By: Helen Oscislawski, Esq.

On April 26, 2011, the United States Supreme Court is scheduled to hear oral argument for IMS Health Inc. v. Sorrell, a landmark case that will decide whether states can place restrictions on mining and repurposing prescription data for secondary uses. See pg 9 of Court’s October 2010 Session case list.

The dispute stems from a Vermont law that banned the use, sale, or transmission of prescriber-identifiable data without first obtaining the prescriber’s consent. Several data mining companies sued the State of Vermont alleging that the statute impermissibly infringed upon their freedom of speech under the First Amendment.  The Second Circuit overturned the statute, holding that it was unconstitutional for Vermont to restrict speech by data miners and pharmaceutical companies without demonstrating a compelling state interest to do so.

However, Vermont is not the only state that has adopted laws restricting the release of physicians’ prescription information. Maine and New Hampshire both have similar laws, and both have been challenged in federal court by market researchers and drug manufacturers. Unlike with Vermont, however, the Court of Appeals for the First Circuit upheld the statutes in New Hampshire and Maine, ruling that the laws restricted market research companies’ conduct, specifically the aggregation of data for drug marketing purposes, rather than their speech.

A split in how the First Circuit and Second Circut Courts have decided these cases has prompted the Supreme Court to review the issues presented. If the Supreme Court follows the opinion of the Second Circuit, this may have profound implications for prescription privacy because without restrictions on data mining, database firms and pharmaceutical intelligence companies such as IMS Health, Inc. may increasingly collect, transmit, and sell prescription data for sales purposes. On the other hand, data mining companies have been collecting pharmaceutical sales and prescription data for years, and pharmaceutical drug companies maintain that the practice is an essential research tool to help educate doctors about prescription drugs in a targeted and expedited manner.

When the Supreme Court makes its decision, it will need to consider all the implications of the practice of data mining. In either case, the impact of the decision will be profound. Readers who are interested in reading the final opinion should expect that the Court’s final decision may not be released until early Fall 2011.

Helen Oscislawski is a principal at Attorneys at Oscislawski llc, a boutique healthcare law firm located in Princeton, New Jersey specializing in privacy, HIE, HIT, and other legal issues affecting the healthcare industry.

McKinsey Quarterly recently reported on the effect of competition on delivery of quality healthcare. Finding that a “judicious use of provider competition can produce desired results” in healthcare delivery, McKinsey authors Penelope Dash, MD and David Meredith nevertheless caution that some socialization (read: governmental oversight) of the system is necessary and constructive.

Sifting empirical evidence through economic theory, Dash and Meredith provide “a framework that health systems can employ to decide” the best use of competition to “drive access to high quality, efficient care.”

With a Republican Congress ascending to House rule in January and cleaving to its mantra that competition creates a “virtuous cycle of innovation, high quality, and efficiency,” the McKinsey report might prove if not clairvoyant in terms of healthcare reform, then at least instructive.

Sink your teeth into the report. (free registration may be required).

Amid the sweltering summer blizzard of last week’s MU finalization, the VCS BlogMasters lost sight of the earlier, July 7, announcement by CMS and ONC that “current health information privacy and security rules will now include broader individual rights and stronger protections when third parties handle individually identifiable health information.”

So, here’s the delayed scoop (if that’s even possible!):

These measures expand and strengthen privacy, security, and enforcement rules of HIPAA ’96.

“Giving more Americans the ability to access their health information wherever, whenever and in whatever form is a critical first step toward improving our health care system,” said David Blumenthal, M.D., M.P.P., HHS’ national coordinator for health information technology,

HHS Secretary Kathleen Sebelius added, “While health information technology will help America move its health care system forward, the privacy and security of personal health data is at the core of all our work.”

The full press release can be found here: http://www.hhs.gov/news/press/2010pres/07/20100708c.html

In a related matter, the National Institute of Standards and Technology has developed and sold a role-based-workflow (RBW) security application that restricts access to patient information based on a situational need. NIST sold the patent.

NIST’s press release can be found here: http://www.nist.gov/itl/csd/health_070610.cfm

Both developments bode well for VCS clients. Ensuring privacy while improving workflow has posed a challenging solution for most HIT vendors even as medical record privacy has been a salient concern for most patients.

Interested in what happens now with healthcare reform? All the fervor has died down and we’re on to the next top issue (Arizona anyone?), but when will we start see the effect... Well, on July 1^st of this year people who have been unable to get health insurance because of preexisting conditions will be able to purchase subsidized coverage via a national high risk pool. On September 23^rd insurers will be banned from dropping people if they develop an illness, the dependent coverage age will extend to 26, no child will be denied because of a preexisting condition, and there will be no annual or lifetime limits. For more details read this, but in 2014 the entire law should be phased in.

That’s a brief synopsis of what’s going to happen in the coming months as a directive straight from the Patient Care and Affordability Act, but what else is going to be indirectly affected? One thing I keep reading is about the number of physicians practicing medicine. It was hard enough to practice with CMS issues, malpractice concerns, and hospital struggles…will the new law make it better for physicians to practice medicine in this country? What about the HITECH push, how is that effecting doctors?

What do you think?

More Reading:

Glamour Answers Pressing Questions

An Employer's Guide to Healthcare Reform

I Have to Buy...or else.

That didn’t take long.

Legislation has been introduced to Congress that would repeal “Patient Protection and Affordable Care Act” sponsored by Rep. Michele Bachmann [R-MN6]. This is in addition to the 12 states suing over the reform bill and 18 states refusing to cover people now uninsured. Even CNN is posting an editorial mentioning that we shouldn’t drink the kool-aid.

