Tag: Health Law

Health Care Information Privacy and Security Forum

The National Law Review is pleased to inform you of American Conference Institute’s Health Care Information Privacy and Security Forum Conference on Monday, December 05 to Tuesday, December 06, 2011 at the Union League, Philadelphia, PA.

ACI

Our Nation is poised to harness the power of information technology to improve health care. Transforming our health care system into a 21st century model is a bold agenda… [I]t is more important than ever to ensure consumer trust in theprivacy and security of their health information and in the industry’s use of new technology.

Statement on Privacy and Security, Building Trust in
Health Information Exchange, July 8, 2010.
We Have Entered the Era of Health Information Technology and Face New and Daunting Challenges in Keeping Health Information Private and Secure. Assess Your Current HIPAA Compliance Program to Ensure Best HIT Practices as You Prepare for New Privacy and Security Responsibilities in the Age of HITECH.

Privacy and security of health care information are critical concerns for HIPAA covered entities and an ever expanding circle of business associates.  Knowing the basics of the HIPAA are no longer enough in the age of HITECH when mandates giving rise to the predominance of EHRs and HIEs are taking center stage in the privacy and security challenges with which privacy, information, and security officers, and their counsel must contend every day.  The modes and modalities for storing health care information are becoming more and more complex in the age of HIT — as are the safeguards for keeping this information from unauthorized disclosure.

Now is Not the Time for Regulatory Paralysis, but for Action.

Industry stakeholders are analyzing their obligations under the draft accounting and disclosure rule and awaiting the release of the final HIPAA privacy rule. However, they know that they cannot remain paralyzed with anticipation, but must act upon the information they have and that which they are already obligated to do. Now is the time to ensure that all systems are in compliance with existing law and regulation and flexible enough for reconciliation with new requirements.

Attend ACI’s Health Care Privacy and Security Forum and Get the Critical Information that You Need to Meet Your HIPAA
and HITECH Privacy and Security Challenges Head-On. 

ACI’s Health Care Privacy and Security Forum has been designed to help you navigate the legal and business complexities associated with HIPAA, HITECH (as well as state privacy and security laws and regulations) and the ever evolving legal and regulatory privacy and security landscape. Our faculty of privacy and security experts will walk you through legal and business challenges associated with the anticipated regulations; HIT infrastructure and EHRs; HIEs; business associates; breach; encryption; and enforcement.

Benefit from Special Training and Strategy Sessions that Will Address the Essentials of HIPAA and HITECH and Critical Privacy and Security Compliance Audit Competencies.

To enhance and complete your conference experience, we are pleased to offer the following training and strategy sessions:

•    HIPAA and HITECH Boot Camp: Intensive Training in Privacy and Security Essentials for Health Care Professionals which will provide you with the legal and regulatory backdrop for the more in-depth HIPAA and HITECH controversies discussed in the main conference. This is the perfect course for attendees who are new to health care privacy and security matters or for more experienced professionals who are in need of a refresher; and

•    The Working Group on Auditing, Updating and Perfecting Your Existing HIPAA / HITECH Privacy and Security Compliance Program which will help you implement best practices to ensure that your current health care privacy and security program is in-check with current law and regulations and prepare you for HITECH-mandated HHS compliance audits applicable to both HIPAA covered-entities and business associates.

As an added bonus, your conference registration includes
your choice of one of these sessions.

Reserve Your Place Now at this Critical HIPAA and HITECH Event.
Clearly, this is the health care privacy and security conference that every legal or business advisor to a HIPAA covered entity or business associate cannot afford to miss. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/HIPAA-HITECH.

Medicare Part B premiums for 2012 lower than projected

Recently posted in the National Law Review an article by U.S. Department of Human & Health Services regarding Medicare Part B premiums:

Health & Human Services

Affordable Care Act helps keep Medicare affordable 

The U.S. Department of Health and Human Services (HHS) announced that Medicare Part B premiums in 2012 will be lower than previously projected and the Part B deductible will decrease by $22. While the Medicare Trustees predicted monthly premiums would be $106.60, premiums will instead be $99.90. Earlier this year, HHS announced that average Medicare Advantage premiums would decrease by four percent and premiums paid for Medicare’s prescription drug plans would remain virtually unchanged.

