Filed under: Health Law, Health Reform, Patient Protection and Affordable Care Act
Cross-Posted at HealthLawProf Blog
Millions – including millions of the “young invincibles” – have been enrolled in the ACA’s private and public insurance programs. And a recent study by Sommers, Long, and Baicker in the Annals of Internal Medicine, suggests that this enrollment will save lives. That’s great news for all interested in progressive health reform. But there is a lot of work to be done to ensure that care follows coverage. In this and subsequent posts, I’ll point to key implementation issues that share two characteristics: First, they go beyond the very important enrollment issues. Second, although federal implementation and advocacy is vital, my issues can be addressed largely through state and local government or private parties.
But before that, let’s call it: 2014 enrollment in ACA-related care is a success. The numbers are quite compelling. Private plan enrollment totals a surprising 13 million. This includes the 8 million signing up through federal or state exchanges, and the additional 5 million signing up outside the exchanges with plans that must meet Qualified Health Plan standards and share a common risk pool with in-exchange plans. About 28% on-exchange, and 45% of off-exchange enrollees are in the important 18-34 age group. More good news? Insurers report that at least 4 out of 5 have already paid their first month’s premium. And an additional 4.8 million are newly enrolled in Medicaid and SCHIP.
Sustaining that success won’t be easy. As Henry Aaron describes in the current issue of the New England Journal of Medicine, the success of the ACA in the short term will be subject to “brutal political war.” Aaron also describes the legacy of the political war that led to crafting of the ACA as an incremental plan, rather than a comprehensive, coherent design. The practical problem, in Aaron’s words, is that:
[R]eform had to be built on the most complex, kludgy, and costly system on planet Earth. Multiple layers of health coverage – as a fringe benefit of private employment, as compensation for military service, as public charity for the poor, as public coverage for the elderly and disabled, and as a private commodity purchased by individuals in a remarkably dysfunctional market – overlap and intersect to pay for care through a bewildering variety of agents in a system that even experts seldom fully comprehend.
“Kludgy” is exactly the word for it (not as cool as Henry Aaron? Here’s a definition). But it is a big step forward from the pre-ACA system – tens of millions newly covered, an end to the worst features of American health insurance underwriting, meaningful financial support for those previously shut out of coverage, and a variety of new delivery design initiatives.
The reforms embodied in the ACA can be sustained and improved, but only through the efforts of those in and out of government dedicated to improving access for those historically shut out of care. The case is not unlike that of Medicare, now a beloved social insurance system with almost 50 million beneficiaries, but in the 1960s a fragile program loved by few and reviled by many. As Ted Marmor, Jonathan Oberlander and others remind us, Medicare was born in a political maelstrom, and has been sustained, changing over time, through the hard work and creative accommodations by many in and out of government.
As with Medicare, there will be tough political fights about the future of the ACA, and grindingly difficult administrative challenges for federal regulators. But the states and private actors are critical to the ACA’s success. The fact is that the ACA’s innovations largely lay over the construct of existing insurance law. In addition, gaps in coverage and ambiguities in the protection of civil rights means that those outside of the federal political and administrative processes will have lots to do. Those tasks include:
- Affordability. Many advocates are concerned that people newly enrolled in QHPs will have trouble affording care notwithstanding the ACA’s subsidy systems. This concern goes beyond premium costs, and runs to patient cost-sharing through deductibles and copayments. States should be considering the adoption of a Basic Health Plan option, and innovative “bridge” and “wrap-around” programs.
- Coverage of immigrants. In perhaps no other area of implementation are the political and the pragmatic so at odds. The fragmented regulation of access to care for different cohorts of immigrants has caused confusion, limitations on access, and bad results – both intended and unintended. States can take the lead here.
- Protection of people with disabilities/chronic conditions. The structure of the ACA’s underwriting reforms are good news for people with disabilities, as are its nondiscrimination mandates, as Sara Rosenbaum has described in detail. But the reforms mix uncertainly with the financial incentives that remain in the insurance system, and state regulatory oversight and advocacy will be essential to fulfill the statute’s goals.
