Clinical Laboratory Improvement Amendments

 By Patricia A. Trites; PhD, MPA, CHBC, CMP™ (Hon)

The Clinical Laboratory Improvement Amendment (CLIA) was passed in 1988 and pertains to any healthcare provider or entity that performs any laboratory test.   

A Series of Acts 

This legislation is actually a series of acts that established quality standards for laboratory testing in order to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.   

Certification Types 

Providers must register with the Centers for Medicare and Medicaid Services (CMS) by filling out an application and paying the required fees. These fees vary upon the type or complexity of certificate requested. After completing all of the requirements, the provider will receive a CLIA Certificate.   

The four types of CLIA certificates are:  

1. Waived Complexity
2. Provider Performed Microscopy [sub-group of moderate complexity]
3. Moderate Complexity
4. High Complexity 

Revised Regulations 

In 1997 CMS enacted a new regulation that requires providers to include their CLIA number on all claim forms (ex: HCFA/CMS 1500) that contain requests for payment for clinical laboratory services.  

This is to insure that: (1) the provider has a current CLIA certificate and, (2) that the provider is performing only the laboratory tests that are allowed for the particular level of certificate. There are specific regulations and documentation requirements for the different levels of service.

Compliance Issues 

A recent study in 2001 found that a large percentage of clinical laboratories were not in compliance.  It has been recommended that increased inspection, both announced and unannounced, be instituted to better insure the quality of laboratory services.  

The CLIA requirements can be found at: http://www.cms.gov/clia. 

Assessment 

What has been your experience with CLIA?

Conclusion

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Good Health Policy or Competitive Anachronism?

By Staff Writers

Modern Healthcare just reported on a new study by an Alabama policy research group that questions whether the state needs to have a certificate of need process in place to limit the growth of healthcare facilities in the state. 

The API Study 

The study, by the Alabama Policy Institute [API], argued that the state’s CON regulations should be repealed. Its author, Roy Cordato, contended that if the state removes its CON restrictions, doctors, clinics and hospitals would be able to respond to competitive marketplace needs more quickly, which would actually improve the efficiency of healthcare delivery there. 

Methodology

To conduct the study, researchers looked at the experience of other states with CON programs.

Assessment

It found that 13 states have recently repealed CON regulations. Removing CON requirements has given consumers improved access to care in those states. Meanwhile, there’s almost no evidence that Alabama’s existing CON process has helped to reduce healthcare costs. 

Conclusion

And so, are CONs needed for competitive modernity, or are they relics of the misguided political past? 

Related info: www.HealthCareFinancials.com 

More info: The US Healthcare Certificate of Need Sourcebook

www.beardbooks.com/beardbooks/the_us_healthcare_certificate_of_need_sourcebook.html

www.HealthcareFinancials.com 

Filed under: Health Law & Policy | Tagged: Health Law & Policy | 2 Comments »

Further Implications of the U.S. Patriot Act for Hospitals

By Dr. David E. Marcinko; MBA, CMP™

By Hope R. Hetico; RN, MHA, CMP™

With the recent popularity and growth of health savings accounts (HSAs) and / or medical savings accounts (MSAs), compliance with the USA Patriot Act of 2002 has become an important issue for these new, hybrid health insurance products.

Many of these insurance plans place patients and insurers into relationships with shared information institutions like hospitals, healthcare organizations, medical clinics and patient clients.

The “Online” Connection

This occurs because many, perhaps even the majority of HSAs, MSAs and high deductible healthcare plans [HD-HCPs] are opened online, as patients and insurance company clients use Internet search engines to find the “best” policy type to meet their needs. 

Ditto, for more traditional health insurance plans, as well? 

Example: 

For example, on October 1, 2003, Section 326 (Customer Identification Program) of the US Patriot Act went fully into effect, requiring the implementation of reasonable procedures to verify the identity of new customers and certain existing customers opening a new MSA or HSA account. 