Thanks to the Affordable Care Act, people with Medicare also receive free preventive services and a 50 percent discount on covered prescription drugs when they enter the prescription drug “donut hole.”  This year, 1.8 million people with Medicare have received cheaper prescription drugs, while nearly 20.5 million Medicare beneficiaries have received a free Annual Wellness Visit or other free preventive services like cancer screenings.

“The Affordable Care Act is helping to keep Medicare strong and affordable,” said HHS Secretary Kathleen Sebelius. “People with Medicare are seeing higher quality benefits, better health care choices, and lower costs. Health reform is also strengthening the Medicare Hospital Insurance Trust Fund and cracking down on Medicare fraud.”

Medicare Part B covers physicians’ services, outpatient hospital services, certain home health services, durable medical equipment, and other items. In 2012, the “standard” Medicare Part B premium will be $99.90. This is a $15.50 decrease over the standard 2011 premium of $115.40 paid by new enrollees and higher income Medicare beneficiaries and by Medicaid on behalf of low-income enrollees.

The majority of people with Medicare have paid $96.40 per month for Part B since 2008, due to a law that freezes Part B premiums in years where beneficiaries do not receive cost-of-living (COLA) increases in their Social Security checks. In 2012, these people with Medicare will pay the standard Part B premium of $99.90, amounting to a monthly change of $3.50 for most people with Medicare. This increase will be offset for almost all seniors and people with disabilities by the additional income they will receive thanks to the Social Security cost-of-living adjustment (COLA). For example, the average COLA for retired workers will be about $43 a month, which is substantially greater than the $3.50 premium increase for affected beneficiaries. Additionally, the Medicare Part B deductible will be $140, a decrease of $22 from 2011.

“Thanks in part to the Affordable Care Act, people with Medicare are going to have more money in their pockets next year,” said Centers for Medicare & Medicaid Services (CMS) Administrator Donald Berwick, M.D. “With new tools provided by the Affordable Care Act, we are improving how we pay providers, helping patients get the care they need, and spending our health care dollars more wisely.”

Today, CMS also announced modest increases in Medicare Part A monthly premiums as well as the deductible under Part A. Monthly premiums for Medicare Part A, which pays for inpatient hospitals, skilled nursing facilities, and some home health care, are paid by just the 1 percent of beneficiaries who do not otherwise qualify for Medicare. Medicare Part A monthly premiums will be $451 for 2012, an increase of $1 from 2011. The Part A deductible paid by beneficiaries when admitted as a hospital inpatient will be $1,156 in 2012, an increase of $24 from this year’s $1,132 deductible. These changes are well below increases in previous years and general inflation.

For more information on how seniors are getting more value out of Medicare, please visit:http://www.healthcare.gov/news/factsheets/2011/10/medicare10272011a.html

For more information about the Medicare premiums and deductibles for 2012, please visit:https://www.cms.gov/apps/media/fact_sheets.asp

© Copyright 2011 U.S. Department of Human & Health Services

Health Care Information Privacy and Security Forum

The National Law Review is pleased to inform you of American Conference Institute’s Health Care Information Privacy and Security Forum Conference on Monday, December 05 to Tuesday, December 06, 2011 at the Union League, Philadelphia, PA.

 

ACI

 

Our Nation is poised to harness the power of information technology to improve health care. Transforming our health care system into a 21st century model is a bold agenda… [I]t is more important than ever to ensure consumer trust in theprivacy and security of their health information and in the industry’s use of new technology.

Statement on Privacy and Security, Building Trust in
Health Information Exchange, July 8, 2010.

 

We Have Entered the Era of Health Information Technology and Face New and Daunting Challenges in Keeping Health Information Private and Secure. Assess Your Current HIPAA Compliance Program to Ensure Best HIT Practices as You Prepare for New Privacy and Security Responsibilities in the Age of HITECH.

Privacy and security of health care information are critical concerns for HIPAA covered entities and an ever expanding circle of business associates.  Knowing the basics of the HIPAA are no longer enough in the age of HITECH when mandates giving rise to the predominance of EHRs and HIEs are taking center stage in the privacy and security challenges with which privacy, information, and security officers, and their counsel must contend every day.  The modes and modalities for storing health care information are becoming more and more complex in the age of HIT — as are the safeguards for keeping this information from unauthorized disclosure.

Now is Not the Time for Regulatory Paralysis, but for Action.

Industry stakeholders are analyzing their obligations under the draft accounting and disclosure rule and awaiting the release of the final HIPAA privacy rule. However, they know that they cannot remain paralyzed with anticipation, but must act upon the information they have and that which they are already obligated to do. Now is the time to ensure that all systems are in compliance with existing law and regulation and flexible enough for reconciliation with new requirements.

