Mary K. Caffrey, Managing Editor, Evidence-Based Diabetes Management

Some of the biggest names in healthcare—CVS, Kaiser Permanente, Walgreen’s, and Veterans Administration (VA)&mdash;are also the nation’s top violators of the law to protect patient privacy, according to an investigation by the public interest journalism organization, ProPublica.

The investigative series revealed that top retail pharmacy chains, health plans, and the VA routinely violate the Health Insurance Portability and Accountability Act (HIPAA), both through sloppy mistakes and rogue acts of spying. What’s worse, the investigation finds, is that repeat offenders face little likelihood of enforcement to the maximum permitted under the law.

The HHS Office of Civil Rights issues only a handful of fines—fewer than 30 since 2009&mdash;on the more than 18,000 HIPAA complaints it receives each year. (CVS did pay a $2.25 million fine in 2009 for tossing prescription bottles in a dumpster, but it still had more than 200 complaints between 2011 and 2014, according to an analysis in the report.)

What kinds of violations occur? Cases reviewed by ProPublica included honest but distressing errors, such as delivering cancer medication to the wrong address.

Worse are the purposeful, intrusive lapses such as sharing patient photos on Snapchat, or the male VA worker who allegedly used records to look up information on a patient he wanted to date. ProPublica found that the HHS Office of Civil Rights has enormous discretion under HIPAA—it can settle cases quietly, which seems to be the modus operandi&mdash;or it can impose finds of up to $50,000 per violation, up to a maximum of $1.5 million per year.

Criminal charges are possible in the most egregious cases, and complaints can be posted online if patient information is withheld. The investigation quotes Deven McGraw, deputy director of health information privacy at the Office of Civil Rights at HHS, who said the agency focuses on cases that involve at least 500 people but it could do more. She thinks it should.

“Often, when we take a look into those breaches, what we find is that they were not accidents. What contributed to the break of thousands, if not tens of thousands of records, was systemic noncompliance … over a period oftentimes of years.”

The top offender during the period examined by ProPublica is another agency of government: the VA. Against the backdrop of all its other problems—huge backlogs in scheduling patients and falsified reports&mdash;were incidents like these:

One VA employee improperly accessed her ex-husband’s medical records more than 260 times.

Another VA employee accessed a patient record 61 times and posted some details on Facebook.

A veteran’s health information was improperly passed along to his parole officer.

Spokespersons for the VA and CVS told ProPublica they took issues of patient privacy very seriously. But other experts questioned how many incidents it would take for HHS to recognize a pattern of noncompliance.

Articles

The public interest journalism group ProPublica examined records from 2011 through 2014 and found that not only are HIPAA violations common, but they also typically go unpunished.

Some of Health Care's Biggest Names Also Top HIPAA Violators, Investigation Finds

What happens to a highly paid executive whose screw-up attracts national headlines, who cries in public and then departs for the private sector? She gets a parting gift of almost $40,000 (and her top deputy doesn’t do badly, either).

 is reporting that Jean Yang, MBA, the former head of the Massachusetts Health Connector, was able to take advantage of state policies that allow state officials to carry over unused vacation time from year to year. The amount Yang was paid upon leaving meant she was paid for 57 unused days—essentially, she didn’t take a day off during her 2-year tenure, according to the report.

Yang stepped down January 6, 2015. She was making $179,243 a year. Her successor, who arrived with the administration of new Governor Charlie Baker, makes $223,000 a year.

While technically legal, Yang’s payment raised eyebrows after the problems with the rollout of the Health Connector. The commonwealth health exchange that performed so badly it was ranked the worst in the nation by 

, and published reports after its disastrous rollout found that state workers had to process health insurance applications by hand while the web site was being fixed.

Yang personally made headlines when she cried at a 2014 board meeting about the problems with the web site. According to the 

 report, the administration of former Governor Deval Patrick knew for months that the website would not work before the start of open enrollment in the first year of the Affordable Care Act, but it hid that fact from the public.

The report said Yang’s deputy, Roni Mansur, also left with unused vacation work nearly $28,000. Citing her LinkedIn page, the Herald said Yang now works at Boston Children’s Hospital and that she could not be reached for comment.

Technical problems with the federal exchange, HealthCare.gov during the first open enrollment period of the ACA in 2013-2014 led to the resignation of President Barack Obama’s first HHS Secretary, Kathleen Sebelius, shortly after open enrollment ended in the spring of 2014. 

In 2014, Forbes said the Massachusetts Health Connector was the worst exchange in the nation.

