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JAN   | 2010




2009 Health Law Year in Review




  101 Eisenhower Parkway     n   Roseland,New Jersey 07068
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New Jersey Court Decisions                                          recourse to the courts for discovery materials sought to be used
                                                                    in a PIP arbitration is inappropriate under the PIP statute, N.J.S.A.
and Cases                                                           39:6A et seq. Such requests, the Court concluded, must instead
                                                                    be approved by the Dispute Resolution Professionals empowered
                                                                    to decide PIP arbitration disputes.
New Jersey Court Finds MRI Facility that Billed Before
                                                                    The decision affirmed the trial court’s dismissal of the plaintiff’s
Licensure Liable under Insurance Fraud Act                          complaint seeking expansive discovery of an assignee health
                                                                    service provider for use in PIP arbitrations. The Court held that
In Open MRI of Morris & Essex, LP v. Frieri, a case decided on
                                                                    petitioning the court, rather than pursuing the PIP arbitration
March 11, 2009, the Appellate Division of the Superior Court
                                                                    appeals mechanisms, would contravene the Legislature’s express
of New Jersey determined that an MRI facility that billed for
                                                                    preference for limited judicial oversight of PIP disputes.
services before it became licensed was liable under the New
Jersey Insurance Fraud Prevention Act even though it applied and
                                                                    New Jersey Attorney General Sues Nonprofit
obtained licensure during a New Jersey Department of Health
                                                                    Corporation Trustees
and Senior Services amnesty period.
                                                                    On September 17 2009, the New Jersey Attorney General filed a
                                                                                       ,
Appellate Division Affirms Adoption of Rules Authorizing            lawsuit against the trustees of Hoboken-based Stevens Institute
New Jersey’s Continued Participation in the Atlantic                of Technology (“Stevens”), a nonprofit corporation, its president,
C-Port Trial, Elective Angioplasty Study                            and the chairman of the board of trustees. The sixteen-count
                                                                    civil complaint alleges financial mismanagement, excessive
On September 10, 2009, the Appellate Division of the Superior       spending of endowment investment gains, improper handling
Court of New Jersey reached a decision in Cooper Univ. Hosp.        of specific endowments and investments, failure to properly
v. Jacobs, that upheld the adoption of rules by the New Jersey      maintain records and accounts, and excessive compensation of
Department of Health and Senior Services (“DHSS”) at N.J.A.C.       the school president. On January 15, 2010, the parties settled.
8:33-3.11(e) (the “Adopted Rules”). The Adopted Rules authorize
New Jersey’s continued participation in the “Atlantic C-Port
Trial, Elective Angioplasty Study, a multi-state demonstration
                                 ”
project intended to assess the safety and efficacy of allowing      Developments Relating to the
community hospitals without on-site cardiac surgical services to
provide elective angioplasty to their patients (the “Project”).
                                                                    Codey Law and Garcia Case
  Prior to the adoption of the Adopted Rules, a hospital without
   on-site cardiac surgical facilities could not perform elective   Bill Revising Codey Law Passed into Law
   angioplasties. Such a hospital could, however, perform
                                                                    On March 23, 2009, Senate Bill S787 Senator Richard J. Codey’s
                                                                                                        ,
   emergency angioplasties.
                                                                    bill revising the 1991 Codey Law, was signed into law (the
   2007, the New Jersey Supreme Court held that
  In                                                                “Law”) by Governor Jon Corzine. The Law modifies the Codey
   while termination of the Project would be “unjust and            Law in the following ways:
   inappropriate, the regulations violated “fundamental
                 ”
   principles relating to the regulatory process, and required
                                                ”
                                                                      Practitioners may refer to ASCs. The Law now expressly
                                                                       provides that a practitioner may refer a patient to an ASC
   that the regulations include more details.
                                                                       or a surgical practice in which the practitioner holds an
   a result of the 2007 decision, DHSS proposed new rules
  As                                                                   ownership interest, provided that: (1) the practitioner who
   and amendments to rules to implement the Project. DHSS              provides the referral personally performs the procedure;
   formally adopted the rules on December 17 2007
                                            ,    .                     (2) the practitioner’s remuneration as an owner is based
   Adopted Rules permit the continued participation by
  The                                                                  on his or her ownership interest and not on the volume of
   New Jersey community hospitals in the Atlantic C-Port Trial,        referrals; (3) all medical decisions at a facility owned in part by
   Elective Angioplasty Study. Of the twelve CN applications           non-practitioners are made by practitioners; and (4) disclosure
   permitted by the Adopted Rules, only nine CNs have currently        of the referring practitioner’s interest is made to the patient in
   been issued.                                                        writing at or prior to the time the referral is made.
                                                                       new ASC Licenses. The Law prohibits the New Jersey
                                                                      No
Appellate Division Rules Insurer Not Entitled to Court                 Department of Health and Senior Services from issuing any
Ordered Discovery in PIP Arbitration Matter Involving                  new ASC licenses unless one of the following scenarios
Ambulatory Surgical Center                                             apply: (1) a change of ownership; (2) the relocation of an
                                                                       ASC within twenty miles or to a “Health Enterprise Zone”
On October 7 2009, in N.J. Mfrs. Ins. Co. v. Bergen Ambulatory
              ,                                                        (provided there is no expansion in the ASC’s scope of
Surgery Ctr., the Appellate Division of the Superior Court of New      services); (3) entities that filed architectural plans within six
Jersey (the “Court”) held that an automobile insurance carrier’s       months of the effective date of the Bill, by September 17     ,
2009; (4) entities that are owned in whole or in part by a New      the time the ASC submitted the claims to Health Net, it did not
   Jersey hospital; or (5) entities that are owned in whole by a       know whether or not it would pursue collection of a particular
   medical school.                                                     patient’s co-insurance obligation. The Appellate Division further
   New Surgical Practices. Further, only existing unlicensed
  No                                                                   noted that there is no statute, regulation or regulatory directive
   surgical practices, as well as those that: (1) change ownership;    in New Jersey barring the waiver of a contractual right to collect
   (2) had construction plans filed by September 17 2009; or
                                                      ,                co-insurance.
