The Hippocratic Math

Bill Requiring Licensure of One-Room Ambulatory Surgery Centers In New Jersey Dies in Gov. Christie’s Pocket

Governor Christie has pocket vetoed a bill that would have required one-room ambulatory surgery centers (ASCs) in New Jersey to be licensed by the State Department of Health and Senior Services (DHSS), as ASCs with more than one operating room already are.

More than One Room

Under current law (e.g., N.J.S.A. 26:2H-1 et seq.; N.J.A.C. 8:43A), ASCs with more than one operating room are subject to a variety of statutes and regulations, including that they must obtain a license that specifies the health care services they are authorized to perform (N.J.S.A. 26:2H-12(a)) and report certain information to DHSS on a quarterly basis (N.J.S.A. 26:25-5.1e).  ASCs providing surgical and related services must “obtain ambulatory care accreditation from an accredited body recognized by [CMS]” as a condition of licensure (N.J.S.A. 26:2H-12(h)).  They also must establish and maintain a uniform system of cost accounting, reports and audits; prepare and annually review a long range plan; and establish and maintain a centralized, coordinated system of discharge planning (N.J.S.A. 26:2H-12(a)).  The statute also assesses various fees, which it caps at $4,000 for applications for licensure or renewal and $2,000 for biennial inspections (N.J.S.A. 26:2H-12(b)).    Since 2004, licensed ASCs with gross receipts greater than $300,000 also must pay an annual assessment based on its gross receipts and the assessment, capped at $200,000 (N.J.S.A. 26:2H-18.57(b); N.J.A.C. 8:31A)), is deposited in the Health Care Subsidy Fund (N.J.S.A. 26:2H-18.58).

DHHS’s implementing regulations cover a broad array of topics, including the qualifications of  persons working at these facilities, housekeeping protocols, emergency equipment, disaster plans, physical plant requirements, and laundry policies and procedures (NJAC 8:43a-1 et seq.).   The regulations impose a biennial inspection fee (N.J.A.C. 8:43A-2.2(m), although DHSS’s web site says that it inspects licensed ASCs every three years.

One Room

ASCs with only one operating room presently escape this licensure requirement (and its corresponding regulatory demands) because they are defined as physician’s surgical practices, which are excluded from the definition of surgical facilities that must be licensed.   (N.J.S.A. 26:2H-12(g)(5); N.J.A.C. 8:43A-1.3)  While surgical practices do not yet need to obtain a license,  they must register with DHSS, which registration, in turn, carries a variety of conditions.  For one, they must “obtain certification by the Centers for Medicare and Medicaid Services [(CMS)] as [] ambulatory surgery center provider[s] or obtain ambulatory care accreditation from an accrediting body recognized by [CMS]” - similar to larger ASCs.  They also must annually report to DHSS data regarding patients serviced by payment source and staffing levels.   The Commissioner of DHSS has the ability to revoke, suspend, or deny an application for a registration if the surgical practice is not in compliance.   The statute also prohibits ownership, management, or operation of a surgical practice “by any person convicted of a crime relating adversely to the person’s capability of owning, managing, or operating the practice.”  (N.J.S.A. 26:2H-12(j)) One-room ASCs also are regulated by the State Board of Medical Examiners as private physician practices.  The BME has enacted regulations establishing policies, procedures, staffing, and equipment requirements when practitioners perform surgery (other than minor surgery), special procedures, and anesthesia services in an office setting (N.J.A.C. 13:25-4A).  The BME has the authority to investigate and bring a licensing action against any physician who fails to comply with these regulations (N.J.S.A. 45:1-18, 45:1-21).  One-room ASCs serving Medicare or Medicaid patients also must satisfy federal standards and be certified by CMS.   If a one-room ASC is certified by CMS, DHSS conducts inspections on behalf of CMS every four years.  DHSS and the BME (N.J.S.A. 45:1-18(c)) also may conduct inspections to investigate complaints filed about a one-room ASC.  But there is no present state requirement that one-room ASCs be inspected by the BME or DHHS.

One Rooms Cited for ‘Immediate Jeopardy’

A report issued by the New Jersey Health Care Quality Institute (NJHCQI) in April 2011 shined the spotlight on the lack of oversight of one-room ASCs.  NJHCQI reviewed reports of inspections in 2009 and 2010 of 91 ASCs in New Jersey that reportedly were funded by a one-time federal grant.  40 of the 91 inspected facilities were unlicensed one-room ASCs, 17 of which (43%) were cited for “immediate jeopardy,” which is “defined as noncompliance with established rules that has caused, or is likely to cause, serious injury, harm, impairment or death to a patient.”  (In comparison, 8 of the 51 licensed facilities (15%) that were inspected were found in “immediate jeopardy.”)   The cited violations included, among others, a variety of improper sterilization and infection control procedures; inadequate tracking of medications, including controlled substances and expired medications; improper anesthesia administration; and failing to have necessary emergency medications or an agreement to transfer patients requiring emergency care to a hospital.  The report concluded that, “[b]ased on this snapshot,  . . there is evidence that consumers may be at greater risk in unlicensed Surgical Practices than in licensed ASCs” (emphasis in original).  Thus, the NJHCQI urged the State to require regular inspections of one-room ASCs and warned patients, in the mean time, not to use these unlicensed facilities.

What Could have Been

S.2780 looked to close the regulatory gap between one-room and larger ASCs - for the most part.  The version that passed New Jersey’s Assembly and Senate on January 9, 2012 would have amended N.J.S.A. 26:2H-12 to require ASCs with one operating room to be licensed by DHSS within one year of enactment as an “ambulatory care facility licensed to provide surgical and related services.”  This licensure requirement would have replaced the current registration requirements.  DHHS, then, would have had to inspect one room ASCs, just as it inspects larger ASCs.

But S.2780 also included provisions that treated one-room ASCs differently than larger ASCs.  All one-room ASCs would have been exempt from paying the ambulatory care facility assessment required by N.J.S.A. 26:2H-18.57.  Those that are certified by CMS (whether in operation on the day of enactment or not) or accredited by the American Association for Accreditation of Ambulatory Surgery Facilities or other CMS-recognized accrediting body (and in operation on the day of enactment) would not have had to meet the physical plant and structural requirements detailed in N.J.A.C. 8:43A-19.1 et seq.  The rest of the one-room ASCs that fail these exemptions would still have been able to seek a waiver (N.J.A.C. 8:43A-2.9) of the physical plant and structural requirements, which the Commissioner could have granted if it would not have “endanger[ed] the life, safety, or health of patients of the public.”  These concessions seemed to respond to reported warnings from some one-room ASC owners that “a new fee and a potential requirement to remodel their offices might drive [them] out of business.”  The bill also would not have subjected one-room ASCs to the current restrictions on DHSS’s ability to issue new licenses to ASCs with more than one operating room (N.J.S.A. 26:2H-12(i)).

Jeffrey Shanton, chair of Advocacy & Legislative Affairs Committee for the New Jersey Association of Ambulatory Surgery Centers, is quoted as describing S2780 as “one of the most important pieces of legislation concerning the ASC industry in New Jersey in years.”  Reportedly, the New Jersey Hospital Association and the Medical Society of New Jersey joined NJAASC in supporting its passage (in addition to consumer groups, like NJHCQI).

But now, S.2780 is dead.  Governor Christie did not veto it - directly.  Instead, by not taking action on this bill, which was passed on the last day of the legislative session, he has killed it via a “pocket veto.”

Going Forward

Legislators can’t override a pocket veto, but they may re-introduce the bill and try again.  If they do, it seems eminently reasonable to require inspections of one-room ASCs, whether by DHHS or BME, as long as there is adequate funding and staffing to complete these inspections without draining resources from other critical public health programs.    It would be critical to ensure that the $2,000 inspection fee is sufficient to cover DHSS’s costs and that the Department would not be prohibited from hiring necessary staff to fulfill this legislative requirement.

