Roy v. City of Harriman, E2007-00785-COA-R3-CV (Tenn. Ct. App. June 30, 2008)
In a recent Tennessee Court of Appeals case, the court held that the Tennessee Peer Review Law creates a privilege that bars not only the discovery of peer review-related information, but also the use of such information.
This cause of action arises out of statements made by Dr. William E. Bennett to PHP Companies, Inc. (“PHP”), a health insurance company, regarding Dr. Francis Roy. Dr. Roy alleges that, in connection with PHP’s review of Dr. Roy’s application to become an approved PHP provider, Dr. Bennett made written statements that reflected poorly on Dr. Roy’s work history and qualifications. Dr. Roy claims that these statements were false and defamatory. In response to Dr. Roy’s complaint, Dr. Bennett filed a motion for summary judgment, contending, among other things, that the document containing the allegedly defamatory statements is privileged and inadmissible under the Tennessee Peer Review Law, Tenn. Code Ann. § 63-6-219 (2004). The court granted Dr. Bennett’s motion. The Tennessee Court of Appeals affirmed.
In considering whether the Peer Review Law renders "information . . . furnished to" a peer review committee inadmissible, or merely not subject to discovery, the court held: "[T]he Peer Review Law creates a privilege that bars the discovery or use of '[a]ll information, interviews, incident or other reports, statements, memoranda or other data furnished to any committee as defined in [the statute], and any findings, conclusions or recommendations resulting from the proceedings of such committee,' unless the information in question falls under an exception to the privilege." (emphasis in original) (citing T.C.A. § 63-6-219(e)).
The court also held that the "regular course of business" exception to the peer review privilege "refer[s] to documents prepared in the 'regular course of business' independent of peer review processes." (emphasis in original).
In a separate concurring opinion, one judge argued that the majority's interpretation of the Peer Review Law as prohibiting the use of peer review-related information, while correct, nonetheless creates "an irreconcilable conflict" in the statute. Section (d)(2) of the statute does not extend immunity to individuals submitting false information to a peer review committee if such individuals had actual knowledge of its falsity. The judge argued that, by prohbiting the discovery and use of peer-review related information, there is no way for a plaintiff to prove that an individual knowingly provided false information to a peer review committee. "I am at a loss as to how any potential plaintiff could proceed against an individual who is not immune from liability because he knowingly provided false information to a Peer Review Committee without being able to discover what was said to the Peer Reivew Committee and then being able to have what was said admitted into evidence." The judge concluded: "The end result is that Tenn. Code Ann. § 63-6-219(d)(2) is effectively deleted from the statute . . . ."
Opinion
Concurring Opinion
Wednesday, July 2, 2008
Monday, June 30, 2008
Plaintiff in Medical Malpractice Action Must File Certificate of Good Faith
Ch. 919, 2008 Tenn. Pub. Acts (effective Oct. 1, 2008)
TN Public Chapter No. 919 amended Title 29, Chapter 26, Part 1 of the Tennessee Code Annotated to require plaintiffs or plaintiff's counsel to file a Certificate of Good Faith within 90 days after filing a complaint in any medical malpractice action in which expert testimony is required by § 29-26-115. The Certificate of Good Faith shall state that plaintiff or plaintiff's counsel has consulted with one or more experts who have provided signed written statements confirming their belief that there is a good faith basis to maintain the action consistent with the Tennessee Medical Malpractice Act. Failure to comply with these requirements shall, upon motion, make the action subject to dismissal with prejudice.
Defendant or defendant's counsel must also file a Certificate of Good Faith within 30 days after alleging in an answer or amended answer that a non-party is at fault for the plaintiff's injuries. Failure to comply shall, upon motion, make such allegations subject to being stricken with prejudice.
Pub. Ch. No.919 also requires a plaintiff in a medical malpractice action to give written notice of potential claims to each health care provider against whom such potential claims are being made at least 60 days before the filing of complaints based upon medical malpractice in any Tennessee court.
Ch. 919
TN Public Chapter No. 919 amended Title 29, Chapter 26, Part 1 of the Tennessee Code Annotated to require plaintiffs or plaintiff's counsel to file a Certificate of Good Faith within 90 days after filing a complaint in any medical malpractice action in which expert testimony is required by § 29-26-115. The Certificate of Good Faith shall state that plaintiff or plaintiff's counsel has consulted with one or more experts who have provided signed written statements confirming their belief that there is a good faith basis to maintain the action consistent with the Tennessee Medical Malpractice Act. Failure to comply with these requirements shall, upon motion, make the action subject to dismissal with prejudice.
Defendant or defendant's counsel must also file a Certificate of Good Faith within 30 days after alleging in an answer or amended answer that a non-party is at fault for the plaintiff's injuries. Failure to comply shall, upon motion, make such allegations subject to being stricken with prejudice.
Pub. Ch. No.919 also requires a plaintiff in a medical malpractice action to give written notice of potential claims to each health care provider against whom such potential claims are being made at least 60 days before the filing of complaints based upon medical malpractice in any Tennessee court.
Ch. 919
Sunday, June 29, 2008
U.S. Court In Tennessee Upholds Exclusion From Participation In Federal Healthcare Programs Applied To “Convicted” Physician
[Source: Health Lawyers Weekly, Vol. 6, Iss. 25, June 27, 2008 - AHLA]
The Department of Health and Human Services Secretary correctly determined that a physician who pled nolo contendere on charges of attempting to defraud TennCare, Tennessee’s Medicaid managed care program, was “convicted” of a criminal offense under applicable federal statutes and therefore subject to a mandatory five-year exclusion from participation in Medicare, Medicaid, and all other federal healthcare programs, a federal district court ruled June18.
. . . .
Physician excluded under 42 U.S.C. § 1320a-7: Among other categories enumerated in that statute, the Secretary is authorized to exclude for a period of not less than five years, “any individual or entity that have been convicted of a criminal offense related to the delivery of an item or service under any state health care program.”
Under another provision of the statute, “convicted,” is further defined as a “judgment of conviction . . . regardless of whether there is an appeal pending or whether the judgment . . . relating to criminal conduct has been expunged,” as well as a “plea of guilty or nolo contendere” accepted by a court, or evidence that an individual or entity has entered into participation in a first offender, deferred adjudication, or other program where judgment of conviction has been withheld.
Continue reading
Gupton v. Leavitt, No. 3:07-cv-185 (E.D. Tenn. June 18, 2008).
The Department of Health and Human Services Secretary correctly determined that a physician who pled nolo contendere on charges of attempting to defraud TennCare, Tennessee’s Medicaid managed care program, was “convicted” of a criminal offense under applicable federal statutes and therefore subject to a mandatory five-year exclusion from participation in Medicare, Medicaid, and all other federal healthcare programs, a federal district court ruled June18.
. . . .
Physician excluded under 42 U.S.C. § 1320a-7: Among other categories enumerated in that statute, the Secretary is authorized to exclude for a period of not less than five years, “any individual or entity that have been convicted of a criminal offense related to the delivery of an item or service under any state health care program.”
Under another provision of the statute, “convicted,” is further defined as a “judgment of conviction . . . regardless of whether there is an appeal pending or whether the judgment . . . relating to criminal conduct has been expunged,” as well as a “plea of guilty or nolo contendere” accepted by a court, or evidence that an individual or entity has entered into participation in a first offender, deferred adjudication, or other program where judgment of conviction has been withheld.
Continue reading
Gupton v. Leavitt, No. 3:07-cv-185 (E.D. Tenn. June 18, 2008).
Saturday, June 14, 2008
U.S. Supreme Court Holds False Claims Act Requires Intent to Defraud Government
[Source: Health Lawyers Weekly, June 13, 2008, Vol. 6, Iss. 23 - AHLA]
The U.S. Supreme Court unanimously held June 9 that the False Claims Act (FCA) requires proof that the defendant “intended that the false statement be material to the Government’s decision to pay or approve the false claim.”
The opinion, authored by Justice Samuel Alito, reversed a Sixth Circuit decision that held it was sufficient under the FCA for a plaintiff to prove merely that a false statement resulted in payment from the government.
According to the Court, “the Sixth Circuit’s interpretation of § 3729(a)(2) [of the FCA] impermissibly deviates from the statute’s language, which requires the defendant to make a false statement ‘to get’ a false or fraudulent claim ‘paid or approved by the Government.’”
Thus, a defendant must intend for the government to pay the claim, the Court held.
“Eliminating this element of intent would expand the FCA well beyond its intended role of combating “fraud against the Government,’” Alito wrote.
. . . . .
See also Waller Lansden bulletin
Allison Engine Co. v. United States ex rel. Sanders, No. 07-214 (U.S. June 9, 2008).
The U.S. Supreme Court unanimously held June 9 that the False Claims Act (FCA) requires proof that the defendant “intended that the false statement be material to the Government’s decision to pay or approve the false claim.”
The opinion, authored by Justice Samuel Alito, reversed a Sixth Circuit decision that held it was sufficient under the FCA for a plaintiff to prove merely that a false statement resulted in payment from the government.
According to the Court, “the Sixth Circuit’s interpretation of § 3729(a)(2) [of the FCA] impermissibly deviates from the statute’s language, which requires the defendant to make a false statement ‘to get’ a false or fraudulent claim ‘paid or approved by the Government.’”
