Thursday, January 31, 2013
The Department of Health and Human Services just released regulations that address, to a degree, the plight of the poor in states that refuse to expand their Medicaid populations. The ACA's original design made it so that the Medicaid expansion would cover childless adults up to 133% of the federal poverty level, and others who obtain health insurance through exchanges would be eligible for a tax credit if they earned between 100% and 400% of the FPL. After NFIB v. Sebelius rendered the mandatory expansion an option, some states have declared that they will not expand their Medicaid programs, thus leaving people under 100% of the FPL subject to the individal mandate but too poor to afford private coverage, even with tax credits. Many states cover childless adults who are extremely poor (e.g., West Virginia covers those who earn up to 17% of the FPL), and people earning above 100% of the FPL will receive tax credits - but we have a gap for people who are very poor but will not be able to enroll in Medicaid in non-participating states.
So, keep an eye out for the new regulations, in which HHS clarifies that the individual mandate does not apply to people who are eligible for Medicaid but barred from entering the program because they live in states that have opted out of the expansion. While the clarification is expected (given the hardship exception that already exists for the individual mandate), it is important to know that HHS intends to protect people from their states' decisions. (How's that for turning federalism on its head?)
Unfortunately, the regulation does not and cannot address the bigger problem: getting the penultimate poor into health insurance. Though they will be exempt from the penalty for lack of insurance, they will not have a health insurance home either, thereby denying them much-needed consistent access to the healthcare market. Congress must either amend the ACA in light of NFIB or produce new legislation addressing this coverage gap.
Wednesday, January 30, 2013
On January 10, in Fleming v. Ireland, the Irish High Court rejected the argument that assisted suicide should be legally permitted as a right of personal autonomy. Explicitly disagreeing with the Canadian court in Carter v. Canada, the Court concluded that the risks of abuse were simply too great. Interestingly, however, the Court also signaled that the Director of Public Prosecutions may exercise discretion not to prosecute in appropriate cases of assisted death. The Court opined that it "feels sure that the Director in this of all cases would exercise her discretion as whether to prosecute or not. This approach leaves the legislative ban intact while ensuring that the Director is afforded the fullest opportunity to consider what she may think are the special and extenuating factors arising from the harrowing experiences being endured by the plaintiff."LPF]
Tuesday, January 29, 2013
While most of the country continues to tie itself in knots agonizing over the Affordable Care Act, debating whether it is a good or bad thing, deciding whether it is truly a "government take-over" of health care, and keeping the courts and government bureaucrats busy responding to the endless questions about the law and its implementation, another small New England state may be acting as the laboratory for the next wave of health care reform (remember, Massachusetts was the model for the ACA). In 2011, Vermont passed a law authorizing the creation of a universal single-payer health insurance system, to be known as "Green Mountain Care" (the current name of the state's public programs, such as Medicaid), According to the Associated Press, this small state next door to Canada wants something closer to the Canadian health-care system for its citizens, rather than the hodge-podge of coverage options that Americans seem to treasure. As a resident of another state that borders Canada, where I hear stories about Canadians coming to the United States to get medical treatment that they would not be able to receive as quickly in Canada, as well as Canadians residing in the United States returning to Canada to get medical treatments that they cannot get at all in the United States because they can't get insurance or can't afford to pay for them privately, I find Vermont's decision to emulate a Canadian-style system interesting. The Vermont law lists as its purpose "to provide, as a public good, comprehensive, affordable, high-quality, publicly financed health care coverage for all Vermont residents in a seamless and equitable manner regardless of income, assets, health status, or availability of other health coverage." Clearly, Vermont lawmakers decided that the possible inconveniences of waiting lists and delays were outweighed by the evils of being unable to get treatment at all. It's a courageous decision, and it will be interesting to see how it unfolds.
The Vermont system can't be implemented until 2017, because the state will require a waiver from the ACA, and those won't be available until 2017. Nevertheless, the governor has been under pressure to explain how much the system will cost and how it will be financed, and last week, Governor Shumlin released a report that said that the state's share of the cost of the new system will be $1.6 billion, out of a total cost of $3.5 billion. The difference will presumably be covered by federal contributions and assorted private payments. Although this sounds scary, the report notes that most individuals and employers would no longer be buying private health insurance, and that would result in a savings of $1.9 billion. The major criticism of the system is coing from people who say the cost is simply too high.