   (3) relocate within twenty miles or to a “Health Enterprise
   Zone” (provided there is no expansion in the surgical practice’s
   scope of services) will qualify for registration.                   New Law Passed in New Jersey
  Exceptions for Lithotripsy and Radiation Oncology                    Relating to Medical Errors
   Abolished. Finally, the Law abolishes the current Codey
   Law exceptions for lithotripsy and radiation oncology unless
   the interest was held prior to one year following the effective     On August 31, 2009, Governor Jon S. Corzine signed Senate Bill
   date of the Law and the practitioner discloses the ownership        S2471, the New Jersey Adverse Event Reporting Act (the “Act”),
   interest in writing.                                                into law. The Act, which will become effective on February 27    ,
                                                                       2010, (1) requires the Department of Health and Senior Services
Change in Notice Requirements under New Jersey’s                       to publicly report certain patient safety indicators by hospital on
Codey Law                                                              an annual basis; and (2) prohibits hospitals from billing a patient
                                                                       or a third party for hospital-acquired conditions, based on a list of
Revisions to the Codey Law, effective as of March 23, 2009,            conditions set by the Centers for Medicare & Medicaid Services.
include new disclosure requirements by practitioners who
refer patients for a health care service in which they have a
financial interest:
                                                                       Proposed New DHSS Rules
  Financial Interest. A referring practitioner must provide
   written disclosure to a patient, at or prior to the time that the   Concerning Collection Stations
   referral is made, of any significant financial interest held by
   the practitioner in the practice or facility where the health
                                                                       On October 19, 2009, the New Jersey Department of Health
   care service would be performed. A copy of this disclosure
                                                                       and Senior Services proposed new rules that would continue
   must also be posted in a conspicuous public place in the
                                                                       to permit clinical laboratories to operate collection stations in
   practitioner’s office.
                                                                       physician offices, but would prohibit the payment of rent, sharing
  Choice of Providers. A patient must be notified that he or           of employees or performing or offering other goods or services
   she may seek treatment at a health care service provider of         by the clinical laboratory. The proposed rules would additionally
   his or her choosing and informed that a listing of alternative      impose requirements on independent collection stations.
   health care service providers may be found in the classified
   section of the telephone directory.
  Out-Of-Network. A patient must be notified when a facility
   is not a participating provider under the patient’s insurance
                                                                       New Jersey Department of
   carrier and that part or all of the upcoming procedure will be      Banking and Insurance
   considered “out-of-network.    ”

Appellate Division Affirms Garcia Decision                             Proposed DOBI Rules Seek to Regulate Managed
                                                                       Care Provider Networks
In a decision issued on November 17 2009, in Garcia v. Health
                                      ,
Net of New Jersey, Inc., the Appellate Division of the Superior        On June 15, 2009, the New Jersey Department of Banking
Court of New Jersey (the “Appellate Division”) upheld the              and Insurance (“DOBI”) proposed new rules that seek to limit
trial court decision which found that physicians’ referrals to         insurance carriers with respect to how network contracts are
                                                                       negotiated with health care providers. As of this date, no further
an ambulatory surgical center (“ASC”) in which they held an
                                                                       action has been taken. The proposed rules would affect the
ownership interest did not violate the New Jersey Insurance
                                                                       negotiation of terms within the ambit of credentialing, pre-
Fraud Prevention Act.
                                                                       certification, fee schedules, and claim denials, and include the
The Appellate Division also affirmed the trial court decision that     following proposed provisions:
the ASC did not knowingly submit false and misleading claims
                                                                         Insurance carriers must complete the provider credentialing
                                                                          
to Health Net when it failed to pursue the collection of patients’
                                                                          process within ninety days.
co-insurance obligations because the ASC routinely had patients
sign a form stating that they would pay co-insurance and at              Insurance carriers will be required to deliver to prospective
                                                                          providers, twenty days before entering into any agreements
with such providers, a complete “provider-specific” or              requirement that insurers maintain their decision
                                                                      The
   “specialty-specific” fee schedule for the carrier’s health          point review plan on the Internet would be removed
   benefits plan.                                                      because DOBI does not have the resources to keep the
                                                                       listings current.
  Provider-specific fee schedules will be required to be
   negotiated between the carrier and provider.
                                                                    Proposed Amendments to the Prompt Payment of
  Specialty-specific fee schedules, on the other hand, may be       Health Claims Regulations
   established by the carrier without any negotiations with the
   provider, but shall have a maximum term of one year.             On July 20, 2009, DOBI proposed to amend its rules governing
                                                                    the prompt payment of health claims to track the language of
  Agreements may not include “most-favored nation” clauses
                                                                    HCAPPA. As of this date, no further action has been taken.
   or mandatory binding arbitration clauses.
                                                                    Currently, when missing information or documentation is a
   schedules, both provider-specific and specialty-specific,
  Fee
                                                                    reason for denying or disputing a claim, the notice must identify
   must be included in the final agreement.
