Prisoner to Cancer Pain -- Donna's story

By: Ty Thomas, MD
Alabam Pain Physicians

 

I want to share a true short story about one woman's struggle with cancer pain.   Unfortunately, cases like this one occur too often.  Many of us know or have treated someone with cancer and have seen how painful and debilitating cancer can be. This pain often destroys any remaining quality of life.   It saddens me when someone suffering from terminal cancer pain is denied relief because many in the medical community do not know what treatment options are available.  I was fortunate to be in a position to help.  Stories like Donna’s need to be heard in the medical community.   Managing pain is about adding quality to life, and I wish we could have provided Donna this valuable time earlier.  

This story was written by Donna's friend. 

The elevator doors slid open to reveal the nurses. I did not need to ask which room my friend occupied. I could hear her cries from around the corner and down the hall. It was 2:54 am. I already knew what to expect as I steadied myself at the door. I had made this same trip many times.

“Hon? Can you tell me what level your pain is?” The nurse held her clipboard, prepared to scribble down Donna’s response. My eyes met those of Donna’s bewildered husband Nick. He sat worn and speechless. Witnessing his beloved 42-year-old wife’s pain had become a daily routine, yet it was one he would never grow accustomed to.

I took off my wool coat as I stepped in. “I think it’s safe to assume it’s a 10.” I hoped my words were not too harsh, but it was a stupid question. Unable to speak through the pain and involuntary rhythmic moans, Donna attempted a slight nod of confirmation.

We had been through this routine with the doctors and nurses countless times during the past four months. Donna suffered from colorectal cancer. Daily cocktails of pain medications left her almost comatose and unable to recognize or respond to her three children.

Donna was diagnosed on March 18, 2010 with stage 3 colorectal cancer. She spent the first months afterwards at home trying to maintain a level of normalcy for 18-year-old Kirk, 14-year-old Jayson and 8-year-old Mattie. Homeschooling them kept her mind focused and off her constant pain. The fear of the unknown and the persistent pain were a constant reminder of the fragility of life.

Radiation and chemotherapy successfully shrank the tumor, but scar tissue and a fistula from the radiation forced an unwelcome colostomy. The pain and discomfort mounted. Further testing to confirm remission left us on edge as we waited, hope and fear intermingled in our thoughts.

Many prayers and meals from family and friends helped sustain the family’s semblance of life. A debilitating phone call came from the doctor after seven months of their new daily routine. “By the way Donna, the cancer is back.”

Over the next 13 days, Donna underwent 26 proton therapy treatments in conjunction with chemotherapy to fight the new tumor. The growth of a new mass explained the unremitting pain.

Donna's familiar family structure no longer existed, but a new form of normal began to take shape. Dinners delivered by extended church family and visits from friends took the place of homework. Donna could no longer lie flat in her bed. Sleeping next to her husband was replaced with restless nights trying to find a moment’s relief in the family room recliner.

The pain intensified as large doses of oral pain medications caused agonizing constipation. The number of weekly visits to the emergency room increased, sometimes to three in a seven-day period.  When the nearly lethal doses of medications would not ease the pain, the emergency room was the only option. The oncologist and pain management team at the hospital did not have any other suggestions for controlling her pain.  I do not believe they did not care. I believe they did not know.

Unbearable pain was simply a part of her cancer. Specialists were sympathetic, but as I witnessed the episodes my friend underwent, I grew angrier and more frustrated. My questions went unanswered. I was surprised at the doctors’ and nurses’ apparent lack of knowledge about this kind of pain and how to treat it.  While she was hospitalized, she just was offered a combination of her at-home medications and IV administered drugs. Overdose was a constant threat from so many drugs. One night, Donna tried to shuffle to the restroom from her hospital bed, lost her balance and landed on her face, resulting in a broken nose.

