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Lame Duck 2013 Gubernatorial Action – Two Successes for Physicians

Lame Duck 2013 Legislative Action
(the Governor has 10 days to sign or pocket veto all bills signed at the end of the two year legislative session)

APN Scope of Practice

Despite our protest, both houses have passed a bill that would permit Advanced Practice Nurses to certify cause of death.  MSNJ opposes this bill because cause of death is in fact a medical diagnosis and should be provided only by a physician. Read MSNJ’s opposition letter. We are hoping for a pocket veto by the Governor, as he did two years ago when the Legislature rushed the bill through in an identical manner.

Pharmacy Vaccines

A3251, the bill allowing pharmacies to administer vaccines has passed both houses and awaits action by the Governor. The bill allows pharmacies to administer to patients 18 and older a vaccine (1) pursuant to a prescription, (2) in immunization programs authorized by a prescriber’s standing order for the vaccine or (3) in immunization programs and programs sponsored by governmental agencies that are not patient specific .  Under the bill, a pharmacist may administer an influenza vaccine to a patient who is seven years of age or older.  For a patient who is under 18 years of age, a pharmacist shall not administer a vaccine except with the permission of the patient’s parent or legal guardian.  For a patient who is under 12 years of age, a pharmacist shall not administer a vaccine unless pursuant to a prescription by an authorized prescriber.  A patient 12 years of age or older does not need a prescription for an influenza vaccine. MSNJ, NJAFP and NJAAP opposed this bill in its original form, but softened when the vaccines for children were limited to flu. This bill still represents a scope of practice expansion of concern to MSNJ.

Physician Loan Redemption

The Legislature passed S162, which establishes a Physician Loan Redemption Program. The bill awaits action by the Governor. MSNJ, along with NJ AFP and COTH worked expediently to improve the bill that was passed by the Senate in a skeletal, flawed form.  With our input, the bill now provides for redemption of eligible qualifying loan expenses for physicians who work for no less than four years at an approved site in the clinical practice of primary care or in the clinical practice of specialized care if the specialty is projected to experience a significant shortage.

Pain Medicine Restrictions

The Senate Budget Committee approved a bill that would limit insurers from using step therapy protocols for pain medication. Though the bill had already passed the Assembly, the Senate failed to vote on it, so it died at the end of the legislative session. MSNJ supported this bill and will work with legislators on the issue in 2014.  Our larger goal is to balance drug abuse reduction with proper access to pain medicine for patients who need it.

Medicaid Provider Rates

Both houses passed S2241, which would prohibit Medicaid managed care organizations from reducing certain provider reimbursement rates without approval from DHS.  The bill stems from an attempt by Horizon last year to slash home care provider rates after the Governor began moving most Medicaid services from fee for service to managed care. The insurance companies oppose the bill and stated that the bill would create a regulatory situation that is not used by any other state and that it will ultimately increase costs to the state. They also stated that the record of managed care in New Jersey is very good and the system is fair. MSNJ supports the bill, which awaits action by the Governor.

Higher Education Epinephrine Emergency Treatment Act

Both houses passed S2448, which allows public and independent institutions of higher education in New Jersey to develop a policy for the emergency administration of epinephrine to a member of the campus community for anaphylaxis when a medical professional is not available.  Institutions of higher education that develop such policies must designate an appropriately licensed physician, physician assistant, advanced practice nurse, or registered nurse to serve as the “licensed campus medical professional,” who will oversee the institution’s epinephrine administration and train designees in the administration of epinephrine via a pre-filled auto-injector mechanism.  The Secretary of Higher Education is to establish guidelines for the development of a policy for the emergency administration of epinephrine, which will be disseminated to the president of each institution of higher education.  In addition, the bill provides immunity for a licensed campus medical professional, a trained designee, and a prescribing physician for good faith acts or omissions committed in accordance with the bill’s provisions.   MNSJ supports this bill, which awaits action by the Governor.