Thus, a defendant must intend for the government to pay the claim, the Court held.
“Eliminating this element of intent would expand the FCA well beyond its intended role of combating “fraud against the Government,’” Alito wrote.
. . . . .
See also Waller Lansden bulletin
Allison Engine Co. v. United States ex rel. Sanders, No. 07-214 (U.S. June 9, 2008).
Tuesday, June 3, 2008
In medical malpractice action, TN Court of Appeals addresses whether hospital is vicariously liable for the acts of emergency room physician
Thomas v. Oldfield, No. M2007-01693-COA-R3-CV (filed June 2, 2008)
The issue on appeal in this medical malpractice action is whether the hospital is vicariously liable for the acts or omissions of an emergency room physician. The trial court summarily dismissed all claims against the hospital finding that it was not vicariously liable for the conduct of the emergency room physician because he was neither its actual or apparent agent. We find the trial court correctly granted summary judgment to the hospital on the issue of actual agency because there are no material facts in dispute and the hospital is entitled to summary judgment on the issue of actual agency as a matter of law. We, however, find that material facts are in dispute concerning whether the hospital held itself out to the public as providing medical services; whether the plaintiff looked to the hospital rather than to the individual physician to perform those services; whether the patient accepted those services in the reasonable belief that the services were provided by the hospital or a hospital employee; and, if so, whether the hospital provided meaningful notice to the plaintiff at the time of admission that the emergency room physician was not its agent. Accordingly, we have determined the hospital was not entitled to summary judgment on the issue of apparent agency. Therefore, we remand to the trial court the issue of apparent agency for further proceedings consistent with this opinion.
Read case
[Note: This case references Boren v. Weeks (May 6, 2008), where the Tennessee Supreme Court adopted the rule of apparetn agency from Restatement (Second) of Torts § 429 - see below]
The issue on appeal in this medical malpractice action is whether the hospital is vicariously liable for the acts or omissions of an emergency room physician. The trial court summarily dismissed all claims against the hospital finding that it was not vicariously liable for the conduct of the emergency room physician because he was neither its actual or apparent agent. We find the trial court correctly granted summary judgment to the hospital on the issue of actual agency because there are no material facts in dispute and the hospital is entitled to summary judgment on the issue of actual agency as a matter of law. We, however, find that material facts are in dispute concerning whether the hospital held itself out to the public as providing medical services; whether the plaintiff looked to the hospital rather than to the individual physician to perform those services; whether the patient accepted those services in the reasonable belief that the services were provided by the hospital or a hospital employee; and, if so, whether the hospital provided meaningful notice to the plaintiff at the time of admission that the emergency room physician was not its agent. Accordingly, we have determined the hospital was not entitled to summary judgment on the issue of apparent agency. Therefore, we remand to the trial court the issue of apparent agency for further proceedings consistent with this opinion.
Read case
[Note: This case references Boren v. Weeks (May 6, 2008), where the Tennessee Supreme Court adopted the rule of apparetn agency from Restatement (Second) of Torts § 429 - see below]
Saturday, May 31, 2008
Federal District Court in Tennessee finds no subject matter jurisdiction in physician's breach of contract claim
[Source: Health Lawyers Weekly, May 30, 2008 (Vol. 6, Iss. 21) - AHLA]
A federal district court ruled May 19 that it lacked subject matter jurisdiction over a physician’s breach of contract and related claims against a hospital that suspended his medical staff privileges following a peer review audit of patient records.
In granting the plaintiff-physician’s motion to remand the case back to state court, the U.S. District Court for the Eastern District of Tennessee concluded the hospital’s potential defense that its actions complied with the federal Health Care Quality Improvement Act (HCQIA), 42 U.S.C. §§11101 et seq., did not confer federal question jurisdiction over the case.
Continue reading
MacManus v. Chattanooga-Hamilton County Hosp. Auth., No. 1:08-cv-96 (E.D. Tenn. May 19, 2008).
A federal district court ruled May 19 that it lacked subject matter jurisdiction over a physician’s breach of contract and related claims against a hospital that suspended his medical staff privileges following a peer review audit of patient records.
In granting the plaintiff-physician’s motion to remand the case back to state court, the U.S. District Court for the Eastern District of Tennessee concluded the hospital’s potential defense that its actions complied with the federal Health Care Quality Improvement Act (HCQIA), 42 U.S.C. §§11101 et seq., did not confer federal question jurisdiction over the case.
Continue reading
MacManus v. Chattanooga-Hamilton County Hosp. Auth., No. 1:08-cv-96 (E.D. Tenn. May 19, 2008).
TN Supreme Court addresses the issue of hospital vicarious liability under apparent agency theory
[Sources: Health Lawyers Weekly, May 30, 2008 (Vol. 6, Iss. 21) - AHLA]
Two hospitals in separate medical malpractice actions may be liable for the alleged negligence of certain independent contractor physicians based on an apparent agency theory, the Tennessee Supreme Court ruled recently.
Reversing appeals court decisions granting summary judgment in the hospitals’ favor, the high court found material issues of fact as to whether the hospitals provided the patients in question with adequate notice that the physicians were independent contractors rather than employees.
The opinions noted the issue of a hospital’s vicarious liability for the actions of independent contractor physicians under an apparent agency theory was one of first impression for the high court.
The high court therefore looked to case law in other jurisdictions and eventually adopted the analysis derived from the Restatement (Second) of Torts § 419, which requires a plaintiff in such cases to show (1) the hospital held itself out to the public as providing medical services; (2) the plaintiff looked to the hospital rather than to the individual physician to perform those services; and (3) the patient accepted those services in the reasonable belief that they were provided by the hospital or a hospital employee.
The high court noted a key issue in resolving vicarious liability actions against a hospital will often turn on whether it provided “meaningful” notice.
Although the patients in both cases at issue signed consent forms indicating the physicians providing the medical services were independent contractors, the high court found material issues of fact as to whether this constituted “meaningful” notice. Continue reading
Boren v. Weeks, No. M2007-00628-SC-R11-CV (Tenn. May 6, 2008).
Dewald v. HCA Health Servs. of Tenn., No. M2006-02369-SC-R11-CV (Tenn. May 12, 2008).
Two hospitals in separate medical malpractice actions may be liable for the alleged negligence of certain independent contractor physicians based on an apparent agency theory, the Tennessee Supreme Court ruled recently.
Reversing appeals court decisions granting summary judgment in the hospitals’ favor, the high court found material issues of fact as to whether the hospitals provided the patients in question with adequate notice that the physicians were independent contractors rather than employees.
The opinions noted the issue of a hospital’s vicarious liability for the actions of independent contractor physicians under an apparent agency theory was one of first impression for the high court.
The high court therefore looked to case law in other jurisdictions and eventually adopted the analysis derived from the Restatement (Second) of Torts § 419, which requires a plaintiff in such cases to show (1) the hospital held itself out to the public as providing medical services; (2) the plaintiff looked to the hospital rather than to the individual physician to perform those services; and (3) the patient accepted those services in the reasonable belief that they were provided by the hospital or a hospital employee.
The high court noted a key issue in resolving vicarious liability actions against a hospital will often turn on whether it provided “meaningful” notice.
Although the patients in both cases at issue signed consent forms indicating the physicians providing the medical services were independent contractors, the high court found material issues of fact as to whether this constituted “meaningful” notice. Continue reading
Boren v. Weeks, No. M2007-00628-SC-R11-CV (Tenn. May 6, 2008).
Dewald v. HCA Health Servs. of Tenn., No. M2006-02369-SC-R11-CV (Tenn. May 12, 2008).
Friday, May 16, 2008
News Updates
More hospitals requiring payment before treatment
In a front-page story, the Wall Street Journal (4/28, A1, Martinez) reports that many "[h]ospitals are adopting a policy to improve their finances: making medical care contingent on upfront payments." According to the American Hospital Association, "[u]ncompensated care cost the hospital industry $31.2 billion in 2006, up 44 percent from $21.6 billion in 2000." Meanwhile, approximately "77 percent of nonprofit hospitals are in the black, compared with 61 percent of for-profit hospitals," data from the American Hospital Directory indicate. Hospitals claim that the figures are "driven by a larger number of Americans who are uninsured" or underinsured, and that "among those with adequate insurance, deductibles and co-payments are growing so big that" even some "insured patients also have trouble paying hospitals." The Journal notes that even though federal law "requires hospitals to treat emergencies, such as heart attacks or injuries from accidents," that "law doesn't cover conditions that aren't immediately life-threatening."
[Health and Life Sciences Law Daily, April 28, 2008 - AHLA]
>>>
U.S. Court In Tennessee Finds Incident Reports Sought By Plaintiff In Malpractice Action Not Privileged Under State Laws
Certain incident reports and other documents requested by the estate of a deceased nursing home resident in a medical malpractice action are not privileged under state peer review and health data reporting laws, a federal district court in Tennessee ruled April 14.
Continue
Brown v. Sun Healthcare Group Inc., No. 3:06-CV-240 (E.D. Tenn. Apr. 14, 2008).
