nj physician magazine march 2013

JULY 2012

Also In This Issue:Massachusetts’ Pioneering Healthcare Reform Offers Early Look at What New Jersey May Face

Campaign Targets Hospital Takeovers by For-Profit Companies

A History of Health Care Reform in the United States

Visit us now online atwww.NJPhysician.org

MARCH 2013

Aiman Hamdan, MD A Multi-Skilled Interventional Cardiologist Who Focuses On Helping Patients Avoid Surgery

State Assembly Committee Approves New Medical Liability Insurance Bill

Princeton Insurance knows New Jersey, with the longest continuous market presence of any company offering medical professional liability coverage in the state.

Now a Medical Protective/Berkshire Hathaway company, Princeton Insurance offers even more resources, strength and innovation to those we insure.

• Measured either by Gross Written Premium or by number of policyholders, Princeton Insurance is New Jersey’s leading healthcare malpractice insurer.

• Serving New Jersey continuously since 1976 and the country since 1899 – the longest track record in the state, the oldest healthcare malpractice insurer in the nation

• More than 56,000 New Jersey medical malpractice claims handled

• Industry-leading financial strength, with a rating of A+ (Superior) from independentrating agency A.M. Best

• Calls handled personally, specialized legal representation, knowledgeable independent agents, 24-hour new business premium quote

• Unmatched ability to innovate, create, develop and support new products

Published by

Montdor Medical Media, LLC

Co-Publisher and Managing Editors

Iris and Michael Goldberg

Contributing Writers

Iris Goldberg

Michael GoldberG

Andrew Kitchenman

Julian Zelizer

Joseph M. Gorrell

Carol Grelecki

John D. Fanburg

Keith J. Roberts

Kevin M. Lastorino

Todd C. Brower

Lani M. Dornfeld

Mark Manigan

Layout and Design

Nick Justus

New Jersey Physician is published monthly by

Montdor Medical Media, LLC.,

PO Box 257

Livingston NJ 07039

Tel: 973.994.0068

F ax: 973.994.2063

For Information on Advertising in New Jersey Physician, please contact Iris Goldberg at

973.994.0068 or at [email protected]

Send Press Releases and all other information related to this publication to

[email protected]

Although every precaution is taken to ensure accuracy of published materials, New Jersey Physician cannot be held responsible for opinions expressed or facts supplied by its authors. All rights reserved, Reproduction in whole or in part without written permission is prohibited.

No part of this publication may be reproduced or transmitted in any form or by any means without the written permission from Montdor Medical Media. Copyright 2010.

Subscription rates:

$48.00 per year

$6.95 per issue

Advertising rates on request

New Jersey Physician magazine is an independent

publication for the medical community of our state and is

not a publication of NJ Physicians Association

Publisher’s Letter

With warm regards,

Michael GoldbergCo-Publisher

Dear Readers,

Welcome to the March edition of New Jersey Physician, now reaching over 28,000 physicians statewide, as well as the Administrative Directors of the ASCs, MGMA members, and major executives of most hospitals in the state.

There is much talk about healthcare reform going on. I decided to look back into history to see if there has been a similar time in medicine and was quite surprised to find that reform efforts have been the subject of political debate since the early part of the 20th century, and there was even some discussion on health care taking place as early as 1854. U.S. efforts to achieve universal coverage began with Theodore Roosevelt who had support of progressive health care reformers in the 1912 election but was defeated. The Great Depression caused many more people to be in a position of not being able to afford medical services. I think this historical study gives us some perspective on the arguments regarding the availability of medical care for all in our time.

A compounding pharmacy in Monmouth County has suspended operations amid a probe for contamination. This has gained the attention of the state government who is now considering the need to more closely regulate such businesses. Med Prep Consulting temporarily halted all operations and voluntarily recalled magnesium sulfate products, after a Connecticut hospital identified some of the company’s products being potentially contaminated with visible particles. New Jersey currently has 41 pharmacies that perform sterile compounding, in addition to pharmacies located in hospitals.

The State Board of Medical Examiners has adopted a rule restricting the prescription and dispensation of anabolic steroids and human growth hormone, effective February 19, 2013. The rule prohibits a physician from prescribing, ordering, dispensing, administering, selling or transferring any anabolic steroid or human growth hormone or its similar analogs unless (1) there is a bona fide relationship with the patient, (2) a medical history has been obtained, and (3) a full physical examination has been performed that establishes a valid medical indication and necessity. Body building, muscle enhancement and increased muscular strength are explicitly excluded from being deemed medically necessary purposes.

The IRS Chief Counsel has issued an advisory to physicians that EHR Incentive Payments must be reported as income.

Our cover story this month focuses on Aiman Hamdan, MD, who is a multi-skilled interventional cardiologist. Dr. Hamdan prides himself in the seven board certifications he has earned, which enable him to, as he says, “treat the whole package”. These skills include some of the most contemporary procedures in his specialty including radial access for angiography. He will soon be part of the team at Saint Joseph’s Medical Center launching a program for Transcatheter Aortic Valve Replacement. Patients are now being recruited for this innovative, minimally invasive procedure.

Contents

2 New Jersey Physician

CONTENTS

49

18

28

STATEHOUSE

HEALTH LAW UPDATE

27

FOOD FOR THOUGHT

HISTORY OF HEALTH CARE

24

Aiman Hamdan, MD

A Multi-Skilled Interventional Cardiologist Who Focuses On Helping Patients Avoid Surgery

SUPPORT GROUPSEHR PAYMENTS /

Available for photography during surgical procedures, with clearance in most NJ hospitals.Familiarity with most procedures • 24/7 emergency availability if necessary.

Experienced surgical and medical photographer available for hospitals, medical practices, lawyers, insurance

companies, and others who need high .yhpargotohp ytilauq

Portfolio of work

available for viewing

[email protected]

Aiman Hamdan, MD Montdor Medical Media, LLC

Promote a new ground breaking procedure . and more . Document injuries for legal issues


Cover Story

Dr. Hamdan shares that a very significant part of his job involves diagnosing

problems in their infancy.

photography by Michael Goldberg

Aiman Hamdan, MDA Multi-Skilled Interventional Cardiologist Who Focuses On Helping Patients Avoid SurgeryBy Iris Goldberg

If there were fewer procedures for him to perform, Aiman Hamdan, MD would be pleased to know that vascular disease is less prevalent. However, with obesity, diabetes and associated complications such as cardiac disease and hypertension reaching staggering levels, there are many patients in New Jersey who require surgery to repair the ensuing vascular damage. Dr. Hamdan’s practice, Advanced Medical Specialist of N. Jersey, is located in Paterson and is an affiliate of St. Joseph’s Cardiovascular Center, where Dr. Hamdan serves as Director Cardiac Clinic, Director of CCU and Site Director Cardiac Fellowship Program.

“Knowledge is power and prevention is better than cure,” Dr. Hamdan says. “When you catch things at the beginning, it is much easier and certainly less expensive,” he adds. Dr. Hamdan goes on to share that 60 to 70 percent of his job involves attempting to diagnose problems in their infancy. “When we can do this we can treat more effectively and control the consequences,” he reports.

In fact, Dr. Hamdan and his capable and caring staff spend a great deal of time educating patients about the importance of preventing the progression of cardiac and vascular disease in order to stay healthier and avoid the need for surgical intervention. Of course this involves a discussion about making lifestyle changes such as stopping smoking, increasing activity levels and modifying food intake.

Diabetes, smoking, hypertension, high cholesterol and heart disease can all cause atherosclerosis, which is a build-up of plaque inside artery walls. The build-

up of plaque narrows and roughens the smooth inner lining of the artery, slowing or even preventing blood flow.

Diabetics, especially, are at increased risk and need to be aggressively managed. “If you look at the statistics, every few minutes someone undergoes an amputation because of vascular insufficiency,” Dr. Hamdan mentions to emphasize the point. Some of the patients he meets for the first time already have significant tissue damage and large infected ulcers.

Dr. Hamdan explains that because of nerve damage that interferes with their ability to feel and perhaps also affects vision, diabetics often overlook small injuries to the lower extremities that continue to progress to the point when the damage becomes irreversible. “That’s why, in this office, anybody who is diabetic or who has complained of claudication or leg pain undergoes non-invasive testing to diagnose as soon as possible,” he relates.

As peripheral artery disease (PAD) progresses, walking even short distances can be associated with pain. This pain cycle (claudication) requires prompt evaluation and treatment. When the artery is narrowed, blood flow is reduced and may not be adequate to meet the body’s need for extra oxygen during walking. If the artery is completely blocked by plaque and there is no blood flow, whatsoever, the patient might even experience pain while resting. Without a constant supply of oxygen, tissue below the blockage is permanently damaged and may become gangrenous, leading to amputation. This often occurs in the feet, especially in the toes.

In order to determine whether there is a significant decrease in blood flow due to narrowed or blocked arteries in the lower extremities, Dr. Hamdan performs an angiogram. During this procedure, dye is injected into the lower body and blood flow can then be seen on x-rays. Also, a detailed image of narrowed or blocked arteries is provided.

When the angiogram reveals the need for surgical intervention, Dr. Hamdan employs minimally invasive endovascular technology to widen a narrowed artery or open a small blockage. During angioplasty, Dr. Hamdan makes a small puncture in the groin and passes a thin guide wire through a catheter and into the damaged artery. The balloon-tipped catheter is then moved to the narrowed area where the balloon is inflated and

March 2013 5

photography by Michael Goldberg

Tibial artery before angioplasty TIbial artery after intervention.

In addition to utilizing angioplasty and stenting to repair peripheral arteries, Dr. Hamdan treats other arterial occlusions as well. For example, blockage of renal arteries is also caused most often by atherosclerosis. Diabetics and patients with years of poorly controlled hypertension are at significantly increased risk for impaired kidney function.

Dr. Hamdan further shares, that in some young hypertensive patients, especially,

deflated to press the plaque against the artery wall. Once the blockage has been opened the catheter is removed. In some cases a tiny wire mesh tube or stent may be placed within the artery to ensure it remains open.

For some patients, Dr. Hamdan performs atherectomy, which is a somewhat newer technology that uses a rotating shaver or other device placed on the end of a catheter to shave away or destroy plaque. The catheter is inserted through an artery in the groin to the blockage. The cutting head is positioned against the plaque and activated. The plaque is ground up and can be suctioned out.

medication-resistant high blood pressure may be the result of narrowed renal arteries. If the blockage affects both kidneys, function can deteriorate resulting in renal failure and the need for dialysis.

Among the more than 10,000 patients with cardiovascular disease that Dr. Hamdan has treated by performing angiograms in the catheterization lab at St. Joseph’s Hospital and Medical Center, are many with damaged renal arteries. The first step is to perform a renal ultrasound to see if there is narrowing, followed by an angiogram to obtain a detailed image of the arteries. Then, angioplasty and stenting are performed by Dr. Hamdan to correct the problem.

To open narrowed or blocked renal arteries, Dr. Hamdan inserts a small catheter through a puncture in the groin. As is done with peripheral arteries, a tiny balloon at the end of the catheter is inflated and deflated, flattening the plaque against the renal artery wall. For renal arteries a tiny mesh stent is usually implanted to prevent the artery from re-narrowing.

