Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

According to the Wall Street Journal's Health Blog:

In letters sent earlier this month to 10 companies, [Senator Chuck] Grassley says that he’s “received complaints” about systems that allow doctors to enter medical orders by computer. (Here’s a copy of the letter.) This is a big deal these days because the stimulus bill provides billions of dollars in federal incentives to encourage doctors and hospitals to start using these sorts of systems.

Grassley asks the companies to send him copies of “complaints and/or concerns” that health-care providers have expressed about the systems. He wants to know whether the companies typically include legal provisions in their contracts that “shift responsibility for errors in the … systems to physicians, nurses, pharmacists, and other health care providers.”

And he cites reports that contracts sometimes “include ‘gag orders,’ which prohibit health care providers from disclosing system flaws and software defects.” He asks the companies how many settlement agreements they’ve executed in the last 18 months.

So far, representatives of Cerner, McKesson and Allscripts indicated that they plan to cooperate with Sen. Grassley's request. 

You can find more information on Grassley's letters via the Washington Post, here.

You can see a copy of Grassley's letter to 3M here.

"Chuck Grassley Has a Few Questions for the Health IT Industry," Health Blog (October 26, 2009).

"Electronic medical records not seen as a cure-all," Washington Post (October 25, 2009).

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On July 20, 2009, Dr. Jay Holland and two hospital employees plead guilty to misdemeanor violations of the health information privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) based on their accessing records of a high-profile patient at the St. Vincent Infirmary Medical Center without any legitimate purpose. 

According to the FBI press release, the doctor has been sentenced to a $5,000 fine to be paid in 60 days, and 50 hours of community service educating professionals on HIPAA.  The two employees were sentenced to to one-year probation each, and a $2,500 fine for one and a $1,500 fine for another, both payable in installments.

The United States Attorney for the Eastern District of Arkansas stated that:

We hope that today’s sentencings send the message that the HIPAA protections apply to every person in the community, regardless of their position or stature. Likewise, the penalties for violating HIPAA apply equally to every person with access to protected health information.

"Doctor and Two Former Hospital Employees Sentenced for HIPAA Violations," FBI Press Release (October 26, 2009).

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In a remarkable 400-0 vote, the U.S. House of Representatives exempted dentists from the requirements of FTC's Red Flags Rule.  The measure garnered rare, unambiguously bi-partisan support in Congress:

It is obvious that physicians and dentists are not creditors, and they should not be forced to spend hundreds of dollars to comply with this needless regulation," said dentist/Rep. Mike Simpson (R-Idaho), one of the key sponsors of the bill. "They don't require full payment at the time of service because they first bill the insurance company, then they bill the patient the remainder of the bill. This system should not be treated the same as a loan with a financial institution," said Congressman Simpson.

Rep. John Adler (D-N.J.), the bill's chief sponsor, said the FTC "went too far. During these tough economic times, the federal government should not be placing burdensome regulations on small businesses."

"By passing this fix today, Congress can provide the FTC a clear definition of how Congress intended the policy to be enacted and protect small businesses and their customers from unnecessary government intervention," said Rep. Christopher Lee (R-N.Y.),  a cosponsor.

"In my opinion, the manner in which this legislation was crafted, with input from both sides of the aisle, with the FTC and with the various sectors that would be adversely affected if we had not acted, is the model for how this House can work to actually solve the problems facing our country," said Rep. Paul Broun (R-Ga.), a physician who cosponsored the measure. 

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By popular demand, here is the video of David Pogue's report on the Obama Administration's efforts to digitize patient records in the U.S. 

Watch CBS News Videos Online

"Charting a New Course," CBS News (September 13, 2009).

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David Pogue, a reporter for the New York Times, posted the transcript of his interview with Dr. David Blumenthal, National Coordinator for Health IT. Mr. Pogue interviewed Dr. Blumenthal for a CBS news report on digitization of healthcare in America (the video is available after the jump).

Here are some highlights from the interview:

On current state of health IT in the US:

We found that about 17 percent of physicians in 2008 had adopted an electronic health record, and about ten percent of hospitals. <...> The rest is paper. It's basically the same system that physicians have used since Hippocrates, which is writing on some piece of paper.

On reimbursement penalties for those failing to achieve meaningful use by 2015:

From 2011 to 2015, there is a bonus. The Congress has put $45 billion on the table to ease physicians and hospitals into this new world of computerized medicine.After 2015, if you have not adopted, and you see Medicare or Medicaid patients, you may experience a penalty. 2015 is six years off. Six years is plenty of time for physicians to get themselves organized to put a record in place and avoid those penalties.

