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January, 2006
Volume 2,  Issue 1

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Welcome To BDB                                   Health & Medicine Reporter

By Priya Bathija

This issue of BDB Health & Medicine Reporter addresses a range of legal topics affecting the healthcare industry.  First, BDB is pleased to announce the appointment of Christopher S. Humphrey, a Shareholder in the firm’s Canton office, to Chairman of the Health & Medicine practice group.  Next, Thomas Himmelspach's article discusses state caps on medical malpractice awards.  In "Ohio's Change in the Medical Records Copy Law," Susan Rank examines the maximum fees that a doctor can charge for providing medical records.  Finally, Thomas Hess addresses the Top 10 healthcare issues of 2006 and the checklist for your annual business review.

The subject of this issue’s attorney profile is Joseph Feltes, a Shareholder in our Canton office.  Joe's practice focuses on both the corporate practice of health law and litigation.  Our “Update” article discusses the HIPAA Privacy Rule, nuclear medicine, new CMS requirements, the OIG Draft Compliance Program and the OIG joint venture.

 

We hope that these items will help you stay current with legal developments.  If you have questions, please call any member of our Health and Medicine Practice Group.

___________________________

 

Priya Bathija is an Associate attorney and member of the Health & Medicine Practice Group.  She can be contacted at pbathija@bdblaw.com or 614.227.4282.

 


Buckingham, Doolittle & Burroughs, LLP is pleased to announce the appointment of Christopher Humphrey, a Shareholder resident in the firm’s Canton office, to Chairman of the Health & Medicine practice group.  Mr. Humphrey assumed the role of Chairman on December 1, 2005. 

 

President and CEO Nick George said, “We are fortunate to have Chris’ leadership.  He has excellent legal skills, a strong focus on the welfare of his clients and dedication to the legal profession.” 

 

Click to view the Press Release.

 


By:  Thomas Himmelspach

 

On August 18, 2005, the Sixth Circuit Court of Appeals ruled that state law damage caps on medical negligence actions do not violate the Seventh Amendment or the Equal Protection Clause. In Andrea Smith v. Botsford General Hospital,[1] the court considered whether Michigan’s cap on non-economic damages in medical negligence cases applied to plaintiff’s wrongful death claim.

In Smith, plaintiff alleged that a hospital violated the Emergency Medical Treatment and Active Labor Act (“EMTALA”) by failing to stabilize decedent, Kelly Smith, before transferring him to a different hospital for treatment of a compound fracture of the femur in an auto accident. The hospital, Botsford General, defended the claim, arguing that it transferred Kelly Smith because it was unequipped to handle a patient of his size, over 600 pounds. Botsford contended it had stabilized Smith before the transfer, but that he died during the 21-minute trip to the second hospital due to complications from his weight and cocaine intoxication.

The jury returned a verdict for plaintiff and awarded $35,000 in compensatory damages and $5 million in non-economic damages, and the district court entered judgment on the verdict. Botsford appealed, arguing that the damages should be reduced in accordance with a Michigan law cap on medical malpractice damages. Under Mich. Comp. Laws Sec. 600.1483, non-economic damages in medical negligence cases are capped at $359,000.

Plaintiff argued first that EMTALA does not incorporate state law damage caps under any circumstances. The court rejected that argument, citing the language of EMTALA that the Act authorizes any individual who suffers harm from a violation of the Act to “obtain those damages available for personal injury under the law of the State in which the hospital is located….”[2]  The court concluded that based on the statute, State law could control EMTALA damages, and announced that it joined “the majority of courts addressing the issue in finding that EMTALA’s incorporation of state law extends to caps on damages.”

The court examined whether the Michigan law applied to the EMTALA claim, i.e., whether a failure-to-stabilize claim is a medical malpractice claim under Michigan law. It cited the decision in Bryant v. Oakpointe Villa Nursing Ctr.,[3] where the court defined a medical malpractice case as one involving resolution of two questions: (1) whether the claim pertains to an action that occurred within the course of a professional relationship; and (2) whether the claim raises questions of medical judgment beyond the realm of common knowledge and experience. The court concluded it had no difficulty finding that the EMTALA failure-to-stabilize claim constitutes a malpractice action under Michigan law, under the Bryant test.  Accordingly, it capped the damages at $359,000.