- Denials and network adequacy. The ACA embodies a paradox: it both federalizes the regulation of health insurance, and largely devolves that federal regulation back onto the states for supervision and enforcement. That means that QHPs will continue to employ utilization management tools, including medical necessity review, to limit access to care – properly and improperly. Perhaps more pressing is the problem of narrowing networks of providers in health plans. Properly constructed networks can be a benefit to consumers; improperly constricted networks can deny access in covert and dangerous ways. Vigilance by states and private actors will be crucial here.
The ACA’s goals are noble, and its somewhat clumsy (or kludgy) structure can succeed, but only through a lot of work from a lot of people. I’ll return to these issues in upcoming posts.
The Australian government has announced a new scheme that will compensate living organ donors with cash payments during their recovery period. This is said to be intended not as a payment for the organ, but as a way to minimize the financial burden of donation. The plan should be seen as a step in the right direction for those who favor legalizing payment for organ donation in the United States, and Congress should seriously consider authorizing a similar pilot program.
Australia’s new program has several features, designed to mitigate fears and concerns about paying organ donors. First, the plan reduces the fear that individuals will look to donate their organs out of desperation and economic necessity. This is accomplished by limiting the payments to the currently employed, including self-employed and part-time workers. Additionally the compensation is not extravagant, topping out at $606 a week for up to six weeks. This limited compensation is unlikely to attract financially distressed donors who would otherwise choose not to donate, though it may make it easier for those who are not well-off to commit to a process that will entail significant time off from work. That being the case, most donors would find themselves afterwards in relatively the same financial situation as before they donated.
Second, the money comes from the Australian government, rather than from the recipients themselves. This reduces the appearance of a cash-for-organs system that might be unpopular and ethically problematic. A third party payment system for bone marrow is already developing in the US. The group moremarrowdonors.org has led the effort for such after the 2012 decision of Flynn v. Holder held that payment for donating bone marrow by apheresis is allowed under the current law. If third parties, be they charitable organizations or the US government, make payments to donors a gap is created between the donor and the recipient. This gap will, presumably, allow donors to still feel that they have actually donated and not sold their organ. And, if the altruistic component of donation can be preserved while reducing the financial burden to the donor then it is unlikely that this new scheme will drive away potential donors who do not like the idea of selling their organs.
If this scheme were adopted by the United States it has the potential to drastically increase the supply of kidneys, especially in minority communities. There is currently a huge gap between the supply and demand for kidneys. For racial minorities this gap is even wider. Modest payment for missed work time, coupled with an awareness campaign, would allow low-income individuals to donate their organs without placing themselves in financial jeopardy from missed work. If the amount of money paid to the donor was kept modest, like the Australian scheme, claims of exploitation would be less persuasive.
The US government should closely monitor the Australian pilot program to see if it is effective. If so, it should be rapidly adopted by the US. If not, then consideration should be given to other means of increasing organ donation, including larger cash payments to donors. A US program similar to the new Australian scheme would go a long way to closing the gap between the need for kidneys and the supply of living donors.
NY/NJ CLE credits available
This four-day educational program, held twice a year, immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud and abuse law,” as well as other healthcare-related laws and regulations, to help them understand the legal underpinnings of the compliance programs they develop and enforce.
Who Should Attend
Pharmaceutical and medical device professionals in compliance, legal, regulatory and medical affairs, sales, marketing, grants and related areas, as well as outside counsel who represent healthcare companies.
Cost & Registration
Tuition for the Program: $2,400. To register, go to http://law.shu.edu/hccp.
- Program faculty include high-level government and private lawyers who are experts in pharmaceutical and medical device fraud and abuse issues.
