II 109th CONGRESS 1st Session S. 1297 IN THE SENATE OF THE UNITED STATES June 23, 2005 Mr. Corzine (for himself, Mr. Bingaman, and Ms. Landrieu) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to reduce the work hours and increase the supervision of resident-physicians to ensure the safety of patients and resident-physicians themselves.

1.

Short title

This Act may be cited as the Patient and Physician Safety and Protection Act of 2005.

2.

Findings

Congress finds the following: (1)The Federal Government, through the medicare program, pays approximately $8,000,000,000 per year solely to train resident-physicians in the United States, and as a result, has an interest in assuring the safety of patients treated by resident-physicians and the safety of resident-physicians themselves. (2)Resident-physicians spend as much as 30 to 40 percent of their time performing activities not related to the educational mission of training competent physicians. (3)The excessive numbers of hours worked by resident-physicians is inherently dangerous for patient care and for the lives of resident-physicians. (4)The scientific literature has consistently demonstrated that the sleep deprivation of the magnitude seen in residency training programs leads to cognitive impairment. (5)A substantial body of research indicates that excessive hours worked by resident-physicians lead to higher rates of medical error, motor vehicle accidents, depression, and pregnancy complications. (6)The medical community has not adequately addressed the issue of excessive resident-physician work hours. (7)The Federal Government has regulated the work hours of other industries when the safety of employees or the public is at risk. (8)The Institute of Medicine has found that as many as 98,000 deaths occur annually due to medical errors and has suggested that 1 necessary approach to reducing errors in hospitals is reducing the fatigue of resident-physicians.

3.

Revision of medicare hospital conditions of participation regarding working hours of medical residents, interns, and fellows

(a)

In general

Section 1866 of the Social Security Act (42 U.S.C. 1395cc) is amended— (1)in subsection (a)(1)— (A)by striking and at the end of subparagraph (U); (B)by striking the period at the end of subparagraph (V) and inserting , and; and (C)by inserting after subparagraph (V) the following new subparagraph: (W)in the case of a hospital that uses the services of postgraduate trainees (as defined in subsection (k)(4)), to meet the requirements of subsection (k). ; and (2)by adding at the end the following new subsection: (k)(1)(A)In order that the working conditions and working hours of postgraduate trainees promote the provision of quality medical care in hospitals, as a condition of participation under this title, each hospital shall establish the following limits on working hours for postgraduate trainees: (i)Subject to subparagraphs (B) and (C), postgraduate trainees may work no more than a total of 24 hours per shift. (ii)Subject to subparagraph (C), postgraduate trainees may work no more than a total of 80 hours per week. (iii)Subject to subparagraph (C), postgraduate trainees— (I)shall have at least 10 hours between scheduled shifts; (II)shall have at least 1 full day out of every 7 days off and 1 full weekend off per month; (III)subject to subparagraph (B), who are assigned to patient care responsibilities in an emergency department shall work no more than 12 continuous hours in that department; (IV)shall not be scheduled to be on call in the hospital more often than every third night; and (V)shall not engage in work outside of the educational program that interferes with the ability of the postgraduate trainee to achieve the goals and objectives of the program or that, in combination with the program working hours, exceeds 80 hours per week. (B)(i)Subject to clause (ii), the Secretary shall promulgate such regulations as may be necessary to ensure quality of care is maintained during the transfer of direct patient care from 1 postgraduate trainee to another at the end of each shift. (ii)Such regulations shall ensure that, except in the case of individual patient emergencies, the period in which a postgraduate trainee is providing for the transfer of direct patient care (as referred to in clause (i)) does not extend such trainee’s shift by more than 3 hours beyond the 24-hour period referred to in subparagraph (A)(i) or the 12-hour period referred to in subparagraph (A)(iii)(III), as the case may be. (C)The work hour limitations under subparagraph (A) and requirements of subparagraph (B) shall not apply to a hospital during a state of emergency declared by the Secretary that applies with respect to that hospital. (2)The Secretary shall promulgate such regulations as may be necessary to monitor and supervise postgraduate trainees assigned patient care responsibilities as part of an approved medical training program, as well as to assure quality patient care. (3)Each hospital shall inform postgraduate trainees of— (A)their rights under this subsection, including methods to enforce such rights (including so-called whistle-blower protections); and (B)the effects of their acute and chronic sleep deprivation both on themselves and on their patients. (4)For purposes of this subsection, the term postgraduate trainee means a postgraduate medical resident, intern, or fellow. . (b)