Attend ACI’s Health Care Privacy and Security Forum and Get the Critical Information that You Need to Meet Your HIPAA
and HITECH Privacy and Security Challenges Head-On.

ACI’s Health Care Privacy and Security Forum has been designed to help you navigate the legal and business complexities associated with HIPAA, HITECH (as well as state privacy and security laws and regulations) and the ever evolving legal and regulatory privacy and security landscape. Our faculty of privacy and security experts will walk you through legal and business challenges associated with the anticipated regulations; HIT infrastructure and EHRs; HIEs; business associates; breach; encryption; and enforcement.

Benefit from Special Training and Strategy Sessions that Will Address the Essentials of HIPAA and HITECH and Critical Privacy and Security Compliance Audit Competencies.

To enhance and complete your conference experience, we are pleased to offer the following training and strategy sessions:

•    HIPAA and HITECH Boot Camp: Intensive Training in Privacy and Security Essentials for Health Care Professionals which will provide you with the legal and regulatory backdrop for the more in-depth HIPAA and HITECH controversies discussed in the main conference. This is the perfect course for attendees who are new to health care privacy and security matters or for more experienced professionals who are in need of a refresher; and

•    The Working Group on Auditing, Updating and Perfecting Your Existing HIPAA / HITECH Privacy and Security Compliance Program which will help you implement best practices to ensure that your current health care privacy and security program is in-check with current law and regulations and prepare you for HITECH-mandated HHS compliance audits applicable to both HIPAA covered-entities and business associates.

As an added bonus, your conference registration includes
your choice of one of these sessions.

Reserve Your Place Now at this Critical HIPAA and HITECH Event.
Clearly, this is the health care privacy and security conference that every legal or business advisor to a HIPAA covered entity or business associate cannot afford to miss. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/HIPAA-HITECH.

HHS Halts Implementation of the CLASS Program

Recently posted in the National Law Review an article written by Meghan C. O’Connor of von Briesen & Roper, S.C. regarding HSS’ announcement regarding CLASS Act:

The U.S. Department of Health and Human Services (HHS) announced plans today (October 14, 2011) to halt implementation of the Community Living Assistance Services and Supports (CLASS) Act. The CLASS Act is a voluntary, federally administered long-term care insurance program introduced in theAffordable Care Act (ACA). The program would have provided benefits to purchase long-term services and supports. Details regarding implementation and enrollment were to be announced by October 1, 2011.

Secretary Sebelius sent a letter to congressional leaders today noting no “viable path forward for CLASS implementation at this time.” The ACA conditioned implementation of the CLASS program on certification that the program would be actuarially sound and financially solvent for 75 years. However, HHS actuaries and the Congressional Budget Office could not find a way to meet these contingencies

Secretary Sebelius emphasized the continued need for affordable long-term care services and the lack of viable options in the current market.

©2011 von Briesen & Roper, s.c

ANALYSIS: 'ObamaCare' label is sticking

Posted on September 29, 2011 in the National Law Review an article by Wendell Potter  of Center for Public Integrity regarding backers of the president’s health plan are loosing the public relations battle:

Backers of the president’s health plan are losing the public relations battle

The Kaiser Family Foundation just released the findings of its annual survey of businesses to determine how much the cost of employer-sponsored health coverage has gone up. There were some unexpected findings.

Tea Party members protest President Obama’s health care mandate in Cincinnati. Tom Uhlman/AP

One was that the average cost of annual premiums for family coverage is now more than $15,000. The 9 percent increase in the cost of health insurance over last year caught many people by surprise, because it represented a bigger hike in premiums than in recent years.

What seems clear is that insurers decided last year to charge their customers considerably more than necessary this year to be able to meet Wall Street’s profit expectations; insurance companies are also concerned that such increases will be more difficult once health care reform is fully implemented in 2014.

Here’s another surprise. Kaiser found that 50 percent of small employers are aware that they are now eligible for a tax credit from the federal government—thanks to the Affordable Care Act—if they provide subsidized coverage to their employees. I can hardly believe the awareness of the tax credit is that high.

As I have traveled across the country in recent weeks, speaking to a wide range of audiences, one thing has become abundantly clear: the provisions of the Affordable Care Act already in effect are anything but abundantly clear to people.