And, Section 3261 of the Act also requires banks, savings associations, insurance companies, hospital and medical union credit unions, and certain non-federally regulated banks to have the CIP fully implemented. Broker-Dealers [BDs] in securities are subject to similar, but slightly different rules.   

Bank Secrecy Act [BSA] 

For additional compliance, The USA Patriot Act also amended the Bank Secrecy Act (BSA) to give the federal government enhanced authority to identify, deter and punish money laundering and terrorist financing activities.

Increased Hospital Vigilance

This, the passage of the USA Patriot Act – and these important derivatives – means that affected hospitals and healthcare organizations must be more vigilant about laws concerning money laundering; reporting of disease and quarantine; and cyber attacks.

Moreover, it means that healthcare organizations must adhere to the Act, regarding affected health insurance policies, by meeting its Customer Identification Program (CIP) and anti-money laundering requirements.  

Assessment

Whatever the financial outlays required for compliance – there be very large savings later if affected hospital assets and patient health insurance information is safeguarded against attacks of virtual or real assets. 

Conclusion

And so, what is your opinion on the above health law and policy? 

Related source:Marc B. Royo and David B. Nash. “Sarbanes-Oxley and Not-for-Profit Hospitals: Current Issues and Future.”

Speaker: If you need a moderator or a speaker for an upcoming event, Dr. David Edward Marcinko; MBA is available for speaking engagements. Contact him at: MarcinkoAdvisors@msn.com

Filed under: Health Law & Policy | Tagged: Health Law & Policy | 7 Comments »

New DOL Regulatory Guidelines Seem Paradoxical

Staff writers 

New regulatory guidelines from the Department of Labor [DOL] may curtail the ability of employers to motivate workers and employees to kick unhealthy habits.  

According to a report in the Wall Street Journal, the guidelines close a legal loophole that could have allowed employers to make health insurance more expensive for unhealthy workers than for their colleagues. 

High Deductible – HCPs 

Some employers have incorporated a form of supplemental insurance into their wellness programs under which workers enroll in an employer sponsored high-deductible health care plan [HD-HCP] and can offset the deductible by earning “wellness credits” for meeting certain health benchmarks – such as weight control or cholesterol levels – issued under a separate supplemental policy.  

Legal Opinions and Risk Management Concerns

But lawyers, benefits managers and risk management consultants have voiced concerns that such programs could hurt employees with health problems, as unhealthy employees could face insurance deductibles more than $1,000 higher than healthier co-workers. 

Conclusion 

And so, is this fair or not – and – does it promote the public good?

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Denies GA Hospital Peer-Review Case

Staff Writers

According to Gregg Blesch of Modern Healthcare, the US Supreme Court just declined to review a case that hospitals hoped would clarify whether federal courts must defer to state laws protecting the confidentiality of peer review. 

The 11th U.S. Circuit Court of Appeals ruled in June that peer-review records should be fair game for a urologist attempting to prove he was the target of racial discrimination at 186-bed Houston Medical Center [HMC] in Warner Robins, GA.

HMC appealed to the Supreme Court. No federal law provides a privilege for hospital peer-review, yet all states have laws that protect the confidentiality hospitals say they need in order to foster the participation and candor crucial to identifying and addressing mistakes. 

And so, have you ever been on a hospital peer-review panel, and what are your thoughts on this case regarding privilege and confidentiality?

Related information: http://www.jbpub.com/catalog/9780763733421

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Applicability to Hospitals and Medical Organizations

By Gregory O. Ginn; PhD, CPA, MBA, CMP™ (Hon)

By Hope Rachel Hetico; RN, MHA, CMP™

After the September 11, 2001 terrorist attacks against the United States, the US Congress passed Public Law 107-56 whose short title is “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT Act) Act of 2001.”

At first blush, the Act seems to have very little to do with hospitals, healthcare organizations or the medical industrial complex; however, upon closer inspection, several sections appear to be relevant to the industry. 

