Filed under: Compliance, Elder Issues, Litigation and Liability, New Jersey, Public Health, Quality Improvement, Whistleblowers
New Jersey has perhaps the most employee-friendly whistleblower law in the nation, and the NJ Supreme Court is one of the most employee-friendly courts. It was, therefore, more than a little surprising to read the court’s most recent Conscientious Employee Protection Act decision, Hitesman v. Bridgeway, Inc.
A quick summary of the law and the facts make it even more surprising.
Law-wise, CEPA protects employees from retaliation for opposing any activity “the employee reasonably believes . . . is incompatible with a clear mandate of public policy concerning the public health.” Further, and seemingly tailor-made for Mr. Hitesman, CEPA also bars retaliation “in the case of an employee who is a licensed or certified health care professional, [for opposing conduct he] reasonably believes constitutes improper quality of patient care.”
As for the facts, plaintiff, a registered nurse who was shift supervisor for the defendant, believed that there was an upswing in respiratory and gastrointestinal infections at the nursing home. He reported his concerns first to management, then to local and state health agencies, and, not getting much of a reaction, went to a local television station. Perhaps needless to say he was fired.
In this kind of scenario, if the whistleblower loses, it’s usually because (1) he can’t prove that he was reasonable in his belief as to a violation of public policy or (2) he can’t prove that the adverse employment action he suffered was causally linked to his protected conduct. But neither was the problem for plaintiff since a jury had found both that Hitesman’s beliefs about improper patient care were “objectively reasonable” and that Hitesman’s reporting his concerns to the government was a “determinative motivating factor” in his discharge.
So why did he lose before the Supreme Court? Apparently, because his attorney never put in evidence that inadequate infection control was a threat to patient health. Really. And in a nursing home at that, which necessarily serves a more vulnerable population. Although it would seemingly have been easy to prove medical standards of care in dealing with potential infection, for example, citing to Center for Disease Control publications, the only evidence put in of the relevant policies was an American Nursing Association Code of Ethics and two internal policies of the nursing home, none of which focused directly on infections.
The court wrote:
[A] pivotal component of a CEPA claim is the plaintiff’s identification of authority in one or more of the categories enumerated in the statute that bears a substantial nexus to his or her claim. . . . [T]he plaintiff must identify the authority that provides a standard against which the conduct of the defendant may be measured.
While CEPA recognizes “a range of standards that may support a claim,” including professional codes, a claim “cannot proceed unless the plaintiff demonstrates a reasonable belief that the defendant’s patient care is ‘improper,’ measured against an authority recognized by CEPA,” which requires plaintiff to “identify a law, rule, regulation, declaratory ruling adopted pursuant to law or professional code of ethics that applies to and governs the employer in its delivery of patient care.”
That plaintiff hadn’t done, or at least so said the majority. The dissent of Justice Albin disagreed on several counts, but one of which was that the plaintiff had testified about the CDC Guidelines on infection control. The majority dismissed this on the ground that “Neither the trial court’s prior references to CDC standards in its summary judgment decision, nor plaintiff’s vague references to CDC-recommended precautions in his testimony” provide the detail of what CEPA requires.
Especially given the court that handed it down, Hitesman is a head-scratcher. Arguably, it’s a sport opinion, whose major impact will be a cautionary tale to attorneys to introduce exhibits citing chapter and verse rather than relying on plaintiff’s testimony and common-sense conclusions. But it’s possible the case may have more significance, signaling to the lower courts that CEPA has been applied too broadly in the past.
Filed under: Accountable Care Organizations, Health Reform, Medicaid, New Jersey, Quality Improvement
Cross-Posted at Bill of Health
Nearly three years ago, in July of 2011, Tara Adams Ragone wrote a blog post for Seton Hall Law’s Health Reform Watch blog entitled “Community Based Medicaid ACOs in New Jersey: A Signature Away”. As Professor Ragone explained, a month earlier the New Jersey legislature had passed Senate Bill 2443, which established a Medicaid accountable care organization (ACO) demonstration project, but Governor Chris Christie had not yet signed it. “It’s an exciting time for growth and innovation in the Garden State,” Professor Ragone wrote, “if we just get that signature.”
Governor Christie did go on to sign Senate Bill 2443 into law, in August of 2011, but the implementation process has been protracted. The act required the Department of Human Services to “adopt rules and regulations” that provided for oversight of the quality of care delivered to Medicaid recipients in the ACOs’ designated geographic areas and set standards for the gainsharing plans that participating ACOs must develop. The deadline for adopting the regulations was in June of 2012, but they were first issued, in draft form, in May of 2013. The final regulations were not adopted until earlier this week, one day before the proposed regulations were due to expire.