That’s because opponents of health care reform have won the public relations battle in defining the Affordable Care Act.

While the most recent Kaiser survey did not seek the views of the general population nor ask employers what they think or know about the Affordable Care Act, other polls show that advocates of the new law have been losing ground in the battle for public support.

This week I have been speaking at Florida churches —  a Catholic church in Winter Park, outside Orlando, Monday night, and a Unitarian Universalist church in Clearwater Tuesday night.  The hosts wanted an overview of what’s in the new law and what’s not—to provide factual, unbiased information and also to dispel many of the myths that have gained traction, starting before the law was even enacted.

What the hosts told me—and what I learned from talking to people who attended the forums—is that the Obama Administration and the national groups that backed  the legislation have essentially been missing in action when it comes to explaining the benefits of the law.

Kaiser’s finding that 50 percent of small businesses were familiar with the tax credit would certainly come as a shock to Dr. Patrick Cannon, advocacy director for Florida CHAIN (Community Health Action Information Network). He has been traveling the state trying to reach small business owners and educate them about the tax credit.

He has found almost no one even knows about it. This undoubtedly helps explain why the number of small businesses offering coverage to their employees dropped significantly in the most recent Kaiser survey.

Cannon believes that one of the reasons is that reform advocates missed an important opportunity to brand the Affordable Care Act in positive terms—starting with the most basic term of all, the name of the law itself.

As Cannon pointed out, opponents of the law  use a single term to describe the law: ObamaCare. The term has so seeped its way into the vernacular that even some of the law’s advocates have started using that pejorative label. The groups that support the law, he notes, use a wide range of terms to describe it.

Cannon is embarking on an effort among supporters to be consistent in calling it the Affordable Care Act.

Because opponents have been able to define the law on their own terms (or term), advocates are finding it increasingly difficult to have civil conversations with people about it—including with independents.

Liz Buckley, executive director of Focus Orlando, told me that, “If you even try to have conversations with people about it, people think you’re just trying to reelect Obama. They just shut down the conversation.”

Why the administration has been so inept or disengaged is baffling. It’s true that people will be skeptical of information about the law that comes straight from the White House, but the folks behind the Obama campaign in 2008 seemed to know how to get third parties motivated and active on behalf of the candidate.

Where are those folks now? If the White House is serious about making sure the law goes forward—and making sure the Obama legacy is a positive one—they better get in gear and turn public awareness and attitudes around. Otherwise, pretty soon,it may be too late.

Reprinted by Permission © 2011, The Center for Public Integrity®. All Rights Reserved.

Specialty Healthcare 357 NLRB Decision No. 83: Impact on Nursing Home and Resident Care Industry

Posted on September 6, 2011 in the National Law Review an article by  Joshua W. Pollack of von Briesen & Roper, S.C. regarding a decision for those in the nursing home and resident care industry:

 

Recently, the National Labor Relations Board (NLRB) handed down an important decision for those in the nursing home and resident care industry: Specialty Healthcare, 357 NLRB No. 83. In this decision, the Board redefined the standard for “unit determination” cases for the “non-acute health care industry.” The Board’s conclusion reversed twenty years of precedent and made further unionization in the nursing home industry likely.

The Board’s decision makes unionization more likely because a key factor in the success of an organizing campaign is the size of the bargaining unit. Traditionally, unions fare better when organizing a smaller unit, whereas employers fare better when the union must organize a larger unit. Under the newly announced “traditional community of interest” standard, smaller units will be harder to challenge by employers, and thus are likely to proliferate. The Board summarized the new standard

[when a union] petition[s] for an election in a unit of employees who are readily identifiable as a group (based on job classifications, departments, functions, work locations, skills, or similar factors), and the Board finds that the employees in the group share a community of interest after considering the traditional criteria, the Board will find the petitioned-for unit to be an appropriate unit, despite a contention that employees in the unit could be placed in a larger unit which would also be appropriate or even more appropriate, unless the party so contending demonstrates that employees in the larger unit share an overwhelming community of interest with those in the petitioned-for unit.

Applying this standard, the Board held that a unit of Certified Nursing Assistants was the appropriate bargaining unit because the employer was unable to show that there was a larger group that had an “overwhelming community of interest” that overlapped the interest of the CNAs. In application, this rule will make it harder for employers to challenge prospective units and increase a union’s ability to organize smaller units.