Donna had been a stay-at-home mom who homeschooled her three children. Eighteen months into her battle, I would enter her hospital room to find books and spiral-bound notebooks spread across her bed while Mattie practiced her fractions. Jayson would sit in the corner and quietly watch over his mother while his father worked. Kirk would join after his classes at the local university.

This family was no stranger to cancer. Jayson won his battle with leukemia as a 3-year-old. This family knew how to be tough. They knew how to be strong. They did not know how to give up. They knew there had to be a way to alleviate the pain.

The pain increased and the doctors grew cavalier in their “comatose is better than pain” attitude. I began to think outside oncology. Donna needed good pain management. How could she fight the cancer if her body was trying to survive the pain?

I contacted my brother – a pain management specialist in Birmingham, Alabama – for help. He too was frustrated and disappointed that health care professionals were still unaware of the treatments available for this type of severe pain.  He recommended a pain pump. A pain pump administers controlled doses of medicine directly into the spinal cord, reducing the side effects of heavy oral medication.

When I mentioned the pump to Donna’s doctors and nurses, they were either unaware of this treatment or did not consider her a candidate. After weeks of being dismissed by local specialists, my brother made the contacts in our area to get a pain pump placed. Twenty-one months after her battle began and a few weeks before Christmas, she received her pain pump.

The pump was a miracle in our search for relief. Donna enjoyed going to the movies with her kids for the first time since the battle began. She was able to help them with their homework and have conversations without falling asleep. Mattie stopped rushing to the front doors to escape her mother’s cries of pain.

“Mama was able to go to Wal-Mart with me for the first time since she got sick.” Mattie did not realize it had been nearly two years. Donna had found a new freedom from pain and a new life.

Donna’s happiest moment after receiving the pump came when she was able to leave  her recliner. Her eyes grew misty with gratitude as she described the feel of her husband’s arms wrapped around her as she lay beside him for the first time since the cancer pain invaded their lives. This was a hope she had given up.

“Who knew my greatest anniversary gift would be the ability to lie next to my wife?” Nick reflected
on the moment he was able to hold his wife again without causing her great pain.

Donna celebrated her 42nd birthday alert and coherent and in minimal pain.  Friends and family gathered with food and gifts to mark the occasion, and Donna was able to sit up and enjoy the party.

The frequency of visits to the emergency room and the nightly monitoring of oral medications decreased. Unfortunately, the cancer had begun to spread. Donna had eight months of relatively controlled pain with her family. Out of 29 months of battling for her life, 21 were spent in excruciating pain. Time Donna should have had to spend with her children was wasted begging for relief in the hospital or being heavily medicated in her recliner, a prisoner to pain.

Her long and frustrating battle was not only against the cancer but with the team of physicians and nurses. Her quality of life for the remaining weeks and months made a difference in a 9-year-old’s last memories with her mother.

Cancer pain is a terrible thing to endure and to witness. Finding relief should not have been so
difficult. “We just didn’t get it in time.” Nick whispered. His regret was mixed with thoughts of “what if.” What if she had gotten the pump twelve months earlier? What if she would have been stronger to fight the cancer? What if she had been able to make the long ride in the car to treatment facilities?

Donna did not survive her battle with colorectal cancer. However, her last days were not spent suffering. For that, her family and friends are forever grateful.

 

THE PATIENT EXPERIENCE!

By Michael Sweeney

 

In an never ending struggle to achieve CMS guidelines, incentives, initiatives and just plain keeping our heads above water with reduced reimbursements, increasing cost and nowmore than ever a competitive landscape to earn and retain patients trust and business; we may have forgotten one of the most important components to any medical practices purpose and success – The Patient.

Have we asked ourselves how are we really perceived from the patient’s perspective? Are we doing a good job? How do we communicate with patient population about what we offer, services provided and healthcare mandates we are trying to implement and achieve for their healthcare. 

