Dreams Deferred

By Wendy Parmet

After the November election, President Obama’s executive order implementing parts of the so-called “Dream Act” was widely credited with shoring up his support within the Latino community.  Less often noted was his Administration’s decision to exclude the “Dreamers” from the benefits afforded by the Affordable Care Act.

Last August, the Center for Medicare Services (CMS) issued an interim final regulation stating that individuals who benefitted from the President’s program, more formally known as “Deferred Action for Childhood Arrivals” or DACA, would not be considered “lawfully present” for purposes of eligibility to health benefits established by the Affordable Care Act, including the Pre-Existing Condition Insurance Plan and the subsidies and credits that will be available in 2014 to purchase insurance through the health insurance exchanges. Pre-Existing Condition Insurance Plan Program, 77 Fed. Reg. 52614-01 (Aug. 30, 2012) (to be codified 45 C.F.R. § 152.2), http://www.gpo.gov/fdsys/pkg/FR-2012-08-30/html/2012-21519.htm.

The impact of this little noticed determination is quite significant. Although most of the estimated 1.7 million DACA immigrants are healthy, because of their age (under 30), many lack access to employer-provided health insurance. Moreover, if as expected, employers begin to shift their health insurance programs to the ACA-created exchanges, DACA immigrants may find themselves barred from employer-provided plans, even though under the President’s executive order they have a legal right to work in the United States.

The insurance gap created by CMS’ determination that the DACA immigrants are not “lawfully present” in the U.S., a decision that is inconsistent with the Administration’s conclusion that other deferred action recipients are eligible for benefits established under the ACA, illuminates the critical relationship between immigration policy and health policy.  To a surprising degree, the health insurance access problem in the U.S. results from laws that bar immigrants (including many with Green Cards) from many government-supported health insurance programs, including Medicaid. In 2010, over 45 % of non-citizens were uninsured, as compared to less than 14 % of native-born Americans. Approximately 65 % of undocumented immigrants are believed to lack health insurance. The ACA is unlikely to reduce those rates, especially regarding undocumented immigrants. Neither, it is now seems, is DACA.

Study Reveals Complexities of Disclosing and Compensating for Medical Mistakes

[Editor’s Note, I am guest posting this on behalf of my wonderful colleague Michelle Mello, at the Harvard School of Public Health]

Gridlock in many state legislatures over proposals to reform medical liability by capping noneconomic damages—and growing recognition that caps have only modest success in addressing the problems with the malpractice system—have led  health care providers and other stakeholders across the country to think hard about alternative approaches.  Alternatives that don’t require the passage of legislation are especially appealing.  Attention has focused in the last couple of years on a promising approach pioneered by a handful of hospital systems, including the University of Michigan Health System: “disclosure-and-resolution” programs, or DRPs.  In DRPs, healthcare facilities and their malpractice insurers disclose unanticipated care outcomes to patients and their families; investigate and explain what caused them; apologize; and, where appropriate, offer compensation without waiting for the patient to sue.

Early adopters of this approach report remarkable success in reducing liability costs and believe they have markedly improved patients’ experience following a medical injury.  But they can’t tell how much of the benefit is attributable to disclosing errors and apologizing, versus offering compensation.  Is it the honesty and empathy, or the money, that matters?  And if it’s the money, how much is enough to get the outcomes healthcare providers want: reduced frequency of malpractice claims, lower defense and indemnity costs, quicker disposition, improvements in staff reporting of unanticipated care outcomes, and a clinical culture that supports open communication with patients?

A new study that I published with my colleagues, Lindsey Murtagh, Penny Andrew, and Tom Gallagher, in Health Affairs this week begins to answer these questions.  We used an experimental survey design to investigate the relative effects of disclosure, explanation, and apology on the one hand, and different kinds of compensation offers on the other, on people’s responses to learning that they were the victim of a medical error.  We fielded an online survey in which 2,112 American adults randomly received one of 16 vignettes in which they were informed of a medical error.  In all vignettes, a physician and administrator explained how the error occurred, took full responsibility, and apologized.  Some vignettes also included an offer of compensation—either waiver of medical bills, limited reimbursement of out-of-pocket expenses, or full compensation—while others included no compensation offer.  Respondents answered several questions about how they would react to the disclosure.  The survey sample was drawn from KnowledgePanel, a standing, probability-based panel of U.S. adults maintained by GfK (formerly Knowledge Networks).  The survey response rate was 65%.