Will the Vermont experimentt be the forerunner of the next wave--a single-payer health system in the United States? Or is the cost really too high? We will have to stay tuned.
Saturday, January 26, 2013
Wednesday, January 23, 2013
HHS has issued a prepublication copy of modifications to the HIPAA rule required by the HITECH Act and GINA, together with some additional modifications to HIPAA to enhance its workability and effectiveness. The official copy of the four final rules will be published on January 25th. In issuing the rules, HHS states that it is unable to give a complete cost/benefit analysis, because of the impossibility of monetizing individuals’ privacy and dignity. The final rules’ effective date is March 26, 2013, and full compliance by covered entities and business associates is required 180 days later (by September 23, 2013); HHS also emphasizes that in the future it will impose the 180-day compliance period for new or modified HIPAA standards. This rulemaking does not address either accounting for disclosures or the HITECH Act requirement to develop a methodology to distribute penalties to individuals harmed by HIPAA violations.
Here are some highlights (of more than 500 pages) of the changes:
The first rule contains modifications to the HIPAA rules required by the HITECH Act. Business associates of covered entities are made directly liable for compliance with some HIPAA rules. The use and disclosure of protected health information (PHI) for marketing or fundraising is made more difficult, and the sale of such information is prohibited without individual patient authorization. The final rule also implements individuals’ rights under the HITECH Act to receive electronic copies of their health information, requires modifications of privacy notices, modifies individual authorization requirements for proof of childhood immunizations and for information concerning decedents, and adopts additional HITECH Act enforcement requirements.
Included in this first rule are a number of provisions about the definition of business associate. One is the addition of patient safety activities as a function giving rise to a business associate relationship. Health Information Organizations (including exchanges and RHIOs), e-prescribing gateways, other facilitators of data transmission, and vendors of personal health records also are included as business associates. HHS did not provide a definition for Health Information Organization, noting that the types of entities undertaking this role continue to evolve. HHS also stated that whether a personal health record vendor offers a PHR “on behalf of a covered entity” is a fact-specific enquire; however, vendors establishing electronic means for a covered entity to send information on patients’ requests are not thereby business associates. The final rule also specifies that “subcontractors” of business associates in the sense of entities delegated functions for covered entities by the business associate are business associates—whether or not they have entered into actual subcontractor relationships. “Researchers” are not business associates, even if they have identifiable health information, unless they perform functions that fall within the definition of business associate, such as creating a de-identified data set.
Privacy advocates may be concerned to learn that HHS decided to retain the provision that PHI does not include information about individuals who have been deceased for more than 50 years.
The second rule implements the tiered civil money penalty structure for HIPAA violations provided by the HITECH Act. This penalty structure has functioned under an interim final rule issued in October 2009. This rule includes clarifications of how HHS will cooperate with the FTC and other federal and state agencies on enforcement. It also modifies the definitions of “reasonable cause” for noncompliance and of “willful neglect,” in order to implement the tiered penalty system. The final rule retains the position in the interim final rule that it is within the Secretary’s discretion to impose the maximum statutory penalty for actions within any of the tiers. The rule also reaffirms methods of calculating the number of violations: each individual, and each day, counts as a separate violation.
The third rule implements the HITECH Act’s breach notification requirements. Most importantly, it replaces the requirement of “harm” with an objective standard, supplanting the interim final rule issued in August 2009.
Fourth, the GINA requirement that health plans may not use or disclose genetic information for underwriting purposes is now incorporated into the HIPAA privacy rule. This NPRM was published in October 2009. An area of contention following the NPRM was whether the GINA protections should be extended to all plans covered by the Privacy Rule—including importantly long term care plans—or whether the protections should extend only to those plans covered by GINA. The final rule extends coverage to all plans covered by the Privacy Rule except long term care plans; these plans successfully made the case to HHS that more information was needed about the likely impact of imposing the GINA prohibitions on the long term care market. HHS plans further study of the issue, perhaps with the National Association of Insurance Commissioners.
Another important provision in the GINA rule is the definition of what it is for a condition to be “manifested”—and thus not covered by the GINA protections. “Manifested” conditions are those that have been or could reasonably have been diagnosed by a health care professional with appropriate training and expertise. Conditions are “manifest” if signs or symptoms are present, even though the condition is diagnosed primarily through a genetic test.