[Health Lawyers Weekly, May 2, 2008 - AHLA]
>>>
Tennessee Senate passes long-term care legislation
The AP (5/2) reported that the Tennessee Senate voted 32 to 0 to approve the Long-Term Care Community Choices Act of 2008 (SB 4181), legislation that would direct roughly half of TennCare's budget toward "home-based care over the next decade." Currently, TennCare "spends almost all of its annual $1.2 billion long-term care budget on nursing homes."
In an op-ed for the Tennessean (5/4), State Sen. Lowe Finney (D-Jackson) noted that the bill would address the Tennessee "system from the top down, from services that are offered, licensure of care providers, expansion of community-based alternatives to quality assurance." Sen. Finney concluded, "We are integrating these long-term care services into our existing managed-care system, which is funded by federal and state dollars," and "[t]his helps us manage growth within our existing resources."
[Health and Life Sciences Law Daily, May 5, 2008 - AHLA]
In a front-page story, the Wall Street Journal (4/28, A1, Martinez) reports that many "[h]ospitals are adopting a policy to improve their finances: making medical care contingent on upfront payments." According to the American Hospital Association, "[u]ncompensated care cost the hospital industry $31.2 billion in 2006, up 44 percent from $21.6 billion in 2000." Meanwhile, approximately "77 percent of nonprofit hospitals are in the black, compared with 61 percent of for-profit hospitals," data from the American Hospital Directory indicate. Hospitals claim that the figures are "driven by a larger number of Americans who are uninsured" or underinsured, and that "among those with adequate insurance, deductibles and co-payments are growing so big that" even some "insured patients also have trouble paying hospitals." The Journal notes that even though federal law "requires hospitals to treat emergencies, such as heart attacks or injuries from accidents," that "law doesn't cover conditions that aren't immediately life-threatening."
[Health and Life Sciences Law Daily, April 28, 2008 - AHLA]
>>>
U.S. Court In Tennessee Finds Incident Reports Sought By Plaintiff In Malpractice Action Not Privileged Under State Laws
Certain incident reports and other documents requested by the estate of a deceased nursing home resident in a medical malpractice action are not privileged under state peer review and health data reporting laws, a federal district court in Tennessee ruled April 14.
Continue
Brown v. Sun Healthcare Group Inc., No. 3:06-CV-240 (E.D. Tenn. Apr. 14, 2008).
[Health Lawyers Weekly, May 2, 2008 - AHLA]
>>>
Tennessee Senate passes long-term care legislation
The AP (5/2) reported that the Tennessee Senate voted 32 to 0 to approve the Long-Term Care Community Choices Act of 2008 (SB 4181), legislation that would direct roughly half of TennCare's budget toward "home-based care over the next decade." Currently, TennCare "spends almost all of its annual $1.2 billion long-term care budget on nursing homes."
In an op-ed for the Tennessean (5/4), State Sen. Lowe Finney (D-Jackson) noted that the bill would address the Tennessee "system from the top down, from services that are offered, licensure of care providers, expansion of community-based alternatives to quality assurance." Sen. Finney concluded, "We are integrating these long-term care services into our existing managed-care system, which is funded by federal and state dollars," and "[t]his helps us manage growth within our existing resources."
[Health and Life Sciences Law Daily, May 5, 2008 - AHLA]
Friday, April 18, 2008
Tennessee Court of Appeals finds Hospital's Bylaws Part of Physician's Employment Contract
The Tennessee Court of Appeals recently found that a hospital's bylaws were part of a physician's employment contract. In James C. Gekas, M.D. v. Seton Corporation, d/b/a Baptist Hospital, the plaintiff physician sued the defendant hospital for breach of contract after the hospital declined to promote him to a permanent position on its medical staff. He claimed that the hospital’s bylaws were part of his employment contract, and that the manner in which the hospital reached its decision violated those bylaws. The trial court granted summary judgment to the hospital. We agree that the bylaws formed part of his contract, but since the record clearly shows that the hospital substantially complied with its bylaws we affirm the trial court.
Reviewing an earlier Tennessee Supreme Court decision, the court noted: "The court concluded that a hospital’s bylaws have become, as a matter of law, an integral part of the contractual relationship between the hospital and the members of its medical staff. Thus, a member of the hospital staff has a contractual right to insist that the hospital follow its own bylaws. Lewisburg Community Hospital v. Alfredson, 805 S.W.2d 756, 761 (Tenn. 1991)."
James C. Gekas, M.D. v. Seton Corporation, d/b/a Baptist Hospital, M2006-00454-COA-R3-CV View
Reviewing an earlier Tennessee Supreme Court decision, the court noted: "The court concluded that a hospital’s bylaws have become, as a matter of law, an integral part of the contractual relationship between the hospital and the members of its medical staff. Thus, a member of the hospital staff has a contractual right to insist that the hospital follow its own bylaws. Lewisburg Community Hospital v. Alfredson, 805 S.W.2d 756, 761 (Tenn. 1991)."
James C. Gekas, M.D. v. Seton Corporation, d/b/a Baptist Hospital, M2006-00454-COA-R3-CV View
Sunday, April 13, 2008
Federal Preemption: The Drug and Device Trilogy
"Federal Preemption: The Drug and Device Trilogy" by J. Carter Thompson, Jr., Stephanie M. Rippee, and Amy L. Champagne, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
[Source: Health Lawyers Weekly, Vol. 6, Iss. 11 - AHLA]
[Source: Health Lawyers Weekly, Vol. 6, Iss. 11 - AHLA]
Lawyers offer guidance for terminating physician-patient relationship.
[Source: Health and Life Sciences Law Daily, March 24, 2008 - AHLA]
The Boston Business Journal (3/21, van der Pool) reported that "healthcare lawyers...say that in recent years they have fielded more inquiries from doctors and healthcare organizations about the best way to terminate a doctor-patient relationship." Since physicians are "under ethical and legal obligations to provide medical services for as long as the patient wants," there is "a laundry list of steps needs to be taken" in order "[f]or a doctor to cut off that relationship and not be successfully sued with an abandonment claim." First of all, there must "be a legitimate reason" for termination, "which could include everything from a patient refusing treatment and repeatedly missing appointments to threats of violence." After this, "a letter should be sent to the patient via certified mail with a detailed explanation of the termination and a note that services will be continued for 30 days, to allow the patient to find another doctor."
The Boston Business Journal (3/21, van der Pool) reported that "healthcare lawyers...say that in recent years they have fielded more inquiries from doctors and healthcare organizations about the best way to terminate a doctor-patient relationship." Since physicians are "under ethical and legal obligations to provide medical services for as long as the patient wants," there is "a laundry list of steps needs to be taken" in order "[f]or a doctor to cut off that relationship and not be successfully sued with an abandonment claim." First of all, there must "be a legitimate reason" for termination, "which could include everything from a patient refusing treatment and repeatedly missing appointments to threats of violence." After this, "a letter should be sent to the patient via certified mail with a detailed explanation of the termination and a note that services will be continued for 30 days, to allow the patient to find another doctor."
Law Professor Questions Constitutionality of Health Insurance Mandates
["Not So Fast on the Health Insurance Mandates" by Karl Manheim, Professor of Law, Loyola Law School Los Angeles, and Jamie Court, Chairman of the Santa Monica-based Consumer Watchdog - The Los Angeles Times, March 24, 2008]
Are health insurance mandates constitutional? They are certainly unprecedented. The federal government does not ordinarily require Americans to purchase particular goods or services from private parties.
The closest we come is when government imposes a condition on the grant of a discretionary benefit or permit. For instance, in most states, you must have auto insurance to drive a car, or you are required to install fire sprinklers when building a new house. But in such cases, the "mandate" is discretionary -- you don't have to drive a car or build a house. Nor do you have a constitutional right to do so.
But Americans do have a constitutional right to live in the United States. Accordingly, neither federal nor state governments can require you to purchase health insurance as a "condition" for residency. The Supreme Court has drawn a distinction between requirements that are flat-out imposed by government and those imposed as a condition for discretionary benefits
Continue reading
Are health insurance mandates constitutional? They are certainly unprecedented. The federal government does not ordinarily require Americans to purchase particular goods or services from private parties.
The closest we come is when government imposes a condition on the grant of a discretionary benefit or permit. For instance, in most states, you must have auto insurance to drive a car, or you are required to install fire sprinklers when building a new house. But in such cases, the "mandate" is discretionary -- you don't have to drive a car or build a house. Nor do you have a constitutional right to do so.
But Americans do have a constitutional right to live in the United States. Accordingly, neither federal nor state governments can require you to purchase health insurance as a "condition" for residency. The Supreme Court has drawn a distinction between requirements that are flat-out imposed by government and those imposed as a condition for discretionary benefits
Continue reading
U.S. Court In Tennessee Finds Hospital Not Liable Under EMTALA For Transferring Inpatient Who Developed Emergency Condition
[Source: Health Lawyers Weekly, Vol. 6, Iss. 13 - AHLA]
A Tennessee hospital is not liable under the Emergency Medical Treatment and Labor Act (EMTALA) for transferring a patient who developed an emergency condition 17 days after she was admitted for hemodialysis to treat her kidney disease, a federal district court in that state ruled March 24.