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Major losses or breaches of personal information are not just for patients anymore:  The Chicago Tribune reports that the Blue Cross Blue Shield Association lost sensitive personal information, including, in some cases, social security numbers, of about 800,000 physicians -- nearly all the doctors in the United States.  As expected, this data loss came from a stolen laptop.  According to the Tribune:

The Chicago-based Blue Cross and Blue Shield Association, a trade group for the nation's Blue Cross health insurance plans, confirmed an employee "broke protocol and transferred to a personal laptop" information that was later stolen in late August.

No patient information was on the database, so concern by consumers having personal health records breached is unwarranted, the association said. And doctors have not reported security breaches.

About 16 to 20 percent of the doctors listed in the database have their Social Security numbers as their medical-care provider identification, putting these health professionals at risk for identity theft.

Despite receiving no reports of identity theft, Blue Cross Blue Shield Association is offering credit monitoring services to those providers whose Social Security numbers were exposed.

"Blue Cross warns doctors about stolen identification data," The Chicago Tribute (October 14, 2009).

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Dr. David Blumenthal, the National Coordinator for Health IT, gave an update on the Obama Administration's efforts to define "meaningful use" and to further adoption of EHRs nationwide.  Blumenthal did not reveal any new details regarding the upcoming regulations on meaningful use, reminding his audience of the upcoming "notice of proposed rulemaking in late 2009 with a public comment period in early 2010."

Meanwhile, according to Government HealthIT, the next meeting of the HIT Policy Committee, which will meet on October 27 and 28, will focus on how to map meaningful use objectives to medical specialties as well as small practices and hospitals.

Speaking at the 81st annual American Health Information Management Association convention in Grapevine, Texas, Dr. Blumenthal stated that he expects 50,000 health information management (HIM) jobs to be created as the U.S. moves from the paper-based to the digital system of healthcare.  AHIMA's CEO, Linda Kloss, noted that the interest in HIM careers has "exploded" during the last year.

Much more news after the jump.
  

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According to Modern Healthcare, several HIT vendors, including GE Healthcare, NextGen Healthcare Information Systems, and Athenahealth, will guarantee that their EHR products will meet or "evolve to meet" the federal requirements for "meaningful use," even though such requirements have not been promulgated yet by CMS.  In fact,

Athenahealth recently upped the ante by guaranteeing that, not only will the company's AthenaClinicals Internet-based electronic health-record service meet federal standards, but the doctors who use it will receive a bonus payment for the 2011 program year under the terms of the [HITECH Act].

The HITECH Act provides for a first-year incentive payment of $18,000 for those eligible professionals who achieve meaningful use of certified EHR technology in 2011 or 2012, instead of a first-year payment of $15,000 thereafter.

Some vendors hope that such guarantees will spur activity in the market, persuading some reluctant healthcare providers not to wait until CMS issues its final "meaningful use" regulations next year.  There is also some doubt whether such guarantees apply to each vendor's existing customers or solely to new customers.

However, whenever a healthcare organization enters into an EMR purchase or license agreement, it must obtain strong warranties from the vendor that its product(s) and system will meet the applicable federal requirement standards at time of issuance of such standards, as well as for duration of the applicable license.  "Meaningful use" requirements will likely change over the life of a license, and a vendor's obligation to meet such evolving standards is absolutely essential.  Healthcare providers must also include proper remedies and appropriate carve-outs from vendor's limitation of liability for a vendor's breach of such warranties.

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The New York Times reported last week that the North Shore-Long Island Jewish Health System (North Shore) will offer its 7,000 affiliated (though not employed by North Shore) physicians subsidies for implementing electronic health records.  Interestingly, this subsidy does not include or prevent such physicians from qualifying for the approximately $44,000 in Medicare incentive payments under ARRA. 

North Shore plans to subsidize 50% of the total cost of the EMR system (which uses Dell hardware and Allscripts software) for practices "who simply install electronic health records that can communicate between the doctor's office, labs and hospitals."  However, the health system will subsidize 85% of the total cost of the EMR -- a figure driven, no doubt, by the exceptions to the Stark and Anti-Kickback laws -- for physicians willing to share some of their patient data. 

North Shore is counting on the availability of shared data to reduce the cost of care through reduction of unnecessary tests and medical mistakes.  A recent PriceWaterhouseCoopers (PWC) survey may support North Shore's reasoning.  The survey found broad agreement among healthcare executives with respect to secondary uses of EMR patient data.  Among other findings (discussed after the jump), the PWC survey found that 42% of organizations already using some form of secondary data use achieved cost savings, 29% increased their revenue, and 59% saw improvements in quality of care.

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