[Source: Health and Life Sciences Law Daily, Oct. 24, 2007]
Congressional Quarterly (10/24, Bloedorn) reports, "Several key medical groups have announced their support for legislation (S 2029) that would require pharmaceutical companies to report any gifts given to physicians." The legislation, "sponsored by Sen. Charles E. Grassley (R-Iowa), and co-sponsored by Sen. Herb Kohl (D-Wis.)," would require "pharmaceutical companies with revenues exceeding $100 million...to file quarterly reports detailing all gifts of $25 or more given to physicians and clinicians." The American Medical Students Association, the National Physicians Alliance, and the Prescription Project said that "such gifts influence doctors to prescribe more expensive name brand medications" rather than "generic drugs." However, the Pharmaceutical Research and Manufacturers of America argues that the legislation "would create a 'reporting bureaucracy and could cause confusion and burdens for companies, physicians and patients.'"
See "Physician Payments Sunshine Act of 2007" (S. 2029) here
Wednesday, October 24, 2007
Friday, October 19, 2007
Interactive Online Tool Provides Side-by-Side Comparisons of Presidential Healthcare Proposals
The Kaiser Family Foundation has released an interactive online tool to compare the healthcare proposals of presidential candidates. The tool, 2008 Presidential Candidate Health Care Proposals: Side-by-Side Summary, summarizes positions in four overall categories: access to healthcare coverage, cost containment, improving the quality of care, and financing.
Nonprofit Panel Releases Principles For Good Governance
[Source: Health Lawyers Weekly, October 19, 2007]
The Panel on the Nonprofit Sector has released Principles for Good Governance and Ethical Practice: A Guide for Charities and Foundations aimed at helping organizations strengthen their effectiveness and accountability.
The Guide describes six principles that all charitable organizations must take because they are required by law as well as 27 additional principles that charities should strongly consider based on their structure and purposes.
The 33 principles are organized under four categories: Legal Compliance and Public Disclosure; Effective Governance; Strong Financial Oversight; and Responsible Fundraising.
Read the Guide.
The Panel on the Nonprofit Sector has released Principles for Good Governance and Ethical Practice: A Guide for Charities and Foundations aimed at helping organizations strengthen their effectiveness and accountability.
The Guide describes six principles that all charitable organizations must take because they are required by law as well as 27 additional principles that charities should strongly consider based on their structure and purposes.
The 33 principles are organized under four categories: Legal Compliance and Public Disclosure; Effective Governance; Strong Financial Oversight; and Responsible Fundraising.
Read the Guide.
Monday, October 15, 2007
Miller v. Tennessee Board of Nursing
Davidson County - This appeal involves a disciplinary proceeding against a registered nurse. After receiving a report that a registered nurse left her patients in a hospital’s medical/surgical unit before the end of her shift, the Tennessee Board of Nursing commenced a contested case proceeding to discipline the nurse. Following the hearing, the Board ordered the nurse to pay a $1,000 civil penalty and also immediately suspended the nurse’s license pending a psychological evaluation. The nurse sought judicial review of the Board’s decision by the Chancery Court for Davidson County, and the trial court affirmed the Board’s finding that the nurse had abandoned her patients, the assessment of the civil penalty, and the immediate suspension of the nurse’s license. The nurse appealed. We have determined that the record contains substantial and material evidence that the nurse abandoned her patients and that the Board did not act arbitrarily by requiring the nurse to pay a $1,000 civil penalty. However, we have determined that the Board acted arbitrarily when it immediately suspended the nurse’s license pending a psychological examination in the absence of any evidence or finding that the nurse was presently mentally unfit to practice nursing.
Case: Miller v. Tennessee Board of Nursing, No. M2005-02383-COA-R3-CV (Tenn. Ct. App. September 26, 2007)
Case: Miller v. Tennessee Board of Nursing, No. M2005-02383-COA-R3-CV (Tenn. Ct. App. September 26, 2007)
Tuesday, October 9, 2007
CMS approves TennCare waiver
[Source: Health and Life Sciences Law Daily, October 9, 2007]
The AP (10/9) reports, "The federal government has approved a three-year TennCare waiver extension that will leave the state with about $270 million less than needed to cover growing hospital costs, state officials announced today." However, the CMS-approved agreement "is an improvement over an original proposal that would have left Tennessee with more than $385 million less than projected."
Modern Healthcare (10/9, Galloro) notes, "The new agreement sets an annual cap of $540 million, or $1.62 billion over the three years of the waiver, on payments that TennCare can make to hospitals to offset the costs of treating uninsured patients not covered by TennCare."
The Chattanooga Times Free Press (10/9, Bregel) adds, "Although the TennCare Bureau submitted its request to renew the waiver in 2006 -- a year in advance of the waiver's originally expiration date of June 30, 2007 -- negotiations fell apart when the CMS added a provision to cap the amount of money TennCare could provide to hospitals as reimbursement for uncompensated care, TennCare Bureau officials have said."
Read the press release posted on TennCare’s website.
The AP (10/9) reports, "The federal government has approved a three-year TennCare waiver extension that will leave the state with about $270 million less than needed to cover growing hospital costs, state officials announced today." However, the CMS-approved agreement "is an improvement over an original proposal that would have left Tennessee with more than $385 million less than projected."
Modern Healthcare (10/9, Galloro) notes, "The new agreement sets an annual cap of $540 million, or $1.62 billion over the three years of the waiver, on payments that TennCare can make to hospitals to offset the costs of treating uninsured patients not covered by TennCare."