Employers should be aware that Specialty Healthcare gives unions an advantage in their organizing efforts, and as a result employers should take proactive steps to prepare for a potential union campaign, especially those employers in the non-acute health care industry. At a minimum, supervisors should know the warning signs of unionization and how to respond. Supervisors should also be empowered with the information necessary to articulate the company’s position of a union-free workplace with credibility. Lastly, employers should also institute policies that guide employees regarding union solicitation, union access to facilities, and employee uniform policies.

©2011 von Briesen & Roper, s.c

ASHHRA 47th Annual Conference & Exposition Sept. 10-13, 2011, Phoenix, AZ

We are pleased to inform you the American Society for Healthcare Human Resources Administration’s 47th Conference & Exposition is taking place on September 10-13, 2011 in Phoenix, Arizona.

 

 

 

Why Should YOU Attend the ASHHRA Conference?  

Educational Programs

  • Enhance your health care business knowledge
  • Advance your leadership capabilities
  • Strengthen your role as a change agent
  • Gain knowledge of the hottest trends in health care HR
  • Network with your peers

Valuable Resources

  • A variety of take-away tools, best practices and policies
  • Networking opportunities with other HR practitioners nationally and regionally
  • Exposure to more than 150 suppliers helping to advance health care HR products and services

Hottest Products & Services

  • More than 150 exhibitors showcasing products that can help you solve problems within your organization
  • Networking and knowledge sharing on state-of-the-art services in health care HR

Smart Investment

  • Take-away tools and resources in health care HR
  • Focused learning on leadership and strategic business knowledge
  • Sessions designed around five leadership competencies
  • Partnership opportunities with top health care HR leaders

    18.5* Recertification Credit Hours

    Earn up to 18.5* Recertification Credit Hours, which includes 17.0 Strategic Business, and 1.5 California Specific Credit Hours.  Check out the “Schedule ” tab to see the learning sessions and secure your spot!

    *The 18.5 general recertification credits include the 6.0 hours of the Pre-conference Learning Tracks on Sept. 10, 2011 in addition to the 12.5 recertification credit hours for Full Conference attendance on Sept. 11-13, 2011. The 17.0 Strategic Business Credit Hours include 6.0 hours of the Pre-conference Learning Tracks on Sept. 10, 2011 in addition to the 11.0 strategic business credit hours for Full Conference attendance on Sept. 11-13, 2011.

    These recertification credit hours are pre-approved for PHR, SPHR and GPHR recertification through the HR Certification Institute. For more information about certification or recertification, please visit the HR Certification Institute website at www.hrci.org.

     Two NEW Learning Tracks at the

    ASHHRA 47th Annual Conference & Exposition

     

    NEW!
    Non-Hospital (NH)
    Learning Track

    NHThe Non-Hospital Track is a new learning track this year at the ASHHRA annual conference.  ASHHRA is seeking to fully understand the needs of HR practitioners who work in a non-hospital setting.  We realize that HR issues and concerns might differ from hospitals, and we want to become the primary source for information, tools, and resources to help members address the challenges faced in non-hospital facilities. 

    If you work at a non-hospital facility setting like:

    • Long-term Care facility
    • Acute Care facility
    • Clinic
    • Treatment center
    • Hospice center

    ASHHRA has created a special learning track that is designed to help address common issues that you may face in your organization.  The Non-Hospital sessions are offered during each learning session time and are indicated by “NH/NH.”

    NEW!
    Advisory Board Company Learning Track

    The Advisory BoardThis track is a continuation of an ongoing collaboration between the Advisory Board Company and ASHHRA, to educate heath care human resources (HR) executives and advance the health care HR field at-large. Two divisions of the Advisory Board Company are represented at the conference.  The HR Investment Center serves HR executives through best practice research and implementation support and has directly embedded a portion of their national member meeting into this year’s conference to help executives optimize their time and travel. The Talent Development division provides comprehensive leader development services and is presenting content from some of their most popular workshops.  This track will help to support the health care HR field with more substantive knowledge, expertise, and best practices for health care organizations.

    For more information about the HR Investment Center, Talent Development partnerships, or any other Advisory Board Company offering, please visitwww.advisory.com or contact Jordan English at englishj@advisory.com

    Click below for the learning sessions
    in this new track.

Wisconsin Supreme Court Delivers Win for Hospital Systems with Offsite Facilities

Posted on August 10, 2011 in the National Law Review an article by Craig J. Johnson, Kate L. Bechen, David J. Hanson and Robert L. Gordon   of Michael Best & Friedrich LLP regarding  a major victory for hospital systems with offsite outpatient facilities in Wisconsin.

