price distinction between whether your health improves with treatment or not. Payment for outcomes is being attempted not only to control costs but to reward good outcomes for patients, unlike FFS. The legal mechanism for the change to payment for outcomes is the Accountable Care Organization, a creation of the Patient Protection and Affordable Care Act. Here is an excerpt from Brian Klepper's post at KevinMD, Hostage to a payment method that puts the interest of patients last.

After all, excess has served healthcare well. A payment structure that values only appropriate care could devastate revenues for the professionals and organizations at the table.

Fee-for-service has made healthcare a merchant enterprise. Every product and service delivers a margin, and so the industry does as many as possible. The payment system’s clear incentive is to deliver more care, and more expensive care, where the absolute profit dollars are higher.

We have become hostage to a payment method that, more often than not, puts the financial interests of doctors, hospitals, and corporations above the interests of patients and purchasers of care.

There is no incentive, no market pressure, for fewer procedures, tests, and consultations at lower costs, or for care that is most likely to produce a good outcome. 

Beaty v. FDA Appealed

No surprise, the FDA has appealed US District Court Judge Richard Leon's ruling on Beaty et al. v. Food and Drug Administration et al., No. 11-cv-289. Nebraska refused to obey the order and urged the FDA to appeal. See Nebraska's Thiopental for Lethal Injection for some links and details.

Oklahoma's Attorney General was joined by the Nebraska AG and thirteen others in a letter to US AG Eric Holder, requesting an appeal of the case so that they can enforce capital punishment in their various states.

Shortage of injectable hydrocortisone sodium succinate

The American Society of Health-System Pharmacists reports a shortage of injectable hydrocortisone sodium succinate. When your body's immune response is killing you or causing you suffering, this injectable steroid will sometimes save your life or alleviate symptoms while another treatment is started. In the case of a life-threatening allergic reaction (anaphylactic shock), it will help you survive. It will also help you through the acute phase of a disease such as ulcerative colitis until a longer-term treatment can take effect. Here is Hospira's drug information sheet. I recommend reading the many uses for this drug. This shortage has probably arisen as a sequel to the Shortage of injectable methylprednisolone acetate.

I find it interesting that Hospira cites lack of manufacturing capacity for their shortage. This is the first time I have noticed something more specific than "manufacturing delays." One thing to keep in mind is that lack of manufacturing capacity can mean that the production line is being used for some other product. The questions are, what product is being manufactured instead, and why? Is the shortage due to negotiations with a contract production company? The answers to these questions are usually unavailable to the public. Manufacturing capacity is also lost when all or part of a facility is shut down because of violations of Good Manufacturing Practices. Pfizer does not give a reason for the shortage of their brand name version, Solu-Cortef.

Missouri Adopts Propofol for Execution by Lethal Injection

As of May 15th, Missouri has adopted this protocol for execution by lethal injection using propofol. (Note the misspelling of the brand name Diprivan.) APP manufactures both Diprivan and generic propofol, Hospira only the generic. The American Society for Health-System Pharmacists reports that the drug is in short supply due to "manufacturing delays" at Hospira.

Given the new protocol, the Missouri Attorney General has petitioned the Missouri Supreme Court to set execution dates for the nine death row inmates who do not already have a date set. All prisoners and their attorneys were also informed, and legal challenges to the untested execution protocol are to be expected.

I tell the detailed story of lethal drugs for injection in my posts below, but here is a summary. Hospira was the only US-approved source of the sodium thiopental that was originally used for lethal injection, but the Italian manufacturing facility with which they contracted refused to produce the drug without guarantees that their output would not be used for executions. Hospira's company policy does not prevent the sale of their products for this purpose. Nebraska fraudulently obtained thiopental from the Indian manufacturer Naari under the guise of having drug samples shipped to Zambia for approval and registration in that country. Naari has requested that the Nebraska Supreme Court order the return of their product, to no avail. After thiopental became hard to obtain, pentobarbital began to be used. It is now unavailable from Lundbeck, the only US-approved supplier, due to the company's enforcement of a shipping procedure designed to prevent the sale of their product for executions. Texas obtained some of their product by deceit, using a DEA registration number for the long-shuttered Huntsville Prison Hospital, and refused to return it to the manufacturer. Texas Attorney General Greg Abbott recently upheld an open records request that revealed that the state has supplies for 23 executions because the Texas Department of Criminal Justice is not following its own protocol and mixing a backup dose. (See syringes 1A, 2A, 3A, and 4A in the Missouri protocol for an example of how backup doses are prepared.)

Shortage of injectable pentobarbital for execution by lethal injection

Shortage of injectable pancuronium

Shortages of Drugs for Lethal Injection

Shortage of injectable potassium chloride

Shortage of sodium thiopental for lethal injection

Nebraska's thiopental for lethal injection

Which Pledge? A Small Break in a United Front

US Congressional Republicans, the most outspoken being the freshman legislators, have made a small break with Grover Norquist and Americans for Tax Reform's pledge to never vote to raise taxes. This is well reported in a post from Politico. Signing the pledge has been a must for winning a Republican primary, and ATR has supported internecine warfare against pledge violators.

On my prior subject of which oath is more important, I note that at least one Republican House freshman emphasizes his oath of office to uphold the Constitution. From the Politico post:

And a spokesman for Rep. Trey Gowdy, one of the most conservative House freshmen, emphasized that, first and foremost, Gowdy has “taken an oath to uphold the Constitution,” though the congressman isn’t backing away from the pledge.

Pledge or no pledge, none of these solons are likely to vote for a tax increase. They do seem more interested in governing than in litmus tests, however.

Which Pledge?
Which Pledge? The Texas Budget Compact