The Prevention and Detection of Money Laundering 

Title III of the USA PATRIOT Act is entitled the “International Money Laundering Abatement and Anti-Terrorist Financing Act of 2001.” The purposes of the Act are “to prevent, detect, and prosecute money laundering and the financing of terrorism.” Healthcare responsibilities in a money laundering program may include:

· Developing internal policies, procedures, and controls;

· Designation a chief compliance officer;

· Ongoing employee training programs; and

· Executing an independent audit program to test compliance 

Preparedness for Biological and Chemical Attacks 

Title X of the USA PATRIOT Act contains several calls for strengthening the public health system. Section 1013(a)(4) calls for “enhanced resources for public health officials to respond to potential bioterrorism attacks.”

Hospitals can take several steps to mitigate even in the absence of significant funding: 

· First, hospitals can establish links with ‘first responders’ such as local law enforcement, fire departments, state and local government, other hospitals, emergency medical services, and local public health departments.

· Second, hospitals can establish training programs to educate hospital staff on how to deal with chemical and biological threats.

· Third, hospitals can make changes in their information technology to facilitate disease surveillance that might give warning that an attack has occurred. Information technology may be useful in identifying the occurrence syndromes such as headache or fevers that might not be noticed individually but in the aggregate would signal that a biological or chemical agent had been released.

· Fourth, hospitals may be able to acquire access to staff and equipment to respond to biological and chemical attack through resource sharing arrangements in lieu of outright purchases. 

Protection of Critical Infrastructures 

Title X of the USA PATRIOT Act also contains section 1016, entitled “The Critical Infrastructures Protection Act of 2001.” It acknowledges that the defense of the United States is based upon the functioning of many networks and that these networks must be defended against attacks of both a physical and virtual nature.

Section 1016 also specifies that actions necessary to carry out policies designed to protect the infrastructure will be based upon public and private partnerships between the government and corporate and non-governmental agencies. 

Toward this end, the Act establishes a National Infrastructure Simulation and Analysis Center (NISAC) to support counter-terrorism, threat assessment, and risk mitigation. NISAC will acquire data from governments and the private sector to model, simulate, and analyze critical infrastructures including cyber, telecommunications, and physical infrastructures.

Health Insurance Implications 

With the recent popularity and growth of High Deductible Health Care Plans [HDHCPs], compliance with the USA PATRIOT Act has becomes an important issue for these new, hybrid health insurance products that place financial services organizations into relationships with shared information institutions like hospitals, healthcare organizations, medical clinics and patient clients.

This happens because many HDHCPs are opened by mail or online, as patients use the internet to search for policies. Appropriately, banks, healthcare entities and hospitals are working with insurance companies, trust companies and broker-dealers to offer identity-compliant and integrated HDHCPs. Verifications that these clients are who they say they are, is as paramount as monitoring their activity?

Healthcare organizations may meet these requirements by implementing a Customer Identification Program [CIP] and/or Anti-Money laundering requirements. Section 314(b) of the Act permits financial institutions, upon providing notice to the United States Department of the Treasury, to share information with one another in order to identify and report to the federal government activities that may involve money laundering or terrorist activity. 

Assessment 

Almost five years after passage of the USA PATRIOT Act, little is known about how it is being used to track terrorists, healthcare organization activity, or innocent Americans.

Unfortunately, the Muslim doctor terrorist incident of July, 2007 in North Staffordshire Hospital near Glasgow, implicated eight medical-workers of a clandestine Al-Qaeda sleeper cell in an attempted attack in Great Britain.  

Although successfully thwarted, the fact that all were tied to the British National Healthcare System [NHS] indicates the international nature of such threats and growing domestic reliance on foreign-trained physicians which must be carefully screened. 

Conclusion

The USA PATRIOT Act provides little indication in its title to affect the management of hospitals. Nevertheless, it is intended to safeguard the nation and its economy.

Since the healthcare industry is such a large part of the economy, it follows that legislation designed to protect our nation and economy will invariably have an effect on hospitals. 

And so, has your hospital or healthcare organization analyzed its activities to comply, prevent and/or mitigate losses and very possibly improve its financial performance by adhering to the US PARIOT Act?