The U.S. District Court for the Eastern District of Tennessee granted summary judgment in favor of the hospital, relying primarily on 42 C.F.R. § 489.24(a)(1)(ii), which states that once a hospital “ admits [an] individual as an inpatient [in good faith] for further treatment, the hospital’s obligation under [EMTALA] ends.”
Continue reading
Anderson v. Kindred Hosp., No. 1:05-cv-294 (E.D. Tenn. Mar. 24, 2008).
A Tennessee hospital is not liable under the Emergency Medical Treatment and Labor Act (EMTALA) for transferring a patient who developed an emergency condition 17 days after she was admitted for hemodialysis to treat her kidney disease, a federal district court in that state ruled March 24.
The U.S. District Court for the Eastern District of Tennessee granted summary judgment in favor of the hospital, relying primarily on 42 C.F.R. § 489.24(a)(1)(ii), which states that once a hospital “ admits [an] individual as an inpatient [in good faith] for further treatment, the hospital’s obligation under [EMTALA] ends.”
Continue reading
Anderson v. Kindred Hosp., No. 1:05-cv-294 (E.D. Tenn. Mar. 24, 2008).
CMS Issues Final E-Prescribing Rule
[Source: Health Lawyers Weekly, Vol 6, Iss. 13 - AHLA)
The Centers for Medicare and Medicaid Services (CMS) issued a final rule April 2 establishing Part D e-prescribing standards for formulary and benefits, medication history, fill status notification, and identification of individual healthcare providers.
The new standards apply to all Part D sponsors, as well as to prescribers and dispensers that electronically transmit prescriptions and prescription-related information about Part D covered drugs prescribed for Part D eligible individuals.
Continue reading
The new e-prescribing standards will be effective on April 1, 2009.
Read the rule.
The Centers for Medicare and Medicaid Services (CMS) issued a final rule April 2 establishing Part D e-prescribing standards for formulary and benefits, medication history, fill status notification, and identification of individual healthcare providers.
The new standards apply to all Part D sponsors, as well as to prescribers and dispensers that electronically transmit prescriptions and prescription-related information about Part D covered drugs prescribed for Part D eligible individuals.
Continue reading
The new e-prescribing standards will be effective on April 1, 2009.
Read the rule.
Tennessee nursing homes pushing for lawsuit limits.
[Source: Health and Life Sciences Law Daily, April 7, 2008 - AHLA]
The Tennessean (4/6, Emery) reported that "the nursing home industry as a whole is fighting to impose new limits" on lawsuits related to negligence. In Tennessee, the Nursing Home Patient Protection Act of 2008, a bill "under discussion in the state Legislature," would "keep many lawsuits out of courts altogether, make the cases more difficult to pursue, and cap damages." Proponents of the measure "suggest that nursing homes are drowning under a flood of litigation from out-of-state lawyers, while critics accuse the industry of cutting off the only recourse for victims of negligence and greed." Gerald Coggin, a senior vice president for National HealthCare Corp., "said that while other states have put limitations on lawsuits, out-of-state law firms have migrated to Tennessee in search of clients, creating a 'huge increase' in lawsuits." Coggin added, "It's driven up the cost of defending and litigating these lawsuits, and taken away (money) that ought to be going into patient care."
The Tennessean (4/6, Emery) reported that "the nursing home industry as a whole is fighting to impose new limits" on lawsuits related to negligence. In Tennessee, the Nursing Home Patient Protection Act of 2008, a bill "under discussion in the state Legislature," would "keep many lawsuits out of courts altogether, make the cases more difficult to pursue, and cap damages." Proponents of the measure "suggest that nursing homes are drowning under a flood of litigation from out-of-state lawyers, while critics accuse the industry of cutting off the only recourse for victims of negligence and greed." Gerald Coggin, a senior vice president for National HealthCare Corp., "said that while other states have put limitations on lawsuits, out-of-state law firms have migrated to Tennessee in search of clients, creating a 'huge increase' in lawsuits." Coggin added, "It's driven up the cost of defending and litigating these lawsuits, and taken away (money) that ought to be going into patient care."
Federal appeals court rules in favor of drugmakers in drug-label preemption case
[Source: Health and Life Sciences Law Daily, April 9, 2008 - AHLA]
The Legal Intelligencer (4/9, Duffy) reports that in a 2-to-1 decision (pdf) issued Tuesday, the 3rd U.S. Circuit Court of Appeals in Philadelphia, Pa., "ruled that the makers of Paxil (paroxetine) and Zoloft (sertraline) cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration (FDA) has explicitly refused to order such warnings." In the opinion, Judge Dolores K. Sloviter, writing for the majority, "said the FDA has 'actively monitored' the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs 'are without scientific basis and would therefore be false and misleading.'"
"While narrowly written, the decision was a clear victory for drugmakers and Bush administration officials," who argue that scientists at the FDA, "not lay juries," should decide drug-labels information, the Philadelphia Inquirer (4/9, Stark) adds. However, "[l]awyers for the plaintiffs countered that the FDA was outgunned and poorly funded at best and that lawsuits represented an important check on the system and a last attempt for injured victims to get redress." Writing in dissent, "Judge Thomas L. Ambro argued that for 75 years, the FDA has viewed state suits 'as complementary to its warning regulations. Only for the last two years has it claimed otherwise.'" The Inquirer notes that the "issue could come to a head in October, when the U.S. Supreme Court is scheduled to hear Wyeth v. Levine, another dispute over the adequacy of a drug label." Some legal experts say the "case could determine the scope of future pharmaceutical litigation unless Congress intervened."
The Legal Intelligencer (4/9, Duffy) reports that in a 2-to-1 decision (pdf) issued Tuesday, the 3rd U.S. Circuit Court of Appeals in Philadelphia, Pa., "ruled that the makers of Paxil (paroxetine) and Zoloft (sertraline) cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration (FDA) has explicitly refused to order such warnings." In the opinion, Judge Dolores K. Sloviter, writing for the majority, "said the FDA has 'actively monitored' the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs 'are without scientific basis and would therefore be false and misleading.'"
"While narrowly written, the decision was a clear victory for drugmakers and Bush administration officials," who argue that scientists at the FDA, "not lay juries," should decide drug-labels information, the Philadelphia Inquirer (4/9, Stark) adds. However, "[l]awyers for the plaintiffs countered that the FDA was outgunned and poorly funded at best and that lawsuits represented an important check on the system and a last attempt for injured victims to get redress." Writing in dissent, "Judge Thomas L. Ambro argued that for 75 years, the FDA has viewed state suits 'as complementary to its warning regulations. Only for the last two years has it claimed otherwise.'" The Inquirer notes that the "issue could come to a head in October, when the U.S. Supreme Court is scheduled to hear Wyeth v. Levine, another dispute over the adequacy of a drug label." Some legal experts say the "case could determine the scope of future pharmaceutical litigation unless Congress intervened."
Sunday, February 24, 2008
Healthcare Final and Proposed Rules: Updates
- CMS proposed rule on Medicaid premiums and cost sharing
- CMS proposed rule on state Medicaid flexibility
- CMS final rule on medical necessity determinations
- CMS final rule on Medicare secondary payer amendments
- CMS final rule reducing provider tax rate
- HHS Proposed Rule implementing Patient Safety Act
Friday, February 22, 2008
TN Law Promotes Effective Communications Between Health Care Providers While Rendering Care to Patients
Public Chapter No. 391 (Amends T.C.A. § 68-11-312)
T.C.A. § 68-11-312(b) states: "There is no implied covenant of confidentiality or other restriction that precludes (1) health care providers from communicating with each other in the course of providing care and treatment to a patient, or (2) a health care provider from responding to a request from a hospital regarding entries in the patient's records of the requesting hospital made or reviewed by that health care provider during the course of providing care and treatment to the patient in the hospital . . . ."
Effective date: July 1, 2007
T.C.A. § 68-11-312(b) states: "There is no implied covenant of confidentiality or other restriction that precludes (1) health care providers from communicating with each other in the course of providing care and treatment to a patient, or (2) a health care provider from responding to a request from a hospital regarding entries in the patient's records of the requesting hospital made or reviewed by that health care provider during the course of providing care and treatment to the patient in the hospital . . . ."
Effective date: July 1, 2007
TN AG Opinion: Notice to Bureau of TennCare re: Medicaid/Medicare Benefits Due to Separation Asset Division
Tennessee Attorney General Opinion No. 08-31, February 20, 2008
(Notice to Bureau of TennCare re: Medicaid/Medicare Benefits Due to Separation Asset Division)
Questions:
(Notice to Bureau of TennCare re: Medicaid/Medicare Benefits Due to Separation Asset Division)
Questions:
- In any case seeking a divorce or legal separation in which the disabled spouse has a conservator and is receiving either Medicare/Medicaid benefits, is notice to the Bureau of
TennCare required as a prerequisite to granting relief? - In cases seeking a divorce or legal separation involving a disabled spouse but where court filings lack information as to whether or not the disabled spouse is receiving TennCare benefits, is notice to the Bureau of TennCare a prerequisite to the maintenance of such complaints?
