‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Erin Fuse Brown joins us to discuss Irrational Hospital Pricing, Price Transparency, the likely SGR Fix, and Non-Profit Tax Status.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?

By Nicolas Terry

Cross Posted from Health Affairs Blog

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.” Continue reading

Is there an IRB inside your Phone?

Apple’s interest in the healthcare space continues to grow. Although the implications of last year’s Health app and HealthKit SDK are still unclear, the company is now entering the crowd-sourced research space with the newly announced ResearchKit.

Apple’s Health app is a powerful health platform, the full promise of which won’t be proven until the imminent launch of Watch, Apple’s first wearable, or some powerful diagnostic apps rather than more mere FitBit clones. As discussed previously Apple, while astutely navigating FDA device regulation, seems to be stepping up to the plate in its embrace of patient privacy in the HIPAA-free mobile app space.

ResearchKit is another edgy innovation. And, again, one marked by the technology giant’s ability to forge partnerships with major stakeholders. ResearchKit was announced in concert with several apps from major healthcare research institutions including Stanford and Mass. General. Early reports suggest that research subjects are signing up in droves, cutting subject recruitment times dramatically. Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week Lindsay Wiley joins us to discuss “New Public Health” and we debate the value and validity of wellness plans.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week Abigail Moncrieff joins us to discuss the King v. Burwell oral arguments, the story behind the amicus brief she authored, and what it was like to hear Justice Kennedy talk about the very issue she raised.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale

Worth Reading This Week

By Nicolas Terry

Time for a Healthcare Data Breach Review?

By Nicolas Terry

Given the increasing numbers of health data breaches, including this week’s announcement from Anthem (potentially exposing 80m records, mine included) a brief review on the subject may be appropriate.

At the federal level both the Security Rule and the Breach Notification Rule are in play. In large part the Security Rule requires covered entities and their business associates to base their security precautions on risk assessment. Required precautions include administrative, physical, and technical safeguards. Many of these are required, for example unique user identities for access and tracking. Some precautions, however, are only “addressable.”

This latter is the case with data encryption, defined in the Security Rule as “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” In practical terms data may need to be encrypted end-to-end (during transmittal) or while stored (at rest). Being only ‘addressable,’ the question whether to encrypt stored data depends on the data custodian’s assessment whether that technology “is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information.” If the risk assessment goes against encryption that decision must be documented and a reasonable and appropriate alternative safeguard implemented. Continue reading

Raising the King v. Burwell Stakes

By Nicolas Terry

Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.

Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.

The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”

The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry

 

Who Will Own Primary Care in 2016?

By Nicolas Terry

Health reform may have signaled the shift from hospital-based “sick” care to primary care and “wellness” but the ACA failed to provide a detailed roadmap. All we know for sure is that primary care (PC) will be hugely important. Increasingly it also seems that it will look quite different. “Old” PC is being battered; Medicaid primary care physicians (PCP) saw their the two-year ACA bonuses expire in December, the OIG just reported that way too many Medicaid-listed doctors are not taking new patients, and the coverage-doesn’t-equal-access mantra is born out by persistent reports of PCP shortages. If PC as we have known it is not going to step up to the plate, what is the “new” model and who will end up owning it?

The ACA gave hospitals both good (fewer uninsureds in ERs, Medicaid expansion) and bad news (fewer profitably occupied beds because of HAC and readmission penalties). Not surprisingly there was a sharp increase in hospitals buying PCP practices. In part this was just hospitals following the money as usual, looking to roll these practices into their new ACOs. But, longer term strategies also persisted, such as strengthening networks, intercepting patients before they turn up in ERs, and creating local or regional dominant positions. Smaller PCP practices have also been more willing to sell as they faced financial regulatory disincentives (such as meaningful use penalties) if they continued as independents.

However, we are seeing hospitals doing more than increasing the number of hospital-based clinics. Many are also opening their own free-standing urgent care clinics, the “new” PC. There are several models, including full ownership as with the Intermountain Healthcare group or, perhaps for those late to the game, strategic partnerships with urgent care specialists like Premier Health or MedSpring. Continue reading

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry

Information Blocking and Interoperability

By Nicolas Terry

The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.

As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks? Continue reading

Worth Reading This Week

By Nicolas Terry

Worth Reading This Week

By Nicolas Terry