- Session topics include Federal and State False Claims Acts, Federal Anti-Kickback Statute, the Food, Drug & Cosmetic Act (FDCA), Data Privacy (HIPAA, HITECH, and others), Food & Drug Administration Amendment Act of 2007 (FDAAA), Foreign Corrupt Practices Act (FCPA), Prescription Drug Marketing Act of 1987 (PDMA), PhRMA Code and AdvaMed Code, The Federal Sunshine Law, federal and state marketing and disclosure laws, OIG compliance guidance, and much more.
- Attendees receive extensive resource materials which will aid them in their ongoing compliance efforts.
- Attendees will receive a certificate issued by Seton Hall Law School upon completion of the Program, and may apply for approximately 26 CEUs for HCCA and SCCE certification and/or NY and NJ CLE credit.
For more information regarding the Program, please contact Sara Simon at email@example.com or call 973-642-8190.
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
Last week, the Jersey Journal reported that a jury recently awarded a former employee of Bayonne Medical Center over $2.1 million in his whistleblower suit against the hospital. The employee, Ceferino Doculan, alleged that the hospital violated New Jersey’s whistleblower statute, the Conscientious Employee Protection Act (CEPA), by terminating his employment as a technician in the hospital’s blood bank because he had complained to hospital personnel that his new supervisor was not qualified to hold that position under New Jersey law.
Although the hospital argued it had terminated Doculan for other reasons, the jury apparently accepted Doculan’s view of the predominant reason for his firing. According to the article, the jury awarded him about $120,000 in compensatory damages (lost wages and pain and suffering) and $2 million in punitive damages. The hospital intends to appeal.
The case offers several lessons regarding whistleblower liability risks for hospitals and other healthcare providers. One broad takeaway is that management of whistleblower risks cannot be disentangled from other compliance matters. So, in addition to the concerns about how to respond to a whistleblower appropriately, Bayonne Hospital had an actual legal problem – the supervisor was not qualified under New Jersey law. CEPA and most other whistleblower laws do not limit protection to complaining employees who are correct about the law; typically, the employee’s report must merely be made in good faith. Yet, intuitively, if the employer has in fact broken the law, the employee may have an easier time establishing her wrongful termination claim, in part because the existence of the legal violation will potentially make the whistleblower more credible in her lawsuit. Thus, vigilance about compliance with the law in the employer’s operations in general – in this case, on a human resources-related matter – is a key component in reducing whistleblower liability risks.
Second, keep in mind that, with rare exception, whistleblower laws protect only reports of illegal conduct or conduct that poses some kind of direct and serious risk to the public. Whistleblower laws do not protect employee reports of violations of employer policies, nonlegal disputes with the employer, or other purely internal matters. But, in highly regulated industries like healthcare, actions that might not otherwise implicate the law often do. For example, in most industries, the law does not require a license, special training, or other credentials to serve as a supervisor; in healthcare, things are different. Compliance personnel in the healthcare context therefore should know that whistleblower liability risks linger in the background of many human resources and other kinds of decisions. Employee complaints and reports regarding such decisions – even those that might seem standard or run-of-the-mill – therefore should be taken seriously and treated like those that obviously involve legal mandates.
Finally, hospitals and other healthcare providers potentially confront multiple whistleblower regimes. High-profile whistleblower litigation in this area often involves federal law, most notably, the False Claims Act (including “qui tam” actions for alleged overbilling of the government). See examples here and here. And the new whistleblower provisions found in the Affordable Care Act are garnering much attention. But, as the CEPA claim in this case suggests, many states provide statutory and common-law whistleblower protections that sweep more broadly, potentially protecting employees who report a wide variety of alleged legal violations. Each of these federal and state regimes has its own set of legal requirements, limitations, and remedies. A working familiarity with these various regimes can enhance compliance and risk management.
For those interested in learning more about federal and state whistleblower regimes, Seton Hall Law School now offers an eight week online course on managing whistleblower risks. The course is designed to introduce human resources and compliance personnel to the laws protecting employees who report alleged misconduct of their employers. If you would like more information, please visit the course website or call 973-642-8482.