Physician Payment Sunshine Act

Posted on July 25, 2012 | Comment (1)
Filed under Fraud and Abuse, Implementation Briefs

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Implementation Briefs

By Jane Hyatt Thorpe and Teresa Cascio

Background

Drug companies and medical device manufacturers commonly collaborate with physicians when developing or modifying drug or devices.^[1] These collaborations may include consulting arrangements in which physicians provide input and guidance related to drug or device development, participation in clinical trials testing the efficacy and effectiveness of the drug or device, or educational programs to train and teach physicians about the benefits of a new drug or in the case of a medical device, how to use the device effectively. In return for their services and expertise, physicians often receive payment or other items of value such as an honorarium and/or travel expenses. These financial relationships between manufacturers and physicians, while largely beneficial, raise concerns about conflicts of interest as physicians’ treatment decisions may be improperly influenced by their financial relationship with a manufacturer. There is also concern in the industry that these types of arrangements are used to disguise illegal kickbacks (i.e., providing money or other items of value in return for prescribing a particular drug or using a particular medical device).^[2] To avoid any real or perceived conflicts or kickbacks from these arrangements and to ensure that patients and consumers are aware of these arrangements when making healthcare decisions, Congress included the Physician Payment Sunshine Act in the 2010 Affordable Care Act.

Changes made by the Affordable Care Act, Public Law No. 111-148, § 6002^[3]

Overview.^[4] The Sunshine Act requires “applicable manufacturers” to annually report “payments or transfers of value” (“payments”) made to “covered recipients” (i.e., physicians and teaching hospitals). The reports must include the following types of information: the name and address of the recipient, the amount and type of value transferred (e.g., cash, stock, services), and the purpose of the payment (e.g., consulting fees, gift). If a manufacturer makes a payment to a covered recipient’s designee, the manufacturer must disclose the name of the covered recipient when submitting their report as well. Manufacturers and Group Purchasing Organizations (GPOs) also must annually report information regarding physician (or immediate family member) ownership of the manufacturer or GPO. Reported physician (or immediate family member) ownership information must include the amount of the investment and the value of the ownership. The reports do not need to include information about ownership and investment interests in publicly traded securities or mutual funds.
Manufacturers and GPOs.^[5] The Act defines “applicable manufacturer” to include any manufacturer of drugs, devices, biologicals, or medical supplies covered by Medicare or Medicaid that operates within the United States. GPOs are organizations that purchase or facilitate the purchase of Medicare or Medicaid covered drugs, devices, biologicals, or medical supplies while operating in the United States.^[6]
Covered Recipients.^[7] The Act defines the term to include physicians and teaching hospitals. The term does not include physicians employed by manufacturers.
Payments or Transfers of Value.^[8] The term refers to “a transfer or anything of value,” but does not include indirect transfers made through a third party if the manufacturer does not know the identity of the recipient.
Exclusions.^[9] Manufacturers do not have to report the following payments or transfers of value: (1) transfers of value less than $10 so long as the aggregate yearly amount does not exceed $100; (2) product samples intended for patient use rather than resale; (3) educational materials intended for patient use; (4) trial loans of Medicare or Medicaid covered devices that do not exceed 90 days; (5) items or services provided pursuant to a warranty so long as the warranty terms appear in the device purchase or lease agreement; (6) transfers made to a covered recipient when they are a patient; (7) discounts and rebates; (8) dividends or profits from an investment in a publicly traded security or mutual fund; (9) “in-kind items used for the provision of charity care”; (10) payments by an applicable manufacturer for its employees’ health care through a self-insured plan; (11) transfers of value for non-medical services provided by a covered recipient that hold a license for such non-medical services; and (12) transfers of value to physicians for services provided in regards to legal proceedings.
Penalties.^[10] Manufacturers and GPOs are liable for $1,000 to $10,000 in civil monetary penalties for each payment or ownership interest they fail to report. Knowing failures to report will result in penalties between $10,000 and $100,000 per violation. Annual liability may not exceed $150,000 for regular violations and $1,000,000 for knowing violations.
Submission of Information.^[11] The U.S. Department of Health and Human Services (HHS) Secretary must create procedures for submitting information.
Public Availability.^[12] The HHS Secretary must publish the payment and ownership information on a website in a form that is searchable, downloadable, and understandable by the public. The published information must include information such as the names of the reporting manufacturers and covered entities, the name and address of the covered recipient, and the amount of value transferred. The HHS Secretary must give manufacturers, GPOs, and recipients 45 days to review and correct the information before publishing the information on the website. However, this review period may not prevent the HHS Secretary from meeting the applicable publishing deadline.
Research and Development.^[13] Manufacturers must report payments made pursuant to their research and development efforts. However, the Act permits the HHS Secretary to delay such reporting until the earlier of (1) the date the FDA approves the product under research and development; or (2) four years after the transaction. Information regarding payments or transactions of value made for research and development purposes will remain confidential until the HHS Secretary publicly publishes the information.
Preemption.^[14] The Act preempts state laws that impose identical payment reporting requirements on manufacturers, but does not preempt state laws that (1) impose reporting requirements on manufacturers that differ from the ACA requirements; (2) require manufacturers to report the payment information expressly excluded by the ACA; (3) impose reporting requirements on entities that do not qualify as “applicable manufacturers” or “covered recipients”; or (4) require reporting to a government entity for public health purposes (e.g. surveillance, investigation).
Reports.^[15] The HHS Secretary must submit annual reports to Congress containing aggregate payment and ownership information as well as a summary of enforcement actions taken in response to noncompliance. The HHS Secretary must also provide states with an annual summary of payment and ownership information pertaining to covered entities located within their borders.
Reporting and Publication Dates.^[16] Manufacturers and GPOs must submit their initial reports by March 31, 2013 and thereafter on the 90th day of each subsequent year. The HHS Secretary must publish the information on the Internet by September 30, 2013 and June 30th of each following year.

