By: Helen Oscislawski, Esq.

Under the current Meaningful Use Rule, substance abuse, behavioral and mental health treatment professionals and facilities are not eligible, standing alone, to receive incentive payments for incorporating meaningful use (MU) of EHR technology into their practices and facilities. As a result, a community behavioral health organization (CBHO) would not be eligible for incentive payments even though it is providing the same or additional services that a hospital (eligible for MU facility incentive payments) might provide.  Likewise, while a psychiatrist, primary care physician or nurse practitioner affiliated with a CBHO could potentially receive incentive payments as "eligible professionals," the facility itself along with other health care providers, such as psychologists and clinical social workers providing services there, would not.

Although the availability of funding may have played a large part of this omission, the exclusion of substance abuse and behavioral and mental health from the EHR Incentive Programs is unfortunate, particularly because the populations served by these types of providers and facilities are in greatest need for the improved efficiency, quality, coordination and integration of health care that EHR technology facilitates.

Last week, however, legislation was introduced into the Senate with the aim of rectifying this oversight. The Behavioral Health Information Technology Act of 2011 ("BHITA"), S. 539, was sponsored by Senator Sheldon Whitehouse and seeks to expand eligibility for Meaningful Use participation to substance abuse and behavioral and mental health providers and facilities. Previous efforts to amend HITECH have unfortunately failed when as a similar bill, the Health Information Technology Extension for Behavioral Health Services Act, H.R. 5040, died in the House last year.  However, the introduction of BHITA shows that policy makers continue to recognize the need to include these vital providers and facilities as part of Meaningful Use.

In sum, BHITA would:

• Extend Medicare and Medicaid eligible professional incentive payments to clinical psychologists and social workers
• Extend Medicare incentive payment eligibility to community mental health centers, private and public psychiatric hospitals, residential/outpatient mental health and substance abuse treatment facilities
• Clarify eligibility for community health centers, psychiatric hospitals, substance abuse and behavioral and mental health professionals, residential/outpatient mental health/substance abuse treatment facilities as Health Information Technology Regional Extension Centers

By: Helen Oscislawski, Esq.

On March 7, CVS Caremark (CVS) hit the HIPAA spotlight again, and not in a good way.  Back in 2009, CVS was the target of a joint U.S. Department of Health and Human Services (HHS) Offices for Civil Rights (OCR) and Federal Trade Commission (FTC) investigation after media reports alleged that certain CVS locations were disposing of pill bottles containing patient information in unsecured dumpsters.  Although CVS denied the allegations, CVS shelled out a $2.25 million settlement as well as took corrective action to settle both potential HIPAA and FTC violations.  As a result, CVS is being actively monitored by HHS until 2012 and by the FTC for the next 20 years.  Then this past October, CVS was sued by six Texas pharmacies for trade secret misappropriation and Racketeer and Influenced and Corrupt Organizations Act (RICO) violations as a result of certain CVS data-mining practices. The plaintiffs, who are board members of the American Pharmacies, alleged that CVS denied patients choice of pharmacies and smothered business competition as well as used patient PHI in violation of HIPAA.

Bloomberg News recently reported that CVS has been sued by a Pennsylvania resident, Arthur Steinberg, and the Philadelphia Federation of Teachers Health and Welfare Fund, for selling patient prescription information to pharmaceutical manufacturers such as Merck & Co, AstraZeneca, and Bayer.  Allegedly, CVS accepted remuneration from pharmaceutical manufacturers in exchange for use of protected health information to encourage physicians to prescribe their drugs to patients. "CVS encouraged physicians to do so through letters which included patient names, dates of birth, and what medications patients were currently prescribed, allegedly obtained from CVS pharmacy services." The lawsuit accuses CVS of unfair trade practices, unjust enrichment, and violating consumer protection laws.

HIPAA as amended by HITECH generally prohibits any Covered Entity or their Business Associate from marketing and selling PHI without first obtaining patient authorization.  Only under very limited circumstances may patient information be "sold" or released without authorization for such purposes.  Investigation by OCR is even more likely given that CVS has been under OCR's watchful eye since 2009.  In addition, CVS's actions could also potentially violate its 2009 settlement agreement with OCR, placing it in even more hot water.

By Helen Oscislawski, Esq.

HHS and OCR held nothing back as the first civil money penalty was assessed under the new categories and increased penalty amounts created by HITECH.  The $4.3 million penalty was imposed against Cignet Health in Prince George County, Maryland, for violating HIPAA patient access rights.  Cignet had denied access to the medical records of 41 patients upon their request between September 2008 and October 2009 and each patient had filed complaints individually with OCR. HIPAA requires Covered Entities to provide patients with copies of their medical records on request within 30 days and in no case later than 60 days from the date of the request. HITECH created new categories of violations, ranging from "did not know" to "willful neglect" to comply with HIPAA, and established a corresponding tiered monetary penalty system.