Healthcare providers have more and more responsibilities and less and less time to accomplish just the basics. Electronic Medical Records were supposed to make providers more productive and compliant. However, more often than not it may have initially taken away productivity, decreased clinic moral, increased patients wait times and in some instances been an investment that did not meet the needs of the practice and is now being replaced. Additionally practices have significant investments in additional services to help supplement their declining fee schedules and reimbursements. Acquiring and implementing anything from diagnostic equipment, DME inventory, on-site pharmacy services, supplemental healthcare products and other ancillary services requiring a significant investment but limited intervention from a provider to deliver such services.

Social Media is offering many options of communication back to patients about their healthcare. A Waiting room or Patient Exam room solution for targeted information, education and ancillary services is a very human answer to communication, whether it is services provided or the diagnosis treatment plan. More times than not patients may seem to be more technologically savvy than we give them credit. Patients walk in with printed research from the web or a smart phone with on-line access because they are connected and desire information.

Blake Bentley, Administrator of SportMed in Huntsville, Al utilizes a program that communicates to patients while waiting to be seen by his providers to explain, educate and deliver information about service provided by his group. “We implemented the LifeSigns solution that allows us to use our existing TV’s to inform patients about which providers are in clinic that day, the benefits of our fitness center, how to prepare for surgeries and diagnostic procedures as well as showing our providers perform certain surgical procedures like ACL, hip and shoulder repairs.”

Jimmy Norman utilizes the same program to educate and promote University Orthopaedic Clinics involvement in the local community. “One of our success stories that are continuing to evolve is our relationship with the local Parks and Recreation department here in Tuscaloosa,Al which is called PARA. Our goal was to treat the injured athlete on the field and then to fast track them into our practice the next day to see a physician.   This direct connection with the orthopedic provider insures a quicker recovery for the athlete to help get them back to their active lifestyle. We also direct patients to like us on Facebook and go to our website for information about our practice and services offered to our patients.” 

 

Covenant Healthcare Centers / Alabama Pain Centers in Huntsville offer a comprehensive, multi-disciplinary approach to the treatment and care of chronic pain patients. Three programs exist: Fast Track, Medical Management and a Multi-Disciplinary Approach.The physicians and multi-disciplinary team work together to create the treatment plan that is best for each individual patient. Part of this plan now includes providing dynamic and relevant patient education while patients wait for the providers in the exam rooms. Clinical support staff queues specific patient related education for review prior to the provider entering the exam room about the organizations philosophy, unique billing procedures and medical treatments plans pertinent to their specific diagnosis.  Not only does it assist in the patient’s healthcare plan but it also reduces their perceived wait time in the clinic.

 

Collaborative Healthcare Initiative, Healthcare Reform, ACO’s, Patient Centered Medical Home Initiative (PCMH), Meaningful Use Stage II, NCQA, PQRI, AQOF, HIE and the list goes on and on…… All of theseplans require organizations including, educating and communicating to their patients in order to receive or meet the expected criteria for incentive reimbursement.  If practices focus on the Patient, educate the Patients and bring awareness to the Patients then everyone should be a winner.

LifeSignsWeb Medical http://lifesignsweb.com/LifeSignsWeb/home.aspx

 

Brand Name Drug Manufacturer Can Be Sued for Injury Caused by Generic Drug

 

By: Kelli F. Robinson
Attorney at Law

Sirote & Permutt, PC

 

On January 11, 2013, the Alabama Supreme Court issued an opinion which found that a brand-name drug manufacturer can be liable for a patient’s injuries caused by a generic drug.  Since its release, the opinion has received national attention due to its potential for far-sweeping consequences on healthcare.

This lawsuit was brought by Danny Weeks and his wife Vicki alleging that side effects of metoclopramide, the active pharmaceutical in Reglan and generic equivalents, caused him to develop a rare and debilitating disorder known as tardive dyskinsesia, which involves involuntary muscle movements.  Weeks alleges that the manufacturer of the brand name version of Reglan, an acid reflux medication, had a duty to warn physicians about the risks associated with long-term use of the generic version of the medication. 

