Transparency-related provisions in the summary of the chairman’s mark that Sen. Max Baucus and the Senate Finance Committee released last week: Lots of new disclosure requirements for physicians who refer patients to hospitals in which they or their family members have a financial interest, for nursing homes, for hospitals, for medical device manufacturers, suppliers, and pharmaceutical companies. Little oversight of government (there’s a few requirements for new entities created by the bill to act in a transparent manner). Still, what’s more interesting is what’s not transparent — updates on that coming later. Here’s the descriptions of the provisions.
page 39: “to ensure transparency and accountability, health plans would be required to report the proportion of premium dollars that are spent on items other than medical care;” “hospitals would be required to list standard charges for all services and Medicare DRGs” [health plans and hospitals]
pages 48-49: “States would be required to: (1) provide notice of the states intent to develop and/or renew a section 1115 waiver and convene at least one meeting of the states medical advisory board to discuss the impacts of the proposed changes; (2) publish for written comment a notice of the proposal that provides information on how the public can submit comments to the state and includes state projections and assumptions regarding the likely impact of the waiver; (3) post the waiver proposal on the states Medicaid or CHIP website; and (4) convene open meetings over the course of the development of the proposal to discuss proposed changes. States could also be required to include information regarding the actions taken to meet the above-listed public notice requirements as a part of their waiver submission to CMS.” [states]
Page 49: The Secretary [of HHS] would be required to: (1) publish a Federal Register notice identifying monthly waiver submissions, approvals, denials, and information regarding methods by which comments on the waiver will be received from the public; (2) publish a copy of the proposed waiver to the CMS website; and (3) allow for, respond to, and make available public comments received about the proposal after it has been posted to the CMS website. Once approved, the Secretary would have to post waiver terms and conditions and related waiver approval documents, quarterly state-reported data and three-year evaluations to the CMS website. The Secretary would also be required to publish a Federal Register notice identifying monthly waiver approvals, denials, and returns to the state without action. [Health & Humans Services]
Page 49: The Chairman’s Mark would add transparency-related statutory requirements associated with the SPA approval process for proposals that limit benefits. States would have to: (1) provide notice of the states intent to develop a SPA and convene at least one meeting of the states medical advisory board to discuss the impacts of the changes requested in the proposed SPA; (2) publish a notice of the proposal that provides information on how the public can submit comments to the state and includes state projections and assumptions regarding the likely impact of the SPA; (3) post the SPA proposal on the state’s Medicaid or CHIP website, and (4) convene at least one open meeting to discuss the proposed SPA. States would also be required to include information regarding the actions taken to meet the above-listed public notice requirements as a part of their SPA submission to CMS. [states]
Page 49: The Secretary [of HHS] would be required to: (1) publish a Federal Register notice identifying monthly SPA submissions and information regarding methods by which comments on each SPA will be received from the public; (2) publish a copy of the proposed SPA to the CMS website; and (3) publish a Federal Register notice identifying monthly SPA approvals, denials, and returns to the state without action. [Health & Human Services]
Page 85: The Chairmans Mark would direct the Secretary [of HHS] to establish a national quality improvement strategy that includes priorities to improve the delivery of health care services, patient health outcomes, and population health through a transparent and collaborative process. In developing these priorities, the Secretary would consider how the priorities would: … enhance the use of health care data to improve quality, efficiency, transparency, and outcomes; [Health & Human Services]
Page 85-86: In developing the national strategy and priorities, the Secretary [of HHS] would take into consideration recommendations submitted by a qualified consensus-based entity as set forth in MIPPA. To develop these recommendations, the qualified consensus based entity would convene a multi-stakeholder group. Stakeholders would include, but would not be limited to representatives of hospitals, physicians, post-acute providers, quality alliances, nurses and other health care practitioners, health plans, consumer representatives, life sciences industry, employers and public purchasers, labor organizations, licensing, credentialing and accrediting bodies, relevant government agency representatives, and others deemed appropriate by the Secretary. This multi-stakeholder group would operate in an open and transparent process. [private nonprofit entity; HHS]
The Secretary would update the national strategy not less than triennially and the first report would be due to Congress on December 31, 2010. Any update would include a review of short and long term goals as well as an analysis of progress in meeting these goals. In addition, the Secretary would make the national strategies available via a public website. [HHS]