State Trauma Plan

Both houses passed a bill that provides for the establishment of a formal Statewide trauma care system plan, which will include all health care facilities in the State providing care to injured patients in the State, to the extent that their resources and capabilities allow.  The Department of Health sought counsel with the American College of Surgeons Trauma System Evaluation and Planning Committee regarding the State’s trauma system.  This bill incorporates the recommendations that resulted from that interaction.  The commissioner is required to appoint a State Trauma Medical Director to oversee the planning, development, ongoing maintenance, and enhancement of the formal trauma system in collaboration with a multidisciplinary advisory body called the State Trauma System Advisory Committee (STSAC).  The STSAC is required to study the State’s trauma care system, collect data, and provide a report on the development of a formal Statewide trauma system plan.  The STSAC’s recommendations will provide the basis for the commissioner’s development of regulations implementing the plan.  The STSAC’s initial report, containing the formal Statewide trauma system plan, is due within one year.  Thereafter, the STSAC will be required to systematically review strategies to maintain and improve the State trauma system, submit an annual report to the commissioner and the director on its activities, and provide recommendations it determines are necessary to improve the State trauma system.  MSNJ is neutral on this bill, which awaits action by the Governor.

Breast Density

Both houses have finally passed the final version of A2022/S792, which now awaits action by the Governor.  MSNJ worked on this bill in great detail. The bill 1) requires insurance companies to cover certain screenings, 2) requires physicians to provide information to  certain patients regarding breast density and 3) requires study of breast cancer risk factors. Radiology facilities must distribute to certain patients a notice that reads as follows: “Your mammogram may show that you have dense breast tissue as determined by the Breast Imaging Reporting and Data System established by the American College of Radiology.  Dense breast tissue is very common and is not abnormal.  However, in some cases, dense breast tissue can make it harder to find cancer on a mammogram and may also be associated with a risk factor for breast cancer. Discuss this and other risks for breast cancer that pertain to your personal medical history with your health care provider.  A report of your results was sent to your health care provider. You may also find more information about breast density at the website of the American College of Radiology,” The bill states that it does not impose a standard of care obligation upon a patient’s health care provider.  The bill requires the Mandated Health Benefits Advisory Commission to prepare a report regarding the implementation and administration of the bill, including analyses of social, medical and financial impact. The bill requires the Department of Health, in conjunction with the Medical Society of New Jersey, to convene a work group to review and report on strategies to improve the dialogue between patients and health care professionals regarding risk factors for breast cancer and breast imaging options.  Though we may have improved the bill, MSNJ remains concerned about legislative interventions into the physician-patient relationship, in general, and notification mandates, specifically.

For Profit Hospital Reporting

After two years of amendments and negotiations, a bill regarding for profit hospitals is finally settled. The Governor rejected a bill in 2012 that would have required detailed financial reports by for profit hospitals, which were growing in numbers at the time.  On the last day of the two year session, the Legislature accepted the watered down rewrite of the bill by the Governor.  The bill now requires the Commissioner of Health to undertake a review of New Jersey’s hospital financial reporting requirements and shall report any findings and recommendations directly to the Governor no later than six months from the date of enactment of.  Specifically, the Commissioner shall examine the impact of, and make recommendations on, the following areas for all entities receiving Health Care Subsidy Fund payments from the State: Internal Revenue Service filings, Securities and Exchange Commission filings, and audited financial statements. The bill takes effect immediately.

Vaccines for Healthcare Workers

Both houses passed A2172, sponsored by Chairman Herb Conaway, which requires health care facilities to annually offer influenza vaccination to their health care workers and require the implementation of an annual influenza vaccination program in accordance with the current recommendations of the Advisory Committee on Immunization Practices of the federal Centers for Disease Control and Prevention and any rules and regulations adopted by the Commissioner of Health.  In lieu of receiving the vaccine at work, a health care worker would be permitted to present acceptable proof, including an attestation by the health care worker, of a current influenza vaccination from another vaccination source, or sign a written declination statement.  Each facility would be required to maintain a record of influenza vaccinations, retain each signed attestation and declination statement, and report to the Department of Health (DOH) the vaccination percentage rate of its health care workforce as part of its program or by other means as attested to by the health care worker.  Each facility would also be required to provide an educational component to its influenza vaccination program and annually evaluate the program with the goal of improving the rate of vaccination among its health care workers. The bill awaits action by the Governor, who pocket vetoed the bill last year.

Newborn Screenings

Both houses passed S2318, a bill that requires newborn infant screening for tongue tie. MSNJ was neutral on the bill.  The bill awaits action by the Governor.