At issue in the case before the Alabama Supreme Court was whether Weeks could bring his lawsuit against Wyeth, Inc., the brand-name drug manufacturer of Reglan now owned by Pfizer, Inc., for failing to warn of the risk of long-term use of the generic drug manufactured and distributed by Actavis Elizabeth, LLC, and Teva Pharmaceuticals USA.  The U.S. District Court for the Middle District of Alabama certified the following question: “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?” 

The Alabama Supreme Court cited a June 2011 U.S. Supreme Court opinion, PLIVA v. Mensing, 131 S. Ct. 2567 (2011), which found that injured patients’ state-law failure-to-warn claims against generic-drug manufacturers are preempted by federal law because the Food and Drug Administration (FDA) requires those manufacturers to use labeling that is the same as the brand-name labeling.  In an 8-to-1 decision written by Justice Michael F. Bolin, the Alabama Supreme Court held that:

. . . an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product.  A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when the patent expires.  It is recognized that generic substitutions are allowed in all 50 states.  A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug. 

Id. at *41-42.  The Alabama Supreme Court also explained that while “the brand-name manufacturer is under a continuing duty to supply the FDA with postmarketing reports of serious injury and can strengthen its warnings on its own accord. . . a generic manufacturer’s label must be the same as the brand-name manufacturer’s label, and the generic manufacturer cannot unilaterally change its warning label.”  Id. at *46-47.

On February 19, 2013, the brand-name manufacturers of Reglan filed an application for re-hearing to the Alabama Supreme Court arguing that the Court’s ruling is inconsistent with rulings in the overwhelming majority of state and federal courts around the nation.  The U.S. Chamber of Commerce, the Business Council of Alabama, the Alabama Policy Institute, the Pharmaceutical Research and Manufacturers of America, the Product Liability Advisory Council, and the Alabama Defense Lawyers Association all filed briefs in support of the brand-name manufacturers’ request.

Although this opinion only affects Alabama state law, it has received national attention due to its potential impact on decisions in other states.  A few months ago, Congress introduced the Patient Safety and Generic Labeling Improvement Act which was promulgated in response to the U.S. Supreme Court’s PLIVA decision.  Critics of the PLIVA decision claim that the U.S. Supreme Court’s decision effectively created dual drug labeling standards for brand-name and generic drug manufacturers.  While brand-name drug manufacturers have to demonstrate to the FDA that a new drug is safe and effective and that the proposed label is accurate and adequate, generic drug manufacturers do not have to meet the same burden. 

The bill seeks to hold generic drug manufacturers to the same standards as the brand-name manufacturers.  Should the bill pass, generic drug manufacturers would also have the burden of showing that their labels are accurate and adequate.

"What I Love About Cardiology"

By: Anuradha Rao, MD
Cardiologist
Cardiovascular Associates
 
Why did you go into Cardiology?  I am asked that question a lot.  I have no simple answer but if you ask me what I love about Cardiology I can perhaps answer that better.  It’s a pretty amazing field that is constantly advancing and new solutions are being found for ancient problems.  Problems that once couldn’t be treated are now treatable and often curable. 

 

‘Barry’ was a 38 year old construction worker I took care of in the late 90’s.  He was hospitalized with acute congestive heart failure and got better quickly with medical management.  He was found to have cardiomyopathy.  His disease was idiopathic and his coronaries were clean.  He had a young family.  I had advised him many times he needed to avoid doing heavy lifting especially in the heat as his heart failure may decompensate and perhaps result in arrhythmia and sudden cardiac death.  He had a big grin and would flash it at me while he told me he had to support his family and he’d be fine working his job.  He tried to take all of his meds but many were not generic.  We tried to load him up on samples but couldn’t always keep up.  Trials were being done at that time in patients with prior MI and had he had CAD he may have had guided therapy and an ultimate ICD. Barry did unfortunately die of sudden cardiac death on a hot summer day while working his construction job.   Studies and subsequent indications for patients with nonischemic cardiomyopathy didn’t occur until a few years later.  He would have been a good candidate for an ICD by today’s standards.  He may also have been a candidate for a biventricular ICD and have had a resultant normalized ejection fraction.  He would have been able to afford all of his medications which are now generic.  I often think of him and his broad grin when recommending an ICD to a patient with cardiomyopathy especially nonischemic cardiomyopathy. 