Page 162: Each entity under contract with the Institute [that is, the Patient-Centered Outcomes Research Institute, which would “assist patients, clinicians, purchasers, and policy makers in making informed health decisions by advancing the quality and relevance of clinical evidence through research and evidence synthesis”] would be required to (1) abide by the same transparency and conflicts of interest requirements that apply to the Institute with respect to the management or conduct of research; (2) comply with the methodological standards adopted by the Board; (3) take into consideration public comments, provided for and transmitted by the Institute, on individual study designs before the finalization of such designs, and submit responses to such comments to the Institute which the Institute would publish with the comments and the finalized study design before the conduct of research; (4) consult with the rare disease advisory panel for the relevant study as appropriate; and (5) allow for a researcher(s) under contract to publish their findings so long as any research published is consistent with products disseminated by the Institute. Research entities under contract that do not meet the publishing requirements set by the Institute would not be allowed to enter into another contract with the Institute for a period of not less than five years. [Patient-Centered Outcomes Research Institute]
Pages 165-166: The Institute would make the following information publicly available (disclosed through the official public Internet site and any other forums the Institute deems appropriate): (1) the process and methods for the conduct of research, including the identity of the entity conducting research, any links the entity has to industry (including links that are not directly tied to particular research being conducted under contract with the Institute); draft study designs, including research questions and the finalized study design together with associated public comments and responses to such comments, research protocols, including clinical measures taken; methods of research and analysis used; research results; key decisions made by the Institute, panels or committees of the Institute; the identity of investigators conducting such research and any potential conflicts of interest; and progress reports the Institute deems appropriate; (2) notice of each of the public comments periods established by the Institute along with any deadlines for public comments for such periods; (3) public comments submitted during each of the public comment periods; (4) bylaws, processes, and proceedings of the Institute, as feasible and appropriate; and (5) any report, research findings, and appropriate related information within 90 days after the receipt of such article by the Institute.
Conflicts of Interest. The Chairmans Mark would direct the Comptroller General to consider and disclose any conflicts of interest of potential Board appointees. Board members would be required to recuse themselves when conflicts of interest arise from participation in Board activities and when such interest is directly related to and could affect or be affected by the members participation. The Mark would require the Institute to take into consideration any conflicts of interest of potential appointees, participants, and staff in appointing members to advisory panels and the methodology committee, in selecting individuals to contribute to any peer-review process, and in employing executive staff. Any such conflicts of interest would be described in the annual report; in the case of peer-reviewers, such descriptions would not allow peer-reviewers to be associated with a particular study.
The Institute, its Board or staff would be prohibited from accepting gifts, bequeaths, or donations of services or property. Further, the Institute would be prohibited from establishing a corporation or generating revenues from activities other than as provided for under the Chairmans Mark. [Patient-Centered Outcomes Research Institute]
Pages 174-175: to address conflicts of interest, an exempt hospital would (1) submit an annual report containing the identity of each physician owner and any other information on the nature and extent of all ownership interests in the hospital; (2) have procedures in place to require that any referring physician owner disclose to each patient (by a time that permits the patient to make a meaningful decision regarding the receipt of care) their ownership interest in the hospital and, if applicable, any such ownership interest of the treating physician; (3) not condition ownership, either directly or indirectly, on the physician owners making or influencing referrals to the hospital; and (4) disclose the fact that the hospital is owned in whole or in part by physicians on any public website for the hospital and in public advertising for the hospital. Information from the annual report would be published and updated annually on the Internet website of the Centers for Medicare & Medicaid Services. [certain Physician-owned hospitals]
Page 175: To ensure patient safety, exempt hospitals would be required to disclose to all patients prior to admission that it does not have any physician available on the premises to provide services during all hours in which the hospital is providing services. [certain Physician-owned hospitals]
Page 175: The process for expansion [of certain Physician-owned hospitals] would allow the opportunity for community input and should permit an applicable hospital to apply for the expansion exception up to once every two years. The Secretary [of HHS] would publish final decisions on an expansion no later than 60 days after receiving a complete application. [HHS]