The results obtained from angioplasty and stenting are about equal to those of open surgery but the endovascular procedure is far less invasive and therefore associated with much less risk. For some, Dr. Hamdan reports, the procedure is so successful that less anti-hypertensive medication is required


Dr. Hamdan beginning coronary angiography via radial (wrist) approach

Studies have shown a significant reduction in morbidity and easier recovery in those who underwent coronary angiography via the radial approach as compared with those undergoing the femoral approach

Perhaps the biggest advantage of the radial technique is the shorter recovery time. When catheters are removed from the wrist artery, patients are only required to wear a wrist band to apply pressure to the wound. For those patients who undergo coronary angiography via the femoral method, pressure must be applied to the groin for at least 40 minutes because the femoral artery is considerably larger. Additionally, these patients must wait a much longer period of time before they are permitted to walk.

Dr. Hamdan discusses other advantages to the radial approach for certain patients. “If you are considerably overweight you could bleed liters of blood from the groin without even realizing,” he explains, referring to the excessive amount of fat surrounding the area. “Also the incidence of infection is higher,” Dr. Hamdan adds.

“For elderly patients or those with back problems, the femoral approach might be uncomfortable because they are forced to remain lying on the back for a long time,” Dr. Hamdan mentions. With coronary angiography through the wrist, the patient can get up and walk away from the table almost immediately after,” he relates.

Often, Dr. Hamdan performs coronary angiography and stenting on patients who are brought into the cath lab from the ER. “I am on the heart attack team at St. Joe’s,” Dr. Hamdan states. “So we all get paged at the same time, the doctor, the tech, the nurse - and we rush in to

subsequently. Most importantly, as Dr. Hamdan says, “We are definitely able to slow the progression of damage to the kidneys and the need for dialysis.”

While the femoral (groin) approach is appropriate for access to peripheral and renal arteries, to perform coronary angiography and stenting in order to treat those patients with narrowed or blocked coronary arteries, Dr. Hamdan most often uses the radial (wrist) approach. Studies have shown a statistically significant reduction in morbidity for patients who underwent angiography via the radial approach. In addition, all radial approach patients were shown to have significantly fewer complaints about pain or recovery time compared with patients who underwent the femoral approach.

open the blockage,” he continues. In this situation when time is of the essence, Dr. Hamdan is pleased to share that he can usually complete the procedure within a few minutes.

Currently, St. Joseph’s Hospital and Medical Center is launching a program for Transcatheter Aortic Valve Replacement (TAVR). Dr. Hamdan and a team comprised of cardiac interventionalists and surgeons are

recruiting appropriate patients to undergo this innovative, minimally invasive procedure.

The aortic valve regulates the flow of blood from the heart. When it can no longer open fully (aortic valve stenosis), chest pain, palpitations, fatigue and shortness of breath can ensue. Cardiac surgeons have been very successful in treating aortic valve stenosis by replacing the faulty valve with a mechanical one

March 2013 7

Dr Hamdan views a detailed image of the blocked artery

Right coronary artery before angioplasty RCA post angioplasty

The implications of this for the many patients who will now be able to receive replacement valves without the risks associated with open surgery are obvious. Many who have been suffering with debilitating symptoms for years will have a good quality of life restored to them. “This is very important to mention,” says Dr. Hamdan, in order to inform physicians within the St. Joe’s community about this minimally invasive procedure now being offered to appropriate patients.

Discussing why his practice is somewhat unique, Dr. Hamdan, who holds seven board certifications (see Fig. 1), mentions that as an interventionalist he also is practicing in other areas such as general cardiology, nuclear cardiology, echocardiography and others. “So here, we can treat the whole package. When you come to us, we take care of every aspect,” he offers.

or a valve constructed with animal tissue. However, some patients are not healthy enough to undergo open-heart surgery and have been disqualified from undergoing aortic valve replacement.

Now, Dr. Hamdan and the surgical team at St. Joe’s will perform a balloon angioplasty in which a catheter with a balloon at the end will be threaded through an artery from a small incision in the groin. The replacement valve can be collapsed to a very small diameter and is fit onto the balloon. The replacement valve is positioned inside the patient’s own defective valve and the balloon is inflated. This causes the replacement valve to expand, forcing the faulty valve aside. The replacement valve will begin to function as soon as the balloon deflates to permit the flow of blood.

Also, noteworthy, the community Dr. Hamdan serves contains many non-English speaking residents and many others who are only minimally conversant in English. Most speak Arabic or Spanish but are able communicate their concerns effectively and understand, as Dr. Hamdan speaks Arabic and the staff is fluent in Spanish. In fact, Dr. Hamdan reports that he sees patients from many parts of the tri-state area and further, who come because they want to understand and be understood.

While interceding with patients before surgery becomes necessary is a major priority for Dr. Hamdan, he does perform

In the radial approach, patients are only required to wear a wrist band to apply

pressure to the wound

more than 800 cardiovascular procedures a year. When a procedure is necessary, Dr. Hamdan’s extensive experience and skill allow him to do what needs to be done in as little time as possible. “When the patient is under the camera, there is radiation involved to me and to the patient. Also, the dye we use can be harmful to the patient’s kidneys, so we try to use the least amount of dye and I am in and out in a very short amount of time,” he shares.

Working with wires and balloons to accomplish results that were previously obtained only with open surgeries is extremely gratifying to Dr. Hamdan. “It takes a lot of training and talent to be able to manipulate catheters and balloons,”


Dr Hamdan works closely in the Catheterization Lab with the expertly trained staff at Saint Joseph’s Medical Center

The community Dr Hamdan serves contains many non-English speaking residents. Dr. Hamdan and his staff are multi-lingulal.

learned so much from nurses throughout the years,” he shares. “I always remind them to listen to the nurses. They might teach you something,” Dr. Hamdan tells them. Whether in the cath lab or the office, Dr. Hamdan never underestimates the contribution of the health professionals that work alongside him.

It was not that long ago when patients who required vascular surgery to correct a host of arterial diseases were forced to undergo open surgical repair. These procedures were extremely invasive with significant blood loss and a lengthy recovery period. With the development of minimally invasive technology, the specialty of intervention has been revolutionized. The risk to patients has been greatly diminished and more patients with comorbidities can be cleared for surgery. Finally, healthcare costs associated with minimally invasive endovascular surgery are a fraction of those for open surgeries. In fact, Dr. Hamdan reports that many times the patient will not even require an overnight hospital stay.

For Dr. Hamdan, bringing this expertise to the patients within the St. Joseph’s Hospital and Medical Center community, where many deal with difficult economic challenges, is an added plus. “St. Joe’s doesn’t always get the recognition that some of the other hospitals do,” he candidly shares. “Some people might not know what we do at St. Joe’s but we do a lot of innovative and exciting things,” Dr. Hamdan notes.

Board Certifications

• Internal Medicine

• Cardiovascular Disease

• Interventional Cardiology

• Vascular Medicine

• Endovascular Medicine

• Echocardiography

• Nuclear Cardiology

Fig. 1

he states. “When you can reach the tiny heart arteries through the leg where the arteries are bigger and you have those skills that allow you to maneuver, it is so much safer,” Dr. Hamdan continues. This is what the modern interventional cardiologist has learned to do,” he emphasizes.

Besides his own specific skill set, Dr. Hamdan is grateful for the capabilities of all of the people with which he works and for the team approach to treating patients. “It’s all about the team,” he believes. “I’ve worked so often with the staff at St. Joe’s that it’s as if they can read my mind,” Dr. Hamdan remarks. “It’s never a one-man show.”

Dr. Hamdan also works closely with a physician assistant. Together they have compiled a booklet containing histories of 100 actual heart attack patients that were seen at St. Joe’s. “We tell how they presented, show their EKG, and then the results of their angiogram and what was done,” he relates. “We use this as a teaching tool for the residents,” Dr. Hamdan explains. “They’ve been able to listen to a case and see the EKG but they’ve never had a chance to be in the cath lab. This gives them an idea of how things look in the cath lab,” Dr. Hamdan elaborates.

Dr. Hamdan believes that one of the most important lessons he gives to the residents and fellows which he trains, is to learn from others on the team. “I have

Still, with all of the technical advancements in vascular surgery, Dr. Hamdan reiterates that his main focus is to educate patients about the things they can do within their own lives to avoid a surgical intervention. “But if we cannot prevent these diseases, at least we can lessen the damage they cause and help people live longer, healthier lives,” he is happy to say.

For more information or to schedule an appointment, please call (973) 782-6615.

March 2013 9

NEW JERSEYFine Print: Emma’s Law

Legislature asked to approve $1.6M to implement screening of newborns for certain genetic disorders

STATEHOUSE

Statehouse

By Andrew Kitchenman,

What it is: A law, S-1999, signed by Gov. Chris Christie in January 2012, requiring that newborns be screened for a series of genetic disorders that attack the nervous systems of infants. The law didn’t include funding to implement testing.

Its goal: To allow babies to be treated as quickly as possible. Early treatment can reduce the negative consequences of the diseases, in which nerve cell insulation is underdeveloped, affecting the child’s mental and physical development. Early cord blood and bone marrow transplants, as well as physical therapy, can benefit the children. There is no effective treatment once the symptoms have started to appear, and the diseases are fatal.

Who Emma was: Emma Daniels was an infant born with Krabbe disease in 2009. While she grew normally at first, her symptoms began at the age of 2 months, beginning with fussiness and irritability. She was not tested for the disorder until she was 4 months old, at which time it was too late for her to be treated. She died at the age of 2 in March 2012. Her family lobbied for the law’s enactment.

What’s new: Christie proposed $1.6 million to fund the screening tests – which cover Krabbe and five similar diseases, known as lysosomal storage disorders -- for the budget year starting on July 1. This will increase the total number of disorders for which newborns are screened from 54 to 60, at a total annual cost to the state of $25 million. Christie mentioned the law during his February 26 budget message to the Legislature and has repeatedly referred to it at health-related public appearances since the speech.

How newborn screenings work: Doctors take a few drops of blood from each newborn’s heel to test for genetic, endocrine and metabolic disorders. According to the federal Centers for Disease Control, early detection, diagnosis and intervention can prevent death or disability and enable children to reach their full potential.

How many babies will be affected: While an estimated 22 of the roughly 110,000 babies born in the state each year have one of 40 lysosomal storage disorders, there are validated screening tests only for the six disorders covered by the bill.

In the future: Funding for Emma’s Law doesn’t figure to be controversial in budget negotiations. The law had bipartisan sponsors in both legislative houses.

Senator: Drug Recall Affirms Need for Closer Government RegulationCompounding pharmacy in Monmouth County suspends operations amid probe for possible contaminationBy Andrew Kitchenman,

A New Jersey compounding pharmacy has recalled its products while it is being investigated for potential contamination, leading a state senator to say the incident points to the need to more closely regulate such businesses.

Med Prep Consulting of Tinton Falls temporarily halted all operations on Friday and voluntarily recalled magnesium sulfate products, after a Connecticut hospital identified some of company’s products as being potentially contaminated with visible particles. No infections have been linked to the Med Prep Consulting products.

All pharmacies need to do some compounding, in which a pharmaceutical product is created to fit the needs of individual patients, such as taking a medication manufactured in solid form and turning it into a liquid.