The Legislature also should be sure public safety requires the one-size fits all regulation model that this bill proposed.  If the costs of complying are too high, small offices may not seek licensure as an ASC and cease performing procedures that patients may have appreciated.  Perhaps that’s an acceptable outcome, but the Legislature should study the public safety benefits against the potential costs on physicians and patient access to services.  The standard of care and quality should not vary in different settings, but perhaps there is a way for the level of formality and overhead to be in proportion to the size of the facility without compromising public safety.

It also is notable that S.2780 did nothing to resolve the existing tangle of issues caused when in-network providers refer their patients to out-of-network ambulatory surgery centers that then charge an out-of-network facility fee.    (Senator Vitale’s earlier amendment to S.2780 conditioning waiver of the ambulatory care facility assessment on the one-room ASCs’ agreement “not to charge patients or third party payors a facility fee, room charge, or other similar fee or charge” did not survive legislative negotiations.)  S.2780 also would have amended N.J.S.A. 45:9-22.5 to extend the exception to the Codey Act’s self-referral prohibitions for larger ASCs to one-room ASCs.  As Kate Greenwood has discussed, there are reasons to question the wisdom of this exception (much less to extend it).

While legislators tackle these issues, one-room ASCs still do not have to be licensed in New Jersey.  But the State may investigate complaints, so be sure to speak up, if you have concerns.  There are links here to check if a facility is licensed, get copies of inspection reports, file a complaint, and search for information about providers.

Photo (Pocket) by ArnoldRheinhold
Photo (Jeopardy!) by Justin_Levy via Flickr

Medicare Payment, a System in Need of Fixing

[Ed. Note: We are pleased to welcome Andy Braver, Esq. back to Health Reform Watch. Andy is a health care attorney who recently completed an LL.M in Health Law at Seton Hall Law. Prior to entering the LL.M. program, Andy spent five years as a healthcare provider, running a state of the art medical diagnostic imaging center.  During that time, he dealt with many important health law issues faces by providers today, including Fraud and Abuse, Medicare and Medicaid licensing and reimbursement, state and private accreditation organizations, private payers, electronic health records, and HIPAA and other privacy issues, to name just a few.]

Medicare’s fee for service payment system has many problems that need fixing.  While recent studies have predicted that Accountable Care Organizations (ACOs) may very well achieve better care and lower costs, any savings generated as a result of these new groups of providers will be just a drop in the bucket solution to a vast problem.

Medicare was projected to spend over $500 billion on patient care in 2010.  Notwithstanding the fact that the White House Office of Management and Budget believes $36 billion of the Medicare and Medicare Advantage payments made in 2009 were improper.

The problem is, there is no distinction made for the provision of quality medical care.  Conversely, there is no check in the system to make sure that the care provided is inadequate.  If you provide the service, you get paid.

I realize that in many areas of medicine, it is difficult or even impossible to create a system to accurately and impartially judge the adequacy of care provided.  How in fact do you measure the ‘quality’ of healthcare?  Do you look at the structure of an entity, its organization and ability to provide what is generally regarded as good care?  Or do you look at the actual process or provision care, measuring relative malpractice claims among other objective factors?  Many believe that better outcomes suggest better care.  While I do not believe that outcome or evidence based medicine is the answer to every problem, it certainly can be a solution to some of these challenges.

There are differences in the Medicare program based on geography, and local coverage determinations and reimbursement rates, whether using the PPS or RVU systems (Part A & B), vary greatly across the country.  That part of the system makes sense by taking into account cost of living, cost of employment, property costs, and local tax rates.

In my mind, however, these processes fail because they do not further take into account advances in technology, or reward investment in the future.  For example, Medicare pays the same amount of money for an MRI exam regardless of the type of machine that was used to take the picture, and without a thought given to the type of storage system employed by the medical provider.  Imagine a facility with a two decade old system, state licensed and able to take pictures, with a machine equivalent to the first generation digital camera I owned 15 years ago, and printed pictures that are stored in a file room.  Then imagine a state of the art facility with an HD camera taking high resolution digital pictures, stored in an electronic file system, in a format that is able to be sent electronically to specialists all around the country (or world), and accessed by the patient quickly and securely on the internet.  Are those two pictures worth the same to Medicare?  There certainly is increased value to the patient in the ‘new’ system.  Better picture quality undoubtedly leads to better diagnostic capability (better medicine), and fewer picture redos over time; long-term storage and record portability is certainly going to lower future treatment costs if the issue is a chronic one.  HITECH and the new EHR incentive programs recognize the importance of electronic medical records, but it remains to be seen how those requirements will affect licensing and reimbursement rates.  Will there be a license ranking and a tiered payment system based on perceived quality or outcome?

I certainly hope that payments are tiered when advanced technology is used, but not according to self-assessment rankings and quality benchmarks.  I would argue that medicine is the one area where any kind of ranking and result (or outcome) based assessment is virtually impossible.   People are not cars, and JD Power cannot provide meaningful answers when it comes to medicine; there is no way to objectively determine a specific course of treatment for a particular patient is better at one hospital versus another.  No two patients are the same, though it is entirely possible they might both drive the same car.  Determining quality in healthcare is exceedingly difficult.  Patient bases are different, whether because of socio-economic reasons, or geography.  So do you then look to the education of the physician to determine quality?  We don’t do the same for lawyers?  Or do we?  Do you look at healthcare structure (how an entity is organized, its equipment, etc…) to determine quality?  Or process (the # of lawsuits against it, for example)?  Better outcomes alone do not mean better healthcare, and none of these items taken alone should affect licensing of healthcare providers.  In the end, this highlights the fact that designing a system that is fair and without major flaws may never be possible with so much money in the system and with so many parties having opposed interests. But that doesn’t mean we shouldn’t try to fix the expensive and broken (the status quo is unsustainable), it just means that attainable reform could very well mean significantly less unfairness and less major flaws. Because ultimately, in this context, the perfect may be the enemy of the good.

Inspirational Healthcare In(ter)ventions

The New York Times has an excellent section on “low-cost innovations that can save thousands of lives.” A conversation today focuses on Dr. Paul Polak, a 78-year-old former psychiatrist.

[Dr. Polak] has focused on creating devices that will improve the lives of 2.6 billion people living on less than $2 a day. But, he insists, they must be so cheap and effective that the poor will actually buy them, since charity disappears when donors find new causes.

His greatest success has been a treadle pump that lets farmers raise groundwater in the dry season, when crops fetch more money. He has sold more than two million, he said. He also helped develop a $25 artificial knee and a $400 hospital lamp to save newborns with life-threatening jaundice.

Dr. Polak’s work reminded me of an inspirational conference in Boston, organized by Kevin Outterson, the Ewing Marion Kauffman Foundation, the Rhode Island College of Pharmacy, Universities Allied for Essential Medicines & Mind the Health Gap. Una Ryan, President & Chief Executive Officer of Diagnostics for All, gave a powerful presentation on her company’s quest to bring tests to individuals for pennies. Developments like these indicate that conditions for the world’s poorest can actually improve.

X-Posted: Concurring Opinions.