Stillbirth Education

Both houses passed the  “Autumn Joy Stillbirth Research and Dignity Act,” which requires DOH to establish protocols for stillbirths and establishes a stillbirth research database. The bill awaits action by the Governor.

Pediatric Respite Care

Both houses approved A3558, which would provide for licensure of pediatric respite care facilities.  The facilities will provide end-of-life care for children up to age 21 with limited life expectancies or complex, life-limiting illnesses and support for their families, and employ interdisciplinary teams to assist in providing curative treatment when possible, palliative care, and supportive services to meet the physical, emotional, spiritual, social, and economic needs of children and their families during illness, as well as during dying and bereavement if no cure is attained. The bill awaits action by the Governor.

Drug Adherence Efforts

Both houses passed A1214, which requires the State Health Benefits Commission and the State Health Benefits Plan Design Committee to establish a three-year pilot program to provide benefits coverage to select employees with chronic health conditions using a value-based benefit design under the State Health Benefits Program (SHBP).  The value-based benefit design will target the following chronic health conditions: diabetes, high cholesterol, hypertension, and asthma. The coverage design will utilize explicit financial incentives to increase the employee’s interaction with appropriate health care providers, and encourage use of those health benefits that specifically relate to the employee’s chronic health condition.  The value-based benefit design pilot program will assign a participating employee to a pharmacist, who, in collaboration with the employee’s primary treating physician, will be responsible for coordinating medication therapy management services within the scope of the pharmacist’s license to practice pharmacy in the State of New Jersey.

The following financial incentives directly related to the diagnosis, care, mitigation, or treatment of the condition for which the employee is participating in the program will be provided:

(1) all tuition costs for any education class attended by the employee which provides medical condition self-management, recommended to the employee by the primary treating physician or assigned pharmacist;

(2) all costs for private visits with the employee’s assigned pharmacist;

(3) all costs for a medical device or supply deemed medically necessary by the primary treating physician or assigned pharmacist;

(4) all costs for laboratory testing; and

(5) waiver of all copayments for any prescription drug..

This bill is based on the well-known Ashville Project.  The bill will most likely be approved by the Senate and head to the Governor’s desk in lame duck.

Reconstructive Breast Surgery

Both houses passed S374, which grants a state sales tax exemption for services prescribed by a doctor in conjunction with reconstructive breast surgery. The procedures, currently subject to the 7 percent tax rate, are utilized to restore the appearance of the breast.  The bill addresses a current loophole where insurance providers cover the costs of the procedures but pass on the cost of the sales tax to the patient.  The bill awaits action by the Governor.

Medical Marijuana

Both houses passed A765, which requires that a registered qualifying patient’s authorized use of medical marijuana be considered equivalent to using any other prescribed medication and not the use of an illicit substance that would otherwise disqualify a qualifying patient from needed medical care, including organ transplantation.  The bill awaits action by the Governor.

Lame Duck 2013 Veto Action

Gender Changes on Birth Certificates

The Senate and Assembly have both passed A4097/S2876, which allows more people to change their birth certificates.  To obtain the amended certificate, a person would be required to submit:  1) a form provided by the State registrar of vital statistics and completed by the person’s licensed health care provider which indicates that the person has undergone clinically appropriate treatment for the purpose of gender transition, based on contemporary medical standards, or that the person has an intersex condition; and 2) a certified copy of a court order indicating the person’s name change, if the person has changed his or her name.  Under current law, a person is required to undergo sex reassignment surgery to receive an amended birth certificate.

Declarations of Death

The Governor signed a bill that removes the statutory authority of the Department of Health (DOH) and the State Board of Medical Examiners (BME) over medical standards governing declarations of death upon the basis of neurological criteria.  The bill requires that a declaration of death upon the basis of neurological criteria be made by a licensed physician professionally qualified by specialty or expertise, based upon the exercise of the physician’s best medical judgment and in accordance with currently accepted medical standards.  Joint DOH/BME regulations would no longer be needed to set forth currently accepted medical standards (including criteria, tests, and procedures) to govern declarations of death upon the basis of neurological criteria.  If they are used, the regulations concerning the declaration of death upon the basis of neurological criteria may not require the use of any specific test or procedure in the declaration of death upon the basis of such criteria. MSNJ supports this bill.