 

I did my residency in Michigan where we saw the snowstorm effect on heart attack rates.  I was at a hospital which was at the cutting edge of cardiology in the late 1980s.  As medical residents we admitted many patients who were having primary angioplasty instead of thrombolysis for heart attacks. I saw interventional cardiologists work day and night on the many patients presenting with massive heart attacks.  (We don’t see as many of these massive heart attacks these days.)  Primary angioplasty was the treatment of choice at my institution and data was collected which would later prove the superiority of primary angioplasty over the use of clot busting thrombolytics.  Data was also being collected and the amount of time it took us to get the patient prepared for the cath lab for an emergent intervention was scrutinized.  Each minute was examined and if the patient didn’t get to the cath lab within 60 minutes of hitting the door with an ST elevation myocardial infarction (STEMI) we knew there would be a price to pay.   I remember a young woman ‘Patty’ in her 40s who had just been injected with an anesthetic that contained epinephrine for bleeding control at her dentist’s office.  She developed severe chest pain and her dentist sent her to our ER, a few blocks away.  She was indeed having a STEMI.  We all worked together and the patient got to the cath labs and had balloon angioplasty in less than 60 minutes.  The next day in morning report our every step was scrutinized for potential for improvement in the time taken to get her to revascularization.  Patty went home a few days later and to my knowledge did well.  She returned to work in less than a week and fortunately had no residual disease.  Now as a cardiologist, I remain very aware of door to balloon time (D2B).  D2B is measured and reported by most hospitals now and is a measure of a hospital’s success with MI care and in preventing permanent myocardial injury. 

 

Finally as a 4^th year medical student I witnessed my grandmother have a stroke while visiting her in India.  My mother and I stood by helplessly as she lost her ability to speak and walk in front of our eyes.  She never regained either.  She was a diabetic and had high blood pressure.  She didn’t understand the implications of either and neither was treated aggressively which was pretty well the norm back then.  Now as a cardiologist I’m pretty aggressive with prevention.  I think of her and that she may well still be living had she lived in the era of more aggressive prevention.  Her uncontrolled hypertension and diabetes would currently not be inevitable. 

 

The basic medicines of cardiac care are now almost all generic and more accessible.  Education has improved the general public’s understanding of CAD and women, who often presented to the ER many hours later than their male counterparts with symptoms of MI, are now presenting much earlier.  Healthcare workers are recognizing atypical symptoms more quickly in women, diabetics, and the elderly.  Angioplasty now has the adjunctive therapy of drug eluting stents preventing restenosis, emergent CABG, and recurrent myocardial injury and subsequent cardiomyopathy.   ICD’s are preventing sudden cardiac death in the patients with the weakest hearts or the potential for fatal arrhythmia.  Abdominal aortic aneurysms are being stented, and keyhole surgery is being done for CABG and valve surgery.  Soon, many valves may be treated percutaneously and event monitors may be injected under the skin instead of being implanted or worn in a cumbersome manner.  I think of many patients who have benefited from current diagnostics and treatment and a few who would probably still be alive or have lived longer had they had access to current state of the art care.  I also think of the countless patients in whom heart disease has been prevented by treatment of cholesterol, blood pressure, and with lifestyle changes who are now outliving many of their family members who didn’t have access or understanding of prevention.  The effects of prevention with medication and lifestyle changes is now being reflected in declining rates of MI, and declining need for interventional procedures and CABG.  I am in awe when I look back at how much has changed in Cardiology.  We’ve come a long way since the days of Foxglove aka digitalis purpurea and from the days when bedrest was considered a must for the cardiac patient. Having coronary disease, stroke, or cardiomyopathy is no longer the inevitable cause of death and disability it once was.