It’s Been Over 50 Years Since the Discovery of Methicillin Resistant Staphylococcus Aureus (MRSA): An Anniversary No One is Celebrating

[Ed. Note: We are pleased to welcome Tara J. Hopper to HRW. She is a candidate for a Master of Laws (LL.M) degree in Health Law here at Seton Hall Law, having  recently graduated from Nova Southeastern University Shepard Broad Law Center, where she received her Juris Doctor with a concentration in Health Law. She also holds a Masters of Social Work (M.S.W.) with an emphasis in mental health from Barry University.  She has worked as a mental health therapist, a mental health advocate and legislative advocate for the Advocacy Center for Persons with Disabilities, Inc., as well as  ChildNet, Inc., and as the Senior Legislative Aide to Florida State Senator Walter "Skip" Campbell while he was acting as Senate Chair of the Committee on Children and Families. She became a strong advocate for creating awareness of, and drafting legislation to help protect patients from, methicillin resistant staphylococcus aureus (MRSA) after her best friend died of MRSA at the age of 33 in 2008. ]

On October 2, 1960, Dr. Patricia Jevons discovered new strains of Staphylococcus Aureus. These strains were later described as Methicillin Resistant Staphylococcus Aureus (MRSA) after being introduced through the British Medical Journal on January 14, 1961. Thus, the discovery of MRSA was fifty-one years ago this month, and the year 2011 marks the 50^th anniversary of when MRSA received its name and, as such, in a sense, came into being.

Unlike other anniversaries where people come together and celebrate, October 1, 2011 marks the third year in a row where MRSA survivors, family and friends of MRSA victims, and policy-makers, gather together to promote MRSA Awareness and to remember and honor loved ones who have been lost to MRSA. World MRSA Day is October 2^nd, and October has been declared World MRSA Awareness Month. The 2011 theme for World MRSA Day is “The MRSA Epidemic - A Call to Action,” and focuses on MRSA as a public health crisis.

MRSA is a bacterial infection that is resistant to penicillin type antibiotics, and for this reason, MRSA has been called a ’super-bug.’  MRSA acquired within a healthcare setting is referred to as a Healthcare-Associated Infection (HAI), if contracted within the community it is referred to as a Community Associated Infection (CA).

Risk factors for acquiring HAI-MRSA include having a history of hospitalizations or surgeries, living in a long-term care facility such as a nursing home, recent use or long-term use of antibiotics, and having had a previous MRSA infection or colonization.

Risk factors for having acquired CA-MRSA include playing contact sports, sharing equipment or towels at a gym, using illegal intravenous drugs, and living in crowded, unsanitary conditions such as a jail or other institution. Your chances are also increased for developing CA-MRSA if you do not keep a pre-existing wound covered by a bandage, or you have a weakened immune system. It is believed that approximately 1% of the community’s population are “MRSA carriers” and are unaware that they have MRSA because they do not have an infection or any MRSA symptoms.  However, MRSA carriers can pass MRSA on to other people who may not have the immune system or antibiotic resistance to fight it.  In addition, people who have certain illnesses such as diabetic foot ulcers and cystic fibrosis have an increased risk of death when tested positive for MRSA.

MRSA infections become invasive when the MRSA infection is isolated in an area of the body that is normally sterile such as the blood, bone, lymph nodes, brain, heart, liver, spleen, kidneys, pancreas, ovaries, and various bodily fluids.  If an invasive MRSA infection is then left untreated, MRSA can spread throughout the entire body.  It is unusual for MRSA to be successfully treated after it spreads to multiple parts of the body.  When there is a delay in treatment for an invasive MRSA infection, the fatality rate of MRSA patients significantly increases. Early MRSA detection through mandatory screening allows for treatment of MRSA before it becomes invasive.

Some World MRSA Day activists argue that there has been such an exceptional increase in the incidence of MRSA that MRSA should be declared an ‘epidemic.’ However, MRSA has yet to be declared an epidemic by any state or federal authority.  Some experts argue that when data is inadequate to determine whether or not there has been an exceptional increase in the incidence of a disease that a “clear temporal increase” in the incidence should be sufficient to declare an epidemic.  Because MRSA screening and MRSA reporting requirements are not mandatory, except in a few states, it is likely that data is inadequate to determine the actual incidence of the disease.

However, recent data regarding MRSA related deaths show that The Center for Disease Control reported in 2007 that “approximately” nineteen thousand people die from MRSA every year. Other studies report that antibiotic resistant germs such as MRSA contribute to the death of approximately 70,000 hospitalized Americans each year.  It is unclear, due to a lack of historical data on MRSA, to fully understand the increase in incidence, and figure out how many people need to die in order to justify MRSA being declared an epidemic.

When issues reach epidemic status, federal dollars usually follow so that proper precautions can be taken, and further research can be done to find a cure and/or remedy.  With many government agencies tightening their belts across the nation, one may surmise that declaring MRSA an epidemic would be disfavored based on the funding requirements alone.  Although an increase in MRSA research funding can promote the development of new antibiotics for MRSA, MRSA research funding does not appear to be a strong federal priority.  In 2010, it was reported that scientists at the University of Nottingham in the UK researched cockroaches and locusts and found that tissues from their brain and nervous system of these bugs killed more than ninety percent of the MRSA in the study. Wouldn’t it be ironic if the MRSA Superbug ends up meeting its eternal demise through the use of antibiotics from actual bugs? Hopefully, through an increase in MRSA awareness, MRSA funding and research will increase so that MRSA related deaths can decrease.

Recent trends of state legislatures show both proposals and adoption of MRSA screening and reporting legislation that promote the early identification of MRSA, and preventing the spread of MRSA. Opponents of MRSA screening legislation argue that it is too costly, impractical and inconvenient. However, MRSA detection plates are available at only a little more than $1.50 per plate, and screening requires only a simple nasal swab to detect MRSA. Recent advancements in MRSA detection devices make it possible to receive test results within 50 and 75 minutes, whereas test results were previously only available within 18 to 48 hours. This shortened time in obtaining test results gives a hospital the ability to isolate and treat the MRSA patient before MRSA is spread to other parts of the hospital.

Although there are legal concerns that screening and reporting requirements may increase hospital liability in medical malpractice suits, MRSA screening upon admission would also be advantageous to hospitals in order to show that the patient had acquired MRSA before entering their facility, therefore, decreasing their opportunity for liability in these instances.  MRSA reporting may initially have a negative impact on hospitals that report higher MRSA rates, but when following MRSA screening procedures and MRSA prevention guidelines such as those provided by The Society for Healthcare Epidemiology of America (SHEA), it is likely that a hospital’s MRSA numbers will significantly decrease.  After the adjustment period is over, hospitals may be happy to report just how MRSA-free their facility has become, and everyone will benefit from such a decrease in this life-threatening infection.

Can’t Teach an Old Doc New Tricks?

Reuters reports that,

According to findings in the American Journal of Medicine, patients whose doctors had practiced for at least 20 years stayed longer in the hospital and were more likely to die compared to those whose doctors got their medical license in the past five years.

The study, which was based in Montefiore Hospital in the Bronx, NYC, examined the records of over 6,500 patients of the teaching hospital from 2002 to 2004. Over the course of the study, there were 59 different attending physicians heading up 6 different teams, consisting of said attending, a medical student, and recent med school graduates.  A junior doctor randomly assigns patients to a team. The researchers grouped patients and according to length of practice for the attending– “five years or less,
six to 10 years, 11 to 20 years, or more than 20 years.”

Reuters reports,

At first glance, compared to patients with the newest doctors, those with the most experienced physicians had more than a 70 percent increase in their odds of dying in the hospital and a 50 percent increase in their odds of dying within 30 days.

However, when the researchers took into account how sick the patients were, they
found that only the sicker patients — those with complicated medical problems — were at higher risk in the hands of the more experienced doctors.

So… the good news here is that only sicker patients are at higher risk in the hands of the more experienced doctors. Those with complicated medical problems are more likely to die if seen by a more experienced doctor. Although I feel as though I should write this again, I fear it still won’t fully resonate. But let me try in simple, quasi-mathematic terms:  More sick + More Experienced Doctor = More Death.

