The recently released proposed regulations for the Physician Payment Sunshine Provisions of Affordable Care Act by the Centers for Medicare and Medicaid Services (CMS) has drawn light to the cost of implementation of this regulation. CMS estimates that the Sunshine provisions will cost healthcare companies and health care provider $224 million in the first year alone.
CMS though readily admits that CMS has no empirical basis for estimating the frequency of such problems (inappropriate use), the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the costs of medical care.
Collection of Information Requirements
CMS is soliciting public comment on the following requirements:
ICRs Regarding Reports Of Payments or Other Transfers of Value and Physician Ownership and Investment Interests
Proposed §403.904 would require applicable manufacturers of covered drugs, devices, biologicals, and medical supplies to report annually to CMS all payments and other transfers of value to physicians and teaching hospitals (collectively, covered recipients).
This information is to be aggregated and posted publicly by CMS on a searchable website. Covered recipients and physician owners or investors must be provided with the opportunity to review and, if necessary, correct the information before it is posted publicly. When reporting the burden of this provision, CMS considered the impact in the first year of the program when applicable manufacturers and applicable GPOs must build reporting systems, and covered recipients and physician owners or investors are becoming accustomed with the review and correction requirements, as well as year 2 and annually thereafter. CMS anticipates that the burden will be reduced by roughly 25 percent in year 2 and remain the same annually thereafter.
The burden associated with these requirements is the time and effort spent by applicable manufacturers and applicable GPOs collecting the data, compiling reports to send to CMS, as well as the processes for registering and submitting the data, and any corrections, if necessary, to CMS. CMS estimates that approximately 1,150 applicable manufacturers, (150 drug and biologic manufacturers, and 1,000 device and medical supply manufacturers), and approximately 420 applicable GPOs would submit reports. – CMS does not account for training, education, compliance, oversight, policies, etc.
CMS based these estimates on the number of manufacturers reporting in States with similar transparency provisions, as well as the number of manufacturers registered with FDA. The number of drug manufacturers is based on reporting in Massachusetts, Minnesota, and Vermont, and the number of device manufacturers is based on reporting in Massachusetts, since Minnesota and Vermont do not require device manufacturers to report. Because the State laws have higher payment thresholds and are specific to the physicians in the State, CMS estimated that the number of manufacturers reporting would be greater under section 1128G of the Act. For device manufacturers, CMS used data from the FDA to identify the total number of manufacturers to use as a ceiling for our estimate. CMS seeks comment on whether there are any other sources of data available.
CMS recognized that larger companies that manufacture more products may have a greater number of financial relationships with a more diverse group of covered recipients. Coordinating the data collection will require ensuring that all payments and other transfers of value are attributed to the correct covered recipient and reported in the manner proposed in this proposed rule. These estimates include CMS’ aggregate estimate of the overall time required to build and maintain the reporting systems (including the development of new information technology systems), obtain NPI and other information from the NPPES system (and if necessary supplement that information), establish whether any owners or investors have physicians as immediate family members (if necessary), organize the data for submission to CMS (within the organization and with any third party vendors), register with CMS and submit the required data, review the aggregated data that CMS produces, respond to any physician or teaching hospital queries during the review process, and resubmit certain disputed information (if necessary).
It allows for time applicable manufacturers and applicable GPOs may sometimes use for "presubmission" reviews but assumes that would be rarely used, and only for complex cases. It also includes the time that applicable manufacturers may elect to spend to submit with their data a document describing their assumptions and methodology for categorizing the nature of payments.
The estimates also include the potentially substantial time savings that would accrue to them as registrants through the ability to query CMS, and receive informal guidance through a listserv or other methods of providing technical assistance and useful information on low cost methods of compliance. As a technical point, we note that CMS proposes a 5-year records retention requirement. CMS believes the costs of this are negligible for electronic recordkeeping, but solicit comment on this approach.
Additionally, the estimates also include the time of employees, such as sales representatives, who have direct relationships with covered recipients and physician owners or investors. These employees would have to record the details of each relationship with the covered recipient, or physician owner or investor for reporting purposes.