The Chattanooga Times Free Press (10/9, Bregel) adds, "Although the TennCare Bureau submitted its request to renew the waiver in 2006 -- a year in advance of the waiver's originally expiration date of June 30, 2007 -- negotiations fell apart when the CMS added a provision to cap the amount of money TennCare could provide to hospitals as reimbursement for uncompensated care, TennCare Bureau officials have said."
Read the press release posted on TennCare’s website.
Monday, October 8, 2007
FTC approves doctor-hospital network integration.
[Source: Health and Life Sciences Law Daily, October 8, 2007]
American Medical News (10/8, Sorrel) reports that on Sept. 17, the Federal Trade Commission (FTC) issued an advisory opinion that "has opened the door for a physician and hospital network to contract jointly with health plans under a clinical integration program." In only the second opinion (pdf) of its kind, "the Health Care Division of the FTC Bureau of Competition said Greater Rochester Independent Practice Assn.'s plan showed no signs of illegal price fixing. Instead, the bureau found that the program had the potential to provide low-cost, high-quality care to patients in the Rochester, N.Y., area." Moreover, "group negotiation appears 'reasonably necessary' to reach that goal, the FTC letter stated." AMNews adds, "Experts say the recent 30-page opinion on the Greater Rochester IPA's plan is chock-full of clues as to what the government might view as acceptable." Eric Nielsen, M.D., chief medical officer for the Greater Rochester IPA, said, "This is valuable not just to our physicians and to us, but to the country as a whole in showing that this model of clinical integration, which has been out there in the theoretical for the past 10 years, really can be implemented."
American Medical News (10/8, Sorrel) reports that on Sept. 17, the Federal Trade Commission (FTC) issued an advisory opinion that "has opened the door for a physician and hospital network to contract jointly with health plans under a clinical integration program." In only the second opinion (pdf) of its kind, "the Health Care Division of the FTC Bureau of Competition said Greater Rochester Independent Practice Assn.'s plan showed no signs of illegal price fixing. Instead, the bureau found that the program had the potential to provide low-cost, high-quality care to patients in the Rochester, N.Y., area." Moreover, "group negotiation appears 'reasonably necessary' to reach that goal, the FTC letter stated." AMNews adds, "Experts say the recent 30-page opinion on the Greater Rochester IPA's plan is chock-full of clues as to what the government might view as acceptable." Eric Nielsen, M.D., chief medical officer for the Greater Rochester IPA, said, "This is valuable not just to our physicians and to us, but to the country as a whole in showing that this model of clinical integration, which has been out there in the theoretical for the past 10 years, really can be implemented."
HHS awards $22.5 million in contracts to implement national electronic health record system.
[Source: Health and Life Science Law Daily, October 8, 2007]
Modern Healthcare (10/6, DerGurahian) reported that the HHS awarded nine grants totaling $22.5 million to health information exchanges "to test implementation of a nationwide health information network, officials announced." Specifically, the grants will be used to test the Nationwide Health Information Network, or NHIN, "a trial network, involving patients, providers and other healthcare stakeholders in exchanging information through the use of electronic health records. Officials stressed that the data will remain private and secure. The organizations represent both statewide and regional information exchanges."
Healthcare IT (10/5, Monegain) added, "The work is intended to move the nation toward President Bush's goal of most Americans having access to secure electronic health records by 2014." HHS Secretary Michael Leavitt said, "Trial implementations of the Nationwide Health Information Network will bring us steps closer to a health IT system that will improve quality of care, increase efficiencies in healthcare, and improve disease prevention." Computer World (10/5) also covered the story.
Modern Healthcare (10/6, DerGurahian) reported that the HHS awarded nine grants totaling $22.5 million to health information exchanges "to test implementation of a nationwide health information network, officials announced." Specifically, the grants will be used to test the Nationwide Health Information Network, or NHIN, "a trial network, involving patients, providers and other healthcare stakeholders in exchanging information through the use of electronic health records. Officials stressed that the data will remain private and secure. The organizations represent both statewide and regional information exchanges."
Healthcare IT (10/5, Monegain) added, "The work is intended to move the nation toward President Bush's goal of most Americans having access to secure electronic health records by 2014." HHS Secretary Michael Leavitt said, "Trial implementations of the Nationwide Health Information Network will bring us steps closer to a health IT system that will improve quality of care, increase efficiencies in healthcare, and improve disease prevention." Computer World (10/5) also covered the story.
Tuesday, October 2, 2007
U.S. Supreme Court grants cert. to determine whether FDA premarket approval of medical device preempts state law
The United States Supreme Court granted certification to review Riegel v. Medtronic, 451 F3d 104 (2nd Cir. 2006), to determine whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval (PMA) from the Food and Drug Administration.
As Bloomberg.com reports, the federal law says preemption applies when the U.S. government imposes a "requirement,'' though it doesn't specify whether that term includes FDA approval.
Court case: 06-179, Riegel v. Medtronic, Inc.
Applicable law:
21 U.S.C. §360k
(a) General rule
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
As Bloomberg.com reports, the federal law says preemption applies when the U.S. government imposes a "requirement,'' though it doesn't specify whether that term includes FDA approval.
Court case: 06-179, Riegel v. Medtronic, Inc.
Applicable law:
21 U.S.C. §360k
(a) General rule
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
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