Tuesday, January 22, 2013
No blog addressing health law should let the 40th anniversary of Roe v. Wade go by without a mention. Whether you think the case was a tragedy, wrongly decided, poorly reasoned, a legal masterpiece, a vindication of women's rights, or a major step forward in gender equality, etc., the debate about the case remains as fresh as if it was decided yesterday. It makes for an interesting contrast with what has happened with other constitutional cases that were ground-breaking, such as Brown v. Board of Education, for example. The principle that segregated education is inherently unequal and that this principle is inherent in the 14th Amendment, memorialized in Brown is rarely, if ever, questioned today. Yet the principle that the right to privacy is inherent in the Constitution (although without consensus on exactly where), and includes the right of a woman to have an abortion, continues to engender hot debate. Both decisions have been criticized as having relied on the wrong things, both involve the treatment of historically disfavored and disenfranchised populations, yet you don't hear criticisms of Brown's basic premise in polite society today. The correctness of Roe v. Wade, however, remains open to debate at all levels, in all forums. Why the difference in treatment of two ground-breaking decisions?
There could be many reasons for the different treatment of the two decisions by the general public (some more cynical than others), but one thing that the continuing debate about Roe v. Wade points out is that when proponents of change to our health care system say health care is different than other commodities we buy and sell on the market (even education), they appear to be correct on a number of levels.
cross-posted on Healthy Interests
Wednesday, January 16, 2013
Over the last few days, the European press has devoted significant attention to a euthanasia case in Belgium. According to the report by Reuters, the 45-year old identical twins, both deaf, had recently learned that they were losing vision as well. Marc and Eddy Verbessem had lived together all their lives and reportedly found it intolerable to imagine lives in which they could no longer hear or see one another, or continue to live independently. Family members tried to talk them out of the decision, but ultimately were with them when they died on December 14, 2012. Apparently they spent two years trying to find Belgian health care providers willing to perform the lethal injections. The case has been less noted in the US, but the Huffington Post blog has just published a very sympathetic account of the twins' decision.
Tuesday, January 15, 2013
Just last week, I gave a talk to a local seniors' group about the Affordable Care Act and changes to Medicare and Medicaid. One member of the audience asked me what Arizona was doing about the Medicaid expansion (lots of folks here in frozen Spokane, Washington spend time in Arizona during the winter). I said, somewhat facetiously, that I didn't know for sure, but I assume that if it is something that the federal government is offering the state, Arizona would say "no thank you." After all, Arizona didn't even join the Medicaid program until 1982, 17 years after the program was enacted. It was the last state to join the program. And Governor Brewer made her feelings about President Obama crystal clear in that famous photographed encounter on an airport tarmac in Mesa, Arizona, where they wagged fingers at each other.
Well, I join with the Arizona legislature in my surprise at Governor Jan Brewer's announcement yesterday that she will push for Arizona to expand Medicaid to childless adults making less than 138% of the federal poverty level. According to the Associated Press, even Republican leaders in Arizona's legislature were surprised by Governor Brewer's announcement, joining surprised journalists who were provided an advance copy of Brewer's speech without the section on the Medicaid expansion.
This speaks to what a good deal the Medicaid expansion is for the states, but it remains to be seen whether or not the Arizona legislature will agree with Governor Brewer. Governor Brewer did say that she would propose that any expansion of Medicaid would include a "circuit-breaker" that would roll back enrollment if federal reimbursement rates decrease from the current low of 90%. It remains to be seen if once a state expands its Medicaid program, it can disenroll from a portion of the program and continue to receive federal funding for the remainder of the program. Until the recent SCOTUS ACA decision, the answer would clearly have been no, but now it is unclear. The SCOTUS decided that the states could decline to expand their programs and must continue to receive federal funding for the pre-existing program, but that does not necessarily mean that the state can expand its Medicaid program for some period of time, and then disenroll from a portion of the program if the federal government changes the matching percentage. Another example of how the SCOTUS decision created at least as many questions as it answered for Medicaid and other cooperative federal-state spending programs.