What did we find?

Read More

Twitter Round-Up (11/25-12/1)

By Casey Thomson

From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics.

  • Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies. (11/26)  He also included a link summarizing key information on H.R.6118, newly passed in the House and Senate and now being presented to the President. Otherwise known as the Taking Essential Steps for Testing (TEST) Act 2012, the bill gives the Centers for Medicare and Medicaid Services (CMS) “greater flexibility in enforcing CLIA [Clinical Laboratory Improvement Amendments] proficiency testing violations” (as noted by Vorhaus). (11/26)
  • Daniel Goldberg (@prof_goldberg) included a post on the inequality in self-rated health as considered by gender. The study, done in Spain, found that females’ lower sense of self-rated health is a reflection of the higher burden of disease in women, and encouraged systems of health to reconsider the approach towards afflictions with lesser impact on mortality that are possibly receiving less attention than is deserved. (11/26)
  • Daniel Goldberg (@prof_goldberg) additionally included a report on the problems parents with disabilities are facing in terms of retaining (or even gaining) their right to be a parent. Such bias against parents, the article notes, may not recognize that ensuring essential support may be all that is needed to discourage problems or eradicate risks for the majority of cases. (11/26)
  • Frank Pasquale (@FrankPasquale) linked to a blog post on the recent protests by AIDS activists in the office of House Speaker John Boehner. The protesters, stripped naked in order to reveal the painted “AIDS Cuts Kill” written on their chests, were there to protest the possible cuts to HIV/AIDS program funding that may follow a fiscal cliff deal.  (11/28)
  • Arthur Caplan (@ArthurCaplan) featured his talk with Boston Public Radio on the fine line politicians must walk when balancing their struggle with a health crisis along with the responsibilities of being a public official. The recent health concerns facing Boston’s Mayor Thomas Menino served as inspiration for this discussion. (11/28)
  • Frank Pasquale (@FrankPasquale) added a news article detailing the recent speech made by principal deputy national coordinator David Muntz of HHS’ Office of the National Coordinator for Health Information Technology. Muntz, in addition to discussing the need to better incorporate technology for fostering stronger communication between patient and doctor, mentioned some striking statistics: “only 15% of patients have renewed a prescription online,” while “just 10% have a personal health record.” (11/29)
  • Arthur Caplan (@ArthurCaplan) posted a link to a new feature on concierge medicine, where appointments can be paid for solely through cash and not through insurance. While previously considered an option only for the rich, concierge medicine has possible implications for the greater body of patients: as the article noted, it may become a more viable option especially as threats of regulation and backlash in a doctor shortage encourage traditionally high-priced firms to backtrack. (11/29)
  • Arthur Caplan (@ArthurCaplan) also shared a video by Canadian comedian Rick Mercer on getting flu shots. (12/1)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

The Readmission Penalty Begins to Bite

By Nicolas Terry

As is well known ACA § 3025 (§1886(q) Social Security Act) established the Hospital Readmissions Reduction program. This is operationalized through deductions built into the Hospital IPPS (Inpatient Prospective Payment Systems) Rule which sets the Medicare reimbursement amounts, here. The excess readmissions ratio initially only applies to readmissions based on MI, Heart Failure, and Pneumonia. Initially the maximum deduction is 1% but that rises to 2% in October 2013 and 3% in October 2015.

A parallel program for Medicaid designed to reduce hospital-acquired infections was introduced in the 2005 Deficit Reduction Act, here. However, Lee and colleagues, here, found no change in infection rates. Nevertheless, the dollars associated with readmissions reduction may give that program greater traction.