This overall estimate is based primarily on the judgmental estimates of persons CMS consulted that are expert in the overall cost of existing reporting systems. CMS welcomes more detailed and disaggregated information that would help them improve the overall estimate or better craft the final rule to deal with specific problems or time-saving options. CMS is particularly interested in the burden of collecting and recording information for each payment or transfer of value by the staff and identifying whether individuals with ownership or investment interests have physicians as immediate family members.
CMS estimates that on average, smaller applicable manufacturers will have to dedicate 50 percent of a full time equivalent (FTE) employee (mainly in the range of zero to one), whereas larger applicable manufacturers may have to dedicate 5 to 15 FTE employees to comply with the reporting requirements (we assume 10 on average). Large manufactures are often multinational enterprises that employ tens of thousands of people worldwide, whereas many small manufacturers only have a few products and employ significantly fewer people. Since there are many more small companies, CMS estimates that on average, 1.74 FTE employees would be needed for each applicable manufacturer in the first year (150 larger firms times 10 FTE and 1000 smaller firms times 0.5 FTE).
CMS appreciates that this is considerable simplification of a far more complex distribution of firms, but thinks that it captures the skewness of the distribution in manufacturing sectors where a relative handful of firms have sales in the billions of dollars annually over a wide range of products, and a far larger number have annual sales in low millions of dollar annually for just a few products, with practices regarding financial relationships with physicians varying widely within each group and, in many cases by product or product class.
The greater staff time for year 1 represents time for applicable manufacturers to alter their systems to collect and report this data. CMS estimates that once procedures and systems are modified, costs would be 25 percent lower, which reduces this value to an average of 1.3 FTEs in year 2 and annually thereafter.
The actual burdens could easily average 25 percent lower or higher, and would depend on manufacturers' changes in practices after the regulations are made final. Some may welcome the new transparency; others may decide to change or eliminate their current practices. CMS’ assumption that smaller firms could in some cases incur no new costs assumes that some do not now have any such financial relationships and that this proportion would grow as some firms decide that the benefits of such relationships are less than the costs of reporting. Other smaller firms with only a few products and only a few financial relationships might well already have systems in place that essentially meet the proposed requirements or that could do so with minimal effort.
CMS welcomes comments that can provide empirical data on the costs to implement the requirements in firms of varying sizes and product portfolios, on the extent to which systems already in place meet the proposed requirements in firms of various kinds and sizes, and on the extent to which firms would modify their practices to avoid reporting costs.
In total, CMS estimated that for applicable manufacturers and applicable GPOs required to report, it will cost $199,387,000 for year 1 and will cost $148,979,000 for year 2 and annually thereafter. For the first 3 years, this averages to a cost of $165,781,000 annually. All estimates are in 2010 dollars.
ICRs Regarding Review and Correction by Physicians and Teaching Hospitals (§403.908(h))
An additional burden associated with section 1128G of the Act is the time and effort spent by covered recipients, and physician owners or investors reviewing, and if necessary, correcting the data before it is reported publicly. Neither the statute, nor this proposed rule, contains a recordkeeping requirement for physicians or teaching hospitals. Therefore, while CMS evaluated the burden associated with the review and correction process, CMS do not include an estimate of the burden for keeping records. CMS seeks comments on this assumption, and on the extent to which physicians and teaching hospitals will keep records in the absence of a requirement to do so.
The statute uses the definition of physician in section 1861(r) of the Act, which includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors. Using the Bureau of Labor Statistics Occupational Outlook Handbook, CMS estimate that information may be available for as many as 892,000 physicians.
However, CMSs believe that not all physicians will have relationships with applicable manufacturers or applicable GPOs. Based on feedback CMS received from stakeholders, CMS estimates that 25 percent of physicians have no relationships with applicable manufacturers or applicable GPOs, which reduces our universe of affected physicians to approximately 669,000.