Had this been the end of the story, Cignet would have walked away with only a $1.3 million penalty for violating HIPAA.  However, not only did Cignet fail to comply with HIPAA patient access rights, but it refused to produce the records when OCR demanded it do so.  Even after OCR presented Cignet with a subpoena, it continued to not produce the records.  Only after OCR filed a petition to enforce the subpoena and subsequently obtained a default judgment in United States District Court against Cignet did Cignet finally turn over the records.  Cignet also made no efforts throughout the entire investigation to cooperate or resolve the complaints informally.  OCR found Cignet's failure to cooperate a willful neglect of the HIPAA Privacy Rule, which requires all Covered Entities to cooperate with investigations by OCR, and an extra $3 million was imposed against Cignet.

The penalties imposed against Cignet dispel any doubt that may have remained concerning HHS' ramped up enforcement of HIPAA.  OCR Director Georgina Verdugo stated, "The U.S. Department of Health and Human Services will continue to investigate and take action against those organizations that knowingly disregard their obligations under these rules." With a hefty $4.3 million penalty as HHS' "first shot", Covered Entities will certainly take notice and action to avoid coming under fire themselves.

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.

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.

The recently published PriceWaterhouseCoopers Health Research Institute report, Ready or Not: On the Road to the meaningful use of EHRs and health IT, has circulated through the blogmasters desk, and in our continuing effort to keep you informed, we’ve produced the following abstract…

After surveying 120 CIO’s and another handful of healthcare executives, the PwC report adds heft to the impact of the ARRA’s Meaningful Use (MU).

The report makes many keen assertions including:

• “Health systems will need to transform the way they deliver care, so they can sustain performance and grow revenue in the future.”
• Successfully achieving meaningful use “hinges on closer integration with key constituents” (physicians, health insurers, patients).
• Health systems that already have connected with physicians, patients, and health insurers around MU are “more likely to be applying for government incentives” than those that haven’t. But only half of respondents expected to apply for incentives in 2011. (By 2014, 90% expect to be applying).
• Health systems that have included patients in the planning are “more confident about meeting MU standards.”
• “Implementing MU can enhance hospital-physician alignment.”
• Most health systems are failing to connect with health insurers around MU.
• 80% of CIO’s are more than concerned about meeting MU requirements by deadlines. (An American Hospital Association survey reports that 55% of hospitals expect to incur penalties.)
• “The benefits of achieving MU outweigh the challenges.” Those benefits include improve healthcare quality, disease management, coordination of care, improved alignment with physicians, increased productivity, market advantage, and improved alignment with payers.

But PwC identified four barriers to attaining MU: Lack of MU standards clarity, shortage of skilled IT staff, vendor readiness, limited capacity of existing infrastructure . . .

and proffered five benchmarks to achieve compliance: Establish governance, balance compliance against competing priorities, forge new public-private ventures, make the patient the purpose, collaborate with physicians and health insurers.

This isn’t anything new, but David Blumenthal recently said: “Certification is a critical piece to providing meaningful use for hospitals and physician practices to be eligible for Medicare and Medicaid incentives under ARRA.”

The new final rule for the temporary certification (you know this is all very technical) should be posted on June 24^th conveniently coinciding with the day that organizations can apply to become an Authorized Testing and Certification Body (ATCB). The ONC’s goal is to have the first EHRs certified by the fall therefore, the certifying entities must be operational by the fall…are you still with me? You can read more details on HealthData Management. In summary:

• ONC is not going to move back “year one” to 2012
• One organization can do both the lab testing and certification or two organizations can partner (and apply for ATCB) in that scenario one would test, the other certify
• ATCB’s must update the list of tested/certified products weekly. The list will be available via the ONC’s website
• Potential ATCB’s applications will be decided on within 30 days
• Of the projected five applicants CCHIT has confirmed that they will apply to be an ATCB

More Reading:

Newly Certified EHRs Expected this Fall

Federal Register

Kick in the Pants?

The winners of Premier Health Alliance’s quality award for excellence in patient care and operational efficiency were announced today and VCS would like to congratulate all 21 winners, but most especially our current and former clients including:

• Albert Einstein Medical Center of Philadelphia
• Beebe Medical Center of Lewes,  Del.
• Bon Secours Maryview Medical Center of Portsmouth, Va.
• Mercy Fitzgerald Hospital of Darby, Pa.
• Paoli Hospital, Main Line Health System of Paoli, Pa.
• SSM St. Mary's Health Center of St. Louis

Congratulations!

VCS representatives are headed to the Lone Star state for this year’s International MUSE Conference in Dallas. We’ll be in booth 719 all week handing out cowboy hats and taking pictures with one of America’s favorite country music stars (sorry…we could only get the cardboard version).

Look out for some wild pictures on our Facebook page soon!

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