As Andrew Kitchenman reports here, with the regulations in place, the three community-based organizations that have been preparing to launch Medicaid ACOs, one in Camden, one in Trenton, and one in Newark, can finally get started. Unlike the State, they will have to move quickly; the deadline for applying to participate in the three-year demonstration is July 7th.
There is, in Kitchenman’s words, “a final piece to the puzzle”—the participation of managed care organizations (MCOs). In 2011, when New Jersey’s Medicaid ACO statute was passed, many of the State’s Medicaid beneficiaries were covered on a fee-for-service basis. The expectation was that ACOs’ efforts to coordinate care and reduce waste would be rewarded with a share of any resulting savings to the State. In 2014, however, the landscape has changed. Nearly all of New Jersey’s Medicaid beneficiaries are now enrolled in Medicaid MCOs, and it is uncertain whether Medicaid MCOs will be willing to enter into shared savings arrangements with Medicaid ACOs.
Recently-released data from the second year of operations of Colorado’s Accountable Care Collaborative Program suggest that, if New Jersey’s MCOs can be persuaded, incentivized, or required to work with its nascent ACOs, there are both cost savings and quality gains to be had. Colorado has not yet enrolled individuals with disabilities or those who are dually eligible for Medicaid and Medicare in its Program, but the Program nonetheless achieved gross savings of $30 per member per month in its second year, adding up to $44 million. The State’s net savings were $6 million, after paying the Program’s regional ACOs and participating primary care providers for care coordination and other services, as well as a contractor charged with providing “actionable data at both the population level and the client level”.
The quality gains Colorado achieved in the Program’s second year were substantial, including a 20% reduction in hospital readmissions, a 22% reduction in hospital admissions among members with chronic obstructive pulmonary disease, and “[l]ower rates of exacerbated chronic health conditions such as hypertension (5%) and diabetes (9%)[.]” Emergency room utilization, on the other hand, increased, albeit at a slower rate than for Medicaid enrollees not participating in the Program.
As Diana Rodin and Sharon Silow-Carroll explained in a March 2013 report on Colorado’s approach to Medicaid accountable care, the State wanted to move away from fee-for-service but did not want to return to traditional capitated managed care, which had led to “nearly all Medicaid managed care plans [leaving] the state as a result of conflict over rates.” Colorado currently makes a portion of the payments it makes to the regional ACOs and to participating providers contingent on the achievement of certain quality improvements. Eventually, the State intends “to increase the portion of the monthly fee that is at risk, as well to pilot payment reforms that test alternatives to the fee-for-service component.”
It will be interesting to see if Colorado succeeds at moving away from fee-for-service without returning to traditional capitated managed care, and if New Jersey succeeds at moving towards accountable care within a managed care environment.
Filed under: Health Insurance, Information Technology, Patient Protection and Affordable Care Act, Quality Improvement
Cross-Posted at Bill of Health
On Wednesday night, I went to a panel presentation sponsored by the group NYC Health Business Leaders on the roll out of New York State’s health insurance exchange. Among the speakers was Mario Schlosser, the co-founder and co-CEO of the venture-capital-backed start-up health insurance company Oscar Health, which offers a full range of plans through New York’s exchange. As NPR reported last month in a story about Oscar, “it’s been years since a new, for-profit health insurance company launched in the U.S.”, but the Affordable Care Act created a window of opportunity for new entrants.
Schlosser began his talk by giving us a tour of his personal account on Oscar’s website, www.hioscar.com. Among other things, he showed us the Facebook-like timeline, updated in real time, which tracks his two young children’s many visits to the pediatrician. He typed “my tummy hurts” into the site’s search engine and the site provided information on what might be wrong and on where he might turn for help, ranging from a pharmacist to a gastroenterologist, with cost estimates for each option. Additional searches yielded information on covered podiatrists accepting new patients with offices near his apartment and on the out-of-pocket cost of a prescription for diazepam (which was zero, since there is no co-payment for generic drugs for Oscar enrollees).
As an audience member noted, none of this is new exactly. What is new is to have this kind of data-driven, state-of-the-art user experience being offered by a health insurer. Schlosser told the audience that Oscar’s pharmacy benefit manager and other vendors are providing the company with real-time data that other insurers have not demanded. And, according to Schlosser, Oscar’s customers are responding. Nearly all of them have used the company’s website. A surprising five percent of them use the company’s website every day.