Further, stakeholders have expressed that many physicians maintain relationships with applicable manufacturers that are relatively insignificant from a financial point of view, so CMS estimates that many physicians will not devote any time to reviewing and correct the aggregated reports from CMS. CMS estimates that only 50 percent of the remaining 669,000 physicians will review the report, which reduces our universe of affected physicians to 334,500 for year 1. For year 2, CMS anticipates that there would be a further reduction in the number of physicians reviewing the data because they would be familiar with the information, so CMS reduced the number of physicians reviewing by another 25 percent, to 250,875 physicians.
For teaching hospitals, CMS knows that about 1,100 hospitals receive Medicare GME or IME payments, all of which are defined as teaching hospitals for this provision. CMS believes that the vast majority of teaching hospitals would have at least one financial relationship with an applicable manufacturer, so CMS did not apply any adjustments to this estimate. CMS also anticipates that there would not be a reduction in the number of teaching hospitals that review the information after the first year because teaching hospitals probably have more complex financial relationships.
Each physician and teaching hospital would be only allowed to review the information attributed to them by all applicable manufacturers and applicable GPOs. CMS estimates that on average, physicians would need one hour to review the information reported. For physicians that choose to review the information, this would range from a few minutes for physicians with few relationships with applicable manufacturers, to at most 10 or 20 hours for the small number of physicians who have lengthy disputes over a payment or other transfer of value, or ownership or investment interest.
CMS believes that teaching hospitals would have to review more payments or other transfers of value and have more complex relationships, so CMS estimates that, on average, it would take a representative from a teaching hospital 10 hours to review the submitted data, ranging from 3 hours for small teaching hospitals that receive few payments or other transfer of value, to 60 hours for teaching hospitals that have lengthy disputes. CMS welcomes comment and data on these estimates, and particularly welcome data from physicians and institutions in States that have required similar reporting in the past.
CMS believes that many physicians would delegate their review responsibilities to their nurses and office assistants. Given this expectation, CMS believes that the Healthcare Practitioners and Technical Occupations cost estimate is appropriate for this calculation. The average hourly rate for Healthcare Practitioners and Technical Occupations is $54.53 in physician offices, which rises to $72.52 with 33 percent fringe benefits and overhead costs. This average includes physicians, who account for about half of the employment in this category. The total number of hours for physicians (including physician offices) would be 334,500 for year 1 and 188,156 hours (250,875 x 0.75 hours) for year 2, which averages to 236,938 hours annually for the first 3 years.
The total estimated cost for the review and correction period for physicians in year 1 is
$24,258,000. For year 2 and annually thereafter, the estimated cost for physician review and correction is $13,645,000. For the first 3 years, the average cost for all physicians review and correction will be $17,190,000 annually.
Cost for Teaching Hospitals
For teaching hospitals, CMS expects a manager to review the payments and other transfers of value. The hourly average rate for Management Occupations is $48.88, or $65.01 when fringe and overhead costs are applied. For year 1, the total number of hours would be 11,000 (1,100 x 10 hours) at $65.01 per hour. For year 2 this would decrease to 8,250 hours (1,100 x 7.5 hours) at $65.01 per hour. For the first 3 years, the total number of hours for teaching hospitals will be 9,167 annually. The total estimated cost for the review and correction period for teaching hospitals is $715,000 for year 1 and $536,332 for year 2 and annually thereafter. On average, the cost for all teaching hospitals will be $595,925 annually for the first 3 years.
Based on the assumptions presented here, CMS anticipates that the total estimated burden of section 1128G of the Act for year 1 is 4,619,000 hours, at a cost of $224,360,000. For year 2 and annually thereafter, the total estimated burden is 3,372,000 hours, at a cost of $163,087,390. Annualized over 3 years, the total number of hours per year is 3,788,000 with a cost of $183,560,000.