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Leapfrog Hospital Quality and Safety Survey

Staff Writers

According to a September 2007 report, just over half of responding hospitals have adopted the new Leapfrog Group Never-Events Policy, which is a list of actions to take whenever a “never-event” – a rare medical error – occurs. By agreeing to this policy, hospitals pledge to:

• Apologize to the patient and/or family affected by the never-event.
• Report the event to at least one of the following agencies: The Joint Commission, a state reporting program for medical errors, a Patient Safety Organization.
• Perform a root cause analysis, consistent with instructions from the chosen reporting agency.
• Waive all costs directly related to the serious reportable adverse event.

The Leapfrog Group follows the National Quality Forum’s (NQF) definition of “never-events”; which includes errors such as surgery performed on the wrong body part or on the wrong patient, leaving a foreign object inside a patient after surgery, and discharging an infant to the wrong person, etc. 

Is this policy reasonable or unreasonable, in your estimation?

Filed under: Health Law & Policy | Tagged: Health Law & Policy | 18 Comments »

Legal Re-Tooling in the Era of Healthcare Reform

[By Staff Writers]

As a tax, estate planning or bankruptcy lawyer, you already know that almost every legal magazine around has articles or advertisements proposing that you become a financial planning professional or business consultant to your physician clients. 

Moreover, lawyers of all stripes are being pushed toward interdisciplinary alliances by encroachment on their turf by the Big Four accounting firms. With audits of publicly held companies now a commodity, the giant accounting firms are getting more of their revenues from consulting, and that puts them into direct competition with attorneys, MBAs, actuaries and other management and financial service professionals. 

Of all careers, you know how absolutely onerous it is to practice medicine today, and are finally thankful that you did not take that career route many years ago. So, like your neighbor the accountant, you begin to explore that potential of developing a service line extension to your legal practice, in order to assist your medical colleagues who have been hit on hard economic times.  

2010 Estate Tax Reform Letter

The Epiphany 

In fact, you soon realize that more than 90,000 trust, probate and estate planning attorneys like yourself are interested in pursuing financial planning in the next decade. And, you reckon, advising physicians has got to be easier than law, or less stressful than the corporate lifestyle of your MBA trained brother-in-law, right? 

So, you set out to stretch your legal horizons and explore the basic legal nuances of those topics not available in law school when you were a student. Things like medical fraud and abuse standards; managed care compliance audits and Medicare recoupments, CPT® codes, OSHA, EMTALA, HIPAA, capitation and EPA standards; anti-trust issues; and managed care contract dilemmas or de-selection appeals; etc. 

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The New World 

What a brave new world the legal profession has become! Even the American Bar Association’s commission on multi-disciplinary practice has recommended that lawyers be permitted to share fees and become partners with financial planners, money managers and other similar professionals. 

As a real life example, the venerated Baltimore brokerage firm of Legg Mason teamed up with the Boston law firm of Bingham Danna, LLC, to create one of the first marriages between a law and securities firm. 

Assessment 

If you want in on the challenge and bucks, you’d better acquire at least a working knowledge of healthcare administration, or perhaps help craft some new case law, or assist your doctor-clients in some fashion; otherwise, you will remain a legal document producer.

Conclusion

Your thoughts and comments on this ME-P are appreciated. Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, subscribe to the ME-P. It is fast, free and secure.

Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko; MBA – Publisher-in-Chief of the Medical Executive-Post – is available for seminar or speaking engagements. Contact: MarcinkoAdvisors@msn.com

OUR OTHER PRINT BOOKS AND RELATED INFORMATION SOURCES:

• PRACTICES: www.BusinessofMedicalPractice.com
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• ADVISORS: www.CertifiedMedicalPlanner.org
• FINANCE: Financial Planning for Physicians and Advisors
• INSURANCE: Risk Management and Insurance Strategies for Physicians and Advisors
• Dictionary of Health Economics and Finance
• Dictionary of Health Information Technology and Security
• Dictionary of Health Insurance and Managed Care

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Filed under: Health Law & Policy | Tagged: Health Law & Policy | 1 Comment »