But compounding pharmacies that mass-produce sterile, injectable products have become more common in order to meet the needs of hospitals that face frequent drug shortages – however, those types of products pose the greatest risk of contamination.

Contamination of compounding pharmacy products has been in the public eye since September, when an outbreak of fungal meningitis was traced to a Massachusetts pharmacy, the New England Compounding Center. The outbreak led to 722 infections and 50 deaths through March 11, including 49 infections in New Jersey.

Sen. Jeff Van Drew (D-Atlantic, Cape May and Cumberland) has proposed the Compounding Pharmacy Quality Assurance Act S-2365, which would require all compounding pharmacies to follow a set of nationally recognized regulations.


Van Drew, a dentist, said the Med Prep Consulting case underscored the need for tighter regulation of the industry. He expressed frustration that Congress has failed to pass legislation that would apply federal drug regulations to compounding pharmacies, whose operations are more similar to pharmaceutical manufacturers than they are to traditional pharmacies.

“These pharmaceutical compounding companies have sprung up and they’re really manufacturing companies,” Van Drew said. “Most of them are good but some of them are not as good as they should be.”

New Jersey has 41 pharmacies that perform sterile compounding, in addition to pharmacies located in hospitals, according to Neal Buccino, a spokesman for the Division of Consumer Affairs in the Department of Public Safety.

State Board of Pharmacy regulations require regular training and testing of all personnel involved in sterile compounding, Buccino said. In addition, the state performs routine, unannounced inspections of compounding pharmacies, he said.

Van Drew said he has heard from anesthesiologists in South Jersey about the potential danger of some compounding pharmacy products. Some compounding pharmacies have increased production to meet the need caused by shortages of some pharmaceuticals.

Van Drew described federal regulation “as the real and best answer” to the need to regulate the industry.

“We should deal with it,” he said. In the absence of federal action, he added, “All we can do is state-by-state, try to ensure that the live up to standards.”

While the current version of the bill would require that all compounding pharmacies be accredited by the Pharmacy Compounding Accreditation Board, a national organization, Van Drew said he plans replace any reference to the organization with requirements that compounding pharmacies follow a set of regulations.

Van Drew said he was “disgusted” by the negligence shown by the New England Compounding Center.

“This is something that is very fixable,” he said.

Michael R. Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based pharmacy monitoring organization, said the lack of federal regulation has led to many questions about safety practices of compounding pharmacies.

State inspections of compounding pharmacies can be costly, according to Cohen, speaking at the Association of Health Care Journalists annual convention on Friday in Boston.

State and federal investigators are investigating the Med Prep Consulting products. The company has agreed to halt its operations at least through at Friday. It agreed with the state Board of Pharmacy to stop producing and shipping medications until more information about its products can be analyzed, Attorney General Jeffrey S. Chiesa said in a statement on Friday. State health authorities have recommended that healthcare facilities that received Med Prep products remove them from use.

A woman who answered the phone at Med Prep Consulting declined to comment on the issue.

Massachusetts’ Pioneering Healthcare Reform Offers Early Look at What New Jersey May FaceSix-year struggle to contain rising medical costs demonstrates unified front is key to success

By Andrew Kitchenman

What does Massachusetts have to teach New Jersey? Plenty -- at least when it comes to health reform.

The Bay State was the first in the country to require residents to have health insurance. Its experience offers a number of lessons to the Garden State. Chief among them: government, health, and business leaders need to work together to contain healthcare costs.

Under former Gov. Mitt Romney in 2006, Massachusetts instituted several of the key features of the Affordable Care Act, four years before the federal law was enacted. These included a mandate for every resident to purchase insurance, as well as public subsidies for low- to middle-income individuals and families to buy coverage.

Today, only 2 percent to 3 percent of the state's population lacks health insurance.

And with the entire country struggling to hold the line on healthcare costs, Massachusetts has gotten an early jump on this potentially divisive issue, according to officials who spoke to a gathering of healthcare reporters in Boston March 14 to 17.

Still, it took until 2012, six years after the state's first healthcare law was passed, for the government to tackle the politically vexing issue of trying to contain costs.

Current Massachusetts Gov. Deval Patrick told the Association of Health Care Journalists that rising costs led to a second healthcare reform law.

This measure encouraged accountable care organizations (ACOs), a network of doctors, hospitals, and other healthcare providers that work together to coordinate quality care for the patients they serve. ACOs are compensated for how well they perform and keep costs down, rather than for each service they provide (as with the conventional medical model).

The cost-containment bill also caps the rise of future healthcare costs to the increase in the size of the state’s economy, projected

March 2013 11

to be 3.6 percent in 2013 and 2014.

Pulling Together

Patrick said state, healthcare, business, and labor leaders continued to work together after the initial law was passed, which ultimately allowed the state to pass the cost-containment legislation.

“They stuck together to implement it and I think that’s especially important, because they realized that this was too big an undertaking to simply pass legislation and then expect that things would work on automatic pilot,” Patrick said.

He added, “I am confident that just as we showed the way for the nation in universal care, Massachusetts will be the place that cracks the code on cost containment.”

Nevertheless, Massachusetts may not be all that far ahead of New Jersey when it comes to ACOs, which several of the state's insurers are adding at a steady clip. And with the additional pressure on costs from increased access when the ACA goes into effect in January 2014, New Jersey may soon follow Massachusetts in a massive adoption of the ACO model.

Andrew Dreyfus, president and chief executive officer of Blue Cross Blue Shield of Massachusetts,

said his company successfully signed ACO-style agreements with most of the company’s primary care providers, rising from 1,373 in 2009 to 5,136 in 2013.

In addition, 328,000 of the company’s 689,000 managed-care customers are now covered by ACOs. Dreyfus said there are early signs that the approach is successful at providing improved-quality care while slowing cost growth.

“They physicians themselves are seeing a difference,” Dreyfus said.

According to Tim Ferris, vice president of Massachusetts General Hospital and Partners HealthCare, “It will be physicians that will convince other physicians to do this.”

Across-the-Board Cuts

David Seltz, a Massachusetts state healthcare regulator, said increases in health insurance-related costs have led to state budget cuts in every other area of government. This has created an urgent need to contain cost increases.

“We knew that the double-digit cost growth wasn’t going to be sustainable,” said Seltz, executive director of the Massachusetts Health Policy Commission. He added that addressing costs has been much more politically difficult than expanding access.

Gov. Chris Christie’s decision to expand Medicaid eligibility was supported by several Massachusetts healthcare players, including Massachusetts Institute of Technology economist Jonathan Gruber, who said that it was “just insane” that states like Texas are turning down federal funding to increase Medicaid.

Gruber, an adviser to crafters of both the Massachusetts and federal laws, pointed to estimates indicating that private insurance rates are expected to rise between 5 percent and 15 percent in states that don’t expand Medicaid, because more low-income residents will be enrolling in private plans rather than low-cost Medicaid.

Gruber also said that having the state government support efforts to reach out to uninsured residents will be crucial in reducing the number of uninsured. He noted that the 2 percent to 3 percent of the Massachusetts population without insurance tend to be residents whose incomes are so low that they're not penalized for going without coverage.

“There needs to be a constant drumbeat of recognition that this is an important population,” Gruber said, adding that research has found that these residents frequently enroll in Medicaid because other family members have joined.

While larger firms pretty much signed on to the law signed by Romney, advocates of smaller businesses were the one group that seemed displeased with how healthcare reform has been implemented in Massachusetts, which may bode ill for small businesses in New Jersey.

Jon B. Hurst, president of the Retailers Association of Massachusetts, said his group was neutral on the 2006 law but has opposed several increases in state insurance mandates since the initial law was enacted.

“That’s where the trouble began,” Hurst said of the later mandates.

Hurst said one effect of the Massachusetts reforms has been to sharply increase the cost of insurance to small employers, whose employees are now included in the same risk pool -- the group of residents whose total risk is used to calculate insurance rates – as residents who buy individual health insurance.

The problem is that individual purchasers tend to have worse-than-average health, which has driven up the rates of small businesses. Since larger businesses are typically self-insured and thus aren’t affected by most state insurance regulations, it’s created an uneven playing field for small businesses that are struggling to offer competitive insurance packages.

New Jersey hospitals, particularly those with a high concentration of low-income residents, may face some of the same challenges as their Massachusetts counterparts at meeting demand. Kate Walsh, president and CEO of Boston Medical Center, New England’s largest safety-net hospital, said that expanding the number of low-income residents with insurance has put a new emphasis on managing costs.


Campaign Targets Hospital Takeovers by For-Profit CompaniesUnions, healthcare advocates call for closer state scrutiny of sales of nonprofit community hospitals

“If we don’t manage carefully the access for all, we’re going to bankrupt the country,” Walsh said. Her hospital -- which relies more than most on Medicare and Medicaid, recently cut a variety of costs by consolidating multiple emergency departments in one location, freezing salaries for two years, and renegotiating union benefits.

By Andrew Kitchenman,

The trend of New Jersey hospitals converting to for-profit status is under attack from labor unions and healthcare-access advocates, who are urging the state to step up scrutiny of hospital sales.

Several labor and advocacy groups announced a campaign yesterday calling on the state to increase and enforce its regulation of hospital conversions with an eye on Prime Healthcare’s proposed purchases of St. Mary’s Hospital in Passaic and Saint Michael’s Medical Center in Newark.

The announcement marks the start of the latest battle in the years-long expansion of for-profit healthcare operations in the state. Opponents of the trend argue that a primary focus on profits harms the ability to deliver less-profitable services, and weakens the financial position of nonprofit operators, while for-profit advocates counter that they can operate hospitals more efficiently and are a victim of a smear campaign by labor unions.

A telephone conference call announcing the campaign included a man who has been battling the Prime Healthcare chain in its home state of California.

Anthony Wright, executive director of the California-based nonprofit Health Access, accused Prime – which has 10 facilities in that state -- of overcharging the Medicare and Medicaid programs. He also said the company has intentionally chosen not to contract with insurers in order to receive higher out-of-network fees.

“These are costs that impact both on relationships with insurers and the cost of the health insurance that we pay in premiums,” Wright said. He also pointed to a case where Prime was audited for questionable business expenses, including the depreciation of a Bentley luxury car and a helicopter.

“This is not just isolated examples of bad behavior, this is a business model of trying to abuse the trust and goodwill that the healthcare system relies on,” Wright said, saying the company focuses on profits rather than patients.

The allegations were denied by Prime spokesman Edward Barrera, who cited independent reviews of the company that found it provided high-quality care.

Barrera said the company’s Medicare billing has been reviewed by state and accreditation bodies, which found no evidence supporting the overbilling allegations. He said the allegations stem from a campaign by a California healthcare union. The company has sued the union, alleging antitrust violations.

“Health Access seems to have allied itself with the California unions, because these are the same discredited allegations,” Barrera said.

He said Wright’s reference to the questionable depreciation was based on claims that occurred more than three years ago. He said state denials of hospital depreciation expenses are routine and that the financial benefit to hospitals of depreciation claims is tiny compared to overall company revenue.