Page 176-177: The Chairmans Mark would require any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, a physician group practice, or a hospital with an approved medical residency training program to report annually, in electronic form, specified information on such transactions to the Secretary of HHS. The report would include the transfer recipients name, business address, amount of the payment, date of the payment, a description of the form of the payment, a description of the nature of the payment, if the payment is related to marketing, education, or research specific to a covered drug, device, biological or medical supply the name of that product, and any other category of information that the Secretary determines appropriate. If the recipient requests a transfer of payment to another entity or individual at the request of the recipient the manufacturer should disclose that information. Delayed reporting requirements would apply for payments made pursuant to a product development agreement or clinical trial. Some information would be excluded from these reporting requirements, including payments or transfers of $10 or less, unless the aggregate annual payments or transfers to a recipient exceeds $100, in which case all payments or transfers shall be reported, samples intended for patient use, patient educational materials, loan of a covered device for a short-term time period, discounts and rebates, payments made to a physician for the provision of health care to employees, payments to a physician who is also a licensed, non-medical professional if the payment is solely related to non-medical services, payments to a physician solely for services related to a civil or criminal action or an administrative proceeding, and in-kind items used for charity care. This reporting requirement would begin on March 31, 2012 and continue on the 90th day of each subsequent calendar year.
The Chairmans Mark also requires any such manufacturer, or related group purchasing organization to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year.
Manufacturers or group purchasing organizations would be subject to a civil money penalty (CMP) of not less than $1,000 but not more than $10,000 for each payment or transfer not reported. The total amount of the penalties for any annual submission shall not exceed $150,000. Any manufacturer or group purchasing organization that knowingly fails to submit information would be subject to a CMP of not less than $10,000 but not more than $100,000 for each payment or transfer not reported. The total amount of the penalties for this failure to report category of submissions shall not exceed $1,000,000 annually.
The Chairmans Mark would require the Secretary to establish procedures no later than October 1, 2010 to ensure public availability of this information. Beginning September 30, 2012 and on June 30 of subsequent years, submitted information should be available on an Internet website that meets formatting, search, and usability requirements. In addition to the transfer information, the website should include information on enforcement actions during the preceding year, background information on industry-physician relationships, a separate listing for payments related to clinical research, and other information that the Secretary deems appropriate. The Secretary should also allow recipients an opportunity to submit corrections to their information. This reporting procedure should be established after consulting the Office of the Inspector General (HHS OIG), affected industry, consumers and other parties in order to ensure that the information is presented in an appropriate context. The Secretary would be required to submit an annual report to Congress and the states beginning April 1, 2012.
Effective January 1, 2011 the Chairmans Mark would preempt any state (or political subdivision of a state) law or regulation that requires manufacturers to disclose the type of information required under this provision regarding payments or transfers to covered recipients. The Mark would not preempt any state (or political subdivision of a state) law or regulation that requires the disclosure or reporting of (1) any information not required under this provision; (2) the types of information excluded from reporting requirements under this provision, with the exception of the $10 de minimis/$100 aggregate reporting requirement; (3) information by any person or entity other than an applicable manufacturer or covered recipient described above; and (4) information reported to a Federal, state, or local government for public health purposes.
The Secretary would be required to consult with the HHS OIG on the implementation of this section. [physicians, device manufacturers, pharmaceutical firms, medical suppliers, HHS]
Page 178: The Chairmans Mark would require drug manufacturers and authorized distributors to report the information required under the Prescription Drug Marketing Act of 1987 to the Secretary of HHS. [drug manufacturers and authorized distributors] (Note: under the Prescription Drug Marketing Act of 1987, manufacturers and distributors can give free samples to physicians that write requesting them; they also must maintain records on who the distributed the samples to for three years. No word on whether this information would be publicly available)
Page 179: Required Disclosure of Ownership. SNFs [Skilled nursing facilities] and nursing facilities would be required to make available on request by the Secretary, the HHS OIG, the state, and the state long term care ombudsman, information on ownership (including direct and indirect ownership) and additional disclosable parties as well as information describing the governing body and organizational structure of the facility. Information would be made available to the Secretary, the HHS OIG, the state and state long term care ombudsman programs upon request. To the extent that the required information is submitted to the IRS as part of Form 990, to the Securities and Exchange Commission, or to the Secretary, facilities would be permitted to make the information available in these formats.