No, it’s still not working for me, but Reuters spoke with Dr. Niteesh Choudhry of Harvard Medical School, who was not involved in the study but is said to have offered the following:

The problem, he said, is not with the capability of the more experienced doctors, but rather, their familiarity with more current guidelines and practices. The results suggest the need to rethink the way doctors are continually educated in the years after completing their certification, he added.

There’s more, and you can read it here.

Community Based Medicaid ACOs in New Jersey: A Signature Away

Almost daily, there is a new article or study emphasizing the need for innovative reform to save Medicaid amidst growing threats of deep cuts to the already struggling program.  New Jersey, as one of the states with the highest Medicaid spending per beneficiary in the country, is paying attention.  And help may be on the way in the form of a medical home/safety net.

Showing promise, the medical home model of care is an oft proposed reform.  As Mary Takach explains in the July 2011 edition of Health Affairs, “[a] patient-centered medical home is an enhanced model of primary care in which care teams, led by a primary care provider, attend to the multifaceted needs of patients and provide whole-person, comprehensive, coordinated, and patient-centered care.”  (See “Reinventing Medicaid: State Innovations to Qualify and Pay for Patient-Centered Medical Homes Show Promising results,” Health Affairs, July 2011, 30(7):1325-34.)

According to the National Academy for State Health Policy, thirty-nine states are working to implement medical homes for Medicaid and CHIP participants, and New Jersey is one of them.  In September 2010, Governor Christie signed Assembly Bill 226 into law, which established a three-year Medicaid medical home demonstration project that, at minimum, will include “primary care providers utilizing a multi-disciplinary team that provides patient-centered care coordination through the use of health information technology and chronic disease registries across the patient’s life-span and across all domains of the health care system and the patient’s community.”  The statute requires that the payment system “be structured to reward quality and improved patient outcomes” and that Medicaid “[c]onsider payment methodologies that support care-coordination through multi-disciplinary teams, including payment for care of patients with chronic diseases and the elderly, and that encourage services such as: (a) patient or family education for patients with chronic diseases; (b) home-based services; (c) telephonic communication; (d) group care; (e) oral health examinations, when applicable; and (f) culturally and linguistically appropriate care.”   You can learn about various medical home initiatives in New Jersey at the National Center for Medical Home Implementation web site.

Takach’s report focuses on seventeen states that have aligned “patient-centered medical home standards with incentive payments to support reform in the delivery of primary care” — Colorado, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and West Virginia.

Although these programs are in their infancy, Takach interprets limited early data from a few states as encouraging. Vermont, for example, documented that inpatient use had decreased twenty-one percent, with a corresponding twenty-two percent decrease in per person per month inpatient costs, and that emergency department use had decreased thirty-one percent, with a corresponding reduction of thirty-six percent in per person per month costs (although its second pilot community had what Takach describes as “mixed results”).  Colorado similarly has seen decreases in its median Medicaid costs per patient for children.

Both Colorado and Oklahoma also have seen increases in participating providers since the medical home model started operating.  In Oklahoma, more than 244 new physicians enrolled in Medicaid.  Ninety-six percent of pediatricians now accept Medicaid in Colorado, up from only twenty percent before the program began.  Increasing the number of Medicaid providers is critical, given national shortages of available primary care Medicaid providers.

As Takach summarizes:

Some of the early findings from Colorado and Oklahoma, which have statewide Medicaid initiatives, demonstrate that modest increases in payment aligned with quality improvement standards have not only resulted in promising trends for costs and quality, but have also greatly improved access to care.  This is an important finding for other states as they consider how to meet the tremendous increase in demand for care that will result from the expansions to Medicaid in the Affordable Care Act of 2010.

But beyond a medical home, there needs to be a safety net for the most vulnerable urban populations who are, in a sense, medically homeless– and are, by EMTALA default,  frequent utilizers of high cost emergency room services.

As this blog and other sources, including The New Yorker, have discussed, New Jersey  is home to the Camden Coalition of Healthcare Providers, which describes itself as “a citywide organization of social workers, nurses, physicians, administrators, hospitals, health services organizations, and clinics that serve the health needs of Camden, New Jersey residents.  [It] work[s] in a variety of settings — from small neighborhood based practices to hospital based offices — with the goal of improving the coordination and capacity of the healthcare system for residents of Camden.” Dr. Jeffrey Brenner has been leading this effort since 2002.  His work offers promising program models for safety-net providers throughout the country to “improve the quality, capacity, and accessibility of the healthcare system for vulnerable populations.” Indeed, even though the budget bill signed by Governor Christie slashed Medicaid funding in New Jersey by $540 million, his Commissioner of Human Services has expressed continuing support for the Coalition’s pilot because it is seen as a smart reform that could save money while improving care.  Newark and Trenton also have established citywide healthcare coalitions to improve medical care for their vulnerable, underserved residents. And we at the Center for Health and Pharmaceutical Law and Policy have worked closely with the Greater Newark Healthcare Coalition.

In a recent post on the Health Affairs blog, Dr. Brenner and Nikki Highsmith note that although the Camden Coalition “has had preliminary successes and offers potential long-term savings, such community-based endeavors are difficult to initiate and sustain without start-up financing, ground-level technical assistance, and buy-in from state and local policymakers, health plans, patients, and community members.”  They thus call on CMS to “jump start investments in safety-net ACOs” by pursuing a national demonstration project to support programs similar to Camden’s pilot.

New Jersey is poised to be ready if CMS heeds this call for a national Safety Net ACO demonstration project because the Coalition and other New Jersey stakeholders, including Seton Hall Law Professor John Jacobi, have been active in advocating for a bill (S2443) authorizing geography-based Medicaid ACOs in New Jersey. As the Coalition’s web site summarizes:

The proposed New Jersey law would authorize a three-year Medicaid ACO demonstration project whereby community-based, non-profit coalitions can apply for recognition by the State of New Jersey as a Medicaid ACO.  The applicants must propose a geographic focus and will need 100% of the [general] hospitals, 75% of the primary care providers, [four] behavioral health providers, and two community [organizations] from that geography on the board of the organization.  The providers in the community will continue to receive their usual Medicaid payments and the ACO, if its providers meet quality benchmarks, would be eligible to receive shared savings payments, that can be distributed to participants based on a proposed gain sharing plan.

The proposed legislation specifically recognizes that patient-centered medical home models are one way, among others, to achieve coordination. On June 27, 2011, the Assembly and Senate passed S2443, and it is awaiting Governor Christie’s signature.

New Jersey’s proposed Medicaid ACOs go beyond Medical Homes. They are built on a foundation of sound primary care, but they offer the promise of reaching vulnerable populations in many settings, and of assuring that the right care is provided at the right location for people who are often left out of health reform efforts. The financing mechanisms provided by the bill awaiting the governor’s signature go some way towards financing these innovating community organizations, although, as Brenner and Highsmith point out, more needs to be done –particularly in the way of providing start-up funding for community providers.

Appropriately cultivated, patient-focused collaborations such as these may  yield synergies in care and cost of a substantial scale.   But another recent Health Affairs article suggests that adoption of the medical home may well develop at a slower pace in states, like New Jersey, where physicians tend to be organized in smaller practices.  New Jersey’s Medicaid ACO pilot could  help to accelerate the development of practice reformation in New Jersey — particularly if CMS provides the support advocated by Jeff Brenner and Nikki Highsmith.

It’s an exciting time for growth and innovation in the Garden State … if we just get that signature.

Final Value-Based Purchasing Rule Released

On April 29, the Department for Health & Human Services (HHS) announced the launch of the Hospital Inpatient Value-Based Purchasing (Hospital VBP) program under the Medicare Inpatient Prospective Payment System (IPPS).  According to HHS, the Hospital HVP program “marks the beginning of an historic change in how Medicare pays health care providers and facilities-for the first time, 3,500 hospitals across the country will be paid for inpatient acute care services based on care quality, not just the quantity of the services they provide.”