Sen. Joseph F. Vitale, D-Middlesex, who joined the conference call, expressed skepticism about Prime. He wants to see the state’s Community Health Care Assets Protection Act enforced more broadly to protect communities served by nonprofits. The state law requires that nonprofit hospital sales undergo a rigorous regulatory review.

The most recent legislative sparring over the issue occurred last year, when Gov. Chris Christie conditionally vetoed a bill that would have tied state charity care payments to a requirement that hospitals make more information publicly available about their finances, governing boards and vendors.

Christie called for a six-month study of the issue, but an aide to bill sponsor Sen. Loretta Weinberg (D-Bergen) said yesterday that Weinberg plans to attempt an override of Christie’s veto.

Ann Twomey, president of the Health Professionals and Allied Employees union, represents workers at four hospitals that have been converted to for-profit status. Despite having three different owners, Twomey said they have largely followed a similar pattern of reducing staff and replacing full-time positions with workers who are paid by the day.

This “means a reduction in patient care, there is no question about it,” Twomey said. She alleged that for-profit operators might be undermining the financial sustainability of their hospitals.

Barrera said Prime is different from the other for-profit operators whose bids for St. Mary’s and Saint Michael’s were rejected.

Campaign supporters expressed concern that for-profits would end hospitals’ role as teaching facilities, as well as the possibility of hospital boards that have mismanaged their facilities being in a position to determine which company will purchase their

March 2013 13

hospitals.

The groups supporting the campaign plan to go door-to-door making their case and plan to hold community hearings in Newark and Passaic on the potential sales to Prime, according to Phyllis Salowe-Kaye, executive director of the nonprofit watchdog group New Jersey Citizen Action.

Paul Bellan-Boyer, an activist with the Jersey City group Save Christ Hospital, asserted that Prime backed out of buying Christ Hospital due to community mobilization against it.

Bellan-Boyer said the campaign opposes selling hospitals to companies that would reduce or eliminate contracts, services, quality, staffing and affordability.

Fight Over Labels for Genetically Modified Food Comes to New JerseyLegislators weigh requirement as industry and activists debate whether engineered food poses health risksBy Andrew Kitchenman,

State legislators are weighing whether all genetically modified foods should be labeled, as New Jersey has become the latest battleground in a national debate over the practice.

Supporters of labeling argue that not enough is known about the long-term health consequences of the technique, in which genetic material from organisms like bacteria is inserted into the DNA of plants and animals to add a specific trait, such as making them resistant to herbicides.

However, advocates for farm, retail, chemical and biotechnology companies argue that a scientific consensus has formed against the need for labeling. They point to a decision by the Food and Drug Administration against labeling the products as evidence that no harmful effects have been found from the genetically modified foods.

Since first being introduced in the mid-1990s, the crops have become pervasive, with the vast majority of corn, cotton, soy and canola now containing genetic modifications. This means that nearly all processed foods also are genetically modified.

Labeling advocates have regrouped after a major effort to add labeling was defeated in a referendum in California last year. They are now pushing for similar measures in several states, including New Jersey.

The bipartisan New Jersey bill, S-1367 and A-3192, is sponsored by Sen. Robert W. Singer (R-Monmouth and Ocean) and Assemblywoman Linda Stender (D-Middlesex, Somerset and Union).

“Every journey starts out slow,” Singer said. “This is a journey that is going to take some time. We have to get it right, but this is a legitimate concern.”

Singer said he was prompted to introduce the bill after speaking with residents concerned about the lack of information about which foods are genetically modified. He said he is interested in input from Gov. Chris Christie’s office and wants to make sure the bill doesn’t conflict with laws being considered in other states.

Officials with Food & Water Watch, an advocacy group, contend that more testing should be done on genetically modified foods. The organization is supporting similar labeling laws across the country.

“This is about giving consumers choices and options about what they want to consume,” said Jim Walsh, state director for the organization. He said industry groups that benefit from genetically modified foods have sponsored nearly all research done in the United States on the issue.

Food & Water Watch spokesman Seth Gladstone compared labeling to current requirements for listing food ingredients and calories.

“A lot of this technology is very new, and just because we have not found yet any evidence of health problems doesn’t mean they don’t exist,” Gladstone said.

While some organic farmers support the measure, most farmers in the state oppose it.

State Board of Agriculture member Hugh McKittrick cited a United Nations study concluding that global food production must double by 2050. He noted that the biotechnology used in genetically modified foods allows increased food production.

“To avoid what technology is available and so far has not been proven to be negative would be a disservice to the human population. How do we eat?” he said.

New Jersey Farm Bureau President Ryck Suydam told legislators at a March 4 hearing that farmers support some labeling, but not mandatory labels.

For instance, Suydam said producers of foods without genetic modifications could label them as such, similar to how organic food is labeled. He said such labels should result from consumer demand, not from government mandates.

He likened genetic-modification techniques to those traditionally used by farmers, such as growing hybrids.


However, Sen. Diane Allen (R-Burlington) said she felt there was a difference between introducing material to corn that has never existed in corn, compared with creating a tomato hybrid from existing tomatoes.

Singer said he expects to make changes to the bill to make it clear that it would only apply to products that have been genetically engineered, rather than to products that have been grown through traditional techniques, such as creating hybrids.

The Food and Drug Administration has found no difference between conventional and modified foods, other than the genetically introduced traits. Since there is no scientific difference, the FDA has found no reason to introduce labeling, according to William K. Hallman, director of the Food Policy Institute at the Rutgers New Jersey Agricultural Experiment Station..

Singer said that labeling wouldn’t prevent farmers from growing and selling the products.

Ed Waters, government relations director for the Chemistry Council of New Jersey, said he’s concerned that the very act of labeling food as genetically modified will lead consumers to believe that it is either inferior or not healthy.

He noted that the American Medical Association and the National Academies of Sciences have found no adverse health effects from genetically modified foods.

The Assembly version of the bill is scheduled to be discussed at an Assembly Health and Senior Services Committee meeting today.

Ethical Challenges of Gene Testing Explored with Cooper Medical StudentsArthur Caplan, renowned medical ethicist, sees changed landscape for new doctors

By Andrew Kitchenman

While genetic testing is presenting new challenges and opportunities for doctors and patients, the most appropriate response in many cases is still the simplest one – focusing on traditional means of improving health.

That was one of the messages delivered yesterday by Arthur Caplan, a leading medical ethicist who spoke to the first class of students at Rowan University’s Cooper Medical School in Camden.

Genetic testing is at the leading edge of “personalized medicine,” in which doctors can tailor treatment based on patients’ genes or other unique characteristics, said Caplan, director of NYU Langone Medical Center’s medical ethics division.

Caplan said genetic research offers some of the most promising opportunities in medicine, including pharmacogenomics – technology used to determine which medications will be most effective based on a patient’s genes.

He added that doctors, before prescribing certain drugs to treat depression of other conditions, might be able to learn whether patients’ genes prevent them from benefiting from the medications.

“It’s having particular information on your genes, your hereditary makeup, that allows you to start to not do medicine as one-size-fits-all,” Caplan said.

But Caplan warned against indiscriminate genetic testing, which he said raises a series of ethical issues without offering much in the way of useful medical knowledge. He said using genetic testing to address the rising challenge of a disease like diabetes is not nearly as important as taking conventional steps like improving diet to prevent or manage the condition.

Many commercial ventures are seeking to cash in on a misplaced belief that genetic knowledge in some areas is more advanced than it is. For example, some companies advertise that their gene tests can indicate what a child’s athletic talents are – something that isn’t possible now.

Caplan said that, within a decade, all pregnant women will be offered genetic tests for their fetuses. He predicted that this will become the next major ethical battleground.

“Let's say I go in with a happy couple, and I get this test result,” he told the medical students. “It says your fetus is at a 30 percent higher risk than average for breast cancer; your fetus is at a 30-percent higher risk than average for being boring; your fetus is at a 50-percent risk than average for being gay; your fetus is likely to be autistic, ranging from Asperger all the way over to institutionalized. So what are parents going to do with this, and who's going to counsel them?”

Such testing could be useful in the early detection of conditions like Huntington’s disease, but, if used unwisely, it could lead opponents of abortion to see all genetic testing as unethical, Caplan added.

Some people have been overly optimistic about being to learn about their own genetic risk for certain diseases, he said.

He cited the example of a woman who wanted a test to see if she had an elevated risk of breast cancer even though she didn’t have a family history that indicated the need for a test.

Caplan then delivered his punch line: The woman was a chronic smoker who wasn’t taking steps to reduce the much-higher cancer risk from smoking.

He questioned the benefits of learning of slightly elevated risks – for example, knowing that a person has a 10-percent increased risk of Alzheimer’s.

March 2013 15

“What are you going to do? What you’re going to do is freak yourself out because every time you can’t remember where the car keys are, you’re going to say, ‘That’s it, I knew it,’ ” Caplan said.

Caplan suggested a ban on the sale of gene tests directly over the counter to the public, since many people are ill-equipped to interpret the results. In addition, he said, there is no scientific basis for conducting the tests unless the patient’s family history indicates a risk for a disease.

Caplan has literally been in the middle of discussions of the human genome – the complete set of a person’s genetic information -- since serving as an intermediary between public and private competitors to map the genome. While scientists have gained a good understanding of what genes people have, they know much less about how those genes interact and are expressed.

Cooper student Sara Zaidi of Closter said the lecture was well-timed, building on what students have been learning in a class on the foundations of medical practice.

She said that while much attention is being focused on genetic testing, Caplan’s lecture reinforced the importance of building traditional medical knowledge.

“It’s like the shiny new thing that everyone wants to do, but at the same time, it’s important to remember that time-tested notions of eating well, taking care of your environment, are important too,” Zaidi said. “It’s a bigger theme for us – remembering the old, but anticipating, accepting and learning to manage the new.”

Caplan, who has written 25 books on medical ethics, noted in an interview before the lecture that the Cooper students will deal with a very different set of ethical challenges compared to what doctors faced 30 years ago. An aging population is bringing new attention to the challenges in managing the process of dying, as well as widening the range of chronic illnesses that elderly patients have, including Alzheimer’s disease.

“Thirty years ago, that group was tiny and not growing,” he said.

In addition, while young doctors of 30 years ago were most excited about the medical miracles from new technology, doctors now are more aware of the cost of treatment and must be careful not to order unnecessary procedures, Caplan said.

“Now, we’re in an age where there is a concern that the cost has just spiraled out of control,” he said.

Finally, the infusion of more female doctors has put a new emphasis on balancing doctors’ personal and private lives, he said.

Dr. John McGeehan, Cooper associate dean for student affairs and admissions, said Caplan’s lecture built on the school’s focus on the social impact of medicine.

Caplan’s lecture was the first in an annual series on medical ethics endowed by Edwin Berkowitz, a Philadelphia philanthropist.


Health care will be an Obama legacyBy Julian Zelizer,

The politics of health care is changing fast. President Barack Obama's Affordable Health Care Act was vulnerable during his first term when Republicans demanded repeal of the law. Even after the Supreme Court upheld its constitutionality, there were still many voices who objected to it.

However, with each passing day, it appears that the program is in good shape, slowly becoming part of the fabric of American government.

Last week, New Jersey Gov. Chris Christie, one of the main potential contenders for the Republican presidential nomination in 2012, said that his state would accept the Medicaid expansion that is part of the ACA. Christie had been one of the president's toughest critics, frequently lambasting the program as a prime example of big government liberalism. But he has changed his tune.