Robotic Surgery in Women's Health

Robert DeSantis, MD

Obstetrics & Gynecology
Trinity OB/GYN

The use of the da Vinci Surgical System in gynecologic surgery has increased exponentially over the past couple of years.  The system was approved by the United States Food and Drug Administration for use in gynecologic surgery in 2005.  Advantages of the robot-assisted surgery include improved precision and dexterity which is obtained by the EndoWrist instrumentation.  This allows for elimination of any surgeon tremor as well as fatigue issues.  Also, the magnification and 3-dimensional view are superior to conventional 2-dimension laparoscopy.

 

The da Vinci system has simplified many of the current minimally invasive procedures that were challenging or complex due to the improved instrumentation.  Traditional laparoscopic surgery has been used in gynecologic procedures for years, however, acceptance has been variable.  Only a small group of skilled surgeons have attempted complex procedures using minimally invasive techniques.  The da Vinci system has allowed more surgeons to perform complex procedures with a minimally invasive approach.  

 

Currently at Trinity Medical Center, we are performing hysterectomies (uterus), oophorectomies (ovaries), myomectomies (fibroid tumors), endometriosis procedures, prolapse/incontinence procedures, bilateral tubal ligation reversals as well as complex gynecologic procedures that generally require opening the abdomen.  These procedures are generally done with 2-4 small incisions.  Single site surgery for gynecologic procedures is currently pending FDA approval.  

 

  

Conversation Project

By:  Dr. Gregory W. Ayers, MD

Medical Director Comfort Care Hospice

 One of the most difficult things to see as a physician is when a family member has to make a decision and they tell me “I know what I would want, but I don’t know what my mamma would want.”  We plan for graduations, weddings, births and all other life events but we don’t prepare for or talk about death.  It’s so important for families to have this conversation at any age.

The Conversation Project is a unique program that was started to help people discuss their preferences for end-of-life care.  This non-profit group teamed up with the National Institute for Healthcare improvement to create a starter kit that is available free of charge at theconversationproject.org.

 ·        70% of people in a recent survey indicated they don’t want to die in the hospital setting or long term care;

 ·        Studies show that about 70% of the population will end up dying in the hospital or in a long term care facility. 

 ·        There is a disconnect between what people say they want, and the type of care they will receive as the end of life draws near.

 ·        82% of people say it’s important to put their wishes in writing and only 23% have actually done so.

 ·        We need to do more to make sure patients have an opportunity to discuss their values and goals for end-of life care.

Source: theconversationproject.org

The Conversation Starter Kit is a booklet that encourages loved ones to sit down together and talk about their values and the role they want to play in deciding the care they receive. 

There are four steps:

 1.     Preparation – this explains the need for the conversation and asks participants to think about what they need in order to have this conversation with family members.

 2.   Asks participants what is important and provides questions with rating scales to help him/her determine where they stand on end-of-life issues.  For instance, one question asks participants to rate on a scale of 1-5 how much they want to know about a diagnosis.  If they rate it as a five, they want to know everything.  If they rate it as one, then they want to know only the basics.

 3.     The third step encourages participants to determine who they need to discuss their wishes and set up a time and place to talk about their wishes

 4.     The last step is encouraging people to translate those wishes into legal documents and provide them to their primary physician, hospital of choice and family members so the documents are easily accessible if the need arises.