Last month the Wisconsin Supreme Court provided a major victory for hospital systems with offsite outpatient facilities. Its decision in Covenant Health Care, Inc. v. City of Wauwatosa (2011 WI 80) reversed a Court of Appeals decision and held that an outpatient clinic owned by St. Joseph Hospital (the “Clinic”) constituted property used for the purposes of a hospital under Wis. Stat. § 70.11(4m)(a). As a result, Covenant Healthcare System, Inc., the sole member of St. Joseph Hospital and the owner of the real property on which the Clinic stands, was entitled to a refund of real property taxes paid on the Clinic’s property.

Background

Wisconsin. Stat. § 70.11(4m)(a) excludes from taxation real property used exclusively for the purposes of any nonprofit hospital. The statute specifies that the exemption does not extend to property that is used for commercial purposes or as a doctor’s office, or the earnings from which inure to the benefit of a member.

The Clinic is a five-story building located approximately five miles from St. Joseph Hospital.  Two of the Clinic’s floors are leased to medical providers as office space. The remaining three floors are used to provide outpatient services and include an Urgent Care Center that is open 24 hours a day, seven days a week and is capable of treating all levels of emergency room care, which generally limits its treatment of serious cases to the extent of stabilizing a patient for transport to a different medical facility.

The City of Wauwatosa took the position that the Clinic was in fact a doctor’s office and, therefore, assessed real property taxes on the Clinic. Covenant challenged this assessment as it applied to the Clinic’s three floors that were not used as office space for medical providers.  The Circuit Court ruled in favor of Covenant but the Court of Appeals reversed, holding that the Clinic was a doctor’s office. The Wisconsin Supreme Court reversed the Court of Appeals, ruling in favor of Covenant.

Ruling

The City of Wauwatosa maintained its position that the Clinic was a doctor’s office. The City also took the alternative positions that the Clinic was used for commercial purposes and that the property’s earnings inure to the benefit of Covenant. The Wisconsin Supreme Court held that Covenant had satisfied its burden of proving that each of the City’s assertions was incorrect.

Doctor’s Office

The Wisconsin Supreme Court considered seven factors that were previously laid out by the Wisconsin Court of Appeals in 1997 in St. Clare Hospital v. City of Monroe, which also considered whether a health care facility constituted a doctor’s office. The Supreme Court concluded that five of those factors weighed against the Clinic being considered a doctor’s office, and the remaining two were not determinative.

The five factors which persuaded the Supreme Court that the Clinic was not a doctor’s office were: (1) physicians practicing at the Clinic do not receive variable compensation related to the extent of their services; (2) Clinic physicians do not receive extra compensation for overseeing non-physician staff; (3) the Clinic’s bills are generated on the same software system as those of St. Joseph Hospital; (4) Clinic physicians do not have their own offices at the Clinic but instead have access to communal cubicle space; and (5) Clinic physicians do not own or lease the building or any equipment at the Clinic.

The two remaining St. Clare factors that weighed in favor of the Clinic being a doctor’s office were (1) the Clinic does not provide inpatient services and (2) most patients are seen at the Clinic by appointment and during regular business hours. However, the Court pointed out that advances in technology have allowed for more procedures to be performed on an outpatient basis than when St. Clare was decided. In addition, St. Joseph Hospital (as well as several other large area hospitals) has an outpatient clinic on its hospital grounds.  This hospital-based outpatient center has never jeopardized the tax exemption of St. Joseph Hospital despite only seeing patients by appointment during regular business hours. Therefore, the Court did not weigh either of these factors as significant in reaching its conclusion that the Clinic is not a doctor’s office.

Commercial Purposes

The Court interpreted the statutory prohibition against commercial purposes as being a prohibition against a facility having profit as its primary aim. In determining that the Clinic did not have profit as its primary aim, the Court cited the Clinic’s business plan as listing several goals beyond increasing profit margin, including promoting a greater faith-based health care presence. Further, the Court found that the Clinic serves a greater portion of Medicare and Medicaid patients than other Milwaukee and Wisconsin hospitals, indicating to the Court a focus other than profit.