How far do you think the repeal will get? When will “Main Street” (to borrow a term) start seeing the changes?

More Reading:

Voters support reform in CA

...so does Schwarzenegger.

Across the Pond: Healthcare & Politics in the UK

All of the economic talk that is so prevalent now and has been for the past two years has intersected with the healthcare reform debates in various ways, but one increasingly concerning event should be focused on. Hospitals are closing. The Wall Street Journal highlighted St. Vincent’s Hospital in NYC closing earlier this month. St. Vincent’s was the last Catholic acute-care center in New York City:

Patients and residents of the Greenwhich Village neighborhood said the closing…meant they would have to travel dozens of blocks on New York City’s congested streets to the nearest emergency room…Staff at other city hospitals, many already inundated with uninsured patients coming into their emergency rooms, were bracing for more people…Patient volume at Bellevue Hospital, a city trauma and acute care center, has jumped 13% in the past 30 days. (WSJ: Hospital Closing Stirs Fear)

The result of one hospital closing means increased ambulance ride times, increased demand for government funding for the remaining hospitals, increased hours for the staff.

What do you think it means for patient safety?

More Reading

NY Times: St. Vincent's

Google “Hospitals Closing”

EP Monthly

Not one Republican voted for it, neither did 34 Democrats. But, with 219 “Yea’s” the rest of the sitting Democrats in the House passed a revolutionary Healthcare Bill that President Obama signed into law on Tuesday.

The primary goal of this bill is to extend healthcare coverage to the 32 million Americans who are currently uninsured, but what’s next? We’ve been hearing about “healthcare reform” since July…wait since Clinton, Carter, Nixon, Johnson…Roosevelt** (Teddy) was in office! Well, according to Politico, Congress needs to sell their actions to Americans and that process is already in motion. In the coming weeks we should start seeing advertisements lauding the good that this bill will accomplish, and (as I’m sure you all know) spots that will decry the horrors soon to befall us.

So, now that it’s signed all Americans are insured, right?? Well, not yet. There were TWO bills that passed simultaneously in the House. HR 3590: the original Patient Protection and Affordable Care Act and HR 4872: the Reconciliation Act of 2010. The reconciliation bill swings back into Senate and they must pass a package that resolves the differences in the House and Senate bills. (In the Senate, Republicans have warned that they will use every means necessary to stall and block the passage of this bill, but their gusto is fading (read about it on The Hill).) Once it is passed in the Senate HR 4872 bill will go in front of the President, and there is little doubt he will sign it into law. As for the original and much lauded HR 3590, President Obama signed it into law stating, “After a century of striving, after a year of debate, after a historic vote, health-care reform is no longer an unmet promise. It is the law of the land.”

Let’s back up a moment… reconciliation—what? I thought BOTH Houses passed “healthcare reform” last year? They did, but here’s the deal.

HR 3590 generally referred to as “Healthcare Reform” was passed by the House on 10/08/09 and the Senate on 12/24/09, they passed two different versions of the same bill though. So, on 03/17/10 HR 4872 was introduced to reconcile the two healthcare bills and yesterday it was passed with the original sending the reconciliation back to the Senate for a final vote and the original to the President’s desk.

It’s still a bit convoluted to me, so if you have additional insights let me know. Please comment with your thoughts!

More Reading:

WSJ’s “Obama Signs Landmark Health Bill”

LexisNexis “How a Bill becomes a Law” (interactive)

PolitiFacts “Top 5 Lies about Healthcare”

Tracking HR 3590 & 4872

*Updated with further and corrected information.

**Not a comprehensive list of all of our Presidents who have called for healthcare reform.

We’ve mention on this blog before how much money could be saved if doctors didn’t have to practice defensive medicine and on the trials of medical malpractice. But, beyond cost saving and healthcare reform there is a human face associated with medical errors. The price of a mistake made by a doctor or nurse goes deeper than a million dollar settlement, not only for the patient and their family, but for the person who made the mistake as well. Today’s Wall Street Journal has an excellent article about adapting a hospital’s culture to not only prevent errors, but to treat clinicians fairly when something does go wrong.

Hospitals are taking what might seem like a surprising approach to confronting [medical errors]: Not only are they trying to improve safety and reduce malpractice           claims, they’re also coming up with procedures for handling-and even consoling-staffers who make inadvertent mistake…”We know punishing human error does not improve safety,” says St. Mary’s Dr. Byrne. “But we have to separate unavoidable error from reckless behavior and unjustifiable risk.”                                                     “The Informed Patient: New Focus on Averting Errors: Hospital Culture”

The article focuses on David Marx who founded a community, Just Culture, which promotes the development of “open, fair, and just cultures that are supportive of system safety by facilitating open communication within the organization, while working within a system of accountability that supports safe behavioral choices among staff.”

While the world is focusing on healthcare reform for a variety of reasons including providing healthcare to those who can’t afford it, we shouldn’t lose sight of the other encompassing problems in the system. When patient safety isn’t a priority it affects more than just the patient.

Will tonight’s State of the Union recharge the fight to reform healthcare?

“Congressional leaders are taking healthcare legislation off the fast track as rank-and-file Democrats, wary of unhappy midterm election voters, look to President Barack Obama for guidance in his State of the Union address.

House and Senate leaders said Tuesday they need time to determine the best way forward on healthcare in the wake of last week's special election loss in Massachusetts, which cost Democrats their filibuster-proof Senate majority”…read more on ModernHealthcare.com.

Will lawmakers come together to finally finish the job?