Implementation

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule for the implementation of the Physician Payment Sunshine Act in December 2011. CMS has not yet finalized these rules, but has announced that manufacturers and GPOs do not need to collect information before January 1, 2013. CMS anticipates releasing the final rule by the end of 2012.^[17]

Key Issues

Classifying payments.^[18] Manufacturers must classify the type of payment made to physicians or teaching hospitals, but this may be a difficult task as payments may fall into multiple categories. CMS proposes to allow manufacturers to voluntarily file a confidential explanation of their classification choices along with the data. This explanation may protect manufacturers from allegations of noncompliance, but it will increase their administrative burden. Additionally, differing classification choices among manufacturers could compromise efforts to aggregate or derive conclusions from the data.
Privacy.^[19] The Act does not require CMS to release the identity of physician family members that have an ownership or investment interest in a manufacturer or GPO. CMS recognizes that such family members have an interest in keeping their identity private, but are considering publishing this information in an effort to further transparency. CMS should carefully consider the comments to the proposed rule so that the final rule properly balances these privacy and transparency interests.
Data Correction and Disputes.^[20] Physicians will only have 45 days to challenge reported information before CMS publishes the information on the website. This period may not provide enough time for manufacturers, GPOs, and physicians to resolve disputes about the accuracy of the information.^[21] If the parties cannot resolve their dispute, CMS proposes to publish the information as provided by both the manufacturer or GPO and physician and use the physician’s version when aggregating totals. This proposal would lend transparency to the dispute, but use of the physician information when aggregating might undermine the soundness of the data.
Third Party Payments.^[22] Members of the medical community have expressed their concerns that drug manufacturers are sponsoring continuing medical education programs as a means of marketing their products to physicians. Regardless of the drug manufacturers’ intent, such accusations exemplify the “appearances of impropriety” that the Sunshine Act seeks to illuminate. However, the Act’s definition of payment could create a loophole for reporting such sponsorship, as manufacturers only need to report indirect payments to third parties if they are aware of the identity of the recipient. Manufacturers could conceivably argue that sponsoring an educational seminar does not give them knowledge of the attendees that would qualify as recipients. CMS addresses this potential loophole in the proposed rule by stating that manufacturers are aware of the recipient’s identity “if the applicable manufacturer has actual knowledge of, or acts in deliberate ignorance or reckless disregard of, the identity of the covered recipient.” Whether third party payments remain an issue depends on whether CMS finalizes this proposal.
Cost.^[23] Complying with the Sunshine Act requirements will cost manufacturers, GPOs, and physicians an estimated $ 224 million during the first year and an estimated $163 million thereafter. These costs could dampen business growth and innovation because manufacturers may have to direct monies towards compliance rather than product development.

Authorized Funding Levels

There is no authorized funding for the Sunshine Act.