Self-Referral Laws

The Governor signed a bill which allows practitioner with financial interest in health care service providing lithotripsy to refer patients to that health care service if certain conditions are met. MSNJ and New Jersey urologists support this bill, which is a “clean up” to the reforms made to self-referral laws (the Codey Act) in 2009. Lithotripsy was left out of the exemptions in 2009.

NJ Supreme Court Requires Same Specialty Expert in Medical Liability Lawsuits- Position Urged by MSNJ

Today, the New Jersey Supreme Court ruled in Nicholas v. Mynster, a medical liability lawsuit, in which MSNJ and AMA filed an amicus–friends of the court-brief. The high court agreed with our position that a challenging expert must be board certified in the same specialty as a board certified defendant. In doing so, the court adopted a ” kind-for-kind” specialty requirement. According to Melinda Martinson, General Counsel of MSNJ, “physicians can now be assured that an expert testifying against them in a medical malpractice case will be qualified on the applicable standard of care and whether there was a deviation from the standard resulting in injury.”
The court recognized that competency to treat a condition is not the same as the qualifications required by statute to testify to the applicable standard of care.The court interpreted the plain language of the statute that specifies the qualifications of a testifying expert necessary to carry out the clear intent of the Legislature when it enacted the “New Jersey Medical Care Access and Responsibility and Patients First Act” in 2004. MSNJ worked hard to pass the legislation that included the standards for experts testifying in medical malpractice cases. Our efforts were necessary to address sky-rocketing professional liability premiums driven by lawsuits that were without merit. Read the court’s opinion.MSNJ appreciates the support of the AMA Litigation Center in joining our brief written by John Zen Jackson and Cecylia K. Hahn of McElroy, Deutsch, Mulvaney & Carpenter.

MSNJ Files Brief in US Supreme Court Advocating for Class Arbitration

By: Melinda Martinson, MSNJ General Counsel

On March 1, MSNJ joined the AMA filing an amici curiae—friends of the court– brief in the U.S. Supreme Court in the matter of Oxford v. Sutter. This case presents the important question of whether physicians may arbitrate as a class when the insurer participation agreement requires that all disputes be submitted to arbitration. The matter is before the Supreme Court, not as a matter of right, but because the high Court granted Oxford’s petition for certiorari signaling that it will reach this important class arbitration issue.

MSNJ and the AMA assert that mandated arbitration without the right to arbitrate as a class leaves “no practical means of enforcing contracts with insurers” and is tantamount to no recourse at all. Dr. Sutter was mandated by Oxford to arbitrate his disputes in 2002. The arbitrator allowed the matter to proceed as a class. Oxford objected, litigated, and has lost at every level of appeal in the courts. Dr. Sutter and all physicians similarly situated, including MSNJ members, have been without a remedy for over ten years.

Read the brief for more details.

MSNJ Supports Medical Liability Reform Legislation as it Advances out of Committee

MSNJ supported medical liability reform in the Assembly Health Committee this week. A1831, sponsored by Chairman Conaway, would prohibit the addition of defendants using fictitious names at least 120 days prior to the date on which the action is set for trial. This bill also clarifies the existing legal immunity for health care professional who volunteers to respond in good faith to an emergency at a hospital or health care, removing the requirement that the service be provided without payment.

The bill provides that an insurer cannot increase the premium of any medical malpractice liability insurance policy based on a claim of medical negligence or malpractice against an insured unless the claim results in a medical malpractice claim settlement, judgment or arbitration award against the insured. Finally, the bill also prohibits an insurer from increasing medical malpractice insurance premiums, if the alleged malpractice occurred in certain charitable or emergency situations. The trial lawyers oppose the bill. Read the New Jersey Lawsuit Reform Alliance’s support letter and flier on the benefit of reform on women’s health.