Regulatory Impact Analysis
Statement of Need
CMS noted that the provisions of the Act were modeled largely on the recommendations of the Medical Payments Advisory Commission (MedPAC), which voted in 2009 to recommend Congressional enactment of a new regulatory program. The problem addressed, as stated by MedPAC, is that "at least some" drug and device manufacturer interactions with physicians "are associated with rapid prescribing of new, more expensive drugs and with physician requests that such drugs be added to hospital formularies," as well as "concern that manufacturers' influence over physicians' education may skew the information physicians receive." MedPAC went on to say that "there is no doubt that those relationships should be transparent," while pointing out that "transparency does not imply that all—or even most—of these financial ties undermine physician-patient relationships."
CMS examined the impacts of this rule as required by various federal laws. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).
CMS estimates that this rulemaking is "economically significant" as measured by the $100 million threshold. Accordingly, CMS prepared a Regulatory Impact Analysis that presents estimated costs and benefits of the rulemaking. CMS solicit comments on all assumptions and estimates in this regulatory impact analysis.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. Under the RFA, "small entities" are those that fall below size thresholds set by the Small Business Administration, or are not-for-profit organizations or governmental jurisdictions with a population of less than 50,000.
For purposes of the RFA, CMS estimates that the majority of teaching hospitals and physicians, and most applicable manufacturers and applicable GPOs are small entities under either the size or not-for-profit standard. CMS seeks comment on assumptions and estimations regarding the RFA.
According to the Small Business Administration size standards the threshold size standard for "small" pharmaceutical manufacturers is 750 employees, for biological products, and surgical equipment, surgical supplies, & electromedical/electrotherapeutic apparatus manufacturers is 500 employees and for drug and medical equipment wholesalers is 100 employees. CMS estimates that approximately 75 percent of applicable manufacturers and applicable GPOs are smaller than these size standards.
In this proposed rule, CMS proposes that applicable manufacturers that do not have payments or other transfers of value or physician ownership or investment interests to report do not need to submit a report. CMS believes that many small applicable manufacturers and applicable GPOs will have no relationships, thus will not have to report, so the burden on them will be negligible. For small entities with financial relationships to report, CMS believes that they will only have a small number to report, making the reporting process significantly less burdensome. CMS believes that the average burden of the reporting requirements will be about $50,000 in the first year (average annual wage rate of $97,595 times 0.5 FTE) for smaller manufacturers, and even less in subsequent years.
This amount is far below the 3 percent of revenues that HHS uses as a threshold for "significant impact" under the RFA, so these regulations will not have a significant effect on these small entities. For example, if a firm with only 100 employees generates annual revenues of $200,000 per employee, or $20 million, a cost of $50,000 would be about one-fourth of 1 percent of revenues. Firms this small would potentially face costs considerably less than $50,000, and hence an even lower effect.
As previously noted, most teaching hospitals and physicians are small entities under the RFA, since most teaching hospitals are not-for-profit and some have revenues below $34.5 million. CMS estimates that 95 percent of physician practices have revenues under $10 million.
CMS believes the regulatory effects of this provision on physicians and teaching hospitals are relatively minor. Physicians and teaching hospitals are provided with the opportunity to review and correct this information, but are not involved in the data collection or reporting processes.
CMS estimated that this review would take the great majority of individual physicians and/or their office staff one hour or less to perform annually and 10 hours or less annually for teaching hospitals, on average. Given that their review will take such a small amount of their time annually, the costs faced by physicians and teaching hospitals are not substantial. As a result, CMS believes that the cost burden of this review and correction period will be far below the 3 percent threshold for "significant impact." Moreover, the amount of time spent on such reviews is entirely discretionary. Therefore, CMS determined that this proposed rule will not have a significant economic impact on a substantial number of small entities in any category of entities it affects.
In addition, section 1102(b) of the Act requires CMS to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. CMS does not believe that any of the affected teaching hospitals are small rural hospitals. Therefore, CMS determined that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any single year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. The estimates presented in this section of this proposed rule exceed this threshold and as a result, we have provided a detailed assessment of the anticipated costs and benefits in section V.C.4. of this proposed rule. Reporting under section 1128G of the Act is required by law, so we are limited in another policy avenue for achieving the expected benefits. Section V.D. of this proposed rule, as well as other parts of the preamble, provide detailed additional information on the alternatives we considered.