- When notice has been provided to TennCare but plaintiff fails to enumerate grounds for divorce or separation pursuant to Tenn. Code Ann. §36-4-102, is there a basis for granting relief under this statute?
Opinions:
- No. In cases seeking a divorce or legal separation there is no statutory requirement of notice to the Bureau of TennCare as a prerequisite to granting relief to the disabled spouse already receiving TennCare benefits.
- No. In any case seeking a divorce or legal separation there is no statutory requirement of notice to the Bureau of TennCare as a prerequisite to the maintenance of such complaints when information is lacking about whether or not the disabled spouse is receiving TennCare benefits.
- While courts are given broad discretion in granting relief in divorce/separation matters, Tenn. Code Ann. §36-4-102 requires that a complaint requesting an order granting legal
separation must set forth grounds for such relief pursuant to Tenn. Code Ann. §36-4-101. Further, if the other party objects to legal separation, the party seeking such relief must establish grounds under Tenn. Code Ann. §36-4-101.
CMS Proposes Rules to Give States More Flexibility in Designing Medicaid Plans
[Source: Health Lawyers Weekly, February 22, 2008 - AHLA]
The Centers for Medicare and Medicaid Services (CMS) proposed a pair of rules February 22 that would give states more flexibility in designing their Medicaid programs and require increased cost-sharing from beneficiaries.
The rules, which would implement provisions of the Deficit Reduction Act of 2005 and the Tax Relief and Health Care Act of 2006, are the latest in a series of regulations to implement the administration’s goals of aligning Medicaid more closely with private market insurance and giving states more control over their Medicaid benefits packages, CMS said in a press release.
Under one rule, states will have the opportunity to offer beneficiaries healthcare that has the same value as plans that are being offered to other populations in the state, through alternative benefit packages called "benchmark plans," the release said.
Continue reading
Read the proposed premiums and cost sharing rule, 73 Fed. Reg. 9727.
Read the proposed rule giving states flexibility, 73 Fed. Reg. 9714.
View CMS' press release.
The Centers for Medicare and Medicaid Services (CMS) proposed a pair of rules February 22 that would give states more flexibility in designing their Medicaid programs and require increased cost-sharing from beneficiaries.
The rules, which would implement provisions of the Deficit Reduction Act of 2005 and the Tax Relief and Health Care Act of 2006, are the latest in a series of regulations to implement the administration’s goals of aligning Medicaid more closely with private market insurance and giving states more control over their Medicaid benefits packages, CMS said in a press release.
Under one rule, states will have the opportunity to offer beneficiaries healthcare that has the same value as plans that are being offered to other populations in the state, through alternative benefit packages called "benchmark plans," the release said.
Continue reading
Read the proposed premiums and cost sharing rule, 73 Fed. Reg. 9727.
Read the proposed rule giving states flexibility, 73 Fed. Reg. 9714.
View CMS' press release.
Thursday, February 21, 2008
U.S. Supreme Court limits suits targeting makers of FDA-approved medical devices.
[Source: Health and Life Sciences Law Daily, February 21, 2008 - AHLA]
In a front-page story, the New York Times (2/21, A1, Greenhouse) reports that on Wednesday, the U.S. Supreme Court ruled in the case of Riegel v. Medtronic Inc. (PDF) that "[m]akers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration (FDA) approved the device before it was marketed and it meets the agency's specifications."
The Los Angeles Times (2/21, Savage) notes, "The 8-to-1 ruling throws out a lawsuit brought by a widow whose husband was badly hurt and later died after a balloon catheter burst in his chest," and represents a broad reading of "federal law...to protect companies from juries or state regulators."
According to the Wall Street Journal (2/21, A8, Bravin), "[l]ower courts in New York dismissed the suit, finding that a 1976 law immunized Minneapolis-based Medtronic, because its catheter had been approved for sale by the FDA." Wednesday's ruling indicated that "state authority surviv[es] only when Congress explicitly permits it a role." The case presented the question of "whether traditional private-product lawsuits, as well as state regulations, may be pre-empted by federal law."
On the front page of its Business section, the Washington Post (2/21, D1, Barnes) details the dissenting argument from Justice Ruth Bader Ginsburg, who wrote that "Congress did not intend the preemption clause...'to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.'" Previously, in 1996 the court found "that devices approved by the FDA under a less-rigorous process were not protected from state lawsuits." However, "the government reversed its position" in 2004.
USA Today (2/21, Biscupic) reports that the case was "a victory for business interests and a setback for state efforts to protect citizens in health-related areas when the federal government already has entered the field." And, "[t]he Medtronic decision could signal a favorable outcome for drug manufacturers in two pending Supreme Court cases."
According to Reuters (2/21, Vicini, Richwine), "The decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said." Other device makers may benefit from the ruling, as they "have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court." In this particular New York case, "Medtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended."
The AP (2/21, Sherman, Yost) adds, "The case has significant implications for the $75 billion-a-year healthcare technology industry, whose products range from heart valves to toothbrushes." During "a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices."
Turning to the implications the case has for patients, Bloomberg (2/21, Stohr) quotes Allison Zieve, the attorney representing the patient's widow, as saying that the ruling is "[p]retty bad for patients, pretty good for industry profits." Zieve added, "Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices."
Meanwhile, Modern Healthcare (2/21, Blesch) details the reaction of Medtronic CEO Jon Haber, who issued a statement saying that the ruling "ensures that patients continue to have appropriate access to innovative, life-saving medical devices."
Pointing to the broader legal implications of Wednesday's ruling, the Legal Times (2/21, Mauro) reports that "the Supreme Court continued its trend toward freeing companies from the conflicting regulation of 50 different states in favor of one federal regime." The Financial Times (2/21, Waldmeir, Bowe), Forbes (3/10, Fisher), the Wall Street Journal's Health Blog (2/20, Goldstein), and the Boston Business Journal (2/21, Hollmer) also cover the story.
In a front-page story, the New York Times (2/21, A1, Greenhouse) reports that on Wednesday, the U.S. Supreme Court ruled in the case of Riegel v. Medtronic Inc. (PDF) that "[m]akers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration (FDA) approved the device before it was marketed and it meets the agency's specifications."
The Los Angeles Times (2/21, Savage) notes, "The 8-to-1 ruling throws out a lawsuit brought by a widow whose husband was badly hurt and later died after a balloon catheter burst in his chest," and represents a broad reading of "federal law...to protect companies from juries or state regulators."
According to the Wall Street Journal (2/21, A8, Bravin), "[l]ower courts in New York dismissed the suit, finding that a 1976 law immunized Minneapolis-based Medtronic, because its catheter had been approved for sale by the FDA." Wednesday's ruling indicated that "state authority surviv[es] only when Congress explicitly permits it a role." The case presented the question of "whether traditional private-product lawsuits, as well as state regulations, may be pre-empted by federal law."
On the front page of its Business section, the Washington Post (2/21, D1, Barnes) details the dissenting argument from Justice Ruth Bader Ginsburg, who wrote that "Congress did not intend the preemption clause...'to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.'" Previously, in 1996 the court found "that devices approved by the FDA under a less-rigorous process were not protected from state lawsuits." However, "the government reversed its position" in 2004.
USA Today (2/21, Biscupic) reports that the case was "a victory for business interests and a setback for state efforts to protect citizens in health-related areas when the federal government already has entered the field." And, "[t]he Medtronic decision could signal a favorable outcome for drug manufacturers in two pending Supreme Court cases."
According to Reuters (2/21, Vicini, Richwine), "The decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said." Other device makers may benefit from the ruling, as they "have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court." In this particular New York case, "Medtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended."
The AP (2/21, Sherman, Yost) adds, "The case has significant implications for the $75 billion-a-year healthcare technology industry, whose products range from heart valves to toothbrushes." During "a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices."
Turning to the implications the case has for patients, Bloomberg (2/21, Stohr) quotes Allison Zieve, the attorney representing the patient's widow, as saying that the ruling is "[p]retty bad for patients, pretty good for industry profits." Zieve added, "Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices."
Meanwhile, Modern Healthcare (2/21, Blesch) details the reaction of Medtronic CEO Jon Haber, who issued a statement saying that the ruling "ensures that patients continue to have appropriate access to innovative, life-saving medical devices."
Pointing to the broader legal implications of Wednesday's ruling, the Legal Times (2/21, Mauro) reports that "the Supreme Court continued its trend toward freeing companies from the conflicting regulation of 50 different states in favor of one federal regime." The Financial Times (2/21, Waldmeir, Bowe), Forbes (3/10, Fisher), the Wall Street Journal's Health Blog (2/20, Goldstein), and the Boston Business Journal (2/21, Hollmer) also cover the story.
Friday, February 8, 2008
"Amendments To Medicare Secondary Payer Laws Impose Substantial New Reporting Obligations And Potential Civil Monetary Penalties For Non-Compliance"
[Source: Health Lawyers Weekly, February 8, 2008 - AHLA]
By Janice Ziegler, Ramy Fayed, and Katie Pawlitz, Sonnenschein, Nath, and Rosenthal LLP
On December 19, 2007, Congress passed the Medicare, Medicaid and SCHIP Extension Act of 2007* (the Act), which included modifications to the Medicare Secondary Payer (MSP) laws. The Act, which was signed into law on December 29, 2007, imposes significant new obligations on insurers, third party administrators (TPAs), and plan administrators or fiduciaries of group health plans that are both self-insured and self administered (Plan Administrators). Specifically, it requires all of these entities for the first time to (1) secure certain information from group health plan sponsors and plan participants, and (2) share such information with the Secretary of the U.S. Department of Health and Human Services (HHS). It also provides significant penalties for failure to do so. This article discusses the MSP amendments and their impact in further detail.