MSNJ News Roundup – January 4, 2013

Medicare Fee Cut Averted Through 2013; Sequester Cut Delayed for Two Months On January 1st Congress passed the American Taxpayer Relief Act  and successfully averted the average 26.5% cut in the Medicare physician fee schedule The act dodges the scheduled fee cut due to the sustainable growth rate (SGR), but does not repeal the flawed formula. The 2% sequestration cuts to Medicare payments have also been delayed, but for only two months. MSNJ and our members actively lobbied our congressional delegation to stop the Medicare fee cut, repeal the SGR and replace it with new payment models that will be sustainable. This action stops the fee cut and allows a year for the repeal and replacement of the SGR. While we are thankful that Congress prevented the drastic cut in fees, MSNJ still believes that a permanent fix to the SGR is necessary and overdue. See Senator Menendez’s response to MSNJ’s request that the SGR be repealed. We will continue our efforts to repeal the SGR.

This $25 billion band-aid was offset by assorted provisions. Thankfully, as advocated by MSNJ and the AMA, the increase in Medicaid payments to primary care providers and funds for preventive services remain untouched. Unfortunately, the offsets will have a negative impact on payments for advanced imaging services and will extend the statute of limitations on recoupment to 5 years. In addition, the act takes back unobligated funds for health insurance co-ops as a cost savings. Existing obligations will be honored.

For details on Medicare and other health provisions contained in the American Taxpayer Relief Act, visit the AMA’s website.

2013 Medicare Fee Schedule- Billing Update & Participation Deadline Extension
Many members have questions about billing Medicare, now that the cut has been averted. Although the fee cut has been prevented, it is an average, not applicable to each CPT code and there may be other changes affecting the 2013 Medicare fee schedule, besides the SGR. While the SGR cut has been delayed until after December 31, 2013, Relative Value Unit (RVU) changes will be different from last year, thus changing the 2013 fee schedule for certain CPT codes–either up or down.

We have asked for implementation information from Novitas (New Jersey’s Medicare Contractor). So far, there is no official Novitas position, but CMS published notice indicating that it is updating the 2013 Medicare Physician Fee Schedule. CMS also noted that the Medicare contractors may hold claims until January 15, 2013, while they test and implement the fee schedule. This falls within the prompt pay timeframe.

CMS will give Novitas until January 23, 2013 to post the updated fee schedule on its website.  As of today, the Medicare fee schedule posted on the Novitas website still reflects the scheduled fee cut. In the meantime, we recommend that members hold claims until Novitas posts the corrected 2013 fee schedule. If a practice uses the wrong fee schedule and bills Medicare less than the new fee schedule amount, Medicare will pay the lesser of the two fees and will not reconsider the claim. CMS has also extended the deadline for changing participation status to February 15, 2013. We will notify members, once additional information is received from Novitas.

First HIPAA Breach Settlement Involving Fewer than 500 Patients Announced
The U.S. Department of Health and Human Services (HHS) recently announced a resolution agreement in which the Hospice of North Idaho (HONI) agreed to pay $50,000 for potential HIPAA violations involving less than 500 patients. This is the first settlement involving a breach of protected health information (PHI) of fewer than 500 patients.  HONI also agreed to a corrective action plan (CAP) that requires HONI to notify HHS of any violation of HONI’s privacy and security policies within 30 days of the breach for two years after the date of the resolution agreement. As part of the CAP, HONI must include a description of the events leading up to the breach, a copy of the policy violated, and a description of the corrective actions taken.

The investigation was prompted by HONI’s submission of a breach report to HHS, a requirement under the HITECH Act. A HONI laptop containing electronic PHI was stolen, putting the privacy of 441 patients at risk. After investigation, HHS found that HONI did not perform necessary risk analysis and failed to establish adequate policies and procedures regarding the security of laptops and other mobile devices containing PHI. These inadequacies were in direct violation of the HIPAA Security Rule.

In its article, New Year, Same Old Health Data Breaches, FierceHealthIT noted that security risks continue to be a problem for the healthcare industry and listed several recent cases of PHI security breaches. HHS recognized that physician education is essential to reduce the frequency of such breaches.  In response, HHS developed an educational initiative, Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information, to assist physicians with HIPAA compliance when using laptops, smart phones, and tablets. Members are encouraged to review the HHS materials and to take the appropriate steps to protect electronic PHI contained in laptops or other mobile devices.

