Sec. 6001. Limitation on Medicare exception to the prohibition on certain physician referrals for hospitals (as modified by sec. 10601 and by sec. 1106 of HCERA).
Adds requirements for rural hospitals to qualify for the rural provider exception to the prohibition on certain physician self-referrals due to ownership or investment. Beginning not later than 9/23/2011, only hospitals with physician ownership or investment and a provider agreement in operation on 12/31/2010 and that meet numerous specified requirements are exempt from the prohibition on self-referral. The requirements include an annual report from each such hospital to the Secretary containing a detailed
description of the hospital’s ownership and investment interests (which information the Secretary is required to publish on the CMS website and update annually); disclosure by the hospital on its website and in any public advertising of the fact that physicians have ownership or investment interests; disclosure to patients concerning any ownership or investment interest of referring or treating physicians; prohibition on the hospital
conditioning any physician ownership or investment interests either directly or indirectly on a physician owner or investor making or influencing referrals; limiting the aggregate value of the ownership or investment interests of physician owners or investors to the percentage they represented on 3/23/2010; procedures to disclose to patients if a physician will not be available on the premises to provide services during all hours in which the hospital is providing services to the patient; and various requirements to assure that physicians’ ownership or investment interests do not result from special favor
from the hospital (such as loans or other assistance in acquiring ownership) or provide for future favors (such as the opportunity to benefit from or to purchase other business interests related to the hospital). The hospital also could not have converted from an ambulatory surgical center to a hospital on or after 3/23/2010.
Limits the number of operating rooms, procedure rooms, and beds for which the hospital is licensed at any time on or after 3/23/2010 to the number of operating rooms,
procedure rooms, and beds for which the hospital is licensed on 3/23/2010. Provides a process to allow qualified hospitals to apply for an exception to the prohibition on expansion. To qualify for an exception, a hospital must either be a high Medicaid facility or satisfy five specified criteria involving location in a state with lower than average bed capacity and higher than average bed occupancy rates; location in a fast-growing county; having average or greater Medicaid percentage of inpatient admissions; and not discriminating against beneficiaries of Federal health care programs and also not
permitting physicians practicing at the hospital to discriminate against such beneficiaries. Qualification for an exception on the basis of being a high Medicaid facility requires not being the only hospital in the county and having an annual percentage of Medicaid admissions that is the highest percentage for all hospitals in the county for each of the three most recent years for which data are available.
Capacity increase is limited to facilities on the main campus and cannot exceed 200% of the number of operating rooms, procedure rooms and beds on 3/23/2010. The Secretary must publish final decisions on an expansion request no later than 60 days after
receiving a complete application. Secretary must issue regulations governing the exceptions process by 1/1/2012 and implement the process on 2/1/2012. There is no administrative or judicial review of the exceptions process.
Secretary must establish policies and procedures to ensure compliance with these requirements beginning on 9/23/2011. Enforcement efforts may include unannounced site reviews of hospitals. Secretary must conduct compliance audits beginning not later than 5/1/2012.
Sec. 6002. Transparency reports and reporting of physician ownership or investment interests.
Requires that, beginning no later than March 31, 2013, covered manufacturers that make a payment or another transfer of value to a physician or a teaching hospital to report annually, in electronic form, specified information on such transactions to the Secretary of HHS. Distributors would not be subject to these reporting requirements. A payment or transfer of value means a transfer of anything of value. Certain information would be excluded from these reporting requirements.
Manufacturers would be allowed to delay submission of their reports pursuant to certain services furnished as part of a product development agreement, or in connection with a clinical investigation of a new drug, device, biological, or medical supply.
Manufacturers and group purchasing organizations are required to report annually certain information regarding an ownership or investment interest held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year. Hospitals not required to report ownership information.
Certain penalties would apply to manufacturers and group purchasing organizations for failure to submit these reports,
Requires establishment of procedures to ensure that information required to be submitted is available through an Internet website.
Preempts, subject to specified exemptions, duplicative state laws.
Sec. 6003. Disclosure requirements for in-office ancillary services exception to the prohibition on physician self-referral for certain imaging services.
Requires the written disclosure by the referring physician to the patient of any ownership interest in certain imaging services to which a physician refers a patient and provide the patient with a list of suppliers of the service in the patient’s area of residence.
Sec. 6004. Prescription drug sample transparency.
Requires drug manufacturers or authorized distributors to report to the Secretary the information they are now required to collect in regard to the drug samples distributed to requesting licensed practitioners.
Sec. 6005. Pharmacy benefit managers transparency requirements.
Requires a pharmacy benefit manager (PBM) or a health benefits plan that provides pharmacy benefits management services that contracts with health plans under Medicare or the state Exchanges to report to the Secretary information regarding the mail order rate; the generic dispensing rate by pharmacy type; the aggregate amount of rebates, discounts, or price concessions negotiated by the PBM that are attributable to patient utilization and passed through to the plan sponsor; and the aggregate amount of the payment difference between the amount the health plans pay the PBM and the amount the PBM pays pharmacies, and the number of prescriptions dispensed. All disclosed information would be confidential, except for certain specific purposes.
Subtitle B—Nursing Home Transparency and Improvement PART I—IMPROVING TRANSPARENCY OF INFORMATION
Sec. 6101. Required disclosure of ownership and additional disclosable parties information.
Requires extensive reporting and disclosure to the Secretary of any ownership or financial interest of at least 5% as well as anyone who exercises financial controls over the facility. Such information to be made available to the public. Effective 90 days after publication of regulations (which are due within 2 years of enactment).
Sec. 6102. Accountability requirements for skilled nursing facilities and nursing facilities.
Requires facility compliance and ethics programs to be followed by their employees and agents. Requires the Secretary to develop regulations within two years of enactment, and facilities to comply with regulations within 3 years of enactment. Requires the Secretary to create regulations on quality assurance and performance improvement (QAPI) plans. SNFs required to implement QAPI plans within one year after regulations are promulgated.
Sec. 6103. Nursing home compare Medicare website.
Increases the comparative information reported by SNFs that is to be provided on the Nursing Home Compare Medicare website (including standardized staffing data, standardized complaint form, survey and certification information, summary of enforcement action, and summary of staffing-related financial information). The
Secretary is required to review accuracy, etc., of information reported on Nursing Home Compare and establish a process to modify same, as appropriate. Also requires addition of consumer rights information page on the website. States are required to submit survey information. SNFs are required to make available to the public, on
request, the preceding 3 years of inspection reports. Effective one year after enactment.
Sec. 6104. Reporting of expenditures.
Requires SNFs to report expenditures for wages and benefits for direct care staff separately on cost reports submitted beginning 2 years after enactment (3/23/2012). Within 30 months of enactment, expenditure information, arrayed by specified functional accounts (direct care, indirect care, capital assets and administrative service costs), is to be publicly available on request.
Sec. 6105. Standardized complaint form.
Requires the Secretary to prepare a standardized compliant form for use by a nursing home resident in filing a complaint with the state. Each state is required to establish a complaint processing program, including a complaint resolution process. Effective not later than 3/23/2010.
Sec. 6106. Ensuring staffing accountability.
Within two years of enactment, SNFs are required to electronically submit to the
Secretary specified direct care staffing information based on payroll and other verifiable data in a uniform format.
Sec. 6107. GAO study and report on Five-Star Quality Rating System.
Within two years of enactment, the GAO shall submit to Congress a report on the CMS Five-Star Quality Rating System for nursing homes.
PART II—TARGETING ENFORCEMENT