                                                                    with specificity the additional information or documentation
   agreements must identify all preferred provider
  All                                                               that is required and the carrier must engage in a good faith
   organizations, organized delivery systems, and other             effort to expeditiously obtain such additional information or
   entities, from which carriers lease networks and to whose        documentation by, among other things, telephoning the provider.
   fees the provider is subject under the agreement.
                                                                    DOBI proposes to amend its rules to track the language of
  Providers would be able to terminate a multi-year term            HCAPPA, which decreases the carrier’s responsibility by
   agreement without cause at the conclusion of each year in        not requiring the carrier to engage in a good faith effort to
   the multi-year term, or as otherwise agreed to by the parties.   expeditiously obtain missing information or documentation.
   Providers may terminate one-year agreements without cause        Under HCAPPA, carriers are only required to distribute to
   at any time during the term of the agreement with sixty          providers, through a posting on their websites, a list of all
   days notice.                                                     documentation and information that must be submitted with
                                                                    claims, and specify the timeframes and means for carriers to
DOBI Issues Cease and Desist Letter to Oxford for                   inform providers that a claim has been denied or that information
Violation of Insurance Laws                                         or documentation is inaccurate.

On June 23, 2009, DOBI issued a cease and desist order to           Under the proposed amendment, the carrier’s right to contest
Oxford Health Plans (NJ) Inc. for illegally seeking recoupment      the claim will not be automatically waived if the carrier does
of monies from health care providers through the extrapolation      not provide adequate notice. Instead, the claim will be deemed
of claims in violation of the New Jersey Health Claims              overdue and claimants will need to pursue the claims payment
Authorization, Processing and Payment Act (“HCAPPA”).               mechanisms made available to them by HCAPPA and pursuant to
                                                                    the procedures and timeframes set forth therein.
Proposed Department of Banking and Insurance Rule
that Affects Personal Injury Protection Benefits and                Amendment to Medical Malpractice Reporting
Dispute Resolutions                                                 Requirement Adopted

On July 6, 2009, DOBI proposed a new rule which, if approved,       On August 7 2009, DOBI adopted its proposal to amend the
                                                                                   ,
will amend the Personal Injury Protection medical benefit           medical malpractice reporting requirements under N.J.A.C.
regulations in what DOBI characterizes as an effort to better       11:1-7 et seq., which require insurance companies to notify the
                                                                            .1
promote cost-efficient quality medical care to persons injured in   Board of Medical Examiners (“BME”) Medical Practitioner Review
automobile accidents. As of this date, no further action has been   Panel in writing of any medical malpractice claim settlement,
taken. Provisions under the proposed rule include:                  judgment or arbitration award involving any practitioner who
                                                                    is licensed by the BME. This information is then included on
  Insurers would be able to waive policy deductibles or
                                                                    the practitioner’s “Physician Profile, which can be accessed at
                                                                                                           ”
   co-payments if a patient decides to obtain treatment
                                                                    http://12.150.185.184/dca. Specifically, effective September 8,
   from an in-network provider contracted by an organized
                                                                    2009, N.J.A.C. 11:1-7  .3(a)1 is amended to provide that, in the
   delivery system.
                                                                    case of a “high/low” agreement, where there is a finding of no
  Insurers would be prohibited from requiring                       liability on the part of the practitioner, but the insurer must make
   “precertification”of the evaluation and management               a payment to the claimant under the “low” provision of the
   visit for a new patient because, in order to develop a           agreement, the insurer would not have to report this information
   plan of care, a provider needs to be able to examine the         for inclusion on the practitioner’s Physician Profile.
   injured insured.
Health Insurers                                                          the procedure, in a language and manner that the patient
                                                                         understands. This notice must also be posted within the ASC
                                                                         in a place likely to be noticed while waiting for treatment.
                                                                         This notice must include contact information for a state
New Jersey Oxford Health Plans Reduce Non-Network                        agency representative to whom complaints may be reported
ASC Reimbursement                                                        and a web site for the Office of the Medicare Beneficiary
                                                                         Ombudsman.
New Jersey Oxford Health Plan (“Oxford”), by letter dated
January 6, 2009, informed out-of-network ambulatory                     Advance Directives. The ASC must provide the patient, prior
surgical centers in New Jersey that, effective that month, as            to the date of the procedure, with information concerning
Oxford members purchased or renewed their coverage, the                  its policies on advance directives, including a description of
reimbursement for non-network ambulatory surgery center                  applicable state health and safety laws, and if requested,
claims would be calculated at 225% of the published rates                official state advance directive forms.
allowed by Medicare, less any applicable co-insurance,                  Informed Decisions. The ASC must inform the patient of
co-payments or deductibles.                                              the patient’s right to make informed decisions regarding care
                                                                         and prominently document in the patient’s medical record
Studies Suggest that Insurance Monopolies in Some                        whether or not an advance directive has been executed.
States, Including New Jersey, Increase Premiums and                     Discharge. All patients must be provided with written
Reduce Provider Reimbursement                                            discharge instructions and overnight supplies and have
                                                                         a written discharge order, signed by the physician who
Two studies performed by Health Care for America Now
                                                                         performed the surgery. According to CMS, all patients must
(“HCAN”) and the American Hospital Association have concluded
                                                                         be discharged in the company of a responsible adult, except
that shrinking competition among health insurance companies is
                                                                         those patients exempted by the attending physician. Note
a major cause of escalating health insurance premium costs and
                                                                         that New Jersey additionally requires that patients who
decreasing reimbursement to providers.