The expansion of Medicaid will allow about 104,000 of the poorest residents in New Jersey to gain access to health insurance. Christie said: "Let me be clear: I am no fan of the Affordable Health Care Act. I think it is wrong for New Jersey and for America. I fought against it and believe, in the long run, it will not achieve what it promises. However, it is now the law of the land. I will make all my judgments as governor based on what is best for New Jerseyans."

Christie's announcement comes on top of an even more dramatic reversal, that of Florida's Gov. Rick Scott.

The former health industry executive, who was elected to lead the Sunshine State in 2010, has been one of the more conservative voices in the GOP. Scott, who once warned that "Obamacare will result in the rationing of health care, significant tax increases, significant job losses and the inability of many Americans to keep their existing health insurance" also announced that Florida would accept the new Medicaid funds.

"When the federal government is committed to paying 100% of the cost," Scott said, "I cannot, in good conscience, deny Floridians that need access to health care."

Republicans are interested in fighting against the ACA any more. Not only is it a losing issue, but in the next few years, the benefits are going to start rolling in and more Americans will come to depend on the protections.

The shift in position by two of the most prominent Republicans suggests that the political dynamics are shifting, as Obama's supporters had always hoped. Republican officials now see powerful incentives for them to embrace the law rather than oppose it.

The biggest watershed moment for the ACA came in June 2012 when the Supreme Court ruled that the health care legislation was constitutional.

Like in 1937, when the Supreme Court declared that the Social Security tax was constitutional, the court's ruling on health care gave Obama's program a legitimacy that undercut some of the thunder coming from the right. The Affordable Care Act became law of the land. Then the 2012 presidential election was an affirmation of popular support for Obama and the policies for which he fought.

March 2013 17

It's not unusual for a big piece of legislation to elicit strong oppositions at first.

With Social Security, the program experienced over a decade of uncertainty. A means tested program for the elderly proved much more popular during the 1940s, and Congress refused to raise Social Security taxes during World War II. But by the early 1950s, Social Security emerged as the primary means of helping the elderly.

As more Americans were receiving their checks, fewer politicians in either party opposed the program. President Dwight Eisenhower concluded that the GOP had little choice but to accept the program. Republicans and Democrats, including Southern Democrats, voted to increase benefits every two years. By the 1980s, Social Security would be considered to be the "third rail" in American politics -- touch the benefits and you die.

Similarly, the Civil Rights Act of 1964 experienced strong reactions. The notion of prohibiting racial segregation was incredibly contentious. But once Congress passed it, Southern politicians, citizens and institutions quickly fell in line. In the 1970s and 1980s, issues such as affirmative action and school busing still riled up many, but de jure racial segregation was no longer considered acceptable by most.

More recently, during President George W. Bush's presidency, the new counterterrorism programs provoked heated debates. Democrats railed against the tough interrogation techniques used by the government to combat terrorism and highlighted institutions such as Guantanamo as symbols of what the nation was doing wrong. But Obama abandoned many of his plans to dismantle these programs.

His nomination of John Brennan to head the CIA and the protection of key documents that allegedly support the assassination of American citizens reveal how much the tide has turned.

Today, there is considerable evidence that the health care law is approaching that turning point.

As Ezra Klein wrote in The Washington Post, "so long as Obamacare is accepted as the law of the land, and repeal is dismissed by most Republicans as little more than a pleasant fantasy, then a constructive process can begin in which Republicans seize on problems with the law as an opportunity to reform the reforms -- and through that process, begin to buy into the new system."

There is still a lot of work that needs to be done, such as making sure that the health care exchanges work and that funding for the program remains adequate. The program's success is not inevitable. But the recent change of heart from the darlings of the Republican Party is an indication the ACA is much further along to becoming one of the most important legacies of the Obama presidency.


History of health care reform in the United StatesThe issue of health insurance reform in the United States has been the subject of political debate since the early part of the 20th century. Recent reforms remains an active political issue. Alternative reform proposals were offered by both of the two major candidates in the

Federal Reform Efforts

19th century

One of the earliest health care proposals at the federal level was the 1854 Bill for the Benefit of the Indigent Insane, which would have established asylums for the indigent insane, as well as the blind, deaf, and dumb, via federal land grants to the states. This bill was proposed by activist Dorothea Dix, which passed both houses of congress, but was vetoed by president Franklin Pierce. Pierce argued that the federal government should not commit itself to social welfare, which he believed was properly the responsibility of the states. After the Civil War, the federal government did establish the first system of national medical care in the South. Known as the Freedmen's Bureau, the government constructed 40 hospitals, employed over 120 physicians, and treated well over one million sick and dying former slaves. The hospitals were short lived, lasting from 1865 to 1870. Freedmen's Hospital in Washington, DC remained in operation until the late nineteenth-century before it became part of Howard University.

The next major initiative came in the New Deal legislation of the 1930s, in the context of the Great Depression.

1900s-1920s

In the first 10–15 years of the 20th century Progressivism was influencing both Europe and the United States. Many European countries were passing the first social welfare acts and forming the basis for compulsory government-run or voluntary subsidized health care programs. The United Kingdom passed the National Insurance Act of 1911 that provided medical care and replacement of some lost wages if a worker became ill. It did not, however, cover spouses or dependents. U.S. efforts to achieve universal coverage began with Theodore Roosevelt, who had the support of progressive health care reformers in the 1912 election but was defeated.[ Progressives campaigned unsuccessfully for sickness insurance guaranteed by the states. A unique American history of decentralization in government, limited government, and a tradition of classical liberalism are all possible explanations for the suspicion around the idea of compulsory government-run insurance. The American Medical Association (AMA) was also deeply and vocally opposed to the idea. In addition, many urban US workers already had access to sickness insurance through employer-based sickness funds.

Early industrial sickness insurance purchased through employers was one influential economic origin of the current American health care system. These late-19th-century and early-20th-century sickness insurance schemes were generally inexpensive for workers: their small scale and local administration kept overhead low, and because the people who purchased insurance were all employees of the same company, that prevented people who were already ill from buying in. The presence of employer-based sickness funds may have contributed to why the idea of government-based insurance did not take hold in the United States at the same time that the United Kingdom and the rest of Europe was moving toward socialized schemes like the UK National Insurance Act of 1911. Thus, at the beginning of the 20th century, Americans were used to associating insurance with employers, which paved the way for the beginning of third party health insurance in the 1930s.

1930s-1950s

With the Great Depression, more and more people could not afford medical services. In 1933, Franklin D. Roosevelt asked Isidore Falk and Edgar Sydenstricter to help draft provisions to Roosevelt's pending Social Security legislation to include publicly funded health care programs. These reforms were attacked by the American Medical Association as well as state and local affiliates of the AMA as "compulsory health insurance." Roosevelt ended up removing the health care provisions from the bill in 1935. Fear of organized medicine's opposition to universal health care became standard for decades after the 1930s.

During this time, individual hospitals began offering their own insurance programs, the first of which became Blue Cross. Groups of hospitals as well as physician groups (i.e. Blue Shield) soon began selling group health insurance policies to employers, who then offered them to their employees and collected premiums. In the 1940s Congress passed legislation that supported the new third-party insurers. During World War II, Henry Kaiser used an arrangement in which doctors by passed tradition fee-for-care and were contracted to meet all the medical needs for his employees on construction projects up and down the West coast. After the war ended, he opened the plan up to the public as a non-profit organization under the name Kaiser Permanente.

Following the second world war, President Harry Truman called for universal health care as a part of his Fair Deal in 1949 but strong opposition stopped that part of the Fair Deal. However, in 1946 the National Mental Health Act was passed, as was the Hospital Survey and Construction Act, or Hill-Burton Act. In 1951 the IRS declared group premiums paid by employers as a tax-deductible business expense, which solidified the third-party insurance companies' place as primary providers of access to health care in the United States.

March 2013 19

1960s-1980s

1960s

In the Civil Rights era of the 1960s and early 1970s, public opinion shifted towards the problem of the uninsured, especially the elderly. Since care for the elderly would someday affect everyone, supporters of health care reform were able to avoid the worst fears of "socialized medicine," which was considered a dirty word for its association with communism, After Lyndon B. Johnson was elected president in 1964, the stage was set for the passage of Medicare and Medicaid in 1965. Johnson's plan was not without opposition, however. "Opponents, especially the AMA and insurance companies, opposed the Johnson administration's proposal on the grounds that it was compulsory, it represented socialized medicine, it would reduce the quality of care, and it was 'un-American.'" These views notwithstanding, the Medicare program was established by legislation signed into law on July 30, 1965, by President Lyndon B. Johnson. Medicare is a social insurance program administered by the United States government, providing health insurance coverage to people who are either age 65 and over, or who meet other special criteria.

1970s

In 1970, three proposals for universal national health insurance financed by payroll taxes and general federal revenues were introduced in the U.S. Congress. In February 1970, Representative Martha Griffiths (D-MI) introduced a national health insurance bill—without any cost sharing—developed with the AFL–CIO. In April 1970, Senator Jacob Javits (R-NY) introduced a bill to extend Medicare to all—retaining existing Medicare cost sharing and coverage limits—developed after consultation with Governor Nelson Rockefeller (R-NY) and former Johnson administration HEW Secretary Wilbur Cohen. In August 1970, Senator Ted Kennedy (D-MA) introduced a bipartisan national health insurance bill—without any cost sharing—developed with the Committee for National Health Insurance founded by United Auto Workers (UAW) president Walter Reuther, with a corresponding bill introduced in the House the following month by Representative James Corman (D-CA). In September 1970, the Senate Labor and Public Welfare Committee held the first congressional hearings in twenty years on national health insurance.

In January 1971, Kennedy began a decade as chairman of the Health subcommittee of the Senate Labor and Public Welfare Committee, and introduced a reconciled bipartisan Kennedy-Griffiths bill proposing universal national health insurance. In February 1971, President Richard Nixon proposed more limited health insurance reform—a private health insurance employer mandate and federalization of Medicaid for the poor with dependent minor children. Hearings on national health insurance were held by the House Ways and Means Committee and the Senate Finance Committee in 1971, but no bill had the support of committee chairmen Representative Wilbur Mills (D-AR) or Senator Russell Long (D-LA).

In October 1972, Nixon signed the Social Security Amendments of 1972 extending Medicare to those under 65 who have been severely disabled for over two years or have end stage renal disease (ESRD), and gradually raising the Medicare Part A payroll tax from 1.1% to 1.45% in 1986. In November 1972, Nixon won re-election in a landslide over the only Democratic presidential nominee ever not endorsed by the AFL–CIO, Senator George McGovern (D-SD), who was a cosponsor of the Kennedy-Griffiths bill, but did not make national health insurance a major issue in his campaign.

In October 1973, Long and Senator Abraham Ribicoff (D-CT) introduced a bipartisan bill for catastrophic health insurance coverage for workers financed by payroll taxes and federalization of Medicaid with extension to the poor without dependent minor children. In February 1974, Nixon proposed more comprehensive health insurance reform—an employer mandate to offer private health insurance and replacement of Medicaid by state-run health insurance plans available to all with income-based premiums and cost sharing. In April 1974, Kennedy and Mills introduced a bill for near-universal national health insurance with benefits identical to the expanded Nixon plan, both of which were criticized by labor and senior citizens organizations because of their substantial cost sharing.