New Jersey Supreme Court Ruling on Statute of Limitations

This week, the New Jersey Supreme Court published its opinion in Kendall v. Hoffman-LaRoche, its latest interpretation of the discovery rule in New Jersey. MSNJ filed an amicus brief in the case because the state courts’ expansion of the two-year statute of limitations for personal injury lawsuits through the discovery rule is of great concern to physicians in the state of New Jersey. We are disappointed that the state’s highest court has again adopted an expansive view of “when the patient knew or should have known” that her injuries were related to the use of Accutane.

MSNJ’s participation in the case is part of our legal advocacy initiative to restrain further inappropriate extension of the statute of limitations. We believe that an expansive interpretation of the discovery rule has a direct impact on the cost of practicing medicine through increased professional liability premiums. The opinion sharpens our resolve to achieve tort reform through legislation.

AMA Names Dr. James Madara New EVP/CEO

Chicago – The American Medical Association (AMA) today named James L. Madara, M.D., as its new Executive Vice President and Chief Executive Officer. Dr. Madara will assume leadership of the nation’s oldest and largest physician group on July 1.

Dr. Madara, 60, is an accomplished academic medical center physician, medical scientist and administrator who served as Timmie Professor and Chair of Pathology and Laboratory Medicine at the Emory University School of Medicine before assuming the Thompson Distinguished Service Professorship and deanship at the University of Chicago Pritzker School of Medicine,  where he was the longest serving Pritzker dean in the last 35 years. Subsequently, he added the responsibility of CEO of the University of Chicago Medical Center, bringing together the university’s biomedical research, teaching and clinical activities. As CEO, he engineered significant new affiliations with community hospitals, teaching hospital systems, community Federally Qualified Health Centers on Chicago’s South Side, as well as with national research organizations including the Janelia Campus of the Howard Hughes Medical Institute in Bethesda and the Ludwig Foundation of New York.

“The AMA is a venerable institution, and I am honored to lead it during this challenging and exciting time,” Dr. Madara said. “The AMA has been at the forefront working to improve public health, physician practice, patient care and our American health care system for the past 164 years. Today more than ever, America’s patients and physicians need a strong and vibrant AMA to tackle the many challenges facing them. I look forward to leveraging my skills and experience to help the AMA succeed and fulfill its core mission to promote the art and science of medicine and the betterment of public health.”

While at the University of Chicago from 2002-2009, Dr. Madara oversaw a significant renewal of the institution’s biomedical campus, including the Comer Children’s Hospital, the Gordon Center for Integrative Science, a new adult hospital pavilion, and the Knapp Center for Biomedical Discovery. His deanship also extended to the University’s renowned Biological Sciences Division.

“The American Medical Association is thrilled to have a proven medical leader like Dr. Madara serve as our next EVP/CEO,” said Ardis D. Hoven, M.D., chair, AMA Board of Trustees. “Dr. Madara is a strong strategic thinker and planner who has a track record of bringing people together to accomplish significant, ambitious, health-related goals and projects. Having overseen a $1.6 billion integrated academic medical center, Dr. Madara understands many of the complex clinical, academic and business-related issues confronting medicine and health care today. His insight and perspective will be invaluable in helping the AMA tackle its agenda.”

Dr. Madara is a noted academic pathologist and an authority on epithelial cell biology and on gastrointestinal disease.  He has published more than 200 original papers and chapters, making important contributions to understanding the biology of the cells that line the digestive tract. His work has garnered both national and international awards.

Dr. Madara has served as President of the American Board of Pathology, as Editor-in-Chief of the American Journal of Pathology, has received a prestigious MERIT Award from the NIH,  has been elected to membership in the Association of  American Physicians, and recently received the Davenport Award for lifetime achievement in gastrointestinal disease from the American Physiological Society.

Most recently, Dr. Madara served as senior advisor with Leavitt Partners, a highly innovative health care consulting firm started by former Secretary of Health and Human Services Mike Leavitt.

Dr. Madara earned his medical degree from Hahnemann Medical College in Philadelphia. He completed his internship and residency at New England Deaconess Hospital in Boston. He subsequently completed a fellowship in anatomy and cell biology at Peter Bent Brigham Hospital in Boston (now Brigham and Women’s Hospital). Following his fellowship, Dr. Madara joined the faculty of Harvard Medical School where he rose to a full tenured professor and served as director of the Harvard Digestive Diseases Center.

Dr. Madara is married to Vicki M. Madara. They have two children: Alexis and Max.