Designation

(1)

In general

The Secretary of Health and Human Services (in this subsection referred to as the Secretary) shall designate an individual within the Department of Health and Human Services to handle all complaints of violations that arise from a postgraduate trainee (as defined in paragraph (4) of section 1886(k) of the Social Security Act, as added by subsection (a), who reports that the hospital operating the medical residency training program for which the trainee is enrolled is in violation of the requirements of such section. (2)

Grievance rights

A postgraduate trainee may file a complaint with the Secretary concerning a violation of the requirements under such section 1886(k). Such a complaint may be filed anonymously. The Secretary may conduct an investigation and take corrective action with respect to such a violation. (3)

Enforcement

(A)

Civil money penalty enforcement

Subject to subparagraph (B), any hospital that violates the requirements under such section 1886(k) is subject to a civil money penalty not to exceed $100,000 for each medical residency training program operated by the hospital in any 6-month period. The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b)) shall apply to civil money penalties under this paragraph in the same manner as they apply to a penalty or proceeding under section 1128A(a) of such Act. (B)

Corrective action plan

The Secretary shall establish procedures for providing a hospital that is subject to a civil monetary penalty under subparagraph (A) with an opportunity to avoid such penalty by submitting an appropriate corrective action plan to the Secretary. (4)

Disclosure of violations and annual reports

The individual designated under paragraph (1) shall— (A)provide for annual anonymous surveys of postgraduate trainees to determine compliance with the requirements under such section 1886(k) and for the disclosure of the results of such surveys to the public on a medical residency training program specific basis; (B)based on such surveys, conduct appropriate on-site investigations; (C)provide for disclosure to the public of violations of and compliance with, on a hospital and medical residency training program specific basis, such requirements; and (D)make an annual report to Congress on the compliance of hospitals with such requirements, including providing a list of hospitals found to be in violation of such requirements. (c)

Whistleblower protections

(1)

In general

A hospital covered by the requirements of section 1866(k) of the Social Security Act, as added by subsection (a), shall not penalize, discriminate, or retaliate in any manner against an employee with respect to compensation, terms, conditions, or privileges of employment, who in good faith (as defined in paragraph (2)), individually or in conjunction with another person or persons— (A)reports a violation or suspected violation of such requirements to a public regulatory agency, a private accreditation body, or management personnel of the hospital; (B)initiates, cooperates, or otherwise participates in an investigation or proceeding brought by a regulatory agency or private accreditation body concerning matters covered by such requirements; (C)informs or discusses with other employees, with a representative of the employees, with patients or patient representatives, or with the public, violations or suspected violations of such requirements; or (D)otherwise avails himself or herself of the rights set forth in such section or this subsection. (2)

Good faith defined

For purposes of this subsection, an employee is deemed to act in good faith if the employee reasonably believes— (A)that the information reported or disclosed is true; and (B)that a violation has occurred or may occur. (d)

Effective date

The amendments made by subsection (a) shall take effect on the first July 1 that begins at least 1 year after the date of enactment of this Act.

4.

Additional funding for hospital costs

There are hereby appropriated to the Secretary of Health and Human Services such amounts as may be required to provide for additional payments to hospitals for their reasonable additional, incremental costs incurred in order to comply with the requirements imposed by this Act (and the amendments made by this Act).