As a part of the launch of the Hospital VBP program, authorized under § 3001(a) of the Patient Protection and Accountable Care Act of 2010 (ACA, codified at 42 U.S.C. § 1886(o)), the Centers for Medicare & Medicaid Services published the final rule outlining the measures, performance standards, scoring methodology, and methodology for translating hospitals’ Total Performance Scores into value-based incentive payments.

Why Should I Care?

Value-based purchasing has been called a “fast-approaching, mandatory competition with millions of dollars on the line.”  The program is aimed to fix two previously identified problems: (1) preventable medical errors and (2) resulting health care costs.  According to CMS:

One in seven Medicare patients will experience some “adverse” event such as a preventable illness or injury while in the hospital.  One in three Medicare beneficiaries who leave the hospital today will be back in the hospital within a month.  Every year, as many as 98,000 Americans die from errors in hospital care.

…

In addition to adding to the suffering of patients and their caregivers, these errors lead to significant unnecessary health care spending. Medicare spent an estimated $4.4 billion in 2009 to care for patients who had been harmed in the hospital, and readmissions cost Medicare another $26 billion.

The Hospital VBP program marks a shift in CMS reforms, from “pay-for-reporting” to “pay-for-performance.”  In 2003, the Hospital Inpatient Quality Reporting (IQR) Program introduced the core-measures concept.  Hospitals that did not successfully report data under the IQR program were penalized by a 2.0 percentage point reduction in their applicable percentage increase.   The Hospital VBP program continues using payment incentives and takes the next logical step “in promoting higher quality care for Medicare beneficiaries and transforming Medicare into an active purchaser of quality health care for its beneficiaries.”  The Hospital VBP program now directly ties payment amounts to a hospital’s performance score.  CMS will begin measuring hospital performance for incentive payments this July.

To fund the Hospital VBP incentive program, CMS will reduce the base operating diagnosis-related group (DRG) payment by 1% in FY 2013 and increase withholding by 0.25% each year until it peaks at 2% in FY 2017.  As a result, approximately $850 million will be allocated for the Hospital VBP program in FY 2013.  Since overall Medicare spending for inpatient stays at acute care hospitals will remain constant, the new payment scheme will benefit some hospitals and hurt others.  As the Hospitalist writes, “[i]t’s also a zero-sum game. That means there will be winners and losers, with the entire cost-neutral program funded by extracting money from the worst performers to financially reward the best.”

How It Works

As summarized by our very own Kate Greenwood:

[§ 3001(a)], which applies to patients discharged on or after October 1, 2012, establishes “value-based purchasing,” meaning that the government will make “value-based incentive payments” to hospitals that provide care to Medicare patients that meets or exceeds certain performance standards to be established by the Secretary of Health and Human Services.  Initially the standards must relate to at least the following five conditions: heart attack, heart failure, pneumonia, surgery, and healthcare-associated infections.  Eventually (by fiscal year 2014) the standards are to incorporate “efficiency measures,” that is Medicare spending per beneficiary must be a factor.

Beginning in FY 2013 (October 1, 2012), hospitals will receive incentive payments “based on how well they perform on each measure or how much they improve their performance on each measure compared to their performance on the measure during a baseline performance period.”  The final rule adopts twelve clinical process of care measures and one patient experience measure, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.  These measures overlap or align with the Hospital Inpatient Quality Reporting (IQR) Program measures.

FY 2013 Objective Measures

Acute Myocardial Infarction
AMI-7a	Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival
AMI-8a	Primary PCI Received Within 90 Minutes of Hospital Arrival
Heart Failure
HF-1	Discharge Instructions
Pneumonia
PN-3b	Blood Cultures Performed in the ED Prior to Initial Antibiotic Received in Hospital
PN-6	Initial Antibiotic Selection for CAP in Immunocompetent Patient
Healthcare-associated Infections
SCIP-Inf-1	Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision
SCIP-Inf-2	Prophylactic Antibiotic Selection for Surgical Patients
SCIP-Inf-3	Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time
SCIP-Inf-4	Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose
Surgical Care Improvement
SCIP-Card-2	Surgery Patients on a Beta Blocker Prior to Arrival That Received a Beta Blocker During the Perioperative Period
SCIP-VTE-1	Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered
SCIP-VTE-2	Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis Within 24 Hours Prior to Surgery to 24 Hours After Surgery

In FY 2014, CMS will add thirteen more measures.

FY 2014 Objective Measures

Acute Myocardial Infarction
Mortality-30-AMI	Acute Myocardial Infarction (AMI) 30-day Mortality Rate
Mortality-30-HF	Heart Failure (HF) 30-day Mortality Rate
Mortality-30-PN	Pneumonia (PN) 30-Day Mortality Rate
Hospital Acquired Condition Measures
	Foreign Object Retained After Surgery
	Air Embolism
	Blood Incompatibility
	Pressure Ulcer Stages III & IV
	Falls and Trauma:  (Includes:  Fracture, Dislocation, Intracranial Injury, Crushing Injury, Burn, Electric Shock)
	Vascular Catheter-Associated Infections
	Catheter-Associated Urinary Tract Infection (UTI)
	Manifestations of Poor Glycemic Control
AHRQ Patient Safety Indicators (PSIs), Inpatient Quality Indicators (IQIs), and Composite Measures
	Complication/patient safety for selected indicators (composite)
	Mortality for selected medical conditions (composite)

Hospitals will be scored according to achievement (compared to all other hospitals) and improvement (over each hospital’s baseline) for each applicable measure.  Achievement points will be awarded if the hospitals performance during the measurement period (quarterly) exceeds the 50^th percentile of hospitals measured during the baseline period (the “threshold”).  Improvement points will be awarded to the extent that a hospital’s current performance exceeds baseline period performance.

Baseline scores for improvement measurement have already been set, during the period from July 1, 2009 to June 30, 2010.  The FY 2013 performance period for clinical process of care measures will be July 1, 2011 through March 31, 2012.  July 1, 2011 will also mark the beginning of a 12-month performance period for the FY 2014 30-day mortality measures.

The Total Performance Score (TPS) is calculated “for each hospital by combining the greater of its achievement or improvement points on each measure to determine a score for each domain, multiplying each domain score by the proposed domain weight and adding the weighted scores together.”  In 2013, clinical measures will account for 70% of a hospital’s performance score and the HCAHPS survey for 30%.  Over time, scoring methodologies will be “weighted more heavily towards outcome, patient experience, and functional status measures.”

Future Changes

Moving forward, CMS will implement other ACA provisions designed to improve care and reduce costs.  For instance, hospitals will begin receiving reduced payments in FY 2015 if they are unable to prevent certain hospital acquired infections or if the hospital fails to “meaningfully use information technology to communicate within the hospital to deliver better, safer, more coordinated care.”  Check prior posts to learn more about HITECH’s “Meaningful Use” Rule.

Gregg Bloche’s The Hippocratic Myth

Georgetown law professor Gregg Bloche’s new book, The Hippocratic Myth, looks to be a major contribution to health policy debates. I haven’t had time to read it yet, but many reviews and radio shows give the impression of a rigorous work leavened with engaging narratives of individual patients and providers.

Bloche’s approach to rationing will rekindle many of the health care debates of 2010. A former advisor to the Obama health policy team, Bloche concludes the following:

Medicine’s therapeutic potential has surpassed our ability to pay for it, but our elected officials are afraid to tell us. The historic health reforms enacted last year will protect 30 million Americans from the Darwinian cruelty of lack of access to care. But contrary to much wishful thinking in Washington, these reforms do little to stave off looming medical cost catastrophe. Our future fiscal and social stability will turn on our ability to gain control of spending without imperiling patients’ trust in their caregivers.