Report: Leader of Botched Health Connector Pockets $40K in Unused Vacation Time

There was no Christmas miracle for a hospital that hoped to join the preferred tier in New Jersey’s largest health insurer network before coverage began last weekend.

But the Christmas Eve preliminary hearing revealed more details about how Horizon Blue Cross Blue Shield built its controversial OMNIA network. Apparently being the only preferred hospital in a market was important.

Judge Frank Ciuffani denied St. Peter University Hospital’s request to be placed in Horizon’s preferred tier, because it would be “extraordinary” to take this step without a full hearing. St. Peter’s, located in New Brunswick, argued that it will suffer irreparable harm, including lost revenue and damaged relationships with patients, once the OMNIA plan takes effect.

The judge told both sides to return January 4, 2016, to schedule depositions and a full hearing, Ciuffani told the parties he wants the matter resolved quickly.

Benefits under OMNIA start Saturday for some public employees covered by the plan, and on January 1, 2016 for everyone else. Horizon attorney Michael Kassak said today OMNIA will cover 3% of the market.

 “Horizon is pleased that the court has refused this effort by St. Peter’s to change the implementation of Horizon’s OMNIA health plans. This is good news for the thousands of individuals who have purchased OMNIA health plans to date,” said Horizon spokesman Thomas Vincz.

Since it was unveiled September 10, 2015, Horizon’s OMNIA plan has drawn fire from mayors, legislators, and hospitals that were not included in the preferred network, known as Tier 1. OMNIA is both a tiered network, which was approved by state regulators, and a population health alliance, which is designed to move away from traditional fee-for-service healthcare delivery as called for under the Affordable Care Act.

Around the country, population health contracts are becoming more common in managed care, as providers work with patients to stay on their medication, get health screenings, and take other steps to avoid major health crises that result in multi-day hospital stays. Providers then share in the savings that result from such activity.

In the case of OMNIA, these agreements came with another element: those in the preferred network would also charge lower rates in exchange for having more patients routed their way. St. Peter’s attorney Jeffrey Greenbaum argued that depositions revealed that giving Tier 1 exclusivity to St. Peter’s competitor in New Brunswick, Robert Wood Johnson, was key to getting the RWJ agreement. Like most of the other OMNIA partners, RWJ is a large, multi-hospital system, while St. Peter’s is a standalone hospital.

In addition to the question of whether St. Peter’s would meet the bar to get an injunction, the hearing centered on 2 questions: How important is market exclusivity to OMNIA partners? And how does each side interpret the 60-day notice in St. Peter’s contract with Horizon?

The 60-day notice existed for St. Peter’s to be given a “fair shake,” during which it could respond to Horizon’s selection criteria and point out errors. Greenbaum went through a series of pieces of incorrect or outdated information he said were revealed in depositions. He accused Horizon of creating “a process to justify the result they wanted,” which favored large health systems at the expense of small, independent hospitals.

 and RWJ New Brunswick have different areas of expertise, Greenbaum said, and the OMNIA network will not collapse if New Brunswick has 2 Tier 1 hospitals. He argued there are areas along the Jersey shore with overlapping Tier 1 hospitals. “Exclusivity seems to be only when they want it, but not all the time,” he said.

Kassak, representing Horizon, said St. Peter’s has completely misinterpreted the meaning of the 60-day notification requirement, and that it merely exists so that hospitals can alert consumers heading into open enrollment of their status. St. Peter’s, he said, “is reading things into the contract that are simply not there.”

He said exclusivity was extremely important—not just to RWJ but also to Horizon, because if anticipated savings were not realized, this would affect rates in the future. When rates are inadequate in a given year, they must be raised in the following year, Kassak said, and “the product is not priced competitively anymore.”

The OMNIA matter is being watched nationwide, since New Jersey’s 

 has reacted harshly to this attempt to use narrow networks to implement population health. Two senators introduced a 4-bill package that would tightly proscribe terms for regulating narrow networks. Hospitals in other states that fear behind left out of similar efforts will likely examine contracts or seek protection from being forced into less-preferred tiers.

The hearing had been set for December 17, 2015, and St. Peter’s CEO Ronald Rak said Horizon was responsible for the delay.

“They are engaging in a tactic of stalling and not producing evidence. We now are in a position where we have to wait for a final hearing to have justice rendered to our hospital.”

St. Peter’s challenge is 1 of 3 involving OMNIA; a group of 17 hospitals has sued to overturn the original approval by the NJ Department of Banking and Insurance, while a smaller group claims Horizon’s marketing of OMNIA as a high quality, low-cost plan has damaged their hospitals.