                                                                         receive anesthesia, excluding minor regional blocks, may
Specific to New Jersey, the study performed by HCAN                      not drive themselves home after discharge and that they
determined:                                                              must be accompanied home by another person who accepts
   2007, Horizon Blue Cross and Blue Shield controlled
   In                                                                    responsibility for the patient.
   34% of New Jersey’s commercial market, and Aetna, Inc.
                                                                        Exceptions. CMS will exempt an ASC from the advance
   controlled 25%, for a combined market share of 59%.
                                                                         notice requirements when the referral to the ASC is made on
  Health insurance premiums increased 71% from 2000                      the day of the procedure and the referring physician provides
   to 2007.                                                              a written statement that it is medically necessary for the
   family health coverage, the average annual combined
  For                                                                    patient to have the procedure on the same day and that an
   premium for employers and employees rose from $7,592 to               ASC setting is suitable for that patient. In this case, the
   $12,979.                                                              aforementioned notice provisions must be provided prior to
                                                                         obtaining the patient’s informed consent.


                                                                      CMS Selects Twelve New Jersey Hospitals to Participate
Centers for Medicare & Medicaid                                       in Medicare Gainsharing Program
Services                                                              On August 17 2009, the Centers for Medicare & Medicaid
                                                                                    ,
                                                                      Services announced that it had selected twelve New Jersey
Change in Medicare Disclosure Requirements                            hospitals to participate in the Physician Hospital Collaborative
                                                                      Demonstration, one of its three new demonstration projects.
On May 18, 2009, changes made by the Centers for Medicare             The Physician Hospital Collaborative Demonstration will evaluate
& Medicaid Services (“CMS”) became effective pertaining               gainsharing as a means of aligning incentives between hospitals
to conditions for coverage (“Conditions for Coverage”) that           and physicians to improve quality of care and efficiency.
ambulatory surgery centers (“ASCs”) must now meet in order to         Gainsharing occurs when a hospital pays incentives to a
participate in the Medicare and Medicaid programs. Such new           physician who assists in saving internal hospital costs while
disclosure requirements include, but are not limited to:              improving quality and efficiency.
  Financial Interests. The ASC must disclose in writing, prior        The participating hospitals are AtlantiCare Regional Medical
   to the date of the procedure, physician ownership in the ASC       Center, Overlook Hospital, Holy Name Hospital, Jersey Shore
   (when applicable).                                                 University Medical Center, Hunterdon Medical Center, Monmouth
  Patient Rights. The ASC must provide written and verbal             Medical Center, St. Francis Medical Center, Our Lady of Lourdes
   notice to a patient of the patient’s rights prior to the date of   Medical Center, The Valley Hospital, Somerset Medical Center,
                                                                      JFK Medical Center, and CentraState Healthcare System.
CMS Finalizes Amendments to the Stark Law                                  arrangement had the potential to generate remuneration
                                                                           prohibited under the federal Anti-Kickback Statute if the requisite
Last year, the Centers for Medicare & Medicaid Services                    intent was present, the OIG stated that it would not impose
published its 2009 final hospital inpatient prospective payment            administrative sanctions because the proposed arrangement
system rule (the “IPPS Rule”), which contained several
                                                                           presented a low risk of fraud and abuse.
significant changes that became effective on October 1, 2009,
to the federal regulations related to the federal Stark Law, the
                                                                           OIG Advisory Opinion Regarding Safe-Harbor for
law that prohibits a physician from making referrals for certain
                                                                           Investment Income from Physician/Hospital-Owned ASCs
designated health services (“DHS”) payable by federal health
care programs to an entity with which the physician has a                  On July 22, 2009, the U.S. Department of Health and Human
financial relationship unless a Stark Law exception applies.               Services Office of Inspector General (“OIG”) issued Advisory
1. “Per-Click” Arrangements                                                Opinion 09-09, which provides guidance on joint ventures
                                                                           between physicians and hospitals. In this case, an orthopedic
The final IPPS Rule prohibits the use of “per-click” payments in
                                                                           surgeon group and a hospital wanted to enter into a joint
the context of lease arrangements between physicians and DHS
                                                                           venture to own and operate an ambulatory surgical center
entities when such payments reflect services referred between
                                                                           with two operating rooms in a medical office building owned
the parties.
                                                                           by the hospital and located on its campus. The OIG found that
2. Percentage-Based Compensation Formula                                   although the arrangement could potentially generate prohibited
Percentage-based compensation arrangements for space and                   remuneration under the federal Anti-Kickback Statute if the
equipment rental charges will no longer be permitted, and any              requisite intent to induce or reward federal referrals was present,
existing arrangements must be amended as of October 1, 2009.               the OIG would not impose administrative sanctions.



OIG Advisory Opinions                                                      Latest Developments Concerning
                                                                           the Red Flags Rule
OIG Opinion Approves Compensation for On-Call Services
                                                                           On October 30, 2009, the Federal Trade Commission once again
On May 21, 2009, the U.S. Department of Health and Human
                                                                           delayed enforcement of the Red Flags Rule. At the request of
Services Office of Inspector General (“OIG”) posted Advisory
                                                                           several members of Congress, enforcement of the Red Flags
Opinion 09-05 concerning a hospital’s proposal to compensate
                                                                           Rule, which went into effect on January 1, 2008, will now be
physicians for providing on-call coverage and other services
                                                                           delayed until June 1, 2010.