Jordan Rau in the New York Times, here, notes that 307 hospitals are already facing the maximum reduction involving many millions of dollars. Not surprisingly some hospitals view the penalties as a distraction while others blame their patients for everything from their level of sickness and poverty to non-compliance. Overall, however, Rau’s article and Amy Boutwell’s recent post at Health Affairs, here, suggest that CMS is succeeding in getting the industry’s attention.

The New Diagnostic Scan for Alzheimer’s Disease

[Ed. Note: We’re happy to announce that after a great month of guest blogging, Chris Robertson will be joining Bill of Health as a regular contributor.]

By Christopher Robertson

The New York Times brings us an interesting story about a new brain scan technology that allows the diagnosis of Alzheimer’s Disease.  Below the fold, I sketch a few interesting themes for health law, including the FDA’s authority over the practice of medicine, the use of blinding to improve clinical decision making, the value of a clinical diagnosis for an untreatable condition, and the problems of pre-existing conditions clauses in long-term care insurance. Read More

Another Contraceptives Mandate Case

Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

More religious objections to contraception coverage

I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:

The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.

The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:

This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…

Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.

The court also found “third party standing”

It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.

These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.

Cross-posted from TIE

@koutterson

Twitter Round-Up (11/11-11/17)

By Casey Thomson

Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, as a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet. With that, read on for this week’s round-up…

  • Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
  • Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
  • Dan Vorhaus (@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
  • Daniel Goldberg (@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
  • Kevin Outterson (@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
  • Daniel Goldberg (@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
  • Dan Vorhaus (@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
  • Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system.  Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)

Opinion granting preliminary injunction on contraceptive coverage mandate

By Christopher Robertson

Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

Read More

Roundup of State Ballot Initiatives on Health Issues

By Katie Booth

This November, voters weighed in on an array of state ballot initiatives on health issues from medical marijuana to health care reform. Ballot outcomes by state are listed below (more after the jump).

Voters in Alabama, Montana, and Wyoming passed initiatives expressing disapproval of the Affordable Care Act, while a similar initiative in Florida garnered a majority of the vote but failed to pass under the state’s supermajority voting requirement. Missouri voters passed a ballot initiative prohibiting the state executive branch from establishing a health insurance exchange, leaving this task to the federal government or state legislature. Florida voters defeated a measure that would have prohibited the use of state funds for abortions, while Montana voters passed a parental notification requirement for minors seeking abortions (with a judicial waiver provision). Perhaps surprisingly, California voters failed to pass a law requiring mandatory labeling of genetically engineered food. Several states legalized medical marijuana, while Arkansas voters struck down a medical marijuana initiative and Montana voters made existing medical marijuana laws more restrictive. Colorado and Washington legalized all marijuana use, while a similar measure failed in Oregon. Physician-assisted suicide was barely defeated in Massachusetts (51% to 49%), while North Dakotans banned smoking in indoor workplaces. Michigan voters failed to pass an initiative increasing the regulation of home health workers, while Louisiana voters prohibited the appropriation of state Medicaid trust funds for other purposes.

Affordable Care Act:

  • Alabama Health Care Amendment, Amendment 6: Approved 59.52% to 40.48% (prohibits mandatory participation in any health care system)
  • Florida Health Care Amendment, Amendment 1: Defeated 51.46% to 48.54% (required 60% support to pass) (would have prohibited passing laws compelling the purchase of health insurance)
  • Missouri Health Care Exchange Question, Proposition E: Approved 61.8% to 38.2% (“prohibit[s] the Governor or any state agency, from establishing or operating state-based health insurance exchanges unless authorized by a vote of the people or the legislature”)
  • Montana Health Care Measure, LR-122: Approved 66.83% to 33.17% (prohibits “the state or federal government from mandating the purchase of health insurance coverage or imposing penalties for decisions related to the purchase of health insurance coverage”)
  • Wyoming Health Care Amendment, Amendment A: Approved 76.98% to 23.02% (stating that “the right to make health care decisions is reserved to the citizens of the state of Wyoming”)