Bloche also observes the importance of the medical profession in upcoming bioethical debates:

Medical judgment incorporates hidden political and moral beliefs, and doctors have become key political and legal decision-makers—on such matters as child custody, criminal punishment, access to performance-enhancing drugs, and the politics of obesity, abortion, and homosexuality.

Doctors and the rest of us will need to address the morality of innovations we never thought possible. Drugs that block—or boost—biological mechanisms of stress resistance, brain-scanning methods that read minds, and medicines that interfere with formation of traumatic memories are among the technologies that will soon be with us.

During his interview with NPR’s Leonard Lopate, Bloche mentioned an aspect of insurer practice that renders suspect many consumer-directed ideals of medical care. Many insurers’ care protocols are kept secret, as proprietary information. Bloche found the practice deeply troubling, and I agree. Insurers’ criteria for providing care are important aspects of the service they are providing. They should not be hidden from patients or doctors. In more encouraging news, Bloche notes that he has not lost an appeal of a medical coverage decision to an insurer.

Enforceable Contracts for Cheaper and More Limited Care

Bloche seems committed to permitting consumers to make enforceable contracts for lower levels of care. Tyler Cowen recently evoked that possibility of ala carte insurance in his evaluation of the recent Ryancare proposal:

Let’s say it’s 2027 and I’ve just turned 65. I fill out a Medicare application on-line and opt for a plan with superior heart coverage (my father died of a heart attack), not too much knee coverage and physical therapy (my job doesn’t require heavy lifting), no cancer heroics (my mother turned them down and I wish to follow her example), and lots of long-term disability. Is that so terrible an approach? Is it obviously worse than having the Medicare Advisory Board make all of those choices for me?

Cowen worries that “Perhaps an individual will choose ‘no coverage for lung cancer,’ but the government cannot precommit to the outcome of no coverage.” But Bloche makes a point in an NPR interview that suggests that a physician’s decision to withhold care in that instance would not violate the Hippocratic Oath:

The rationale there is that the doctor who stints on care three years later when you get really sick is acting in accordance with your preferences as you expressed them in the employee benefits office three years before. And therefore, the doctor is not violating the Hippocratic Oath. The doctor is merely complying with your preferences when you rolled the dice in the employee benefits office.

Of course, that is in the private insurance context, not Medicare, and I don’t know if that distinction would make a difference for Bloche. But it does help me see how the book attracted a blurb from a Heritage Foundation analyst. Contemporary conservative health policy experts are committed to giving individuals the chance to buy low-cost plans, and so far the Obama Administration has been quite accommodating in granting waivers for them. My sense is that Bloche is committed to a minimum essential benefits approach that would allow consumers to opt out of “cancer heroics” (perhaps defined as biotechnology drugs costing over $7 million over one’s lifetime?), but not to waive “lung cancer” coverage generally.

Bloche argues in the book that:

[M]edicine’s capabilities and costs will inexorably grow. Increasingly, doctors will need to say no to care that’s technologically possible and that could prolong life, but that does so in competition with other national priorities. We must empower them to do so even when the consequences seem tragic. But we must give them this power without asking them to break faith at the bedside. To this end, the current regime of covert rationing, under cover of ‘medical necessity,’ should be supplanted by visible resource allocation rules–rules set for doctors and patients by social institutions. (58-9)

Transparency of this sort will compel us to come to terms the truth that insurers must say no to beneficial care to stay within the limits we impose when we seek low prices for products for products and services, elect politicians who promise low taxes, and choose cheaper health care plans for ourselves.

Though I hate to disagree with such an eloquent statement by so eminent a scholar, I am slightly troubled by that language. I think money saved from the health sector is more likely to go to new adventures in the Middle East or dot-com, housing, and commodities bubbles than it is to be allocated to “other national priorities.” Health care is only one of many sectors where US-style casino capitalism has seriously distorted capital allocation.

I also believe that the invocation of “we” here glosses over the moral role of redistribution in an extremely unequal economy. A privately insured person who really wants a procedure can spend himself down to bankruptcy, then apply for Medicaid. At that point, the government must make a decision. Given that “the government collected less in taxes in 2010 than it has in over three generations, and tax rates are at historic lows” for the very wealthy, I don’t think it is entirely fair to say “we” can’t afford certain care. Rather, those at the top of the income and wealth scale are increasingly supporting politicians who will not tax the wealthy. The current scarcity of care for the least well off is not a natural feature of the world; rather, it is epiphenomenal of repeated decisions not to impose certain tax burdens today even though they would have seemed perfectly fair 50 years ago. Since a “Wall Street transactions tax of only 0.50% on short-term speculation could raise up to $170 billion annually,” I fail to see an imperative to reduce incomes in the health sector until problems in much less socially productive sectors are addressed.

On the other hand, if our government “of the top 1%, by the top 1%, for the top 1%” continues, major cuts to the health sector are inevitable. If they must come, we need more trusted and fair voices like Bloche’s at the table. As Daniel Alpert has observed, “the U.S. has engineered a winner-take-all economy and indebted both the majority of its people and its government to keep a ‘don’t tax, but spend anyway’ consumerist fantasy alive.” Bloche helps us face the difficult task of unwinding the consequences of all those bad economic decisions.

Bloche is also admirably restrained in his sense of how much current law can do to rationalize health care spending. As he notes in a book excerpt:

30 percent of health spending [is] wasted on worthless care—about the price of the $700 billion mortgage bailout, squandered each year. . . [One study estimated that only] about 10 to 20 percent of medical procedures rest on “gold-standard” evidence — randomized clinical trials. . . . Risky and pricey therapies routinely make their way into common use without such studies. . . .

Change is looming. The 2010 health reform law created a “Patient- Centered Outcomes Research Institute,” funded by levies on Medicare and private insurers, to sponsor such research. But the funding level, less than a tenth of a percent of what Americans spend on health care each year, will do little to increase the fraction of medical decisions that rest on science. And the Institute’s governing body — composed mostly of representatives from the hospital, insurance, and drug and device industries, as well as physicians — seems almost designed to enable stakeholders to block studies that threaten their interests. Moreover, multiple provisions in the law (sought by providers and drug and device makers) hobble Medicare’s ability to base coverage decisions on research the Institute sponsors.

The mix of hope and realism in the paragraphs above reflects the judicious sensibility of the many Bloche articles I have had the good fortune to learn from. I look forward to reading his book.

Dialysis and the Problem of Unintended Consequences

A recent New York Times article by Gina Kolata highlighted the debate surrounding dialysis as an end-of-life treatment.  In reading the article and surfing the internet for counter-arguments, I found two points of interest.

Background

According to the Medicare ESRD Network Organizations Manual, Section 299I of the Social Security Amendments of 1972, Pub. Law 92-603, which “created the National End Stage Renal Disease (ESRD) Program … [and] extended Medicare coverage to individuals with ESRD who require either dialysis or transplantation to maintain life.”  In addition, depending on your perspective, Sec. 299I requires/limits the entitlements for/to individuals under the age of 65 who have insurance coverage (remember this age and insurance coverage part — it will be important later in the discussion).

By the time the legislation was adopted in 1972, only 10,000 individuals were being dialyzed in the country and only 20,000 to 25,000 were considered candidates for the procedure.  Section 299I was estimated to cost $250 million over the first four years.  Now, according to the N.Y. Times, about 400,000 people will undergo dialysis at an estimated cost of $40 billion to $50 billion in this year alone.

Has the entitlement had the unintended consequence of benefiting those over 65?

Kolata argues that this law was intended “to keep young and middle-aged people alive and productive” and has had the unintended consequence of financing dialysis treatment for (primarily elderly) individuals who are too sick to benefit from the treatment.  She explains:

When Congress established the entitlement to pay for kidney patients in October 1972… [Congress expected] that most of those patients would be healthy — except for their failed kidneys — and under age 54.