In addition to an improved user experience that incorporates increased price transparency, Oscar heavily emphasizes telemedicine, with the goal of giving every customer the feeling of having “a doctor in the family.” As Forbes reported last year, Oscar has “a unique partnership with the telemedicine company TeleDoc” which will allow its customers to speak to a doctor at any time of the day or night without incurring any out-of-pocket expense. With regard to the physicians in Oscar’s network, Schlosser explained that the company does not intend to incentivize or require physician compliance with quality measures, as some insurers do. Oscar will instead use its core function—reimbursement—to encourage, for example, email and phone communications between doctors and their patients.
Oscar’s service area is currently limited to New York’s nine downstate counties, but the company hopes to expand. It will be very interesting to see if it succeeds. Schlosser emphasized that Oscar has its genesis in the frustration that he and his co-founders felt dealing with their previous employer-provided health insurance plans. He joked about Explanation of Benefits forms that do anything but explain what your benefits are. The idea of putting these frustrations in the rear-view mirror is a very attractive one.
In the end, Oscar’s success may hinge on its ability to earn and sustain its customers’ trust. Will customers trust the advice given to them by an insurance company-paid doctor whom they have never met? Will they trust that the physicians Oscar’s website directs them to are chosen with customers’ interests in mind? Will they trust Oscar to use the additional data it collects in ways that serve, or at least do not harm, their interests? An audience member’s joking reference to the National Security Agency—Schlosser responded with a smile that one of Oscar’s employees in fact did use to work for the NSA—suggests that I was not the only one thinking about questions of data and trust.
Cross-Posted at Bill of Health
As I have blogged about before, including in this post from 2010, and this one from 2009, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why. An article by Robert Goldenberg and colleagues in this month’s issue of the American Journal of Perinatology suggests that the knowledge gap is likely to persist.
As Goldenberg explains, the three tests that provide the most information about what caused a stillbirth are (1) an autopsy, (2) an examination of the placenta, fetal membranes, and umbilical cord, and (3) a karyotype (a test for chromosomeabnormality). Of the members of the American College of Obstetricians and Gynecologists who responded to a 2011 survey, however, 23.3 reported that they infrequently ordered an autopsy when a stillbirth occurred (0.4 percent reported that they never did) and 24.8 percent reported that they infrequently ordered a karyotype (0.3 percent reported that they never did). These results comport with the findings of a qualitative study published in 2012 in BMC Pregnancy & Childbirth. The authors, Maureen Kelley and Susan Trinidad, reported that obstetrician-gynecologists in two focus groups “would not routinely offer an autopsy to the parents, but would conduct one if requested. Some would offer/order lab work on the placenta if the cause of the stillbirth were not known.”
A surprisingly high 30.2 percent of the doctors who responded to Goldenberg’s survey indicated that they frequently, but do not always, review the results of post-stillbirth testing; an additional 11.9 percent admitted that they infrequently review such results. The survey also revealed that “the large majority of stillbirth certificates are filled out prior to the return of all test results”, some “by providers other than the physician”, “making it “highly likely that that the vital statistic cause of death reports are inaccurate.”
As Goldenberg notes, there is, as with many surveys, the possibility of a response bias, since obstetricians who were interested in stillbirth were more likely to respond. In practice, the percentage of physicians who do not order the appropriate tests may be even higher than the survey revealed. The failure to order the appropriate tests and then interpret and report their results has obvious public health implications. Goldenberg explains that, despite advances, “the U.S. stillbirth rate is among the highest in developed countries, substantial disparities remain in stillbirth rates between various populations of U.S. pregnant women, and about one-third of stillbirths may be preventable.” Further study is needed and better data is a necessary first step.
Failing to order the appropriate tests can also harm individual grieving families. Soo Downe and colleagues conducted a qualitative interview study, published earlier this year in BMJ Open, and found that while “[f]ifteen [of the twenty-five parents interviewed] expressed a strong drive to find out why their baby died”, just ten had had an autopsy. These parents “emphasized the importance of discussions and accurate information about maternal and child blood tests, placental investigations, postmortem examination and any other tests that could be conducted.”
To improve stillbirth-related knowledge and practice among obstetricians, Goldenberg recommends addressing the relevant issues during residency, in continuing medical education programs, and in grand rounds. Learning how best to manage a relatively rare occurrence like stillbirth is likely to continue to fall low on the list of priorities of busy physicians with competing obligations, though. More promising, I think, is Goldenberg’s recommendation that hospitals help by, among other things, developing protocols and standardized order sheets. Goldenberg’s survey showed that ”only about half the hospitals had written guidelines for evaluation and management of a stillbirth, and only 25% of the respondents had preprinted orders at their hospital for stillbirth tests.” Remedying this would help physicians and patients navigating an exquisitely difficult time; it could also go a long way to improving the current quality and quantity problems with stillbirth data.