Continue reading
* Medicare, Medicaid, and SCHIP Extension Act of 2007, Pub. L. No. 110-173, § 111(a)(7)(A), 121 Stat. 2492, 2497-2498, available here
By Janice Ziegler, Ramy Fayed, and Katie Pawlitz, Sonnenschein, Nath, and Rosenthal LLP
On December 19, 2007, Congress passed the Medicare, Medicaid and SCHIP Extension Act of 2007* (the Act), which included modifications to the Medicare Secondary Payer (MSP) laws. The Act, which was signed into law on December 29, 2007, imposes significant new obligations on insurers, third party administrators (TPAs), and plan administrators or fiduciaries of group health plans that are both self-insured and self administered (Plan Administrators). Specifically, it requires all of these entities for the first time to (1) secure certain information from group health plan sponsors and plan participants, and (2) share such information with the Secretary of the U.S. Department of Health and Human Services (HHS). It also provides significant penalties for failure to do so. This article discusses the MSP amendments and their impact in further detail.
Continue reading
* Medicare, Medicaid, and SCHIP Extension Act of 2007, Pub. L. No. 110-173, § 111(a)(7)(A), 121 Stat. 2492, 2497-2498, available here
Compliance Series - OIG/AHLA
Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors (4/2003)
This educational resource is designed to help health care organization directors ask knowledgeable and appropriate questions related to health care corporate compliance. These questions are not intended to set forth any specific standard of care. Rather, this resource will help corporate directors to establish, and affirmatively demonstrate, that they have followed a reasonable compliance oversight process.
An Integrated Approach to Corporate Compliance: A Resource for Health Care Boards of Directors (7/2004)
This document addresses the roles of the in-house corporate general counsel (“General Counsel”) and an organization’s Chief Compliance Officer in supporting the compliance oversight function of health care organization governing boards (“Boards of Directors” or “Boards”). This supplemental educational resource addresses issues raised by recent developments in the law with respect to corporate responsibility and lawyers’ professional ethics, the modifications to the Federal Sentencing Guidelines for Organizations (“Sentencing Guidelines”), and the recommendations of the American Bar Association Task Force on Corporate Responsibility (“ABA Task Force”). It addresses these issues in the unique context of health care compliance and health care law, particularly in light of the expressed view of the OIG regarding the risk of structuring an organization’s compliance function as subordinate to the General Counsel function.
Corporate Responsibility and Health Care Quality – A Resource for Health Care Boards of Directors (9/2007)
The guide will provide insight into the OIG’s priorities and practical tools for healthcare organization boards to carry out their fiduciary responsibilities.
This educational resource is designed to help health care organization directors ask knowledgeable and appropriate questions related to health care corporate compliance. These questions are not intended to set forth any specific standard of care. Rather, this resource will help corporate directors to establish, and affirmatively demonstrate, that they have followed a reasonable compliance oversight process.
An Integrated Approach to Corporate Compliance: A Resource for Health Care Boards of Directors (7/2004)
This document addresses the roles of the in-house corporate general counsel (“General Counsel”) and an organization’s Chief Compliance Officer in supporting the compliance oversight function of health care organization governing boards (“Boards of Directors” or “Boards”). This supplemental educational resource addresses issues raised by recent developments in the law with respect to corporate responsibility and lawyers’ professional ethics, the modifications to the Federal Sentencing Guidelines for Organizations (“Sentencing Guidelines”), and the recommendations of the American Bar Association Task Force on Corporate Responsibility (“ABA Task Force”). It addresses these issues in the unique context of health care compliance and health care law, particularly in light of the expressed view of the OIG regarding the risk of structuring an organization’s compliance function as subordinate to the General Counsel function.
Corporate Responsibility and Health Care Quality – A Resource for Health Care Boards of Directors (9/2007)
The guide will provide insight into the OIG’s priorities and practical tools for healthcare organization boards to carry out their fiduciary responsibilities.
Sunday, February 3, 2008
39 States Have Begun to Enact Comprehensive Healthcare Access Reform
According to a study, A Progress Report On State Health Access Reform, published in Health Affairs, enactment of ambitious health reform laws in Massachusetts and Vermont in 2006 helped instigate a wave of state legislative activities to expand coverage to uninsured people. The study identifies thirty-nine states that have enacted laws in at least one access category since 2006. At least thirteen states have begun processes to enact comprehensive reforms to cover at least half of their uninsured residents. Key activities involve coverage expansions for uninsured children and for uninsured adults; regulatory changes in small-group and individual insurance markets; and individual and employer mandates. The future extent and durability of this wave are uncertain.
While at least 10 states have proposed legislation involving individual or employer mandates or both, only three have enacted such measures (Massachusetts, Vermont, and Rhode Island), the report noted.
Health Affairs 27, no. 2 (2008): w105-w115 (published online 29 January 2008; 10.1377/hlthaff.27.2.w105)
While at least 10 states have proposed legislation involving individual or employer mandates or both, only three have enacted such measures (Massachusetts, Vermont, and Rhode Island), the report noted.
Health Affairs 27, no. 2 (2008): w105-w115 (published online 29 January 2008; 10.1377/hlthaff.27.2.w105)
Hospital Investments in Competitiveness: Financing Options
Waller Lansden publishes its 2007 Hospital Investments in Competiveness: Financing Options survey.
Tennessee Court Rejects False Certification Claim
In Waller Lansden's Healthcare blog, attorneys Jim Mathis and Josh Collins note that the U.S. District Court for the Western District of Tennessee recently dismissed a qui tam suit brought against Baptist Medical Center in Memphis, Tenn., which alleged that Baptist violated the False Claims Act (FCA) by falsely certifying compliance with Medicare’s Conditions of Participation (CoPs). The court noted that, unlike Conditions of Payment, CoPs are not a prerequisite to a particular reimbursement. Alleged non-compliance with CoPs could lead to corrective action, but because the government would not have immediately withheld Medicare payments as a result of such deficiencies, they were neither material to payment nor so deficient as to constitute worthless services. Under the FCA, a false statement within a claim only makes the claim fraudulent if that statement influences the decision making body.
United States ex rel. Landers v. Baptist Mem’l Health Care Corp., No. 2:99-cv-2097 (W.D. Tenn. Dec. 17, 2007).
United States ex rel. Landers v. Baptist Mem’l Health Care Corp., No. 2:99-cv-2097 (W.D. Tenn. Dec. 17, 2007).
Venture Capital Activity Expected to Rise in 2008, Survey Finds
FierceBiotech reports that according to a recent survey of more than 350 venture capitalists, entrepreneurs, corporate buyers, investment bankers and research analysts, KPMG, LLP (the U.S. audit, tax and advisory firm) found that 51 percent of respondents expected venture capital activity to continure rising in 2008. Of those surveyed, 24 percent indicated that greentech/cleantech sectors will likely receive the most capital over the next two years, followed by biotech/pharmaceuticals (15%), Internet services (13%), and mobile technology (11%).
Outside the U.S., investors are looking to the emerging markets in China and India as investment favorites. Over 64 percent of respondents indicated that China and India are the most attractive locations for entrepreneurs to find funding, while 61 percent of those surveyed expect both to have increased IPO activity over the next two years.
The investors surveyed also expect rising merger and acquisition activity in the next year. Forty-nine percent expect an increase, with 33 percent believing it will be about the same levels, and only 11 percent foreseeing a decrease in deals during the period.
. . . . .
KPMG LLP, the audit, tax and advisory firm (http://www.us.kpmg.com/), is the U.S. member firm of KPMG International. KPMG International's member firms have 123,000 professionals, including more than 7,100 partners, in 145 countries.
Outside the U.S., investors are looking to the emerging markets in China and India as investment favorites. Over 64 percent of respondents indicated that China and India are the most attractive locations for entrepreneurs to find funding, while 61 percent of those surveyed expect both to have increased IPO activity over the next two years.
The investors surveyed also expect rising merger and acquisition activity in the next year. Forty-nine percent expect an increase, with 33 percent believing it will be about the same levels, and only 11 percent foreseeing a decrease in deals during the period.
. . . . .
KPMG LLP, the audit, tax and advisory firm (http://www.us.kpmg.com/), is the U.S. member firm of KPMG International. KPMG International's member firms have 123,000 professionals, including more than 7,100 partners, in 145 countries.
Employment Edges Up at Hospital and Physician Offices
Modern Healthcare Online reports: Hospitals added roughly 10,000 workers in January, climbing 0.2%, to bring total hospital employment to about 4.58 million, according to seasonally adjusted figures from the Bureau of Labor Statistics. All figures are preliminary. For the 12 months ended in January, hospital payrolls added nearly 112,600 workers, an increase of 2.5%.