In August 1974, after Nixon's resignation and President Gerald Ford's call for health insurance reform, Mills tried to advance a compromise based on Nixon's plan, but gave up when the conservative half of his committee instead backed the limited American Medical Association (AMA) "Medicredit" voluntary tax credit plan. In December 1974, Mills resigned as chairman of the Ways and Means Committee and was succeeded by Representative Al Ullman (D-OR), who opposed payroll tax and general federal revenue financing of national health insurance.

In January 1975, in the midst of the worst recession in the four decades since the Great Depression, Ford said he would veto any health insurance reform, and Kennedy returned to sponsoring his original universal national health insurance bill. In April 1975, with one third of its sponsors gone after the November 1974 election, the AMA replaced its "Medicredit" plan with an employer mandate proposal similar to Nixon's 1974 plan. In January 1976, Ford proposed adding catastrophic coverage to Medicare, offset by increased cost sharing. In April 1976, Democratic presidential candidate Jimmy Carter proposed health care reform that included key features of Kennedy's universal national health insurance bill.

In December 1977, President Carter told Kennedy his bill must be changed to preserve a large role for private insurance companies, minimize federal spending (precluding payroll tax financing), and be phased-in so not to interfere with balancing the federal budget. Kennedy and organized labor compromised and made the requested changes, but broke with Carter in July 1978 when he would not commit to pursuing a single bill with a fixed schedule for phasing-in comprehensive coverage.

In May 1979, Kennedy proposed a new bipartisan universal national health insurance bill—choice of competing federally-regulated private health insurance plans with no cost sharing financed by income-based premiums via an employer mandate and individual


mandate, replacement of Medicaid by government payment of premiums to private insurers, and enhancement of Medicare by adding prescription drug coverage and eliminating premiums and cost sharing. In June 1979, Carter proposed more limited health insurance reform—an employer mandate to provide catastrophic private health insurance plus coverage without cost sharing for pregnant women and infants, federalization of Medicaid with extension to the very poor without dependent minor children, and enhancement of Medicare by adding catastrophic coverage. In November 1979, Long led a bipartisan conservative majority of his Senate Finance Committee to support an employer mandate to provide catastrophic-only private health insurance and enhancement of Medicare by adding catastrophic coverage, but abandoned efforts in May 1980 due to budget constraints in the face of a deteriorating economy.

1980s

The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) amended the Employee Retirement Income Security Act of 1974 (ERISA) to give some employees the ability to continue health insurance coverage after leaving employment

The Clinton initiative

was a bus tour that started the end of July 1994. It involved supporters of President Clinton's na

Health care reform was a major concern of the Bill Clinton administration headed up by First Lady Hillary Clinton; however, the 1993 Clinton health care plan was not enacted into law.

The "Health Security Express" national health care reform. Several buses leaving from different points in the United States, such as Portland, Oregon, and Boston, Mass crossed the country and stopped in many cities along their way to their final destination at the White House in Washington, DC on August 3, 1994. During these stops, each of the bus riders would talk about their personal experiences, health care disasters and why they felt it was important for all Americans to have health insurance. When the Health Security Express bus tour ended, all of the riders were greeted by President Clinton and the First Lady on the White House South lawn for a rally on Wednesday, August 3, 1994, which was broadcast all over the world by many international networks including C-SPAN.

Bush era debates

In 2000 the Health Insurance Association of America (HIAA) partnered with Families USA and the American Hospital Association (AHA) on a "strange bedfellows" proposal intended to seek common ground in expanding coverage for the uninsured.

In 2001, a Patients' Bill of Rights was debated in Congress, which would have provided patients with an explicit list of rights concerning their health care. This initiative was essentially taking some of ideas found in the Consumers' Bill of Rights and applying it to the field of health care. It was undertaken in an effort to ensure the quality of care of all patients by preserving the integrity of the processes that occur in the health care industry. Standardizing the nature of health care institutions in this manner proved rather provocative. In fact, many interest groups, including the American Medical Association (AMA) and the pharmaceutical industry came out vehemently against the congressional bill. Basically, providing emergency medical care to anyone, regardless of health insurance status, as well as the right of a patient to hold their health plan accountable for any and all harm done proved to be the biggest stumbling blocks for this bill. As a result of this intense opposition, the Patients' Bill of Rights initiative eventually failed to pass Congress in 2002.

As president, Bush signed into law the Medicare Prescription Drug, Improvement, and Modernization Act which included a prescription drug plan for elderly and disabled Americans.

During the 2004 presidential election, both the George Bush and John Kerry campaigns offered health care proposals. Bush's proposals for expanding health care coverage were more modest than those advanced by Senator Kerry. Several estimates were made comparing the cost and impact of the Bush and Kerry proposals. While the estimates varied, they all indicated that the increase in coverage and the funding requirements of the Bush plan would both be lower than those of the more comprehensive Kerry plan.

In 2006 the HIAA's successor organization, America's Health Insurance Plans (AHIP), issued another set of reform proposals.

In January 2007 Rep. John Conyers, Jr. (D-MI) has introduced The United States National Health Care Act (HR 676) in the House of Representatives. As of October 2008, HR 676 has 93 co-sponsors. Also in January 2007, Senator Ron Wyden introduced the Healthy Americans Act (S. 334) in the Senate. As of October 2008, S. 334 had 17 cosponsors

Also in 2007, AHIP issued a proposal for guaranteeing access to coverage in the individual health insurance market and a proposal for improving the quality and safety of the U.S. health care system.

"Economic Survey of the United States 2008: Health Care Reform" by the Organization for Economic Co-operation and Development, published in December 2008, said that:

• Taxbenefitsofemployer-basedinsurancesshouldbeabolished.

• Theresultingtaxrevenuesshouldbeusedtosubsidizethepurchaseofinsurancebyindividuals.

• Thesesubsidies,"whichcouldtakemanyforms,suchasdirectsubsidiesorrefundabletaxcredits,wouldimprovethe current situation in at least two ways: they would reach those who do not now receive the benefit of the tax exclusion; and they

March 2013 21

would encourage more cost-conscious purchase of health insurance plans and health care services as, in contrast to the uncapped tax exclusion, such subsidies would reduce the incentive to purchase health plans with little cost sharing."

In December 2008, the Institute for America's Future together with the chairman of the Ways and Means Health Subcommittee Pete Stark launched a proposal from Jacob Hacker who is co-director of the U.C. Berkeley School of Law Center on Health that in essence said that the government should offer a public health insurance plan to compete on a level playing field with private insurance plans. This was said to be the basis of the Obama/Biden plan. The argument is based on three basic arguments. Firstly public plans success at managing cost control (Medicare medical spending rose 4.6% p.a. compared 7.3% for private health insurance on a like-for-like basis in the 10 years from 1997 to 2006). Secondly public insurance has better payment and quality-improvement methods based on its large databases, new payment approaches, and care-coordination strategies. Thirdly it can set a standard against which private plans must compete which would help unite the public around the principle of broadly shared risk while building greater confidence in government over the long term.

Also in December 2008, America's Health Insurance Plans (AHIP) announced a set of proposals which included setting a national goal to reduce the projected growth in health care spending by 30%. AHIP said that if this goal were achieved, it would result in cumulative five-year savings of $500 billion. Among the proposals was the establishment of an independent comparative effectiveness entity that compares and evaluates the benefits, risks, and incremental costs of new drugs, devices, and biologics. An earlier "Technical Memo" published by AHIP in June 2008 had estimated that a package of reforms involving comparative effectiveness research, health information technology (HIT), medical liability reform, "pay-for-performance" and disease management and prevention could reduce U.S. national health expenditures "by as much as 9 percent by the year 2025, compared with current baseline trends."

Debate in the 2008 presidential election

Both of the major party presidential candidates offered positions on health care.

John McCain's proposals focused on open-market competition rather than government funding. At the heart of his plan were tax credits - $2,500 for individuals and $5,000 for families who do not subscribe to or do not have access to health care through their employer. To help people who are denied coverage by insurance companies due to pre-existing conditions, McCain proposed working with states to create what he called a "Guaranteed Access Plan."

Barack Obama called for universal health care. His health care plan called for the creation of a National Health Insurance Exchange that would include both private insurance plans and a Medicare-like government run option. Coverage would be guaranteed regardless of health status, and premiums would not vary based on health status either. It would have required parents to cover their children, but did not require adults to buy insurance.

The Philadelphia Inquirer reported that the two plans had different philosophical focuses. They described the purpose of the McCain plan as to "make insurance more affordable," while the purpose of the Obama plan was for "more people to have health insurance." The Des Moines Register characterized the plans similarly.

A poll released in early November, 2008, found that voters supporting Obama listed health care as their second priority; voters supporting McCain listed it as fourth, tied with the war in Iraq. Affordability was the primary health care priority among both sets of voters. Obama voters were more likely than McCain voters to believe government can do much about health care costs.

2009 reform debate

In March 2009 AHIP proposed a set of reforms intended to address waste and unsustainable growth in the current health care market. These reforms included:

• Anindividualinsurancemandatewithafinancialpenaltyasaquidproquoforguaranteedissue

• UpdatestotheMedicarephysicianfeeschedule;

• Settingstandardsandexpectationsforsafetyandqualityofdiagnostics;

• Promoting care coordination and patient-centered care by designating a "medical home" thatwould replacefragmented care with a coordinated approach to care. Physicians would receive a periodic payment for a set of defined services, such as care coordination that integrates all treatment received by a patient throughout an illness or an acute event. This would promote ongoing comprehensive care management, optimizes patients’ health status and assist patients in navigating the health care system

• Linkingpayment toquality, adherence toguidelines, achievingbetter clinicaloutcomes,givingbetterpatientexperience and lowering the total cost of care.

• Bundledpayments(insteadof individualbilling)forthemanagementofchronicconditions inwhichproviderswould have shared accountability and responsibility for the management of chronic conditions such as coronary artery disease, diabetes, chronic obstructive pulmonary disease and asthma, and similarly

• Afixedrateall-inclusiveaveragepaymentforacutecareepisodeswhichtendtofollowapattern(eventhoughsome acute care episodes may cost more or less than this).

On May 5, 2009, US Senate Finance Committee held hearings on Health care reform. On the panel of the "invited stakeholder", no


supporter of the Single-payer health care system was invited. The panel featured Republican senators and industry panelists who argued against any kind of expanded health care coverage. The preclusion of the single payer option from the discussion caused significant protest by doctors in the audience.