Private Inurement

Finally, the Court determined that the language of the statutory prohibition against private inurement to any member does not contemplate a not-for-profit member of a nonprofit corporation. According to the Court, interpreting the statute to penalize Covenant’s corporate structure would be an unreasonable construction, and would end up requiring a nonprofit corporation to distribute its assets upon dissolution to unrelated nonprofit entities, rather than its actual member(s), in order to qualify for property tax exemption.

Conclusion

The earlier Court of Appeals decision in this case called into question the property tax exemptions of nonprofit hospital systems with offsite facilities. The reversal by the Wisconsin Supreme Court has provided some reassurance to Wisconsin’s hospital systems. Although the decision was based on facts unique to the Clinic and did not set bright line standards going forward, the Court confirmed that offsite hospital facilities can qualify as exempt under Wis. Stat. § 70.11(4m)(a), and provided guidance on what types of facts and organizational structures will be considered to qualify an offsite facility for exemption.

© MICHAEL BEST & FRIEDRICH LLP

Proposed HIPAA Reporting Requirement May Lead to Increased Compliance Costs and Enforcement Action

Recently posted in the National Law Review an article by Nancy C. Brower and Elizabeth H. Johnson of  Poyner Spruill LLP about HHS’ notice of proposed rulemaking (NPRM) that would allow individuals to obtain an “access report” from HIPAA .  

 

 

On May 31, 2011, the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) that would allow individuals to obtain an “access report” from HIPAA covered entities reporting virtually every instance of access to their electronic protected health information (ePHI), including all access by individual employees. The proposed access report must reflect the full name of every person or entity that accessed an individual’s ePHI (if maintained in a designated record set) in the prior three years.

An express purpose of this proposal is to allow individuals to identify situations in which a member of a covered entity’s workforce inappropriately accessed their ePHI. Individuals can then file a complaint with the OCR claiming improper employee access to ePHI.

In a recent case, the OCR entered into a $865,000 settlement with the University of California at Los Angeles Health Systems (UCLAHS) after investigating celebrity complaints of potential inappropriate ePHI access by UCLAHS employees. The investigation led to OCR allegations that UCLAHS employees repeatedly accessed ePHI of many patients, including several celebrity patients, when they did not have any job-related need to access the data, and that UCLAHS failed to implement security controls to reduce the risk of impermissible access, failed to provide Security Rule training, and failed to apply appropriate sanctions against workforce members who violated UCLAHS policies and procedures.

In the NPRM, OCR stated that it believes the degree of access logging required in the new access report is currently being captured and stored by covered entities’ electronic information systems because OCR interprets HIPAA’s audit controls standard (45 C.F.R. § 164.312(b)) and information system activity review implementation specification (45 C.F.R. § 164.308(a)(1)(ii)(D)) to require that all such access be logged, including “view” or “read only” access. However, this interpretation of the Security Rule is much broader than many had believed, and the NPRM has already fallen under criticism as a result. If the new rule is implemented as proposed, many covered entities will incur significant unexpected costs related to systems modifications, data storage (access logs must be retained for three years), training, privacy notice revision and redistribution and response to individual requests.

Business associates will have to undertake a similar degree of implementation to provide covered entities with access logs relevant to the access report, and covered entities will need to consider updating their business associate agreements to reflect this requirement. Individual privacy complaints filed with covered entities and OCR may well increase if this new rule is adopted, either because covered entities will fail to completely or timely provide the access report, or because individuals reviewing their access report will find real or (more likely) perceived cases of inappropriate access to their records.
© 2011 Poyner Spruill LLP. All rights reserved.

Myriad Federal Circuit Decision Affirms Patentability of Claims to “Isolated” DNA but Methods Involving Only “Comparing” or “Analyzing” DNA Sequences Unpatentable and No Declaratory Judgment for Those Who Simply Disagree With Patent

Posted on Thursday, August 4, 2011 in the National Law Review an article by Thomas J. Kowalski and Deborah L. Lu of Vedder Price P.C.  about  long-awaited decision in the Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”).

On July 29, 2011, the Federal Circuit issued its long-awaited decision in the Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”).  The plaintiffs in Myriad are an assortment of medical organizations, researchers, genetic counselors, and patients who challenged Myriad’s patents under the Declaratory Judgment Act. The Federal Circuit Decision held that those parties who simply disagree with the existence of a patent or who suffer an attenuated, non proximate effect from the existence of a patent, do not meet the requirement for a legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment and, thus, do not have standing to be a plaintiff. The Court could not see how “the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.” However, with at least one plaintiff having standing, the Federal Circuit turned to the merits; namely, whether claims to “isolated” DNA and methods using that “isolated” DNA are eligible to be patented under Section 101 of the Patent Statute (35 U.S.C. § 101).