Information to be disclosed would include the identity of and information on each member of the governing body of the facility (name, title, period of service); each person or entity who is an officer, director, member, partner, trustee, or managing employee of the facility; and each person or entity who is an additional disclosable party of the facility.
Additional disclosable parties would be defined as any persons or entities (1) that exercise operational, managerial or financial control over the facility or part thereof, or provides policies or procedures for any of the operations of the facility, or provides financial or cash management services to the facility; (2) lease or sublease real property to the facility, or owns a whole or part interest equal to or exceeding five percent of the total value of such real property; (3) lend funds or provide financial guarantees which is equal to or exceeds $50,000; and (4) that provide management or administrative services, management or clinical consulting services, or accounting or financial services to the facility.
The reporting of a person or entitys organizational structure would also be required. Organizational structure would be defined as officers, directors and shareholders who have an ownership interest equal to or greater than five percent in the case of corporations. For a limited liability company, organizational structure would be defined as members and managers; for a general partnership, the partners; for a limited partnership, general partners and any limited partners who have an ownership interest equal to ten percent or greater in the limited partnership; for a trust, the trustees; for an individual, contact information; and for any other person or entity, such information as the Secretary determines appropriate.
The Secretary and the states would be required to develop a standardized format through regulation for facilities to report information about ownership and additional disclosable parties within two years of enactment.
The Secretary, within one year of promulgating regulations requiring reporting by facilities, would be required to make available to the public information about ownership and additional disclosable parties. The Secretary would also be required to provide guidance and technical assistance to states on how to adopt the standardized format. [Nursing homes, HHS, states]
Page 180-181: The Chairmans Mark would require the Secretary to include additional information on the Medicare Nursing Home Compare website. This additional information includes: (1) standardized staffing data on nursing staff and other staff providing medical and therapy services available on facilities that is submitted by facilities in a uniform format; (2) links to state internet websites regarding state survey and certification programs, and links to Form 2567 (or successor form) inspection reports, links to facility plans of correction or responses to such reports and information to guide consumers in how to interpret and understand these reports; (3) a standardized complaint form including explanatory material on how to use the complaint forms, and how to file a complaint with the state survey and certification program and the state long term care ombudsman program; (4) a summary of information on enforcement action against the facility that includes substantiated complaints and remedies proposed and imposed during the preceding three years; and (5) a summary of facility expenditures for direct care staffing based on data submitted.
The Secretary would be required to establish a process to review the accuracy, clarity of the presentation, timeliness, and comprehensiveness of information currently reported on Nursing Home Compare; and a process to modify or revamp the site in accordance with comments received after review. In conducting the review, the Secretary would be required to consult with state long term care ombudsman programs, consumer advocacy groups, provider stakeholder groups, and other representatives of programs or groups as the Secretary determines appropriate.