Finally, plaintiff argued that the cap was unconstitutional in violation of the Seventh Amendment and the Equal Protection Clause. Following the decision in Boyd v. Bulala,[4] the court rejected the challenge under the Seventh Amendment. It noted that the jury’s role as fact finder is “to determine the extent of a plaintiff’s injuries,” and not “to determine the legal consequences of its factual findings.” Accordingly, the court concluded that the Michigan law damage cap did not violate any protected jury rights and did not offend the Seventh Amendment.

It also rejected the challenge under the Equal Protection Clause, reasoning that a limitation on common law damages “does not violate a fundamental right or create a suspect classification,” but, rather, is “a classic example of an economic regulation” which is “subject only to a limited rational basis review.” The test, therefore, was whether the Michigan law rationally furthered a legitimate governmental interest. The court cited Zdrojewski v. Murphy,[5] that:

“The purpose of the damage limitation was to control increased health care costs by reducing the liability of medical care providers, thereby reducing malpractice insurance premiums, a large component of health care costs. Controlling health care costs is a legitimate governmental purpose. By limiting at least one component of health care costs, the noneconomic damage limitation is rationally related to its intended purpose.”

The Sixth Circuit concluded that the Michigan damage cap was rationally related to a legitimate governmental interest and, therefore, did not violate plaintiff’s rights under the equal protection clause.


[1] Smith v. Botsford General Hospital, 419 F.3d 513 (6th Cir. 2005).

[2] 42 U.S.C. 1395dd(d)(2)(A). (Emphasis added.)

[3] Bryant v. Oakpointe Villa Nursing Ctr., 684 N.W.2d 864 (Mich. 2004).

[4] Boyd v. Bulala, 877 F.2d 1191 (4th Cir. 1989).

[5] Zdrojewski v. Murphy, 657 N.W.2d 721, 739 (Mich. App. 2002).

 

______________________________

 

Thomas Himmelspach is a Partner of the Health & Medicine Practice Group.  He can be contacted at thimmelspach@bdblaw.com or 330.491.5284. 

 

 

 

 

By:  Susan Rank

 

Ohio law sets forth maximum fees that doctors can charge for providing medical records.  The previous law, which was in effect since March 22, 2001, was changed by the 125th General Assembly, made effective on December 21, 2004.  Substitute House Bill 331 changed the old medical copy law, extending the law governing fees for copies of medical records. The new law changed the fees that health care providers and medical records companies may charge for copies and changed who may receive one free copy of the patient’s medical record.  The following provides highlights of the new law.

If the patient or patient’s representative requests the patient’s medical records, the following fees apply:

            Search Fee                                                                   No charge

            Paper Records                                                             $2.50 for the first 10 pages

                                                                                                $0.51 for pages 11 – 50

                                                                                                $0.20 for pages 51 +

            Postage Fee                                                                 Actual postage, if mailed

            Non-paper Records                                                     $1.70 per page

If anyone other than the patient or patient’s representative requests the records, the following fees apply:

            Search Fee                                                                   $15.35

            Paper Records                                                             $1.02 for the first 10 pages

                                                                                                $0.51 for pages 11 – 50

                                                                                                $0.20 for pages 51 +

            Postage Fee                                                                 Actual postage, if mailed

            Non-paper Records                                                     $1.70 per page

Additionally, one free copy of the patient’s medical record must be provided, upon request, to the following:  Ohio Bureau of Workers’ Compensation, Ohio Industrial Commission, Ohio Department of Job and Family Services, Ohio Attorney General’s Office, and to the patient or patient’s representative for Social Security Disability Claims, pursuant to Ohio Revised Code 3701.741(C).

Finally, the law allows for adjustment of the fees, based on the average percentage of increase or decrease in the consumer price index for all urban consumers (United States city average), prepared by the U.S. Department of Labor on a yearly basis.

If you would like a free copy of the law, go to www.legislature.state.oh.us and enter Bill Number 331.

______________________________

 

Susan Rank is an Associate of the Employment & Workers' Compensation and Health & Medicine Practice Groups.  She can be contacted at srank@bdblaw.com or 330.491.5247. 