cross-posted on Healthy Interests
Wednesday, January 9, 2013
A very nice article in today's New York Times by Eduardo Porter lays out in clinical fashion the failures of for-profit health care in the US (and the failure of reliance on for-profit entities for other essential services, too). Although the data about high costs, populations without access, and poor quality even for those who have access are well known, Porter presents them starkly. One of the best-taken points in the article is Porter's comparison between the tax burden in countries where health care is viewed largely as a public responsibility and what we ought to see as the tax burden in the United States, if we just added health insurance premiums in as an additional tax: "In a way, private delivery of health care misleads Americans about the financial burdens they must bear to lead an adequate existence. If they were to consider the additional private spending on health care as a form of tax — an indispensable cost to live a healthy life — the nation’s tax bill would rise to about 31 percent from 25 percent of the nation’s G.D.P. — much closer to the 34 percent average across the O.E.C.D."
Tuesday, January 8, 2013
2013 promises to be a very active year for health-care-related cases at the SCOTUS. Today, the SCOTUS is hearing oral argument in Delia v. E.M.A., in which the state of North Carolina defends its statute creating a lien on any tort recovery equal to the lesser of (a) the total funds advanced by the state Medicaid program for the medical expenses of a Medicaid recipient or (b) one-third of the total recovery. The question to be decided is whether the North Carolina statute is preempted by the Medicaid Act’s anti-lien provision, 42 U.S.C. §§ 1396a(a)(25), 1396k(a)? Apparently, the Fourth Circuit and the Supreme Court of North Carolina disagree about this, with the Fourth Circuit holding the statute preempted, and the North Carolina Supreme Court holding it is not preempted. The case highlights many of the problems with insurer or government attempts to recover payments made for medical care out of tort recoveries, especially the ability of the tortfeasor and the plaintiff in such a case to characterize settlements so that the payments are not allocated as reimbursement for medical expenses already incurred. In this case, there is a particularly sympathetic plaintiff, a child who sustained birth injuries and received a multi-million-dollar settlement against the physicians who attended the birth. Interestingly, despite the push to cut costs in public spending programs, the United States is at odds with the state in this case, siding with the child. Sounds like North Carolina will be going it alone on this one. Should be an interesting oral argument.
Cross-posted on Healthy Interests
As the National Football League (NFL) finally has come to take seriously the problem of concussion, litigation by many former players will focus on the question whether the league acted unreasonably in not taking action sooner.
In reviewing the response of NFL to concussion, one can easily think that the league was too slow to worry about the medical consequences of head trauma. Despite concerns being raised for many years about the risk to player health, it took until December 2009 for the NFL to advise its teams that players should not return to play or practice on the same day that they suffer a concussion.
But the NFL was not alone in viewing concussion as a relatively mild problem. Physicians also did not worry very much about the medical consequences of concussions. For decades, neurologic experts disagreed as to whether concussions could cause permanent injury, with many attributing patient symptoms to psychological issues or to the incentives created by compensation programs for people with disabling conditions.
While the NFL may have responded slowly to problems from concussion, the extent to which its response was unreasonable is unclear. If many medical experts did not worry about concussions, it is difficult to fault the NFL for not worrying either. Still, one can question the NFL’s failure to adopt concussion guidelines in the late 1990’s when they were being issued by medical experts.
For more detail on these questions, see a forthcoming article that I've co-authored.
[DO; cross-posted at Faculty Lounge]
Wednesday, January 2, 2013
Just a brief note about a British right to life case. David James, a patient in a Liverpool hospital at the center of a right to life controversy, died this week. James had entered the hospital last spring for what newspapers describe as "suspected constipation"; he had a history of bowel cancer and was scheduled for scans. While waiting, he contracted hospital-acquired pneumonia and septicemia. The hospital sought to place him on what is called the Liverpool Care Pathway -- an end of life care protocol that is described by its supporters as an extension of the benefits of hospice to hospitalized patients and by its detractors as euthanasia for the elderly. His family challenged the decision in court, but lost the case a little over a week before James's death. Newspaper reports indicate that although the family wanted CPR and dialysis for James, neither were administered, following medical judgments that they would be futile. Reports also indicate that the family plan to challenge both the earlier care that James received and the decisions about care management at the end of his life.
Britain has had several recent "right to die" cases, in which patients such as Tony Nicklinson with "locked in" syndrome were refused aid-in-dying. These cases were presented very sympathetically in the press, and the James case appears likely to present advocates of life-preservation with a sympathetic story on the other side.