States would be required to submit survey information to the Secretary no later than they send such information to the facility, and requires the Secretary to use this information to update Nursing Home Compare as expeditiously as practicable. Facilities would be required to have available on request the preceding three years of inspection reports (Form 2567 reports), complaint investigations and the facilitys plan of correction or other response to the Form 2567 report. Facilities would also be required to post notice of the availability of such reports in areas of the facility that are prominent and accessible to the public. The Secretary would be required to issue guidance to states on establishing electronic links to Form 2567 reports, to facility plan of correction reports or other responses to 2567 reports, and posting of complaint investigation reports. [HHS, states, nursing homes]
Page 181: The Chairmans Mark would amend the Social Security Act by adding requirements that SNF and nursing homes report expenditures for wages and benefits for direct care staff on facility cost reports. The reporting of expenditures on wages and benefits for direct care staff would be required to be broken out into categories including registered nurses, licensed professional nurses, certified nurse assistants, and other medical and therapy staff. The Secretary would be required to consult with government and private sector cost report experts to assist in categorizing by functional area SNF expenditure data, as well as in making it publicly available. [nursing homes, HHS]
Page 181: The Chairmans Mark would require the Secretary to establish a process to require SNF and nursing facilities to regularly report staffing data, including agency and contract staff, by staff position categories (based on payroll and other verifiable and auditable data). The reporting requirements would include the category of work an employee performs such as whether the employee is an RN, LPN, LVN, CNA, or other medical or therapy staff providing direct resident services, resident census data, information on employee turnover and tenure, and the hours of care provided per resident per day. The Secretary would be required to consult with stakeholders in developing the reporting requirements. The process would be electronic and data would be reported in a uniform format. The Secretary would submit a report to Congress no later than six months after the completion of a one-year design phase. Not later than one year following the evaluation, the Secretary would require facilities to begin electronically submitting staffing information in a uniform format. [nursing homes, HHS [public disclosure of this information?]
Page 182: The Chairmans Mark would require SNFs and nursing homes to notify in a timely fashion state, Federal, and stakeholder officials, as well as residents and their representatives of an impending nursing facility closure. Facilities would be required in the notice to issue a plan for the transfer and relocation of residents.
The administrator of a facility that is preparing to close would be required to provide written notification to residents, legal representatives of residents or other responsible parties, the state, the Secretary and the long term ombudsman program. This notification would have to be made at least 60 days before closure. [Nursing homes]
Page 184: Beginning in 2011, the Chairmans Mark would establish a national requirement for acute care hospitals to make their charges for each Medicare diagnostic related group (DRG) available to the public and upon request to any patient served by the facility. Hospitals would be required to provide the average charge and the range between the 2nd and 4th quintiles of charges across all commercial payers and for self-pay patients for each DRG; hospitals would update their information on an annual basis. If the hospital does not comply with the requirement, the Secretary of Health and Human Services would be authorized to impose a civil money penalty on the facility in the amount of $50,000. [hospitals]
Pages 211-212: Each hospital facility would be required to conduct a community health needs assessment at least once every three years and adopt an implementation strategy to meet the community needs identified through such assessment. The assessment may be based on current information collected by a public health agency or non-profit organizations and may be conducted together with one or more other organizations, including related organizations. The assessment process must take into account input from persons who represent the broad interests of the community served by the hospital, including those with special knowledge or expertise of public health issues. The hospital must disclose in its annual information report to the IRS (i.e., Form 990 and related schedules) how it is addressing the needs identified in the assessment and, if all identified needs are not addressed, the reasons why (e.g. lack of financial or human resources). Each hospital facility would be required to make the assessment widely available. [nonprofit hospitals]
Page 213: The Chairmans Mark would require the Secretary and the Secretary of Health and Human Services to annually report to Congress the levels of charity care, bad debt expenses, unreimbursed costs of means-tested government programs, and unreimbursed costs of non-means tested government programs incurred by private tax-exempt, taxable, and governmental hospitals as well as the cost of community benefit activities incurred by private tax-exempt hospitals. In addition, the Secretary, in conjunction with the Secretary of Health and Human Services, must conduct a study of the trends in these amounts with to the results of the study provided to Congress five years from date of enactment. [HHS]
While waiting for my Fred Flintstone vintage computer to download the Senate Finance Committee health care bill, I couldn’t help but notice how high tech the committee’s site is:
This site is optimized for Netscape Navigator 4.x or Internet Explorer 4.x, with an 800×600 screen resolution.
They helpfully provide a link where you can get the optimal version of Netscape.
Netscape 4.0 was introduced in June 1997, according to Wikipedia.
Take a look at the Social Security Act of 1935 — cut and paste and put into Word (12 point Times New Roman), it’s a mere 33 pages long.