 

 

 

By Thomas Hess

When Congress created the Medicare program in 1965, it said the law “shall not be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided....”[1]  As we know, Congress has not followed its original pronouncement.  The healthcare industry is one of America’s most regulated industries, and creates budget issues at both the federal and state levels.  Regulations governing provider conduct are promulgated weekly, which make it difficult for the provider to address patient needs and deliver appropriate, necessary, and reasonable care. 

A panel of healthcare experts was asked recently what will be the top 10 issues in 2006.  According to the panel, the top 10 issues will be:

1.                  “Fraud and Abuse” because controlling healthcare costs is the government’s number one concern.

2.                  Medicare and all of the new programs created by the Medicare Prescription Drug Improvement and Modernization Act of 2003.

3.                  Health information technology and the necessity to ensure privacy and security.

4.                  Legislative oversight in regulatory enforcement involving both exempt and full-profit healthcare organizations.

5.                  Medicaid because of its impact on state budgets.

6.                  “Quality of care” as interpreted by the provider, the payor and the recipient – all of who have different interpretations.

7.                  An increase in provider regulation and oversight to ensure compliance with standards associated with the delivery of healthcare services.

8.                  FTC enforcement of anti-trust laws focusing on physician organizations, hospital mergers and other consolidations.

9.                  An increased focus on healthcare plan regulation and what impact the Part D program and changes to Part C, Medicare Advantage, will have upon Medicare beneficiaries.

10.              The impact natural disasters and bioterrorism will have upon public health.

As you can see, healthcare providers face another year of challenges.  As a provider, you should expect more oversight and more accountability.  Hopefully, the challenges will not make it more difficult to deliver appropriate, necessary, and reasonable healthcare services.


 


[1] See 42 U.S.C. § 1395. 

 

 

 

By Thomas Hess

Now that 2005 has ended, it is important to start the new year with a review of both the accomplishments of the past year and the tasks to be performed during 2006.  Planning for 2006 will involve considering more than just corporate, financial and tax issues. 

The following checklist offers items you should consider when planning for the upcoming year.  Specifically, consider whether an item should be updated, amended, or modified to meet the present and future needs of your company or organization. 

v     Business advisors

List your accountant, insurance representative, business manager, bank or banker, and legal counsel.  Does your company work well with each of these business advisors?  Do the business advisors timely respond to your questions and other matters?  Do you have the correct contact information for each business advisor listed?

v     Corporate record concerns

Determine whether the corporate record or minute book is up-to-date.  Must any actions be taken to bring the record or minute book up-to-date?  Have all major company actions been recorded in the record or minute book?  Are all documents in the record or minute book signed by the appropriate parties?  Are there any matters that have not yet been completed?

v     Employee matters

What is the date of last review for the Employee Handbook?  Does the Employee Handbook need to be revised to include new policies? 

Is the company in compliance with federal, state, county and city governmental law regarding payroll and withholding tax (including workers’ compensation and unemployment compensation)?  Is the company in compliance with minimum wage laws? 

Do any employees need a new or modified employment agreement?  Are there any negotiations or plans for negotiation of any employment agreements? 

Review bonus and incentive arrangements for the upcoming year.  Review employee benefit plans for the upcoming year.  Do the benefits plans meet the needs of your employees? 

v     Loss of key employees

What effect would the death, disability, retirement or resignation of a key employee have on company operations?  What provisions or plans are in place to maintain operations if the company loses one or more key employees?

v     Litigation

Are there any lawsuits pending against the company?  If so, what is the status of the litigation?  Is there any litigation initiated or to be initiated by the company?  If so, what is the timetable and who needs to be involved?

v     Audits

Are there any audits, financial or governmental, planned for the upcoming year?  If so, when will the audits take place?  Who needs to be involved?

v     Intellectual property

Are any trademarks, service marks, patents, fictitious names or trade name registrations required?

v     Business agreements

List all contracts and agreements currently executed.  Which contracts and agreements will expire in the upcoming year?  Which contracts and agreements will automatically renew?  Does the company wish to terminate, renew or modify any contracts or agreements?  Does the company have any leases that need to be reviewed? 

v     Record retention and disposition

Does your company or organization have a policy concerning record retention and disposition?  If so, does the policy need to be updated? 