to uninsured patients seeking care through the hospital’s
emergency department. Although the OIG found that the




            Health Law Practice Group

            John D. Fanburg/Chair            Lani M. Dornfeld                  Counsel:                          Rita M. Jennings
            jfanburg@bracheichler.com        ldornfeld@bracheichler.com                                          rjennings@bracheichler.com
                                                                               Richard B. Robins
            973.403.3107                     973.403.3136                                                        973.364.5204
                                                                               rrobins@bracheichler.com
                                                                               973.403.3147                      Leonard Lipsky
                                             Kevin M. Lastorino
                                                                                                                 llipsky@bracheichler.com
            Members:                         klastorino@bracheichler.com
                                                                               Associates:                       973.364.5218
                                             973.403.3129
            Todd C. Brower                                                     Jenny Carroll                     Isai Senthil
            tbrower@bracheichler.com         Mark E. Manigan                   jcarroll@bracheichler.com         isenthil@bracheichler.com
            973.403.3103                     mmanigan@bracheichler.com         973.364.5223                      973.403.3150
            Carol Grelecki                   973.403.3132
                                                                               Deborah A. Cmielewski             Joseph B. Vas
            cgrelecki@bracheichler.com                                         dcmielewski@bracheichler.com
                                             Debra C. Lienhardt                                                  jvas@bracheichler.com
            973.403.3140                                                       973.364.5213
                                             dlienhardt@bracheichler.com                                         973.403.3135
            Joseph M. Gorrell                973.364.5203                      Eric W. Gross                     Edward J. Yun
            jgorrell@bracheichler.com                                          egross@bracheichler.com           eyun@bracheichler.com
            973.403.3112                                                       973.364.5228                      973.364.5229

            In Memoriam: Burton L. Eichler, 1933-2009 Pioneer of Healthcare Law in New Jersey

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Brach Eichler L.L.C. Healthcare Year in Review

  • 1. JAN | 2010 2009 Health Law Year in Review 101 Eisenhower Parkway n Roseland,New Jersey 07068 t. 973.228.5700 n f. 973.228.7852 n www.bracheichler.com
  • 2. New Jersey Court Decisions recourse to the courts for discovery materials sought to be used in a PIP arbitration is inappropriate under the PIP statute, N.J.S.A. and Cases 39:6A et seq. Such requests, the Court concluded, must instead be approved by the Dispute Resolution Professionals empowered to decide PIP arbitration disputes. New Jersey Court Finds MRI Facility that Billed Before The decision affirmed the trial court’s dismissal of the plaintiff’s Licensure Liable under Insurance Fraud Act complaint seeking expansive discovery of an assignee health service provider for use in PIP arbitrations. The Court held that In Open MRI of Morris & Essex, LP v. Frieri, a case decided on petitioning the court, rather than pursuing the PIP arbitration March 11, 2009, the Appellate Division of the Superior Court appeals mechanisms, would contravene the Legislature’s express of New Jersey determined that an MRI facility that billed for preference for limited judicial oversight of PIP disputes. services before it became licensed was liable under the New Jersey Insurance Fraud Prevention Act even though it applied and New Jersey Attorney General Sues Nonprofit obtained licensure during a New Jersey Department of Health Corporation Trustees and Senior Services amnesty period. On September 17 2009, the New Jersey Attorney General filed a , Appellate Division Affirms Adoption of Rules Authorizing lawsuit against the trustees of Hoboken-based Stevens Institute New Jersey’s Continued Participation in the Atlantic of Technology (“Stevens”), a nonprofit corporation, its president, C-Port Trial, Elective Angioplasty Study and the chairman of the board of trustees. The sixteen-count civil complaint alleges financial mismanagement, excessive On September 10, 2009, the Appellate Division of the Superior spending of endowment investment gains, improper handling Court of New Jersey reached a decision in Cooper Univ. Hosp. of specific endowments and investments, failure to properly v. Jacobs, that upheld the adoption of rules by the New Jersey maintain records and accounts, and excessive compensation of Department of Health and Senior Services (“DHSS”) at N.J.A.C. the school president. On January 15, 2010, the parties settled. 8:33-3.11(e) (the “Adopted Rules”). The Adopted Rules authorize New Jersey’s continued participation in the “Atlantic C-Port Trial, Elective Angioplasty Study, a multi-state demonstration ” project intended to assess the safety and efficacy of allowing Developments Relating to the community hospitals without on-site cardiac surgical services to provide elective angioplasty to their patients (the “Project”). Codey Law and Garcia Case   Prior to the adoption of the Adopted Rules, a hospital without on-site cardiac surgical facilities could not perform elective Bill Revising Codey Law Passed into Law angioplasties. Such a hospital could, however, perform On March 23, 2009, Senate Bill S787 Senator Richard J. Codey’s , emergency angioplasties. bill revising the 1991 Codey Law, was signed into law (the    2007, the New Jersey Supreme Court held that In “Law”) by Governor Jon Corzine. The Law modifies the Codey while termination of the Project would be “unjust and Law in the following ways: inappropriate, the regulations violated “fundamental ” principles relating to the regulatory process, and required ”   Practitioners may refer to ASCs. The Law now expressly provides that a practitioner may refer a patient to an ASC that the regulations include more details. or a surgical practice in which the practitioner holds an    a result of the 2007 decision, DHSS proposed new rules As ownership interest, provided that: (1) the practitioner who and amendments to rules to implement the