Physician office employment grew by about 8,400 workers, or 0.4%, last month to total 2.25 million employees. For the 12 months ended in January, physician offices added roughly 74,100 workers, an increase of 3.4%.
Physician office employment grew by about 8,400 workers, or 0.4%, last month to total 2.25 million employees. For the 12 months ended in January, physician offices added roughly 74,100 workers, an increase of 3.4%.
Vanderbilt To Ban Gifts from Drug Reps
The Tennessean reports: Vanderbilt Medical Center has decided to stop doctors, faculty members and others who work on campus from accepting meals or gifts from the drug industry in a bid to reduce the companies' influence on patient care and trim spending on drugs (the drug industry spends $25 billion a year on promotions to influence patients and doctors who write prescriptions). The plan will also preclude drug companies from sponsoring or attending conferences or continuing medical education classes on Vanderbilt's campus.
Its latest policy applies to the more than 400 pharmaceutical representatives and about 1,300 device and equipment representatives that frequent the medical center.
Vanderbilt's plan, however, does not include penalties for violaters.
The new conflicts of interest policy is set to be phased in by July 1.
Details
Its latest policy applies to the more than 400 pharmaceutical representatives and about 1,300 device and equipment representatives that frequent the medical center.
Vanderbilt's plan, however, does not include penalties for violaters.
The new conflicts of interest policy is set to be phased in by July 1.
Details
Friday, February 1, 2008
U.S. Supreme Court Agrees to Hear Five Preemption Cases
Corporate Counsel reports: Corporate America has generally argued that the federal government should prevail over the states when they have conflicting laws and regulations. The question of who trumps whom is now before the U.S. Supreme Court, which has agreed to hear five cases involving preemption. The five preemption cases before the Supreme Court involve product liability, transportation of dangerous substances, labor, and other issues.
New York University law professor Catherine Sharkey is one of those who hope that the high court can settle the debate. "Almost every scholar and litigant calls [the existing standards on preemption] a muddle, a mess," Sharkey says. In her view, the Supreme Court "is poised to begin to fashion a kind of framework for preemption jurisprudence."
First out of the box is Riegel v. Medtronic Inc., which was argued before the justices on December 3. At issue: whether a provision in the federal Food, Drug, and Cosmetic Act forecloses suits that claim injury from a medical device approved by the Food and Drug Administration if the actions are based on state law.
Continue reading
. . . . . .
New York Times reports on the product liability cases before the Supreme Court, which consider preemption issues relating to drug and cigarette labeling requirements.
. . . . . .
From the FDA News Drug Daily Bulletin (Jan. 29, 2008): The U.S. Supreme Court will hear a second drug preemption case to decide whether the FDA’s authority to regulate labeling of a Wyeth drug preempts Vermont state law for product liability.
The court granted Wyeth’s request for writ of certiorari for Wyeth v. Levine. The company filed the request after the Vermont Supreme Court awarded $6.8 million to Diana Levine, a professional musician who received Wyeth’s antinausea drug Phenergan (promethazine) in a hospital during treatment for a migraine headache.
The drug was mistakenly injected into an artery, causing injuries that “quickly and irreversibly” led to the amputation of her right arm, according to the Public Citizen Litigation Group, Levine’s co-counsel.
Public Citizen said the court should deny review because Levine’s claim was not preempted by FDA drug labeling regulations and there is no conflict among appellate courts.
For Wyeth v. Levine, the petitioner’s brief is due Feb. 25, and the respondent’s brief is due March 24.
New York University law professor Catherine Sharkey is one of those who hope that the high court can settle the debate. "Almost every scholar and litigant calls [the existing standards on preemption] a muddle, a mess," Sharkey says. In her view, the Supreme Court "is poised to begin to fashion a kind of framework for preemption jurisprudence."
First out of the box is Riegel v. Medtronic Inc., which was argued before the justices on December 3. At issue: whether a provision in the federal Food, Drug, and Cosmetic Act forecloses suits that claim injury from a medical device approved by the Food and Drug Administration if the actions are based on state law.
Continue reading
. . . . . .
New York Times reports on the product liability cases before the Supreme Court, which consider preemption issues relating to drug and cigarette labeling requirements.
. . . . . .
From the FDA News Drug Daily Bulletin (Jan. 29, 2008): The U.S. Supreme Court will hear a second drug preemption case to decide whether the FDA’s authority to regulate labeling of a Wyeth drug preempts Vermont state law for product liability.
The court granted Wyeth’s request for writ of certiorari for Wyeth v. Levine. The company filed the request after the Vermont Supreme Court awarded $6.8 million to Diana Levine, a professional musician who received Wyeth’s antinausea drug Phenergan (promethazine) in a hospital during treatment for a migraine headache.
The drug was mistakenly injected into an artery, causing injuries that “quickly and irreversibly” led to the amputation of her right arm, according to the Public Citizen Litigation Group, Levine’s co-counsel.
Public Citizen said the court should deny review because Levine’s claim was not preempted by FDA drug labeling regulations and there is no conflict among appellate courts.
For Wyeth v. Levine, the petitioner’s brief is due Feb. 25, and the respondent’s brief is due March 24.
Sunday, January 27, 2008
"Amendments To Labeling: Implications For Preemption Defense" by Joseph P. McMenamin and Deborah M. Russell, McGuireWoods LLP
"Amendments to Labeling: Implications for Preemption Defense," Health Lawyers Weekly, AHLA, January 25, 2008 by Joseph P. McMenamin and Deborah M. Russell, McGuireWoods LLP
In what is sure to be seen as more ammunition for the battle over the preemption defense, the Food and Drug Administration (FDA) proposes rulemaking to codify its longstanding view that changes to labeling for approved products (i.e. drugs, biological products, and medical devices) may be made before agency review only as a narrow exception to the requirement of FDA approval and under limited circumstances. In its proposed rule announced last week, a supplemental application to change labeling may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction in advance of the agency’s review of such change, but only based on newly acquired and novel safety information and only if there is sufficient evidence of a causal association with the drug, biologic, or device. The agency wishes to formalize this “narrow exception” position. See 73 Fed. Reg. 2848 (Jan. 16, 2008).
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In what is sure to be seen as more ammunition for the battle over the preemption defense, the Food and Drug Administration (FDA) proposes rulemaking to codify its longstanding view that changes to labeling for approved products (i.e. drugs, biological products, and medical devices) may be made before agency review only as a narrow exception to the requirement of FDA approval and under limited circumstances. In its proposed rule announced last week, a supplemental application to change labeling may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction in advance of the agency’s review of such change, but only based on newly acquired and novel safety information and only if there is sufficient evidence of a causal association with the drug, biologic, or device. The agency wishes to formalize this “narrow exception” position. See 73 Fed. Reg. 2848 (Jan. 16, 2008).
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Sixth Circuit Upholds 188 Months' Prison Sentence for TN Physician Convicted of Fraud
[Source: Health Lawyers Weekly, January 25, 2008 - AHLA]
A Tennessee physician who was convicted of healthcare fraud and making false statements for administering partial doses of chemotherapy medications to cancer patients while billing for full doses received a “reasonable” prison sentence of 188 months (15 years, eight months), the Sixth Circuit ruled January 16.
Among other issues, the appeals court considered the lower court’s decision to grant the federal government’s request to increase the maximum sentencing range under the federal Sentencing Guidelines by two level enhancements.
The Sixth Circuit concluded the district court did not err in increasing the physician’s sentencing range under the Guidelines because her conduct created a risk of death or serious bodily injury, affected a large number of “vulnerable victims,” and also constituted obstruction of justice.
The court also ordered the physician to pay $432,238 in restitution to the state Medicaid program, Blue Cross and Blue Shield, and other private health plans.
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Case: United States v. Moon, No. 06-5581 (6th Cir. Jan. 16, 2008).
A Tennessee physician who was convicted of healthcare fraud and making false statements for administering partial doses of chemotherapy medications to cancer patients while billing for full doses received a “reasonable” prison sentence of 188 months (15 years, eight months), the Sixth Circuit ruled January 16.
Among other issues, the appeals court considered the lower court’s decision to grant the federal government’s request to increase the maximum sentencing range under the federal Sentencing Guidelines by two level enhancements.
The Sixth Circuit concluded the district court did not err in increasing the physician’s sentencing range under the Guidelines because her conduct created a risk of death or serious bodily injury, affected a large number of “vulnerable victims,” and also constituted obstruction of justice.
The court also ordered the physician to pay $432,238 in restitution to the state Medicaid program, Blue Cross and Blue Shield, and other private health plans.
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Case: United States v. Moon, No. 06-5581 (6th Cir. Jan. 16, 2008).
GGRA May Petition U.S. Supreme Court to Determine Whether ERISA Preempts a San Francisco Ordinance Setting Healthcare Spending Mandates for Employers
[Source: Health Lawyers Weekly, January 25, 2008 - AHLA]
The Golden Gate Restaurant Association (GGRA) said January 21 that it has decided not to petition the full Ninth Circuit to overturn a unanimous panel decision allowing a San Francisco ordinance setting new healthcare spending mandates for employers to go into effect.