After reviewing these items, prioritize the matters that the company needs to address, and contact the appropriate business advisor for any necessary assistance.  Because this list is not complete, always consult with the company’s business advisors to ensure successful business operations in the upcoming year. 

This article was adapted from a Business Review Checklist developed by Thomas W. Hess, Esq., Buckingham Columbus. 

______________________________

 

Thomas Hess is a Shareholder of the Health & Medicine Practice Group.  He can be contacted at thess@bdblaw.com or 614.227.4260

 

 

 

Buckingham CantonSM

330.491.5225

jfeltes@bdblaw.com

 

Joe Feltes is a member of the Health & Medicine Group, has been practicing health law for nearly 29 years, representing a wide variety of clients, including hospitals, physicians, managed care organizations, durable medical goods suppliers, and allied practitioners. He is a Shareholder resident in the firm’s Canton office.

Joe’s practice focuses on both the corporate practice of health law and litigation. He advises clients in regulatory compliance, contracting, and Medical Staff issues.  He also defends health care providers in civil litigation, as well as in governmental investigations and enforcement actions. 

“This is a practice area that is constantly evolving and reinventing itself in response to changes in the dynamic field of health,” Joe explains.  “When I first began practicing, much of my attention had been on Certificate of Need.  Now, I spend my time wrestling with Stark II and the anti-kickback provisions of the Social Security Act.

“One positive note is the attention paid to quality in healthcare.  Many of the laws are aimed at improving quality of care, assuring access, and ensuring proper reimbursement. The challenge is to understand the parameters of these laws and advise clients how to operate successfully within them.  

Prior to graduating from Georgetown University Law Center, Joe taught dramatic literature and writing at the University of Pittsburgh, which he claims was a natural transition to practicing law. “Being an effective attorney requires good communication skills—written and verbal.  It also is important to stress the importance of communication to clients.  I believe that many lawsuits result when communication breaks down.  Good communication often deters litigation. For me, the same skills that are required to explain Chaucer to a class of students can be used to explain a legal concept at a medical staff meeting, or to a jury.”

Joe recently published an article on Ohio’s “I’m Sorry” law. This law allows physicians to say to a patient or family, “I’m sorry for your loss,” when an untoward clinical outcome occurs – without the statement’s being used as an admission against interest. “It is my belief,” Joe says, “that many malpractice lawsuits arise, not so much out of greed as out of anger, when the patient or family believes that the provider does not care. The “I’m Sorry” law allows physicians to express condolences in an appropriate way.”

Joe feels that his healthcare practice is distinctive because he advises and litigates. “A lot of really good healthcare lawyers focus just on the corporate side of the law. I also have a background in litigation. Consequently, I always begin my analysis with the courtroom in mind. I ask myself two questions: ’How do we avoid the court room?’ and if we wind up there, ‘How would this play in front of a jury?’” 

In his spare time, Joe enjoys the company of his two sons. He is a passionate adventure traveler. Recent trips have taken him to base camp of Mount Everest in Tibet, to the summit of Mount Kilimanjaro in Tanzania, and to Machu Picchu in Peru where he trekked the Inca Trail.  Joe’s next trip will be a sea kayaking adventure in Antarctica.

 

 

 

HIPAA Three Year Notice Obligation Quickly Approaching 

When the HIPAA Privacy Rule went into effect, each covered health plan was required to distribute its privacy practices notice to each of its enrollees by its Privacy Rule compliance date (April 14, 2003 for most health plans; April 14, 2004 for small health plans).  The notice requirement, however, did not end there.  Thereafter, each health plan was required to give notice to each new enrollee at enrollment, and send a reminder to every enrollee at least once every three years that the notice is available upon request.[1] 

Well, believe it or not, it has been three years since the HIPAA Privacy Rule went into effect and it is now time for most covered health plans to notify all individuals presently covered by the plan of the availability of its notice of privacy practices, and the method of obtaining such notice.  Most health plans must provide this notice by April 14, 2006.  (Small health care plans will have until April 14, 2007). 

If you have any questions or concerns regarding this requirement, contact Shila Nalawadi.


 


[1] 45 C.F.R. §§ 164.520(c)(1)(i)(B-C); 164.520(c)(1)(ii).