CMS noted that while this proposed rule does preempt certain elements of State law, the regulatory standard simply follows the express preemption provision in the statute. Because of this and the fact that this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.
The regulatory impact of this provision includes applicable manufacturers and applicable GPOs collection and submitting this information to CMS, and physician and teaching hospital review and correction period. CMS estimated a total cost of about $224 million for the first year of reporting, followed by about $163 million in the second year and annually thereafter. CMS solicits comments on the assumptions, data, estimates, and anticipated effects described throughout this analysis and section III. of this proposed rule.
Effects on Applicable Manufacturers and Applicable GPOs
Only applicable manufacturers that made reportable payments or other transfers of value, or have physicians (or immediate family members of physicians) holding ownership and investment interests, would be required to submit reports. CMS estimated that approximately 1,150 applicable manufacturers (150 drug and biologic manufacturers and 1,000 device and medical supply manufacturers) and 420 applicable GPOs would submit reports. Across applicable manufacturers CMS estimates that, on average, fewer than two FTE employees would be needed for each applicable manufacturer submitting a report, and that for smaller manufacturers the effort would be on average about half of an FTE employee.
CMS noted that the costs of applicable manufacturers may be partially offset because many companies are already required to report to States with similar disclosure requirements, but would no longer be so required to report the same information to state after the final rule is issued.
In addition, a few large companies are already reporting similar information on a national level in order to comply with Corporate Integrity Agreements (CIAs) with HHS OIG. These companies may not have to invest as much to comply with the requirements in section 1128G of the Act, so the burden of these requirements may be lower for these companies. However, given the differing requirements for each State and CIA, and broad scope of section 1128G of the Act, CMS does not believe it is possible to approximate the lessened burden for entities already reporting.
We seek comment on this interpretation and whether there is a more precise way to quantify these estimates. Further, CMS estimates that applicable manufacturers and applicable GPOs may face significant first year costs in scaling and staffing up to meet the reporting requirements. However, once systems are in place and reporting becomes routine, such costs would decrease in subsequent years. Therefore CMS estimates that the cost for year 2 would be approximately 25 percent less for applicable manufacturers and applicable GPOs.
Effects on Physicians and Teaching Hospitals
We also have estimated costs for physicians and teaching hospitals, since they would have an opportunity to review and correct the data submitted by applicable manufacturers. CMS estimates the number of physicians as defined in the statute, which includes a number of provider types, including doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors. We also reduced these numbers to adjust for physicians with no financial relationships and those who would not review and correct the data submitted on their behalf. See the Table 6 for a breakdown of this calculation. Roughly 1,100 teaching hospitals meet the proposed definition of teaching hospital and would need to review the data submitted during the 45-day review period.
CMS estimates that it would take on average one hour for physicians or their office staffs to review the information reported. For teaching hospitals, CMS estimates that, on average, it would take a representative from a teaching hospital 10 hours to review the submitted data, ranging from 3 hours for small teaching hospitals that receive few payments or other transfer of value, to 60 hours for teaching hospitals that have lengthy disputes.
Further CMS estimates that as physicians and teaching hospitals become accustomed to receiving these reports that the amount of time they spend reviewing them and interacting with applicable manufacturers and applicable GPOs would decrease in year 2 and subsequent years of reporting. These assumptions are described in more detail in section III.B. of this proposed rule. Additionally, more detailed information regarding these costs is provided in Tables 3 and 4 of this proposed rule.
Collaboration among physicians, teaching hospitals, and industry manufacturers can contribute to the design and delivery of life-saving drugs and devices. While collaboration is beneficial to the continued innovation and improvement of our health care system, some payments from manufacturers to physicians and teaching hospitals can introduce conflicts of interests that may influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care, and lead to increased program costs. It is important to understand the extent and nature of relationships between physicians, teaching hospitals, and industry manufacturers through increased transparency, and to permit patients to make better informed decisions when choosing health care professionals and making treatment decisions.