The Federal Circuit held that method claims directed to only “comparing” or “analyzing” DNA sequences are patent ineligible under Section 101 because they have no transformative steps and cover only patent-ineligible abstract, mental steps. However, the claim that recites a method that comprises the steps of (1) “growing” host cells transformed with an altered gene in the presence or absence of a potential therapeutic, (2) “determining” the growth rate of the host cells with or without the potential therapeutic and (3) “comparing” the growth rate of the host cells includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates and is eligible for patent protection. The steps of “growing” transformed cells in the presence or absence of a potential therapeutic, and “determining” the cells’ growth rates, are transformative and necessarily involve physical manipulation of the cells.

The Federal Circuit also held that isolated cDNA—DNA that has had introns removed, contains only coding nucleotides, and can be used to express a protein in a cell that does not normally produce it—while inspired by nature, does not occur in nature, and is likewise eligible to be patented under Section 101.

Most significantly, the Myriad Majority and Concurring Opinions concluded that isolated DNA molecules are patent-eligible under 35 U.S.C. § 101, and the Court reversed the previous holding by Judge Sweet of the Southern District of New York. Both the Myriad Majority and Concurring Opinions rely on U.S. Supreme Court precedent, and the Myriad Concurring Opinion states that claims to isolated DNA had previously been held to be valid and infringed by the Federal Circuit.

The distinction between a product of nature and a human made invention for purposes of Section 101 turns on a change in the claimed composition’s identity compared with what exists in nature. According to the Federal Circuit in Myriad, the US Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.

In reaching the conclusion that isolated DNA molecules are eligible to be patented under Section 101, the Myriad Majority Opinion focused on the fact that isolated DNA was cleaved or synthesized to consist of a fraction of a naturally occurring DNA molecule and therefore does not exist in nature. The Court stressed that isolated DNA is not the same as purified DNA. Isolated DNA is not only removed from nature, but it is chemically manipulated from what is in nature—in the human body in this case. Accordingly, isolated DNA is a distinct chemical entity from that which is in nature. The Myriad Concurring Opinion views isolated DNA as truncations that are not naturally produced without the intervention of man and can serve as primers or probes in diagnostics; a utility that cannot be served by naturally occurring DNA.

The Myriad Majority and Concurring Opinions reject the Solicitor General’s “child-like simpl[e]” suggestion that for determining patent-eligible subject matter the Court use a “magic microscope” test, under which, if one can observe the claimed substance in nature, for example, by zooming in the optical field of view to see just a sequence of fifteen nucleotides within the chromosome, then the claimed subject matter falls into the “laws of nature” exception and is unpatentable subject matter—including because an isolated DNA molecule has different chemical bonds as compared to the “unisolated” sequence in the chromosome (because the ends are different). Simply, according to the Myriad Majority and Concurring Opinions, isolated DNA is a different molecule from DNA in the chromosome.

The Myriad Majority and Concurring Opinions also give great deference to the grant by the United States Patent & Trademark Office (“USPTO”) of numerous patents to isolated DNA over approximately the past thirty years, as well as that in 2001 the USPTO issued Utility Examination Guidelines, which reaffirmed the agency’s position that isolated DNA molecules are patent-eligible, and that Congress has not indicated that the USPTO’s position is inconsistent with Section 101. The Federal Circuit thus held that if the law is to be changed, and DNA inventions are to be excluded from the broad scope of Section 101, contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.

In contrast, the Myriad Dissenting Opinion sought to hold isolated DNA as unpatentable and compared isolated DNA with a leaf snapped from a tree. TheMyriad Majority Opinion addresses the Dissent’s analogy by making clear that a leaf snapped from a tree is a physical separation that does not create a new chemical entity, whereas isolated DNA is a new chemical entity as compared with DNA in nature.

Myriad provides the biotechnology community with an immediate sigh of relief. However, it is expected that parties to Myriad will likely ask the Federal Circuit to review its divided Decision en banc and that whatever the result from that request, appeal to the US Supreme Court will also be inevitable. We expect there is more to come and that the July 29, 2011 Myriad Federal Circuit Decision may be only one step toward an ultimate Court decision finally concluding that isolated DNA is indeed patent-eligible subject matter.

© 2011 Vedder Price P.C.