 

____________________________________

 

CMS Adds Nuclear Medicine to Stark List of Designated Health Services

Beginning January 2007, CMS will add nuclear medicine services and supplies to the list of designated health services subject to Stark.[1] CMS added nuclear medicine services to the designated health list as part of an attempt to curb the dramatic increase in the number of medical scans ordered by physicians at imaging centers that they have a financial interest in outside of their main practice. 

 

The addition of nuclear medicine to Stark means physicians and hospitals that bought nuclear cameras and set up imaging centers together will no longer be able to refer federally insured patients there unless they sell their share in the centers, or the arrangement fits under a Stark exception.  CMS originally proposed prohibiting nuclear medicine referrals in 2006, but moved back the date to 2007 in order for providers to restructure existing arrangements to fit under a Stark exception. 

 

If you have questions or concerns regarding this change or need help restructuring an existing nuclear services arrangement, please contact Don Antrim or Joe Feltes.  


 


[1] See:  CMS 2006 Physician Fee Schedule released November 2, 2005. 

 

____________________________________

 

New CMS Requirements Lay out Roles and Responsibilities for Medical Directors

Providers really cannot win when it comes to hiring a medical director.  On one hand, the OIG is scrutinizing payments to medical directors to ensure they are not kickbacks for referrals.  On the other hand, CMS Transmittal 15, published November 28, 2005, now requires facilities to hire medical directors. 

In addition to requiring facilities to hire medical directors, the Transmittal lays out in detail the roles and responsibilities CMS expects medical directors to fulfill.  It also requires compliance officers to document medical director activities.  Providers must act quickly though, because this Transmittal went into effect on November 25, 2005.  For a copy of Transmittal 15, visit http://www.amda.com/federalaffairs/ftag/Final%20Version%20F501.pdf.

 

 

OFFICE OF INSPECTOR

GENERAL UPDATES

 

OIG Draft Compliance Program Guidance for Federal Grant Awardees

On November 28, 2006, the Office of the Inspector General (“OIG”) posted a draft of its Compliance Program Guidance for Recipients of PHS Research Awards on its website, giving researchers a heads-up on what they should do to catch fraud and abuse.  Although the guidance was written specifically for federally funded researchers, it highlights major risk areas and should be read by all providers who do research, who receive grants, or whose patients participate in studies. 

The guidance is similar to other compliance guidance published by OIG, but it goes one step further.  In addition to the seven standard elements of compliance,[1] OIG adds an eighth element requiring researchers to clearly define roles and responsibilities and to assign oversight duties to specific individuals.

This eighth element places higher accountability on all employees, and makes all employees responsible for compliance, not just the compliance officer.  Providers can easily designate compliance responsibility by doing the following:  (1) including a paragraph in each person’s job description that requires them to comply with all the rules; (2) following up with each employee during annual reviews to ensure they upheld their compliance responsibilities; and (3) establishing a chain of command in which each supervisor certifies that the billing and reporting statements of the person below him are true and accurate.

For a copy of the Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards, visit the OIG Web Site at http://oig.hhs.gov/fraud/complianceguidance.html.


 


[1] The seven standard elements of compliance offered by the OIG are as follows:  1) clear policies and procedures, 2) a designated research compliance officer; 3) effective training; 4) effective lines of communication; 5) internal audits; 6) disciplinary guidelines; 7) fast resolution of problems.

 

____________________________________

 

OIG Allows Joint Venture Even Though Owners are Referral Sources

In OIG Advisory Opinion 05-12, the OIG gave a group of psychiatrists the green light to establish a day treatment facility even though they are all potential referral sources, and the fraud risk is “especially high.” 

The OIG approved the arrangement because of the following safeguards:

ú         The patient mix minimizes the risk that the government will pay for inappropriate services or referrals (very few patients will be federally insured).

ú         Each psychiatrist will pay an equal amount to create the facility, and they will each receive money back in proportion to how much they invested.

ú         Referrals from each psychiatrist will be confidential.

ú         Payment for services the psychiatrists and other clinicians provide the facility will be based on fair market value.

ú         Each psychiatrist will maintain an outside practice that competes with the others, making it unlikely that they will refer to each other.

ú         About 95% of patients will be referred by outside clinicians who have no financial interest in the facility.

ú         Patients referred by an owner will be evaluated by a third party to determine medical necessity.