Additionally, it is important to develop a system that encourages constructive collaboration, while also discouraging relationships that threaten the underlying integrity of the health care system.
Recent increases in both the amount and scope of industry involvement in medical research, education, and clinical practice has led to considerable scrutiny. Both the Institute of Medicine and other experts, such as the Medicare Payment Advisory Commission (MedPAC), have recommended enhanced disclosure and transparency to discourage the inappropriate use of financial incentives and lessen the risk of such incentives interfering with medical judgment and patient care. CMS recognized that disclosure is not sufficient to differentiate beneficial, legitimate financial relationships from those that create a conflict of interest or are otherwise improper.
However, transparency can shed light on the nature and extent of relationships, and discourage inappropriate conflicts of interest. CMS has no empirical basis for estimating the frequency of such problems, the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the costs of medical care. However, CMS observes, that the costs of the proposed rule for preparing reports are small in relation to the size of the affected industry sectors.
CMS said that applicable manufacturers and applicable GPOs subject to State requirements would not have to comply with multiple State requirements, and instead would only have to comply with a single Federal requirement with regard to the types of information required to be reported under 1128G(a) of the Act.
CMS noted that the Act encourages transparency of financial relationships between physicians and teaching hospitals, and the pharmaceutical and device industry. Although, many of these relationships are beneficial, close relationships between manufacturers and prescribing providers can lead to conflicts of interests that may affect clinical decision-making. Increased transparency of these relationships tries to discourage inappropriate relationships, while maintaining the beneficial relationships. Public reporting and publication is the only identified option for obtaining this transparency and achieving the intensions of this provision. In developing this proposed rule, we tried to minimize the burden on reporting entities by trying to simplify the reporting requirements as much as possible within the statutory requirements.
The statute is prescriptive as to the types of information required to be reported, and the ways in which it is required to be reported; however wherever possible we tried to allow flexibility in the reporting requirements. For example--
CMS does not propose to require the submission of an assumptions document for nature of payment categories, but allow applicable manufacturers and applicable GPOs to submit this voluntarily; and
The Secretary is allowed discretion to require the reporting of additional information, but we tried to use this discretion as sparingly as possible, in large part because of the strong desire expressed by stakeholders that we not expand reporting categories.
For example, CMS considered asking applicable manufacturers and applicable GPOs to report the method of preferred communication and email address for physicians and teaching hospitals with which they have relationships, but have solicited comment on whether this would be useful or additionally burdensome. These examples demonstrate CMS’ effort to minimize the regulatory burden of this proposed rule and we solicit comments on all the alternatives considered in this section or elsewhere in the preamble. Other examples CMS said demonstrate it considered alternatives include:
- not including the two proposed limitations on the definition of covered drug, device, biological, and medical supply.
- It’s definition of "common ownership"
- Whether applicable manufacturers should report another unique identifier
- Definition of a GPO
45 day review period: Here CMS request comments on alternative time periods and, especially, on possible alternatives to this approach that might better serve the interest of all concerned in publication of accurate information. For example, should there be a two-step process, in which the information when first released is labeled provisional, and "final" data is labeled as such after a second opportunity for correction?
They also request comments on any approach that minimizes costs or improves accuracy of the information with respect to applicable manufacturers and applicable GPOs being required to inquire of covered recipients and physician owners or investors of their opportunity to review the data.
They also want comments on or information on the likely frequency of cases in which additional communication methods would be necessary, useful, costly, inexpensive, or otherwise better or worse.
To Submit Comments
Comments are due by 5:00pm Eastern, February 17, 2012.
You may submit comments in one of four ways
Electronically: You may submit electronic comments on this regulation to
http://www.regulations.gov. Follow the "Submit a comment" instructions.
Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
P.O. Box 8013,
Baltimore, MD 21244-8013.
Express or overnight mail
Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850.
By hand or courier.
Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
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Washington, DC 20201