St. Peter's University Hospital of New Brunswick argued that it will suffer irreparable harm if Horizon's OMNIA plan takes effect in the new year and it is not included in the preferred hospital tier.

NJ Judge Won't Grant Hospital Injunction in Horizon Dispute

At the American College of Cardiology meeting in March this year, a major presentation on ticagrelor, a drug to treat acute coronary syndrome, found the drug reduced the likelihood of heart attacks but might produce “minor bleeding.”

The scientist who presented the findings downplayed the concerns, saying there was a big difference between “intracranial hemorrhage” and a nosebleed. Fast forward to November at the American Heart Association meeting, when a follow-up presentation found that one-third of the patients in the ticagrelor study stopped taking the drug—even though it “worked.”

Researchers suspect too many found that daily nosebleed insufferable.

“Often in trials we categorize events as nonserious, but they have importance for patients,” said Marc Bonaca, MD, of Brigham and Women’s Hospital. It’s the kind of thing researchers could have learned before they published the first set of results in the 

But while doctors tallied up “adverse events,” no one measured how patients felt about the nosebleeds. The network PatientsLikeMe hopes to put that patient voice in the equation.

For a decade now, the group has provided a platform for patients to connect with others who are dealing with the same disease, while assembling lots of valuable data that has been of great use to regulators, pharmaceutical manufacturers, and researchers.

Co-founder and President Ben Heywood, who created PatientsLikeMe after his brother Stephen was diagnosed with amyotrophic lateral sclerosis, or ALS, has seen many success stories, but the biggest one may be yet to come: creating validated measures that would ensure the patient’s voice plays a role in whether drug makers, physicians, and hospitals get paid.

The elements of PatientsLikeMe are coming together for the benefit of future patients, as the group makes use of a $900,000 grant from the Robert Wood Johnson Foundation. Part of the grant will allow PatientsLikeMe to spend the next year working with the National Quality Forum (NQF), the organization best known for establishing measures of health care quality, to create ways to measure how healthcare works through a patient’s eyes or experiences.

The idea of ensuring that patient input helps hold the healthcare system accountable, through the use of “patient-reported outcome measures,” or PROMs, has gained momentum in recent years, as CMS and commercial payers put more emphasis on value-based payment models. Creating a validated measure of patient-reported outcomes has huge implications, Heywood said in an interview with The American Journal of Managed Care.

“It puts patient input into the broader realm of patient-generated evidence, and that’s a really important thing; that really allows the patient voice to be added to scalable medical evidence,” unfiltered by interpretation by an investigator or some other third party.

This opens the door to doing more to rewarding doctors and hospitals that do the best job of getting people well—or keep them from becoming ill. It would seem logical to include measures that reflect a satisfied patient, one who feels informed, free of pain, and presented with choices that make sense.

PatientsLikeMe took a huge leap forward in shaping health outcomes research in 2013, when RWJF funded the Open Research Exchange (ORE). Through this initiative, PatientLikeMe’s 380,000 members help research to create, test and validate new measures.

In short, no longer do the “experts” write the questions and patients give their answers—the patients, who are the experts in receiving health care, help shape what the questions will be. That ORE platform will be foundation for the work with NQF. In deciding what measures to use for gauging patient-reported outcomes, the first step will involve asking patients what’s important to them.

From there, PatientsLikeMe will develop measures and test them, including in clinical settings. Heywood said PatientsLikeMe will work through NQF’s new Measure Incubator, an initiative that connects groups with those skilled at developing measures and helps them do so in a fraction of the time it would otherwise take.

The goal is produce useful measures of patient experience, which could deployed in the real world and tied to reimbursement, perhaps on a schedule to help CMS achieve its goal of linking 50% of payments to alternate payment models by 2018. Of course, it would be up to NQF to endorse any measure that might arise from the work done by PatientsLikeMe, which Heywood emphasized.

He’s full of enthusiasm as he talks about the success stories at PatientsLikeMe—like the multiple sclerosis patient who used shared data to get reimbursement for an off-label use of a therapy, or the way FDA is using data as an ancillary source of information on drug safety.  

What’s notable, Heywood said, is the way the science around patient-reported outcomes is growing. There’s a framework taking shape for gathering patient-reported data, creating measures, and testing them in both a virtual and a clinical setting.  

The goal is to get to the point that what matters to patients helps drive the development of healthcare products and services.

“We’re bringing patients into the equation,” Heywood said.      

The elements of PatientsLikeMe are coming together for the benefit of future patients.