For a copy of OIG Advisory Opinion 05-12 visit

http://oig.hhs.gov/fraud/docs/advisoryopinions/2005/ao0512.pdf

 

 

 

KUDOS                                                                                                

 

Joe Feltes, Buckingham CantonSM, wrote an article entitled, "I'm Sorry -- A Prescription for Preventing Malpractice Suits."  The article discusses the physician-patient relationship, and how litigation may be avoided if the physician takes the time to show compassion and concern when things just do not turn out right.

 

_______________________________

 

Susan Rank, Buckingham CantonSM, wrote an article for the December, 2005 issue of Employee Benefit Plan Review. The article is entitled, "Are Self Audits Necessary Under the Fair Labor Standards Act?," and it discusses how in fiscal year 2004, the United States Department of Labor’s Wage and Hour Division collected $165 Million in back wages mostly for overtime violations. In her article, Susan suggests companies may want to participate in a self-audit to eliminate wage and hour issues.

 

_______________________________

 

Ronald Wilt, Buckingham ClevelandSM, co-authored an article which will appear in the January, 2006 issue of American Journal of Roentgenology.  The article is entitled, "Computer-Aided Detection as Evidence in the Courtroom:  Potential Implications of an Appellate Court's Ruling."  The article discusses the use of computer-aided detection (CAD) in radiology and its impact on determinations of standards of clinical practice. 

 

 

 

 

 

Save the Date for these Upcoming Presentations:

January 28 - Christopher Humphrey, Buckingham CantonSM, will be speaking at a seminar sponsored by Guidant Corporation regarding "Medical Records Documentation."

 

February - Stephen Griffin, Buckingham CantonSM, will be addressing the medical staff of The Ohio State University Medical Center on the topic of "The Malpractice Experience"

March 14 - Thomas Hess, Buckingham ColumbusSM, will be speaking at a Lorman Education Services seminar in Independence, Ohio. His topic will be "How to Survive a Government Audit."

 

 

Out and About – Recent Presentations:

David Abromowitz, and Priya Bathija, Buckingham ColumbusSM, spoke to the Akron General Hospital Center for Family Medicine.  Their topic was "Physician Contracts."

_______________________________

 

G. Brenda Coey, Buckingham CantonSM, made a presentation on "Legal Documentation."

_______________________________

 

Thomas Hess, Buckingham ColumbusSM, presented at an Ohio Health Care Association seminar.  His topic was "Advance Directive."

_______________________________

 

Richard Milligan, Buckingham CantonSM, presented at the AultCare Provider Physicians Conference.  The titles of his presentations were "Tort Reform - Is it Making a Difference?" and "Understanding and Avoiding Medical Malpractice Risk."  Mr. Milligan also spoke to the Akron-Canton Chapter of the Association of Perioperative Registered Nurses (AORN).  His topic was "Under Attack:  Your Documentation on Trial."

_______________________________

 

 

 

If you are interested in obtaining information on upcoming seminars or would be interested in having speakers from BDB make a presentation to your organization, please contact: Lorna J. Henderson, Client Relations Administrator, at 800.686.2825 ext. 86473 or lhenderson@bdblaw.com.

www.bdblaw.com
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1.800.682.2825 - Buckingham Boca Raton SM
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BDB Health & Medicine Reporter contains articles delivered as a free service from the law firm of Buckingham, Doolittle & Burroughs, LLP (BDB) to make clients and friends aware of legislative changes and laws affecting their businesses and personal lives.  If you enjoy reading BDB Health & Medicine Reporter, please tell a friend or colleague.  The BDB Health & Medicine Reporter is sent only to subscribers who have requested it. Anyone can sign up for a free subscription or view prior BDB Health & Medicine Reporter by visiting our web site at http://www.bdblaw.com/newpublications.asp.

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BDB also publishes Workfor$e, an Employment & Workers' Compensation newsletter, Advisor, which is a general newsletter that addresses a variety of law practice areas, Build on This, a Real Estate & Construction Law newsletter, and several Special Alert publications that cover changes in laws which may affect our clients.

The material appearing in future BDB Health & Medicine Reporter newsletters is meant to provide general information only and not as a substitute for legal advice.  With regard to specific law issues, readers of this newsletter should seek specific advice from legal counsel of their choice.

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