[1] Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests 76 Fed. Reg. 78742 (Dec. 19, 2011).
[2] Gardiner Harris, Crackdown on Doctors Who Take Kickbacks (Mar. 3, 2009), http://www.nytimes.com/2009/03/04/health/policy/04doctors.html.
[3] Patient Protection and Affordable Care Act § 6002, 42 U.S.C. 1320a-7h (2010).
[4] § 6002; 42 U.S.C. 1320a-7h(a).
[5] § 6002; 42 U.S.C. 1320a-7h(e)(1)-(2).
[6] The Sunshine Act also applies to manufacturers and GPOs located within one of the United States’ territories, commonwealths, or possessions. Id.
[7] § 6002; 42 U.S.C. 1320a-7h(e)(6).
[8] § 6002; 42 U.S.C. 1320a-7h(e)(10).
[9] Id.
[10] § 6002; 42 U.S.C. 1320a-7h(b).
[11] § 6002; 42 U.S.C. 1320a-7h(c).
[12] Id.
[13] § 6002; 42 U.S.C. 1320a-7h(c)(E).
[14] § 6002; 42 U.S.C. 1320a-7h(d)(3).
[15] § 6002; 42 U.S.C. 1320a-7h(d)(1)-(2).
[16] § 6002; 42 U.S.C. 1320a-7h(a)-(d).
[17] Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests 76 Fed. Reg. 78742 (Dec. 19, 2011); Centers for Medicare & Medicaid Services, Information on Implementation of the Physician Payments Sunshine Act, THE CMS BLOG (May 3, 2012), http://blog.cms.gov/2012/05/03/information-on-implementation-of-the-physician-payments-sunshine-act/.
[18] 72 Fed. Reg. at 78748.
[19] Id. at 78752.
[20] Id. at 78755.
[21] Charles Fiegl, Organized medicine seeks more latitude to challenge industry gift reports, AMERICAN MEDICAL NEWS (Mar. 12, 2012), http://www.ama-assn.org/amednews/2012/03/12/gvsa0312.htm.
[22] Larry Husten, Ray of Light for the Physician Payment Sunshine Act, FORBES (Dec. 22, 2011) http://www.forbes.com/sites/larryhusten/2011/12/22/ray-of-light-for-the-physician-payment-sunshine-act/; Daniel Carlat, Diagnosis: Conflict of Interest, N.Y. TIMES (June 13, 2007) http://www.nytimes.com/2007/06/13/opinion/13carlat.html?_r=1; 72 Fed. Reg. at 78751.
[23] 72 Fed. Reg. at 78761.

Comment (1)

Josh DeBoer says:

July 25, 2012 at 12:12 pm

Chiropractic – My Anti-Drug

Drug companies are just making people more sick and these deals prove that the drug industry is shady at best. When there is billions to be made… follow the money to the root source.

CMS to launch payment disclosure website

April 23, 2013

By the end of September 2014, the Centers for Medicare and Medicaid Services (CMS) will launch a new website that publishes payments made to physicians and teaching hospitals by drug and device manufacturers. The website, OPEN PAYMENTS, is a product of the National Physician Payment Transparency Program required by Section 6002 of the Affordable Care Act (ACA). OPEN PAYMENTS will not only collect and aggregate data regarding potential conflicts of interests between manufacturers and providers, but it will also allow providers to access their data prior to public posting and enable them to address any data disputes.

CMS releases long-awaited Physician Payment final rule

February 4, 2013

The Centers for Medicare & Medicaid Services (CMS) released a final rule on Friday regarding the implementation of the Physician Payment Sunshine Act, which requires drug and device-makers to disclose financial relationships with doctors. Passed under the 2010 Affordable Care Act (ACA), the law was supposed to make a database describing these relationships available by September 2013. The final rule requires companies to begin collection of the information in August 2013, and to begin reporting it to the U.S. Department of Health and Human Services (HHS) by March 2014.

CMS releases Medicaid primary care physician payment rule

November 6, 2012

Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to implement increased payments to primary care physicians for specified Medicaid services, as forwarded by the Affordable Care Act (ACA). Under the ACA provision, certain physicians who provide eligible primary care services will be paid the Medicare rates (as opposed to the Medicaid rates currently in place) in 2013 and 2014. The payment increase applies to primary care services delivered by family medicine, general internal medicine, or pediatric medicine physicians or related subspecialists. States will receive 100 percent federal financial participation (FFP) for the difference between the Medicaid state plan payment amount as of July 1, 2009, and the applicable Medicare rate. The rule includes information about the identification of eligible providers and services, how to meet the requirements when making these payments for managed care services, and how this policy applies to the Vaccines for Children (VFC) program.

Obama administration announces new rules to simplify administrative rules for doctors and hospitals

August 7, 2012

Health and Human Services (HHS) Secretary Kathleen Sebelius announced today the release of a new rule for doctors, hospitals, and health plans. According to the HHS press release, in combination with a previously issued regulation, the rule will save up to $9 billion over the next ten years. The regulation finalizes rules for making health care claim payments electronically and describing adjustments to claim payments. The press release noted that studies have found that the average physician spends three weeks a year on billing and insurance related tasks, and, in a physician’s office, two-thirds of a full-time employee per physician is necessary to conduct these tasks. By receiving payments electronically and automating the posting of the payments, a physician practice and hospital’s administrative time and costs can be decreased.