Project. DHSS provides the referral personally performs the procedure; formally adopted the rules on December 17 2007 , . (2) the practitioner’s remuneration as an owner is based    Adopted Rules permit the continued participation by The on his or her ownership interest and not on the volume of New Jersey community hospitals in the Atlantic C-Port Trial, referrals; (3) all medical decisions at a facility owned in part by Elective Angioplasty Study. Of the twelve CN applications non-practitioners are made by practitioners; and (4) disclosure permitted by the Adopted Rules, only nine CNs have currently of the referring practitioner’s interest is made to the patient in been issued. writing at or prior to the time the referral is made.    new ASC Licenses. The Law prohibits the New Jersey No Appellate Division Rules Insurer Not Entitled to Court Department of Health and Senior Services from issuing any Ordered Discovery in PIP Arbitration Matter Involving new ASC licenses unless one of the following scenarios Ambulatory Surgical Center apply: (1) a change of ownership; (2) the relocation of an ASC within twenty miles or to a “Health Enterprise Zone” On October 7 2009, in N.J. Mfrs. Ins. Co. v. Bergen Ambulatory , (provided there is no expansion in the ASC’s scope of Surgery Ctr., the Appellate Division of the Superior Court of New services); (3) entities that filed architectural plans within six Jersey (the “Court”) held that an automobile insurance carrier’s months of the effective date of the Bill, by September 17 ,
  • 3. 2009; (4) entities that are owned in whole or in part by a New the time the ASC submitted the claims to Health Net, it did not Jersey hospital; or (5) entities that are owned in whole by a know whether or not it would pursue collection of a particular medical school. patient’s co-insurance obligation. The Appellate Division further    New Surgical Practices. Further, only existing unlicensed No noted that there is no statute, regulation or regulatory directive surgical practices, as well as those that: (1) change ownership; in New Jersey barring the waiver of a contractual right to collect (2) had construction plans filed by September 17 2009; or , co-insurance. (3) relocate within twenty miles or to a “Health Enterprise Zone” (provided there is no expansion in the surgical practice’s scope of services) will qualify for registration. New Law Passed in New Jersey   Exceptions for Lithotripsy and Radiation Oncology Relating to Medical Errors Abolished. Finally, the Law abolishes the current Codey Law exceptions for lithotripsy and radiation oncology unless the interest was held prior to one year following the effective On August 31, 2009, Governor Jon S. Corzine signed Senate Bill date of the Law and the practitioner discloses the ownership S2471, the New Jersey Adverse Event Reporting Act (the “Act”), interest in writing. into law. The Act, which will become effective on February 27 , 2010, (1) requires the Department of Health and Senior Services Change in Notice Requirements under New Jersey’s to publicly report certain patient safety indicators by hospital on Codey Law an annual basis; and (2) prohibits hospitals from billing a patient or a third party for hospital-acquired conditions, based on a list of Revisions to the Codey Law, effective as of March 23, 2009, conditions set by the Centers for Medicare & Medicaid Services. include new disclosure requirements by practitioners who refer patients for a health care service in which they have a financial interest: Proposed New DHSS Rules   Financial Interest. A referring practitioner must provide written disclosure to a patient, at or prior to the time that the Concerning Collection Stations referral is made, of any significant financial interest held by the practitioner in the practice or facility where the health On October 19, 2009, the New Jersey Department of Health care service would be performed. A copy of this disclosure and Senior Services proposed new rules that would continue must also be posted in a conspicuous public place in the to permit clinical laboratories to operate collection stations in practitioner’s office. physician offices, but would prohibit the payment of rent, sharing   Choice of Providers. A patient must be notified that he or of employees or performing or offering other goods or services she may seek treatment at a health care service provider of by the clinical laboratory. The proposed rules would additionally his or her choosing and informed that a listing of alternative impose requirements on independent collection stations. health care service providers may be found in the classified section of the telephone directory.   Out-Of-Network. A patient must be notified when a facility is not a participating provider under the patient’s insurance New Jersey Department of carrier and that part or all of the upcoming procedure will be Banking and Insurance considered “out-of-network. ” Appellate Division Affirms Garcia Decision Proposed DOBI Rules Seek to Regulate Managed Care Provider Networks In a decision issued on November 17 2009, in Garcia v. Health , Net of New Jersey, Inc., the Appellate Division of the Superior On June 15, 2009, the New Jersey Department of Banking Court of New Jersey (the “Appellate Division”) upheld the and Insurance (“DOBI”) proposed new rules that seek to limit trial court decision which found that physicians’ referrals to insurance carriers with respect to how network contracts are negotiated with health care providers. As of this date, no further an ambulatory surgical center (“ASC”) in which they held an action has been taken. The proposed rules would affect the ownership interest did not violate the New Jersey Insurance negotiation of terms within the ambit of credentialing, pre- Fraud Prevention Act. certification, fee schedules, and claim denials, and include the The Appellate Division also affirmed the trial court decision that following proposed provisions: the ASC did not knowingly submit false and misleading claims   Insurance carriers must complete the provider credentialing   to Health Net when it failed to pursue the collection of patients’ process within ninety days. co-insurance obligations because the ASC routinely had patients sign a form stating that they would pay co-insurance and at   Insurance carriers will be required to deliver to prospective providers, twenty days before entering into any agreements