Now… More than a third of the patients are 65 or older, and they account for about 42 percent of the costs. People over 75 make up the fastest-growing group of dialysis patients. And most elderly dialysis patients have other serious diseases like diabetes, heart failure, stroke and even advanced dementia. One-third of them have four or more chronic conditions.

Others, however, would argue that Sec. 299I has not benefited the elderly because they were already entitled to Medicare coverage prior to its enactment.  In the “Dialysis from the sharp end of the needle” blog, Bill Peckham writes in response to Kolata’s argument:

No no no. Dialyzors who are “old and have other medical problems” have access to Medicare due to age or disability, “patients who take advantage of the law” are few: only about 25,000 people [out of about 417,000] have access to Medicare as a consequence of Section 299I of the Social Security Amendments of 1972.

Well…  According to Kaiser, the source of Peckham’s figures, only 5.8% of Medicare enrollees with ESRD directly benefit from Section 299I.  But what about indirect benefits? A comprehensive history of Section 299I can be found in Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972, a chapter in Biomedical Politics.  Richard A. Rettig writes:

It was presumed that the benefit existed for the elderly, however, because a Medicare benefit could not be established for those under 65 and not be available for the elderly. In fact, very few elderly persons were being dialized at the time and none were receiving transplants.  Although the Bureau of Health Insurance had answered several inquiries in the previous year, the nature and extent of coverage for the elderly had not been clarified.

The entitlement for those under the age of 65 extends from the third month after “a course of renal dialysis is initiated” until a year after the person has a renal transplant or ends the course of dialysis.  This section could have been read to provide an entitlement to dialysis and renal transplant solely to those under the age of 65, or it could be interpreted to create a near universal entitlement to such treatments.

It seems that President Nixon’s administration read Section 299I according the latter interpretation, because in his statement on the Signing of the Social Security Amendment of 1972 Nixon said, “it extends Medicare coverage for kidney transplants and renal dialysis.”

Aggressive Treatment and End of Life Care

“Clearly, when the program was initiated in the 1970s, the hope and expectation was that this program would return otherwise healthy people back into society so they could work and be productive,” said Dr. Manjula Kurella Tamura, a kidney specialist at Stanford. But, she added, “dialysis at the end of life is a different sort of treatment.”

A second important aspect of the article is its focus on end-of-life care.  Even Peckham concedes that, “caring for the elderly is expensive and aggressive treatment may not always be in the interest of the ill. That is a serious discussion our electorate should have but has not been able to have.”

The article highlights new clinical practice guidelines produced by the Renal Physicians Association designed to promote, through shared decision-making and informed consent, “medical management without dialysis.”  Particularly concerning is that the provision of dialysis gives patients false hope of survival.  According to the NY Times:

Recent studies have found that dialysis does not prolong life for many elderly people with other serious chronic illnesses. One study found that the procedure’s main effect is to increase the chances that such patients will die in the hospital rather than at home.

Yet, a 78-year-old woman is quoted as saying, “I go to dialysis because I want to live.  I want dialysis.”  Although he doctors explained that dialysis would not necessarily prolong her life, she chose aggressive treatment because, “Some life is better than no life.”  This anecdotal story raises a HUGE informed consent problem because it appears that the patient may not have understood the risks and benefits of undergoing dialysis.

Key to the decision to forego, commence, or withdraw dialysis is a properly informed consent. The above guidelines state that certain patients, including those age 75 years and older, those with high comorbidity scores, those with marked functional impairment, or those with severe chronic malnutrition, “should be informed that dialysis may not confer a survival advantage or improve functional status over medical management without dialysis and that dialysis entails significant burdens that may detract from their quality of life.”

***

The ESRD program has provided life-saving dialysis to many people.  However, as with many other tests and treatments performed in the last year of life, it is important to ensure that patients (or their legal decision-makers) are properly informed about the risks and benefits of all options, including palliative care, at the end of life.

60 Minutes, Glaxo’s Bad Day & Why Compliance is So Terribly Important

In case you missed it: 60 Minutes segment with whistleblower Cheryl Eckerd, a former manager of global quality assurance for GlaxoSmithKline. She describes her experience inspecting Glaxo subsidiary, Cidra, in Puerto Rico. It views like an in-house counsel’s nightmare and a PR professional’s worst day. CBS states:

“But in November, we found out just how much could go wrong at one of the world’s largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to [a felony] distributing adulterated drugs.

“There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough.”

Ms. Eckerd brought suit under the Federal Whistleblower Act, with the government ultimately recovering $750 million; Ms Eckerd who was “downsized” by Glaxo, received $96 million as her share of the recovery. In addition, when Ms. Eckerd made the information she had gathered about the plant in Puerto Rico available to the FDA, federal agents executed a search warrant and seized drugs worth “hundreds of millions of dollars.”

Of Phones and Dogs and Wonders

In yesterday’s post we talked about the recent conference convened by Health Affairs entitled “Innovations Across the Nation in Health Care Delivery.” More specifically, we looked at the keynote address of Dr. Richard Gilfillan, the acting director of the Center for Medicare and Medicaid Innovation, and a decidedly low-tech example he gave of a program which produced marked savings in hospitalization costs for patients suffering from chronic disease (the patient in his specific example suffered from diabetes and COPD), while also improving the quality of life for the patient. The innovation in that instance involved not much more than providing the patient (and the patient’s daughter) with a hotline phone number to a particular nurse familiar with the patient’s case history. Simple, but effective. The particular patient quoted attributed to the service, sine qua non, her life– and her hospitalizations, and the major expense which accompanies such, were down. A phone and someone who knows– go figure.

If that’s not low-tech enough for you, the Wall Street Journal ran an article on the benefits of the use of dogs in doctors’ offices– surgeons, neurologists, pyschiatrists, psychologists, therapists and even hospital staff are said to have all have derived benefit from the use of dogs. The Journal writes:

Research shows that a few minutes of stroking a pet dog decreases cortisol, the stress hormone, in both the human and the dog. It also increases prolactin and oxytocin, hormones that govern nurturing and security, as well as serotonin and norepinephrine, neurotransmitters that boost mood. One study found that five minutes with a dog was as relaxing as a 20-minute break for hospital staffers.

“It’s chemical, not magical,” says Rebecca Johnson, who teaches a popular course in animal-human interaction at the University of Missouri and has conducted much of the research.

and that

Experts speculate that people give off tell-tale scents under certain physical or psychological conditions that only dogs can detect.

That acute sense of smell also enables specially trained service dogs to recognize when seizures, diabetic comas or heart attacks are imminent in humans. Some dogs can even detect the presence of cancer cells in lab specimens—much like detecting traces of contraband or explosives in luggage.

Regular readers of this blog and others like it in the health reform world are regularly treated, by necessity, to the complexity of medical science as it intersects with law– often in an attempt to ascertain ways to enhance patient well being while implementing cost control and what one hopes ultimately amounts to a sustainable health care system. Can some of the answers really be this easy? A phone line and a dog?

On a personal note, having lost our Great Pyrenees, Molly, two years or so ago, the picture above is of the newest addition to our family– a six month old female Eskimo Spitz named by my son (it’s at least nominally his dog), “Doctor Wiggles.” I’m not all that happy about the name, and it can be somewhat arduous to acclimate a puppy–but it is somehow superbly comforting to live again with a dog. And if nothing else the name affords me the opportunity to walk into the house after a long hard day and say “Paging Doctor Wiggles. Paging Doctor Wiggles.” And she comes. Happy as can be to see me as we prepare get down to the most serious business of rubbing her belly and throwing her ball.