*I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue. (My prior posts are here, here, here, and here). Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.
When patients undergo surgical or other medical procedures, they hope to receive optimal care provided by experienced physicians. They are rarely concerned about proper sterilization of surgical instruments and other medical equipment as it is likely assumed that the health care facility has applied this standard precaution. Unfortunately, however, not every medical center is adequately sterilizing its equipment, yet this is a crucial element of successful medical care.
According to a report by The Center for Public Integrity, a patient who underwent a routine rotator cuff repair surgery at a Texas hospital in 2009 was readmitted weeks later due to an infection from the deadly bacteria known as P. aeruginosa. An investigation conducted by the Centers for Disease Control and Prevention (CDC) and the hospital revealed that the arthroscopic shaver utilized for the surgery contained the deadly bacteria even after the sterilization process.  A more recent incident occurred in March of this year where a routine inspection at an oral surgeon’s office in Tulsa, Oklahoma exposed sterilization issues, including cross-contamination problems. The Department of Health stated, “more than 60 former patients [of the oral surgeon] tested positive for hepatitis and HIV.”
Medical device manufacturers originally sold “single-use” devices because of the demand for disposable equipment. In the late 1970s, hospitals began reusing medical devices intended for or labeled as “single-use” as a cost control measure. The FDA explains that “single-use” devices are to be used once or on one patient during a single procedure whereas reusable medical devices are those that can be reused to treat several patients.
Contaminated reusable medical devises can lead to infections but a method known as “reprocessing” involves meticulous sterilization intended to prevent infections. Reprocessing generally includes the following steps: 1) preliminary decontamination and cleaning in the area of use such as the operating room to inhibit drying of blood and other contaminants on the devises; 2) transfer of the devise to the reprocessing area where careful cleaning occurs and 3) final disinfection or sterilization to allow the devise to be reused. The FDA further explains that problems arise for reprocessing when sterilization instructions by the manufacturer are “unclear, incomplete, difficult to obtain from the manufacturer, or impractical for the clinical environment.”  Manufacturer designs that render proper cleaning difficult in addition to scantily paid sterilization technicians are other sources of concern.
There are some diseases that preclude the reuse of medical devices, specifically Creutzfeldt-Jakob Disease (CJD). CJD is a neurodegenerative disorder that causes rapidly advancing dementia, deteriorating memory, drastic changes in behavior, and coordination and visual issues. It is 100% fatal; patients with CJD usually die within one year of disease symptom onset. CJD results when normal brain proteins are transformed into abnormal and infectious forms known as prions. Infected pituitary hormones, dura mater transplants, cornea grafts, and neurosurgical instruments are some examples of materials that can transmit the disease to patients. Most disinfectant and sterilization procedures do not eliminate the infected prions. Importantly, although fatality normally occurs within one year of symptom onset, the disease has an incubation period of up to 50 years, it is not readily detectable until symptoms occur, and is seemingly capable of transmission to others during the incubation period.
The World Health Organization (WHO) released infection control guidelines for health facilities handling patients with CJD. Essentially, any reusable surgical instruments that come into contact with “high infectivity areas” including the brain, spinal cord, and eye should be disposed of and incinerated. But the difficulty, of course, is knowing who is infected with this infectious fatal disease with the disturbingly long incubation period.
Ensuring that hospitals follow proper sterilization is integral, but technician certification is also an important aspect of the overall sterilization scheme. As the director of sterilization at a healthcare facility in New York so accurately stated, “The people who do your nails, they have to take an infection control course before they can apply for a license …Yet the people who deal with lifesaving equipment, they are required to have zero education.” Currently, New Jersey is the only state that makes certification mandatory for sterilization technicians.
As the provision of health care becomes more transparent, patients not only have the ability to choose where to obtain services based on price and reputation of a facility, but they are also, presumably, able to learn about various quality measures. By filtering a search based on location or hospital name, the Centers for Medicare & Medicaid Services’ (CMS) Hospital Compare Website enables patients to view quality measures such as readmission, complication, and mortality rates. There, patients are able to examine the facility’s rates in comparison to the national average. Therefore, improper sterilization leading to increased infection rates will likely be exposed to the public, however attenuated, which could cause patients to seek care elsewhere—at least in time, among consumers able to bring choice to the equation (non-emergency, non-insurance dictated) and who have the ability to comprehend the data. But seemingly, more direct measures can be taken to ensure patient safety.
 http://www.publicintegrity.org/2012/02/22/8207/filthy-surgical-instruments-hidden-threat-americas-operating-rooms, http://www.today.com/health/today-investigates-dirty-surgical-instruments-problem-or-1C9382187