  • 4. with such providers, a complete “provider-specific” or    requirement that insurers maintain their decision The “specialty-specific” fee schedule for the carrier’s health point review plan on the Internet would be removed benefits plan. because DOBI does not have the resources to keep the listings current.   Provider-specific fee schedules will be required to be negotiated between the carrier and provider. Proposed Amendments to the Prompt Payment of   Specialty-specific fee schedules, on the other hand, may be Health Claims Regulations established by the carrier without any negotiations with the provider, but shall have a maximum term of one year. On July 20, 2009, DOBI proposed to amend its rules governing the prompt payment of health claims to track the language of   Agreements may not include “most-favored nation” clauses HCAPPA. As of this date, no further action has been taken. or mandatory binding arbitration clauses. Currently, when missing information or documentation is a    schedules, both provider-specific and specialty-specific, Fee reason for denying or disputing a claim, the notice must identify must be included in the final agreement. with specificity the additional information or documentation    agreements must identify all preferred provider All that is required and the carrier must engage in a good faith organizations, organized delivery systems, and other effort to expeditiously obtain such additional information or entities, from which carriers lease networks and to whose documentation by, among other things, telephoning the provider. fees the provider is subject under the agreement. DOBI proposes to amend its rules to track the language of   Providers would be able to terminate a multi-year term HCAPPA, which decreases the carrier’s responsibility by agreement without cause at the conclusion of each year in not requiring the carrier to engage in a good faith effort to the multi-year term, or as otherwise agreed to by the parties. expeditiously obtain missing information or documentation. Providers may terminate one-year agreements without cause Under HCAPPA, carriers are only required to distribute to at any time during the term of the agreement with sixty providers, through a posting on their websites, a list of all days notice. documentation and information that must be submitted with claims, and specify the timeframes and means for carriers to DOBI Issues Cease and Desist Letter to Oxford for inform providers that a claim has been denied or that information Violation of Insurance Laws or documentation is inaccurate. On June 23, 2009, DOBI issued a cease and desist order to Under the proposed amendment, the carrier’s right to contest Oxford Health Plans (NJ) Inc. for illegally seeking recoupment the claim will not be automatically waived if the carrier does of monies from health care providers through the extrapolation not provide adequate notice. Instead, the claim will be deemed of claims in violation of the New Jersey Health Claims overdue and claimants will need to pursue the claims payment Authorization, Processing and Payment Act (“HCAPPA”). mechanisms made available to them by HCAPPA and pursuant to the procedures and timeframes set forth therein. Proposed Department of Banking and Insurance Rule that Affects Personal Injury Protection Benefits and Amendment to Medical Malpractice Reporting Dispute Resolutions Requirement Adopted On July 6, 2009, DOBI proposed a new rule which, if approved, On August 7 2009, DOBI adopted its proposal to amend the , will amend the Personal Injury Protection medical benefit medical malpractice reporting requirements under N.J.A.C. regulations in what DOBI characterizes as an effort to better 11:1-7 et seq., which require insurance companies to notify the .1 promote cost-efficient quality medical care to persons injured in Board of Medical Examiners (“BME”) Medical Practitioner Review automobile accidents. As of this date, no further action has been Panel in writing of any medical malpractice claim settlement, taken. Provisions under the proposed rule include: judgment or arbitration award involving any practitioner who is licensed by the BME. This information is then included on   Insurers would be able to waive policy deductibles or the practitioner’s “Physician Profile, which can be accessed at ” co-payments if a patient decides to obtain treatment http://12.150.185.184/dca. Specifically, effective September 8, from an in-network provider contracted by an organized 2009, N.J.A.C. 11:1-7 .3(a)1 is amended to provide that, in the delivery system. case of a “high/low” agreement, where there is a finding of no   Insurers would be prohibited from requiring liability on the part of the practitioner, but the insurer must make “precertification”of the evaluation and management a payment to the claimant under the “low” provision of the visit for a new patient because, in order to develop a agreement, the insurer would not have to report this information plan of care, a provider needs to be able to examine the for inclusion on the practitioner’s Physician Profile. injured insured.
  • 5. Health Insurers the procedure, in a language and manner that the patient understands. This notice must also be posted within the ASC in a place likely to be noticed while waiting for treatment. This notice must include contact information for a state New Jersey Oxford Health Plans Reduce Non-Network agency representative to whom complaints may be reported ASC Reimbursement and a web site for the Office of the Medicare Beneficiary Ombudsman. New Jersey Oxford Health Plan (“Oxford”), by letter dated January 6, 2009, informed out-of-network ambulatory   Advance Directives. The ASC must provide the patient, prior surgical centers in New Jersey that, effective that month, as to the date of the procedure, with information concerning Oxford members purchased or renewed their coverage, the its policies on advance directives, including a description of reimbursement for non-network ambulatory surgery center applicable state health and safety laws, and if requested, claims would be calculated at 225% of the published rates official state advance directive forms. allowed by Medicare, less any applicable co-insurance,   Informed Decisions. The ASC must inform the patient of co-payments or deductibles. the patient’s right to make informed decisions regarding care and prominently document in the patient’s medical record Studies Suggest that Insurance Monopolies in Some whether or not an advance directive has been executed. States, Including New Jersey, Increase Premiums and   Discharge. All patients must be provided with written Reduce Provider Reimbursement discharge instructions and overnight supplies and have a written discharge order, signed by the physician who Two studies performed by Health Care for America Now performed the surgery. According to CMS, all patients must (“HCAN”) and the American Hospital Association have concluded be discharged in the company of a responsible adult, except that shrinking competition among health insurance companies is those patients exempted by the attending physician. Note a major cause of escalating health insurance premium costs and that New Jersey additionally requires that patients who decreasing reimbursement to providers. receive anesthesia, excluding minor regional blocks, may Specific to New Jersey, the study performed by HCAN not drive themselves home after discharge and that they determined: must be accompanied home by another person who accepts    2007, Horizon Blue Cross and Blue Shield controlled In responsibility for the patient. 