Comfort Care Hospice is providing a printed version to the community for more information contact Comfort Care Hospice at 205-663-6887 or email cgreer@comfortcarehospice.org

Final HIPAA and HITECH Privacy and Security Rule Effective March 23, 2013

By Kristen A. Larremore with Bradley Arant Boult Cummings LLP

The Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services published its final privacy and security regulations under the Health Insurance Portability and Accountability Act (“HIPAA”) on January 25, 2013 (the “Final Rule”).  The Final Rule implements the Health Information Technology for Economic and Clinical Health Act (“HITECH”) under HIPAA.  The Final Rule becomes effective March 26, 2013, and, in general, covered entities and business associates are required to comply by September 23, 2013. Previously, business associates were generally not directly governed by the Privacy or Security Rules under HIPAA, but that is no longer the case.

“Covered entities” are defined by HIPAA as (1) health plans, (2) health care clearinghouses, and (3) health care providers who electronically transmit any health information in connection with transactions for which the U.S. Department of Health and Human Services has adopted standards. For example, hospitals, academic medical centers, physicians, and other health care providers who electronically transmit claims transaction information directly or through an intermediary to a health plan are covered entities. Covered entities can be institutions, organizations, or persons.  The definition of “business associate” has been modified by the Final Rule and is discussed below.

What does this mean for you?

Compliance with the Final Rule will require significant effort on the part of covered entities and business associates (including subcontractors of traditional business associates).  It will be necessary for these entities to:  revise policies and procedures; train workforces regarding new requirements (in particular breach reporting requirements); update business associate agreements, notices of privacy practices, marketing authorizations and other forms; and maintain documentation to demonstrate compliance with the Final Rule.

Some of the most significant changes under the Final Rule are those affecting business associates.  The Final Rule expands the definition of a “business associate” to cover certain organizations, some of which have only indirect relationships with the health care industry and may have little awareness of their compliance obligations.  The definition now includes health information organizations, personal health record vendors, patient safety organizations, and e-prescribing gateways (or others providing data transmission services with respect to protected health information (“PHI”) to a covered entity that requires routine access to the PHI).  Additionally, and significantly, the Final Rule expands the definition of “business associate” to include subcontractors who create, receive, maintain or transmit PHI on behalf of a business associate.  A “subcontractor” means a person to whom a business associate delegates a function, activity or service (other than in the capacity of a member of the workforce of such business associate) that the business associate has agreed to perform on behalf of the covered entity.  Under the Final Rule, the business associate designation follows subcontractors down the chain of the information flow.  As a result, if a subcontractor delegates a function to a third party, that third party is now also a business associate to the subcontractor under HIPAA and subject to direct compliance obligations under the Final Rule in the same manner as any other business associate.

The expansion of the definition of a “business associate” is significant because, under the Final Rule, business associates are directly liable for:

1. uses and disclosures of PHI not permitted under HIPAA;
2. a failure to provide breach notification to the covered entity;
3. a failure to provide access to a copy of electronic PHI to the covered entity, the individual, or the individual’s designee (as specified in the business associate agreement);
4. a failure to disclose PHI to the Secretary of Health and Human Services to investigate or determine the business associate’s compliance with the HIPAA Rules;
5. a failure to provide an accounting of disclosures; and
6. a failure to comply with the HIPAA Security Rule.
Additionally, business associates remain contractually liable for other provisions of business associate agreements and, accordingly, careful negotiation of business associate agreements is necessary.

Covered entities should inventory their existing business associates and business associate agreements, and business associates should begin to assemble lists of their direct subcontractors with whom they may be required to enter into a business associate agreement under the Final Rule.  A transition rule under the Final Rule permits covered entities and business associates to continue operation under certain existing business associate agreements for up to one year beyond the compliance date of September 23, 2013. An existing business associate agreement will be deemed compliant until the earlier of (i) the date such agreement is renewed or modified on or after September 23, 2013, or (ii) September 22, 2014. The transition rule applies only to language in existing business associate agreements; the parties must operate as otherwise required under the Final Rule in accordance with the applicable compliance dates.