I’d be lying if I said I wasn’t better for it.

Health Affairs: Innovations Across the Nation in Health Care Delivery

Health Affairs recently convened a day-long conference entitled “Innovations Across the Nation in Health Care Delivery.” Dr. Richard Gilfillan, the acting director of the Center for Medicare and Medicaid Innovation, keynoted the event as one of a number of stops on his recent “listening tour” across the states in an effort to garner input for the Center’s quest to eliminate waste and to create “a sustainable system” in health care.

The Center’s mandate under the law is “to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished.” But as Dr. Gilfillan mentioned, perhaps the most interesting aspect of the law is that if the Center can show that it has found a way to fulfill its mandate– demonstrating such and proving it to the CMS actuaries, then the Secretary can sign into effect new regulations to effectuate  new payment models for CMS.

An underlying guidance, if not a mantra, for Dr. Gilfillan is the notion that, as contained in an Institute of Medicine study, there is 30%  waste in medical services. Much of this, he believes, is attributable to our fragmented health care system; thus, the emphasis going forward should be on implementing “seamless coordinated care.” An interesting example of something that works, is a chronic care “hotline.” Dr. Gilfillan described the innovation–where a chronic disease patient, suffering from both COPD and diabetes, cold call a particular nurse, Mary, to express concerns she might have about some aspect of her health– be it weight gain, increased shortness of breath, or anything else. The patient’s daughter could Mary as well. They did. The patient’s hospitalizations are down– and the patient attributes to the program the fact that she’s still alive.

According to Health Affairs, “The program also featured several panels of CEOs and program leaders from institutions that have innovated at the patient care level; in the creation of more highly coordinated patient care systems; and at the population level, in terms of improving population health.”

It’s an interesting conference. You can find the panel videos, including Dr. Richard Gilfillan’s address  here.

HHS Releases Much Anticipated Medical Loss Ratio Regulations

Closely resembling model regulations recently released by the National Association of Insurance Commissioners, the Obama administration today released regulations implementing the provisions of the ACA which govern the amount of each premium dollar that health insurers must spend on medical care. This amount that must be spent on actual health care or quality improvement (as opposed to administrative costs or dividends) is known as the medical loss ratio.

The ACA requires that health insurers spend at least 80% of premium revenue on treatment or quality improvement in the small group market, and 85% in the large group market. The statute also provides that the premium dollars required to be spent on health care or quality improvement, but which are not in fact spent on such services, must be rebated to the insured.

Healthcare.gov’s factsheet on medical loss ratios states that:

In 2011, the new rules will protect up to 74.8 million insured Americans, and estimates indicate that up to 9 million Americans could be eligible for rebates, starting in 2012, worth up to $1.4 billion.  Average rebates per person could total $164 in the individual market.

One aspect of the regulations that has caught the attention of many is a provision allowing health insurers to include the money they spend on federal taxes towards their medical loss ratio — essentially making it easier for insurers to meet the requisite level. As Bloomberg reports:

U.S. health insurers can include the cost of federal taxes in determining whether they spend enough on patient care, increasing the amount that can be kept for administration or profit under new rules. Company shares rose.

Bloomberg , quoting the U.S. Health and Human Services Department, also notes that insurance companies may receive favorable treatment in terms of the timing of the MLR rules:

Health plans led by Indianapolis-based WellPoint Inc. may also win delays from the spending requirements if individual states show the federal government that the so-called medical- loss ratio rule will destabilize insurance markets.

HHS has provided a number of resources on the medical loss ratio regulations, including:

• A News Release
• A Fact Sheet
• The Regulation (pdf)

Barring any of the possible delays mentioned above, the rules are slated to go into effect in 2011, with rebates, if any, being provided in 2012.

Medicare, Hospitals, Serious Harm and Death

The Inspector General of the Department of Health and Human Services, Daniel R. Levinson, published an Op-ed in USA Today that is well worth considering.  The column, entitled “Medical mistakes plague Medicare patients,” speaks volumes. Levinson writes:

Today’s hospitals are modern-day marvels of healing, and we expect them to be models of patient safety as well. But a just-released report from my office shows that medical care is falling short for too many hospitalized Medicare patients. A decade after an Institute of Medicine study placed preventable medical errors among the leading causes of death in the United States, our latest study found that a disturbing number of hospitalized patients still endure harmful consequences from medical care, 44% of them preventable. These instances, which the report calls “adverse events,” include infections, surgical complications and medication errors

Such occurrences are not always preventable, particularly since many Medicare patients are elderly and have complicated health problems. But enough patient harm is avoidable to make a strong case for action. Hospitals must improve, but they need the help of lawmakers, medical professionals and patients to do so.

We’ve written about this issue before here on HRW (in the context of various calls for medical malpractice reform as part of health care reform and studies that show hospital staff neither washing their hands regularly nor utilizing the simple but effective surgical checklist). The Institute of Medicine study Inspector General Levinson referred to estimated 98,000 deaths per year. Last year I wrote:

Bloomberg reports that “The U.S. Institute of Medicine found a decade ago that medical errors kill 98,000 Americans a year” according to Les Weisbrod, president of the Washington-based trial lawyers’ group, the American Association of Justice.

According to Medical News Today, the medical error fatality figures above were supported by “Dr. Chunliu Zhan and Dr. Marlene R. Miller in a research study published in the Journal of the American Medical Association (JAMA) in October of 2003. The Zhan and Miller study supported the Institute of Medicine’s (IOM) 1999 report conclusion, which found that medical errors caused up to 98,000 deaths annually and should be considered a national epidemic.

A study by HealthGrades found more than twice that number in “potentially preventable deaths.”

And now this study. Look at the numbers; they aren’t pretty–and they cast some present doubt on the 98,000 number if one considers the rubric, “contributed to their deaths.” Levinson writes:

Errors prolonged hospital stays

This study began in response to a congressional mandate to determine the number of harmful medical events Medicare patients experienced, and the cost to taxpayers. My office arranged for physician reviewers to examine a random sample of 780 Medicare patients discharged from hospitals around the country during the month of October 2008.

Physicians determined that about one in seven patients (13.5%) experienced at least one serious instance of harm from medical care that prolonged their hospital stay, caused permanent harm, required life-sustaining intervention, or contributed to their deaths. Projected to the entire Medicare population, this rate means an estimated 134,000 hospitalized Medicare beneficiaries experienced harm from medical care in one month, with the event contributing to death for 1.5%, or approximately 15,000 patients.

That’s per month. Some quick math will give us the yearly death figure: 15,000 x 12 months = 180,000 per year. And that’s just Medicare patients.

The “seriously harmed” equals 1,608,000 per year. Again, just Medicare.

Levinson continues:

Strikingly, medication errors factored in more than half the patient fatalities in our sample, including use of the wrong drug, giving the wrong dosage, or inadequately treating known side effects. Such events were commonly caused by hospital staff diagnosing patients incorrectly or failing to closely monitor their conditions.

Less serious harm also occurred. An additional one in seven hospitalized Medicare patients experienced temporary problems, such as allergic reactions or injuries from falls. And many experienced multiple events, including an elderly heart patient who had six separate events during a single hospital stay. Obviously, this situation is unacceptable — and expensive, costing taxpayers more than $4 billion a year due to the need for additional treatment or longer hospitalizations (and even more if you add costs for follow-up care).

I’ve said it before and I’ll say it again. “Seemingly, one would define “defensive medicine” as that which a doctor [or hospital] does, which he or she would not do, if solely exercising his or her [or its] discretion without the fear of being sued. Therefore, might I suggest that “defensive medicine” is only excessive if the doctor’s [or hospital's] best estimation of the situation is correct.”

You can read the rest of Inspector General Levinson’s Op-ed here. He offers some direction– much needed direction.

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