34% of New Jersey’s commercial market, and Aetna, Inc.   Exceptions. CMS will exempt an ASC from the advance controlled 25%, for a combined market share of 59%. notice requirements when the referral to the ASC is made on   Health insurance premiums increased 71% from 2000 the day of the procedure and the referring physician provides to 2007. a written statement that it is medically necessary for the    family health coverage, the average annual combined For patient to have the procedure on the same day and that an premium for employers and employees rose from $7,592 to ASC setting is suitable for that patient. In this case, the $12,979. aforementioned notice provisions must be provided prior to obtaining the patient’s informed consent. CMS Selects Twelve New Jersey Hospitals to Participate Centers for Medicare & Medicaid in Medicare Gainsharing Program Services On August 17 2009, the Centers for Medicare & Medicaid , Services announced that it had selected twelve New Jersey Change in Medicare Disclosure Requirements hospitals to participate in the Physician Hospital Collaborative Demonstration, one of its three new demonstration projects. On May 18, 2009, changes made by the Centers for Medicare The Physician Hospital Collaborative Demonstration will evaluate & Medicaid Services (“CMS”) became effective pertaining gainsharing as a means of aligning incentives between hospitals to conditions for coverage (“Conditions for Coverage”) that and physicians to improve quality of care and efficiency. ambulatory surgery centers (“ASCs”) must now meet in order to Gainsharing occurs when a hospital pays incentives to a participate in the Medicare and Medicaid programs. Such new physician who assists in saving internal hospital costs while disclosure requirements include, but are not limited to: improving quality and efficiency.   Financial Interests. The ASC must disclose in writing, prior The participating hospitals are AtlantiCare Regional Medical to the date of the procedure, physician ownership in the ASC Center, Overlook Hospital, Holy Name Hospital, Jersey Shore (when applicable). University Medical Center, Hunterdon Medical Center, Monmouth   Patient Rights. The ASC must provide written and verbal Medical Center, St. Francis Medical Center, Our Lady of Lourdes notice to a patient of the patient’s rights prior to the date of Medical Center, The Valley Hospital, Somerset Medical Center, JFK Medical Center, and CentraState Healthcare System.
  • 6. CMS Finalizes Amendments to the Stark Law arrangement had the potential to generate remuneration prohibited under the federal Anti-Kickback Statute if the requisite Last year, the Centers for Medicare & Medicaid Services intent was present, the OIG stated that it would not impose published its 2009 final hospital inpatient prospective payment administrative sanctions because the proposed arrangement system rule (the “IPPS Rule”), which contained several presented a low risk of fraud and abuse. significant changes that became effective on October 1, 2009, to the federal regulations related to the federal Stark Law, the OIG Advisory Opinion Regarding Safe-Harbor for law that prohibits a physician from making referrals for certain Investment Income from Physician/Hospital-Owned ASCs designated health services (“DHS”) payable by federal health care programs to an entity with which the physician has a On July 22, 2009, the U.S. Department of Health and Human financial relationship unless a Stark Law exception applies. Services Office of Inspector General (“OIG”) issued Advisory 1. “Per-Click” Arrangements Opinion 09-09, which provides guidance on joint ventures between physicians and hospitals. In this case, an orthopedic The final IPPS Rule prohibits the use of “per-click” payments in surgeon group and a hospital wanted to enter into a joint the context of lease arrangements between physicians and DHS venture to own and operate an ambulatory surgical center entities when such payments reflect services referred between with two operating rooms in a medical office building owned the parties. by the hospital and located on its campus. The OIG found that 2. Percentage-Based Compensation Formula although the arrangement could potentially generate prohibited Percentage-based compensation arrangements for space and remuneration under the federal Anti-Kickback Statute if the equipment rental charges will no longer be permitted, and any requisite intent to induce or reward federal referrals was present, existing arrangements must be amended as of October 1, 2009. the OIG would not impose administrative sanctions. OIG Advisory Opinions Latest Developments Concerning the Red Flags Rule OIG Opinion Approves Compensation for On-Call Services On October 30, 2009, the Federal Trade Commission once again On May 21, 2009, the U.S. Department of Health and Human delayed enforcement of the Red Flags Rule. At the request of Services Office of Inspector General (“OIG”) posted Advisory several members of Congress, enforcement of the Red Flags Opinion 09-05 concerning a hospital’s proposal to compensate Rule, which went into effect on January 1, 2008, will now be physicians for providing on-call coverage and other services delayed until June 1, 2010. to uninsured patients seeking care through the hospital’s emergency department. Although the OIG found that the Health Law Practice Group John D. Fanburg/Chair Lani M. Dornfeld Counsel: Rita M. Jennings jfanburg@bracheichler.com ldornfeld@bracheichler.com rjennings@bracheichler.com Richard B. Robins 973.403.3107 973.403.3136 973.364.5204 rrobins@bracheichler.com 973.403.3147 Leonard Lipsky Kevin M. Lastorino llipsky@bracheichler.com Members: klastorino@bracheichler.com Associates: 973.364.5218 973.403.3129 Todd C. Brower Jenny Carroll Isai Senthil tbrower@bracheichler.com Mark E. Manigan jcarroll@bracheichler.com isenthil@bracheichler.com 973.403.3103 mmanigan@bracheichler.com 973.364.5223 973.403.3150 Carol Grelecki 973.403.3132 Deborah A. Cmielewski Joseph B. Vas cgrelecki@bracheichler.com dcmielewski@bracheichler.com Debra C. Lienhardt jvas@bracheichler.com 973.403.3140 973.364.5213 dlienhardt@bracheichler.com 973.403.3135 Joseph M. Gorrell 973.364.5203 Eric W. Gross Edward J. Yun jgorrell@bracheichler.com egross@bracheichler.com eyun@bracheichler.com 973.403.3112 973.364.5228 973.364.5229 In Memoriam: Burton L. Eichler, 1933-2009 Pioneer of Healthcare Law in New Jersey