There is one bill currently before Congress but others are expected to be presented soon. A merged single bill is the likely outcome. The Affordable Health Choices Act is currently before the House of Representatives and the main sticking points at the markup stage of the bill have been in two areas; should the government provide a public insurance plan option to compete head to head with the private insurance sector, and secondly should comparative effectiveness research be used to contain costs met by the public providers of health care. Some Republicans have expressed opposition to the public insurance option believing that the government will not compete fairly with the private insurers. Republicans have also expressed opposition to the use of comparative effectiveness research to limit coverage in any public sector plan (including any public insurance scheme or any existing government scheme such as Medicare), which they regard as rationing by the back door. Democrats have claimed that the bill will not do this but are reluctant to introduce a clause that will prevent, arguing that it would limit the right of the DHHS to prevent payments for services that clearly do not work. America's Health Insurance Plans, the umbrella organization of the private health insurance providers in the United States has recently urged the use of CER to cut costs by restricting access to ineffective treatments and cost/benefit ineffective ones. Republican amendments to the bill would not prevent the private insurance sectors from citing CER to restrict coverage and apply rationing of their funds, a situation which would create a competition imbalance between the public and private sector insurers. A proposed but not yet enacted short bill with the same effect is the Republican sponsored Patients Act 2009]

On June 15, 2009, the U.S. Congressional Budget Office (CBO) issued a preliminary analysis of the major provisions of the Affordable Health Choices Act. The CBO estimated the ten-year cost to the federal government of the major insurance-related provisions of the bill at approximately $1.0 trillion. Over the same ten-year period from 2010 to 2019, the CBO estimated that the bill would reduce the number of uninsured Americans by approximately 16 million. At about the same time, the Associated Press reported that the CBO had given Congressional officials an estimate of $1.6 trillion for the cost of a companion measure being developed by the Senate Finance Committee In response to these estimates, the Senate Finance Committee delayed action on its bill and began work on reducing the cost of the proposal to $1.0 trillion, and the debate over the Affordable Health Choices act became more acrimonious. Congressional Democrats were surprised by the magnitude of the estimates, and the uncertainty created by the estimates has increased the confidence of Republicans who are critical of the Obama Administration's approach to health care.

However, in a June New York Times editorial, economist Paul Krugman argued that despite these estimates universal health coverage is still affordable. "The fundamental fact is that we can afford universal health insurance--even those high estimates were less than the $1.8 trillion cost of the Bush tax cuts."

In contrast to earlier advocacy of a publicly funded health care program, in August 2009 Obama administration officials announced

March 2013 23

they would support a health insurance cooperative in response to deep political unrest amongst Congressional Republicans and amongst citizens in town hall meetings held across America. However, in a June 2009 NBC News/Wall Street Journal survey, 76% said it was either "extremely" or "quite" important to "give people a choice of both a public plan administered by the federal government and a private plan for their health insurance."

During the summer of 2009, members of the "Tea Party" protested against proposed health care reforms. Former insurance PR executive Wendell Potter of the Center for Media and Democracy- whose funding comes from groups such as the Tides Foundation argue that the hyperbole generated by this phenomenon is a form of corporate astroturfing, which he says that he used to write for CIGNA. Opponents of more government involvement, such as Phil Kerpen of Americans for Prosperity- whose funding comes mainly from the Koch Industries corporation counter-argue that those corporations oppose a public-plan, but some try to push for government actions that will unfairly benefit them, like employer mandates forcing private companies to buy health insurance. Journalist Ben Smith has referred to mid-2009 as "The Summer of Astroturf" given the organizing and coordinating efforts made by various groups on both pro- and anti-reform sides.

State and city reform efforts

A few states have taken serious steps toward universal health care coverage, most notably Minnesota, Massachusetts and Connecticut, with recent examples being the Massachusetts 2006 Health Reform Statute and Connecticut's SustiNet plan to provide quality, affordable health care to state residents. The influx of more than a quarter of a million newly insured residents has led to overcrowded waiting rooms and overworked primary-care physicians who were already in short supply in Massachusetts. Other states, while not attempting to insure all of their residents, cover large numbers of people by reimbursing hospitals and other health care providers using what is generally characterized as a charity care scheme; New Jersey is perhaps the best example of a state that employs the latter strategy.

Several single payer referendums have been proposed at the state level, but so far all have failed to pass: California in 1994, Massachusetts in 2000, and Oregon in 2002. The state legislature of California has twice passed SB 840, The Health Care for All Californians Act, a single-payer health care system. Both times, Governor Arnold Schwarzenegger (R) vetoed the bill, once in 2006 and again in 2008.

The percentage of residents that are uninsured varies from state to state. Texas has the highest percentage of residents without health insurance at 24%. New Mexico has the second highest percentage of uninsured at 22%.

States play a variety of roles in the health care system including purchasers of health care and regulators of providers and health plans, which give them multiple opportunities to try to improve how it functions. While states are actively working to improve the system in a variety of ways, there remains room for them to do more.

One municipality, San Francisco, California, has established a program to provide health care to all uninsured residents (Healthy San Francisco).

In July 2009, Connecticut passed into law a plan called SustiNet, with the goal of achieving health-care coverage of 98% of its residents by 2014. The SustiNet law establishes a nine-member board to recommend to the legislature, by January 1, 2011, the details of and implementation process for a self-insured health care plan called SustiNet. The recommendations must address (1) the phased-in offering of the SustiNet plan to state employees and retirees, HUSKY A and B beneficiaries, people without employer-sponsored insurance (ESI) or with unaffordable ESI, small and large employers, and others; (2) establishing an entity that can contract with insurers and health care providers, set reimbursement rates, develop medical homes for patients, and encourage the use of health information technology; (3) a model benefits package; and (4) public outreach and ways to identify uninsured citizens. The board must establish committees to make recommendations to it about health information technology, medical homes, clinical care and safety guidelines, and preventive care and improved health outcomes. The act also establishes an independent information clearinghouse to inform employers, consumers, and the public about SustiNet and private health care plans and creates task forces to address obesity, tobacco usage, and health care workforce issues. The effective date of the SustiNet law was July 1, 2009, for most provisions.

In May of 2011, the state of Vermont became the first state to pass legislation establishing a Single-Payer health care system. The legislation, known as Act 48, establishes health care in the state as a "human right" and lays the responsibility on the state to provide a health care system which best meets the needs of the citizens of Vermont. The state is currently in the studying phase of how best to implement this system.



HEALTH LAW UpdateHealth Law Update

Assembly Proposes Legislation Requiring Reporting of Patients Likely to Engage in Harmful ConductThe New Jersey assembly introduced a bill, A3754, that, if passed into law, would require health care professionals currently providing treatment services to report to the Attorney General (AG) the name and other information of a patient that the provider determines, in the exercise of reasonable professional judgment, is likely to engage in conduct that would result in serious harm to self or others. If the AG finds that a firearms permit or license has been issued, the AG would cause any firearm possessed by the individual to be seized pending a hearing. The health care professional would be provided with civil immunity relating to the disclosure of privileged information.

For additional information, contact:

Joseph M. Gorrell / 973.403.3112 / [email protected]

Carol Grelecki / 973.403.3140 / [email protected]

State Assembly Committee Approves New Medical Liability Insurance BillOn February 7, 2013, the New Jersey State Assembly Health and Senior Services Committee approved legislative bill A1831 which amends the laws governing lawsuits and insurance coverage for medical malpractice, and would, if passed into law, represent significant tort reform. The bill generally encourages practitioners to provide emergency and charitable care without the fear of increased insurance premiums and liability to patients.

Specifically, in its current draft, the bill grants immunity from civil damages to practitioners who volunteer to respond to an emergency at a hospital or other health care facility. Additionally, insurance carriers would be prohibited from increasing insurance rates in cases where the insured practitioner provides medical services in connection with emergency or charitable circumstances. Further, an insurance carrier would be prohibited from increasing a practitioner’s premium rate in connection with a malpractice complaint unless the case results in a settlement between the parties or a final judgment or arbitration award against the insured practitioner, as opposed to the current situation in which insurance carriers may increase premiums even if an action is dismissed in the early stages of litigation.

The committee amended the bill as originally proposed to qualify the immunity provision and provide that a health care professional who volunteers to respond in good faith to an emergency situation has immunity for civil damages if the professional has not treated the patient during the two years prior to the emergency treatment at issue. The bill is now before the General Assembly for full consideration.


John D. Fanburg / 973.403.3107 / [email protected]

Keith J. Roberts / 973.364.5201 / [email protected] of Medical Examiners Adopts Rule Restricting Prescription of Steroids and HGH

The New Jersey State Board of Medical Examiners (BME) adopted a rule restricting the prescription and dispensation of anabolic steroids and human growth hormone, effective February 19, 2013 (N.J.A.C. § 13.35-7.9). The rule provides practice standards for physicians licensed in New Jersey who may not be governed by existing federal laws restricting the possession and distribution of anabolic steroids and human growth hormone.

The rule prohibits a physician from prescribing, ordering, dispensing, administering, selling or transferring any anabolic steroid or human growth hormone (HGH) or its similar analogs unless (1) there is a bona fide relationship with the patient; (2) a medical history has been obtained; and (3) a full physical examination has been performed that establishes a valid medical indication and necessity. In the case of anabolic steroids, “valid medical indication and necessity” includes, among other indications, a hormonal deficiency causing short stature in children; long-term growth failure due to lack of endogenous GH secretion; short stature associated with Turner’s syndrome; adult short bowel syndrome; adult deficiency due to pituitary tumors or muscle-wasting disease associated with HIV/AIDS. With respect to human growth hormone, “valid medical indication and necessity” includes primary hypogonadism; delayed puberty in males; a need in female patients for palliative treatment of breast cancer; AIDS wasting syndrome; anemia accompanying renal failure; bone marrow failure; severe burn injury and severe weight loss from cancer chemotherapy. However, body building, muscle enhancement and increased muscular strength are explicitly excluded from being deemed medically necessary purposes. Additionally, the rule sets forth a non-exclusive list of anabolic steroids, HGHs and similar analogs covered by the restrictions.


Kevin M. Lastorino / 973.403.3129 / [email protected]


DOH and NJHA Release Practitioner Orders for Life-Sustaining Treatment FormThe New Jersey Department of Health (DOH) and the New Jersey Hospital Association have recently released a new form for terminal patients to use to make their wishes known regarding end-of-life treatment.

The DOH is recommending that the form, known as the Practitioner Orders for Life-Sustaining Treatment (POLST), be completed by physicians or advance practice nurses for all patients who have a life expectancy of fewer than five years. The POLST is designed to complement a patient’s advance directive and to express the patient’s preferences for levels of treatment and other artificial life support and can indicate full treatment, including resuscitation attempts, or can be used to limit those interventions.

The law regarding the use of the POLST was signed into law by Governor Chris Christie in December 2011. Use of the POLST is voluntary, but once completed, the medical orders contained in a POLST must be followed by all health care professionals treating that patient.


Todd C. Brower / 973.403.3103 / [email protected]

Lani M. Dornfeld / 973.403.3136 / [email protected]

Class Action Counsel Takes a Second Swipe at Establishing that Horizon Swindled ProvidersAn amended complaint was filed late January in Edwards v. Horizon Blue Cross Blue Shield of New Jersey, 08-cv-6160, in federal court in Newark, New Jersey. The amended complaint stems from a seven year long litigation that alleges Horizon, New Jersey’s largest health insurer, under-reimbursed ambulatory surgery and surgical centers throughout the State of New Jersey that are out-of-network.

A proposed $22 million settlement of consolidated similar suits previously won primary approval in October 2010, but collapsed when a majority of the class members refused to participate.