HHS Office of Inspector General’s Top Management and Performance Challenges for Fiscal Year 2010

March 18, 2011

The complexity and size of the U.S. health care system makes it susceptible to fraud and abuse in both the public and private insurance markets. According to the National Health Care Anti-Fraud Association (NHCAA), an estimated 3% of all health care spending is lost to fraud; government and law enforcement agencies have estimated fraud-related loses to be as high as 10% of annual health care expenditures. The financial ramifications of these fraudulent schemes are enormous to patients, providers and the federal government. Indeed, the U.S. Government Accountability Office (GAO) estimates that for 2010, Medicare alone had $48 billion in improper payments (underpayments and overpayments). In response to its findings, the GAO recommended that the Centers for Medicare and Medicaid Services find ways to address the vulnerabilities to improper payments and enhance program integrity.

HHS/DOJ issue annual report on fraud and abuse

January 25, 2011

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) have issued their annual report on health care fraud and abuse. The report shows that the Federal Government's Health Care Fraud and Abuse Control Program recovered more than $4 billion of taxpayer dollars during fiscal year 2010. HHS Secretary Kathleen Sebelius said, "Thanks to the President’s leadership and the new tools provided by the Affordable Care Act, we can focus on stopping fraud before it happens."

HHS issues proposed rule to stem Medicare, Medicaid, and CHIP fraud

September 21, 2010

The Department of Health and Human Services has issued a proposed rule to stem fraud in the Medicare, Medicaid, and Children's Health Insurance Program under authority created by the health reform law. According to the agency, the proposed rule will:

"Establish the requirements for suspending payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
"Establish the authority for imposing a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
"Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
"Outline requirements for states to terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
"Solicit input on how to best structure and develop provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements."

GAO releases report on the Medicare physician payment rule

December 27, 2012

The Middle Class Tax Relief and Job Creation Act of 2012 required that the Government Accountability Office (GAO) examine private-sector initiatives that base or adjust physician payment rates on quality and efficiency, and the applicability of these initiatives to the Medicare program. The resulting GAO report provides information on private entities with payment incentive initiatives, physician perspectives on themes within those initiatives, and the extent to which CMS’s financial incentive initiatives for Medicare physicians reflect such themes. The report identifies several common themes among private entities that provide incentives for high-quality, efficient care, and selected physician organizations generally support these themes:

Private entities generally measure performance and make incentive payments at the physician-group level rather than at the individual-physician level. Physician organizations favor this approach.
Private entities use nationally endorsed performance metrics and noted the need for a standardized set of metrics across all payers. Physician organizations concur that a standardized set of metrics would be less administratively complex.
Most private entities in GAO's study provide financial incentives tied to meeting absolute benchmarks--fixed performance targets--or a combination of absolute benchmarks and performance improvement. Physician organizations prefer incentives tied to absolute benchmarks over those based on how physicians perform relative to their peers. Physician organizations also favored incentives that reward improvement because baseline levels of performance vary.
While private entities' incentive payments vary in size and in method, private entities typically provide such payments within 7 months of the end of the performance measurement period. Physician organizations stated that financial incentives should be distributed soon after the measurement period to have the greatest effect on performance.

The Centers for Medicare & Medicaid Services (CMS) is currently making efforts to transform the physician payment system in Medicare reflect the themes that GAO identified among selected private entities with physician payment incentives.

A New Era of Healthcare Corporate Compliance

May 4, 2012

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the ACA)<sup>[1]</sup> arms the federal government with significant new and enhanced tools to identify and pursue financial recovery for fraudulent, wasteful, and abusive healthcare practices. The cost of implementing other programmatic provisions of the ACA, such as coverage for the uninsured and increased fraud and abuse enforcement activities, will be paid for, in part, by monies recovered from prosecution of healthcare fraud and savings achieved from deterring fraudulent practices. Furthermore, reducing fraudulent and abusive practices is directly linked to the transformation of the health care system to a value-based system that rewards high-quality and efficient care delivery at lower cost. As the $4.1 billion recovered by the federal government in 2011 from fraud and abuse enforcement indicates, healthcare organizations, including providers (practitioners, hospitals, nursing homes), health plans, manufacturers (medical device, pharmaceutical), and suppliers (e.g., durable medical equipments companies), should expect continued aggressive enforcement in the coming years.<sup>[2]</sup> The ACA heralds a new era of compliance in healthcare that will require these organizations to monitor their operations, implement robust compliance programs, report publicly a vast array of information about their business arrangements, and face significant penalties for violations.

HHS Office of Inspector General’s Top Management and Performance Challenges for Fiscal Year 2010

March 18, 2011