A three-judge panel of the Ninth Circuit in a January 9 order agreed to stay an earlier federal trial court decision that the Employee Retirement Income Security Act (ERISA) preempted the San Francisco Health Care Security Ordinance, which was scheduled to go into effect January 1, 2008 for large employers.
GGRA said it reached the decision because of the “minimal opportunity for success,” adding that the “emergency stay order was granted without a dissenting opinion, and the schedule for the appeal totals 3 ½ months which is a short time frame to the court.”
In addition to the appeals process before the Ninth Circuit, GGRA said it is researching the potential of petitioning U.S. Supreme Court Justice Kennedy to overturn the emergency stay order.
“We believe this case will most likely end up in front of the US Supreme Court, and take many more months to complete,” the group said.
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Further coverage:
- USA Today, "Universal Health Care Plans Up Against U.S. Law" [January 16, 2008]:
California, Colorado, Michigan and Minnesota have proposals pending that rely on partial funding by employers. The lower court ruling "raises doubt with regard to all of the state health reform proposals," says Atlanta attorney John Hickman, an expert on the federal law.
If the 9th U.S. Circuit Court of Appeals ultimately rules in the city's favor, the case may end up before the U.S. Supreme Court, says Phyllis Borzi, a George Washington University health policy professor.
That's because last January, the 4th U.S. Circuit Court of Appeals reached the opposite conclusion over a Maryland law. That law charged very large employers a fee if they did not spend 8% of payroll on health care, essentially affecting only Wal-Mart. The appeals court ruled the measure violated federal law.
If the appeals courts disagree, "it sets up a conflict, which is the classic pathway to having the Supreme Court resolve it," Borzi says. A similar law in Suffolk County, N.Y., was rejected by a lower court in July; the county decided not to appeal.
- AHLA, Health and Life Sciences Law Daily, January 23, 2008:
The AP (1/22, Woodward) reports that the Washington "state Senate's healthcare chairwoman unveiled Monday an ambitious universal healthcare plan, bankrolled by payroll taxes, that she hopes to implement by 2010." Sen. Karen Keiser (D-Kent) modeled the Washington Health Partnership "after a $15 billion program proposed in the Wisconsin Legislature." In the version proposed for Washington, new taxes would be levied "on businesses and workers," with proceeds extending "health benefits to all Washingtonians not covered by a federal program." Workers would pay between a two and four percent tax on payroll, while employers would pay between nine and 12 percent. The plan calls for residents to "get a voucher to enroll in their choice of private health networks, which would compete to provide the benefits called for by a state administrative board."
The Golden Gate Restaurant Association (GGRA) said January 21 that it has decided not to petition the full Ninth Circuit to overturn a unanimous panel decision allowing a San Francisco ordinance setting new healthcare spending mandates for employers to go into effect.
A three-judge panel of the Ninth Circuit in a January 9 order agreed to stay an earlier federal trial court decision that the Employee Retirement Income Security Act (ERISA) preempted the San Francisco Health Care Security Ordinance, which was scheduled to go into effect January 1, 2008 for large employers.
GGRA said it reached the decision because of the “minimal opportunity for success,” adding that the “emergency stay order was granted without a dissenting opinion, and the schedule for the appeal totals 3 ½ months which is a short time frame to the court.”
In addition to the appeals process before the Ninth Circuit, GGRA said it is researching the potential of petitioning U.S. Supreme Court Justice Kennedy to overturn the emergency stay order.
“We believe this case will most likely end up in front of the US Supreme Court, and take many more months to complete,” the group said.
Continue reading
- - - - - - -
Further coverage:
- USA Today, "Universal Health Care Plans Up Against U.S. Law" [January 16, 2008]:
California, Colorado, Michigan and Minnesota have proposals pending that rely on partial funding by employers. The lower court ruling "raises doubt with regard to all of the state health reform proposals," says Atlanta attorney John Hickman, an expert on the federal law.
If the 9th U.S. Circuit Court of Appeals ultimately rules in the city's favor, the case may end up before the U.S. Supreme Court, says Phyllis Borzi, a George Washington University health policy professor.
That's because last January, the 4th U.S. Circuit Court of Appeals reached the opposite conclusion over a Maryland law. That law charged very large employers a fee if they did not spend 8% of payroll on health care, essentially affecting only Wal-Mart. The appeals court ruled the measure violated federal law.
If the appeals courts disagree, "it sets up a conflict, which is the classic pathway to having the Supreme Court resolve it," Borzi says. A similar law in Suffolk County, N.Y., was rejected by a lower court in July; the county decided not to appeal.
- AHLA, Health and Life Sciences Law Daily, January 23, 2008:
The AP (1/22, Woodward) reports that the Washington "state Senate's healthcare chairwoman unveiled Monday an ambitious universal healthcare plan, bankrolled by payroll taxes, that she hopes to implement by 2010." Sen. Karen Keiser (D-Kent) modeled the Washington Health Partnership "after a $15 billion program proposed in the Wisconsin Legislature." In the version proposed for Washington, new taxes would be levied "on businesses and workers," with proceeds extending "health benefits to all Washingtonians not covered by a federal program." Workers would pay between a two and four percent tax on payroll, while employers would pay between nine and 12 percent. The plan calls for residents to "get a voucher to enroll in their choice of private health networks, which would compete to provide the benefits called for by a state administrative board."
Monday, January 7, 2008
Bush administration imposing restrictions on states' abilities to expand Medicaid eligibility.
[Source: Health and Life Sciences Law Daily, January 4, 2008 - AHLA]
In a front-page article, the New York Times (1/4, Pear) reports, "The Bush administration is imposing restrictions on the ability of states to expand eligibility for Medicaid." The restrictions prevent states "from offering coverage to families of modest incomes who, the administration argues, may have access to private health insurance." The Medicaid restrictions are similar to "those the administration placed on the State Children's Health Insurance Program in August after states tried to broaden eligibility" for that program. Previously, "states had generally been free to set their own Medicaid eligibility criteria, and the Bush administration had not openly declared that it would apply the August directive to Medicaid." However, according to some state officials in Louisiana, Ohio, and Oklahoma, the "administration's intent" was discovered during "negotiations with the federal government over the last few weeks." The Times notes that last month, the Bush administration "rejected a proposal by Ohio to expand its Medicaid program to cover 35,000 more children by "increasing the [family income] limit to three times the poverty level." Some administration officials claim that government programs such as Medicaid begin "to 'crowd out' private insurance when they cover families with incomes from 250 percent to 300 percent of the poverty level."
According to White House spokesman Tony Fratto, "This policy demonstrates the President's compassion. He wants to direct scarce tax dollars to those with the greatest needs," reports the UPI (1/4).
In a front-page article, the New York Times (1/4, Pear) reports, "The Bush administration is imposing restrictions on the ability of states to expand eligibility for Medicaid." The restrictions prevent states "from offering coverage to families of modest incomes who, the administration argues, may have access to private health insurance." The Medicaid restrictions are similar to "those the administration placed on the State Children's Health Insurance Program in August after states tried to broaden eligibility" for that program. Previously, "states had generally been free to set their own Medicaid eligibility criteria, and the Bush administration had not openly declared that it would apply the August directive to Medicaid." However, according to some state officials in Louisiana, Ohio, and Oklahoma, the "administration's intent" was discovered during "negotiations with the federal government over the last few weeks." The Times notes that last month, the Bush administration "rejected a proposal by Ohio to expand its Medicaid program to cover 35,000 more children by "increasing the [family income] limit to three times the poverty level." Some administration officials claim that government programs such as Medicaid begin "to 'crowd out' private insurance when they cover families with incomes from 250 percent to 300 percent of the poverty level."
According to White House spokesman Tony Fratto, "This policy demonstrates the President's compassion. He wants to direct scarce tax dollars to those with the greatest needs," reports the UPI (1/4).
Tennessee grants funds to non-profit organization offering free sample medications to the uninsured.
[Source: Health and Life Sciences Law Daily, January 2, 2008 - AHLA]
The AP (12/29) reported that the Dispensary of Hope, a "nonprofit organization that provides free sample medications to Tennesseans who don't have insurance, will be able to expand its program with the help of a $1 million grant from the state." The funds will enable the program "to expand from three sites to nine in Tennessee." Additionally, a "new service that will allow people to receive medications through the mail" will be launched by 2008.
According to Scott Cornwell, the organization's managing director, the "dispensary is stocked by donations from 300 doctor's offices and clinics, as well as pharmaceutical companies," added the Tennessean (12/26, Pinto). Offering "more than 900 medications" since its inception in 2004, approximately "75,000 prescriptions" have been filled.
The AP (12/29) reported that the Dispensary of Hope, a "nonprofit organization that provides free sample medications to Tennesseans who don't have insurance, will be able to expand its program with the help of a $1 million grant from the state." The funds will enable the program "to expand from three sites to nine in Tennessee." Additionally, a "new service that will allow people to receive medications through the mail" will be launched by 2008.
According to Scott Cornwell, the organization's managing director, the "dispensary is stocked by donations from 300 doctor's offices and clinics, as well as pharmaceutical companies," added the Tennessean (12/26, Pinto). Offering "more than 900 medications" since its inception in 2004, approximately "75,000 prescriptions" have been filled.
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