The amended complaint alleges, among other things, that Horizon decided in 2003 to save money reimbursing out-of-network ambulatory care centers by hiring a company, Navigant, to prepare a new database that would realize those savings without regard to levels of reimbursement in accordance with applicable law and regulations. We will monitor the progress of the lawsuit.


Mark Manigan / 973.403.3132 / [email protected]

Keith J. Roberts / 973.364.5201 / [email protected]

March 2013 25

Permitting trained nuclear technicians in hospitals to prepare radiopharmaceuticals for nuclear medicine without being directly supervised by the supervising physician or pharmacist

Removal of the requirement that hospital governing bodies include a medical staff member.

CMS is accepting comments to the proposed rule until April 8, 2013.



Mark Manigan / 973.403.3132 / [email protected]

$4.2 Billion Recovered for Health Care Fraud and Abuse in 2012Last month, the U.S. Department of Health and Human Services (DHHS) and the U.S. Department of Justice (DOJ) released their annual report on health care fraud and abuse. The report summarizes their efforts to combat fraud and abuse in federally-funded health care programs, as well as their enforcement actions and recoveries in 2012. Of note, last year:

DHHS and DOJ recovered approximately $4.2 billon through health care fraud actions and administrative proceedings

DOJ opened 1,131 criminal health care fraud investigations and 826 defendants were convicted of health care fraud and related crimes

DOJ opened 885 civil health care fraud investigations

Federal Bureau of Investigation disrupted 329 criminal fraud organizations and the hierarchy of 83 criminal enterprises

Office of Inspector General excluded 3,131 individuals and entities, of which 287 were related to criminal convictions for Medicare or Medicaid fraud, 212 were for patient abuse or neglect, and 1,462 were for license revocations.

These results were, in part, due to improvements in data analysis and data mining capabilities. These agencies continue to use data mining, predictive analytics, trend evaluation and modeling approaches to better analyze and target health care fraud. Under the Patient Protection and Affordable Care Act, the federal government has allotted increased funding to these agencies to combat fraud and abuse.


Lani M. Dornfeld / 973.403.3136 / [email protected]

Carol Grelecki / 973.403.3140 / [email protected]


New Jersey Hospital Pays $12.5 Million to Settle Kickback AllegationsIn late January, Cooper Health System settled a suit with the U.S. Department of Justice. Under the settlement, Cooper will pay $12.5 million for alleged improper payments to physicians for patient referrals in violation of the federal False Claims Act and New Jersey False Claims Act.

The Department of Justice and the State of New Jersey alleged that from October 1, 2004 through December 31, 2010, Cooper recruited local, outside physicians to serve on the Cooper Heart Institute Advisory Board (CHIAB), and these physicians were paid $18,000 a year to attend four meetings per year. The alleged purpose of these payments was to induce referrals, and subsequently referrals were made and billed to Medicare and Medicaid, violating state and federal anti-kickback laws.

This settlement also resolves a False Claims Act suit by a physician who was recruited to take part in CHIAB but instead filed a whistleblower “qui tam” action. Both federal and state false claims laws permit private individuals to file such actions and share in a portion of the proceeds recovered. The whistleblower will receive $2.4 million from the governments’ recoveries, in addition to $430,000 from Cooper for expenses and attorneys’ fees.




CMS Issues Proposed Rule to Promote Program Efficiency, Transparency and Burden ReductionOn February 7, 2013, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to reform Medicare regulations that it has identified as unnecessary, obsolete or excessively burdensome on hospitals and health care providers. CMS estimates the provisions contained within the proposed rule could save $3.4 billion over five years.

Key provisions include:

Reducing the requirements that ASCs must meet in order to provide radiology services to match the services they actually perform, including the requirement that a radiologist supervise the radiology services performed in ASCs

Allowing registered dietitians to order patient diets independently, without physician supervision

March 2013 27

IRS Chief Counsel Advice Requires Inclusion of EHR Incentive Payments as IncomeThe Electronic Health Record (EHR) Incentive Program was created by the American Recovery and Reinvestment Act. The goal of the program is to improve health care quality and efficiency by encouraging health care providers to record patient data electronically. Providers that demonstrate "meaningful use" of EHR technology can receive annual incentive payments from the Center for Medicaid Services (CMS) under the EHR program. Providers must demonstrate meaningful use by meeting specific guidelines outlined by CMS, such as issuing prescriptions electronically or electronically checking for drug interactions. CMS makes these payments based on the demonstration of meaningful use by individual providers rather than their practices.

CMS has stated that these payments are an incentive to encourage providers to record patient data electronically and not a reimbursement of the cost of implementing EHR technology. For this and other reasons, in a recent Chief Counsel Advice announcement, the IRS has concluded that these payments are includable as gross income and are not considered to be a return of capital. If a provider receives an incentive payment and is required to remit that payment to another entity, such as their practice, the payment is not considered gross income of the provider.

The IRS further concluded that CMS must report the amount of the annual incentive payment paid to each recipient on a Form 1099. CMS has a reporting obligation to the recipient of the payment and not to the party whom is responsible for including the amount as gross income (such as the provider's practice group).

EHR Payments

Support Groups Attendees Find Help from Those with Similar Situations. The New Jersey Self-Help Clearinghouse has been helping people find and form support groups for over 31 years. Plans for the Clearinghouse began in 1980. Armed with a wooden card file box and index cards, the Clearinghouse began to collect information on self-help support groups. This list continued to grow and was printed as a directory in January of 1980. The Self-Help Clearinghouse was funded through a grant from the State Division of Mental Health and operations began in January 1981. The Clearinghouse became a department of Saint Clare’s Health System in 1985.

The Clearinghouse lists over 6,750 support groups all over the state of New Jersey for just about any type of health and/or stressful situation that affects people’s well-being. The Clearinghouse has, over the years, built and continually updates a rather extensive database of support groups. Groups cover a wide range of life-situations such as addictions, bereavement, disabilities, behavioral and physical health, parenting, care giving, and much more.

The Clearinghouse provides free consultation and training services to persons developing no-fee support groups; free training workshops on the development and facilitation of self-help groups, how to deal with difficult people, developing listening skills, and more as well as providing free assistance with the “how to’s” of starting a group.

People attending support groups find others who share similar experiences. They have the chance to collectively share practical information, exchange coping strategies, as well as being part of a community that understands them and their unique circumstances. If you would like information on attending or starting a support group, call the New Jersey Self-Help Group Clearinghouse, Monday – Friday, 8:30am-5pm, at 1-800-367-6274 or 973-989-1122.

_______________________________

“My years as a medical practitioner, as well as my own first-hand experience, have taught me how important self-help groups are in assisting their members in dealing with problems, stress, hardship and pain…Today, the benefits of mutual aid are experienced by millions of people who turn to others with a similar problem to attempt to deal with their isolation, powerlessness, alienation, and the awful feeling that nobody understands.”

- Former U.S. Surgeon General, C. Everett Koop, MD

Support Groups


By Iris Goldberg

March can be a tough month for some of us. This year especially, spring has officially started but we have been tightly held in winter’s grip. What better reason to get out of the house and share a cozy meal with good friends or with someone you love? I have a great place in mind for you to try that will surely chase those winter blues away. In fact, Michael and I were there on the evening before the last snow storm of the season arrived.

Not far from Overlook Hospital, the Huntley Taverne offers classic seasonal cuisine from casual “bar” fare to full-course dinners and an extensive 250 bottle wine list to enhance whatever type of food one chooses to enjoy. The place is really attractive with cathedral, beamed ceilings, two wood-burning fireplaces and large beautiful windows. There is a loft dining room that overlooks the handsome bar or a wrap-around porch for dining that opens during the warmer months. We were in the mood to be somewhat less formal on this frigid evening and asked to be seated at one of the tables in the bar itself. The bar was jumping, the fire was glowing and before too long, our frosty cheeks and hands were thawing.

From the first moment we sat down we were impressed with the attentive service. The hostess came by to answer any questions and was happy to discuss the special beer offerings with Michael, who has very particular preferences when it comes to beer. We ordered our drinks and studied the menus while we observed the contagious merriment being shared among the many people seated and standing at the bar.

In lieu of salad we decided to share a trio of appetizers which included Maryland crab cakes, curried lemongrass chicken satays and Asian tuna tartare. I love having a variety of foods to taste and this sampling was perfect as a starter. The crab cakes were crisp and succulent with a tangy remoulade. The satay was moist, not dry and well-seasoned and the tuna tartare was as good as any that I have had. While we were savoring this first course, the Manager came by to inquire if everything was to our satisfaction so far. With my mouth full, I enthusiastically nodded to indicate my approval.

For our dinner, we decided to choose from the Taverne menu, which, by the way, is always available. Michael was determined to have a burger, his only problem was deciding between the Huntley Burger, which is served with grilled red onions, pancetta, maytag bleu cheese and truffled pomme frittes or the Vermont Cheddar Burger, served with regular fries. He really wanted the Cheddar Burger but asked if he could get some grilled onions as well. Since I had already eaten my quota of red meat that week, I chose the Cuban Pork Sandwich, which consists of cumin roasted pork tenderloin, ham, pickles, gruyere cheese, mustard and mayo, served with tomato salsa, baby arugula and shaved red onion salad. I must say, this was, unexpectedly, one of the most delicious sandwiches I have ever tasted. The bread was grilled and the cheese, melted. The pork was thinly sliced and as tender as could be. The seasonings and other ingredients all blended so well that each mouthful was a treat. The accompanying salsa and salad worked quite well as a counterpoint. I only wished that I had room to finish but despite my best effort, I unfortunately had to leave almost half on my plate.

Michael’s burger was to his liking, cooked rare, as he requested, which is difficult to get at many restaurants due to health concerns. After he cleaned his plate I asked if he would like to finish my pork sandwich. He managed only one bite but agreed that it was a very special sandwich, indeed.

With our meal finished, the thought of venturing back outdoors was not appealing at all. Our appetites were certainly satiated and we both felt that the warmth of this lovely room with its noisy and happy patrons had somehow settled within each of us. We promised ourselves to return and experience the more formal cuisine, which is quite enticing, at another time but we couldn’t imagine enjoying any meal more than the one we had just shared.

The Huntley Taverne is located at 3 Morris Avenue, Summit, NJ 07901. (908) 273-3166

Food for Thought

Summit, New Jersey


Let Brach Eichler’s Health Law Practice Group Help You Chart a Strategic Course

For Your Health Care Business

101 Eisenhower Parkway - Roseland, New Jersey 07068 - t. 973.228.5700. f. 973.228.7852. - www.bracheichler.com

Coverage is subject to meeting eligibility requirements and company approval.

www.Bollinger.com/pro

Talk to Bollinger about your Professional Liability … Before entering this room.

With one of the largest professional liability divisions in the region, Bollinger has the expertise and resources to help ensure that your liability threats are properly addressed.

To learn more about how Bollinger can help your practice, contact Brian S. Kern, Esq.

973-921-8497 or [email protected]

• BROAD COVERAGE FORMS • FINANCIALLY STRONG INSURANCE COMPANIES • ADVANCED RISK MANAGEMENT SERVICES AND STRATEGIES • HIGHLY COMPETITIVE PRICING

nj physician magazine march 2013

Documents

medical community

healthcare reform

independent publication

written permission

livingston nj

issueadvertising rates

early look

subscription rates