On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency provisions—collectively known as the Physician Payment Sunshine Act—of the Patient Protection and Affordable Care Act of 2010 (the ACA). The rule becomes effective on April 9, 2013, 60 days after the publication date.

Drug and device manufacturers will be required to track payments or transfers of value to physicians and teaching hospitals, and physician ownership and investment interests in such manufacturers, beginning on August 1, 2013, and their first report of such payments and ownership and investment interests (covering the last five months of 2013) will be due on March 31, 2014. Companies would be well advised to begin implementing systems, practices, and procedures that will allow them to begin tracking all relevant transactions and ownership and investment interests, if they have not started already. Transparency will impose a major burden on manufacturers, as compliance with the rule will exact from them considerable time and resources.

CMS had published a proposed rule in December 2011 and received 373 comments from various stakeholders. In response, CMS made some significant changes to the proposed rule, narrowing its scope somewhat, and clarified many of its provisions. Nevertheless, the final regulation keeps intact most of the proposed rule.

Executive Summary

The ACA requires manufacturers to submit two separate but related reports to the Department of Health and Human Services (HHS). First, applicable manufacturers of drugs, devices, biologicals, or medical supplies that are available for coverage under Medicare, Medicaid, or the Children's Health Insurance program (CHIP) must report annually to HHS certain payments or other transfers of value¹ to covered recipients, namely, physicians and teaching hospitals. The rule provides definitions of numerous terms, such as "applicable manufacturer" and "covered drug, device, biological, or medical supply." In addition, it clarifies how applicable manufacturers should report and characterize payments or other transfers of value, including rules for research payments and indirect payments provided to a covered recipient through a third party. The rule also finalizes which payments are excluded from the reporting requirements.

Second, applicable manufacturers and group purchasing organizations (GPOs) must report information on ownership and investment interests in such entities held by physicians or their immediate family members. The rule details what constitutes an ownership or investment interest and defines for whom they must be reported. The rule also clarifies the content of the report concerning ownership of investment interest.

The rule finalizes the processes and requirements for applicable manufacturers and GPOs to submit their reports to CMS, including the specific data elements that are required to be included in the reports and the report format. It also details the processes for the review, dispute, and correction period when applicable manufacturers and GPOs, covered recipients, and physician owners or investors are provided the opportunity to review, dispute, and propose corrections to the reported payments, or ownership or investment interests, attributed to them.

The rule clarifies the information to be included on the publicly available website, as well as the usability of the public website. In addition, the rule includes details on the processes for reporting and publishing payments that are eligible for delayed publication.

Finally, the rule includes details regarding the statutorily authorized civil monetary penalties for failure to report payments, or physician ownership or investment interests. It also clarifies the statutory requirements for the preemption of state laws.

Notable Changes to the Proposed Regulation

Among the more significant changes to the proposed regulation issued by CMS in December 2011 are the following:

• The definition of "applicable manufacturer" has been slightly narrowed by excluding hospitals, hospital pharmacies, and compounding pharmacies that prepare drugs or devices for their own patients, and companies that have no physical presence or activities in the United States.
• The reporting burden has been reduced for companies:
  • that only manufacture products under contract;
  • whose gross revenue from covered products is less than 10 percent of total gross revenue;
  • that assist corporate affiliates with manufacturing, marketing, promotion, sale, or distribution; and
  • with operating divisions that do not manufacture covered products.
• Payments for continuing medical education programs that are accredited by the Accreditation Council for Continuing Medical Education (ACCME) or other specified accrediting organizations need not be reported, as long as the manufacturer neither pays faculty directly nor suggests or recommends faculty members.
• Manufacturers will not be charged with knowledge of the identities of physicians paid by third parties to participate in blinded market research studies.

Nonetheless, CMS does not have much to show for the 16 months it took to finalize the proposed regulation issued in December 2011. One wonders whether CMS will have sufficient resources to monitor thousands of manufacturers for compliance with the ACA and final regulation.

The remainder of this WSGR Alert summarizes some of the key provisions of the final rule.

Reports on Payments and Other Transfers of Value (Transparency Reports)

Who Must Submit Reports?

Transparency reports must be submitted by "applicable manufacturers," which CMS defines as entities operating in the United States and falling into one of these two categories:

• An entity that is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply, but not if such [product] is solely for use by or within the entity itself or by the entity's own patients. This definition does not include distributors or wholesalers (including, but not limited to, repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological, or medical supply.
• An entity under common ownership with an entity described above, which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply.²

What Is a Covered Drug, Device, Biological, or Medical Supply?

Any drug, device, biological, or medical supply for which "payment is available" under Medicare, Medicaid, or CHIP, either separately or as part of a bundled payment, is covered by the rule. Covered drugs or biologicals include only those that require a prescription, so over-the-counter (OTC) drugs are not covered. Devices or medical supplies are covered only if they require premarket approval by the U.S. Food and Drug Administration (FDA) or premarket notification (i.e., 510(k) clearance), so 510(k) Class I-exempt devices and 510(k) Class II-exempt devices are not covered. A product that is not approved or cleared nevertheless may be a covered product if "payment is available" for it under Medicare or Medicaid. For example, payment is available under Medicare for certain devices covered under an investigational device exemption (IDE), and payment may be available under Medicaid for certain unapproved pre-1962 prescription drugs. When a manufacturer's first product becomes eligible for payment under Medicare, Medicaid, or CHIP, CMS will allow a grace period of 180 days after the product becomes "covered" before the manufacturer must begin complying with the data collection and reporting requirements.

Who Are Covered Recipients and How Are They Identified?

"Covered recipients" are either physicians (other than bona fide employees of a manufacturer) or teaching hospitals.

CMS defines "physicians" as doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors who are licensed by the state in which they practice. Other provider types, such as nurse practitioners or residents, are not included in the definition. Manufacturers must report a physician recipient's name, business address, National Provider Identifier (NPI), and specialty. If the physician's NPI is not available on the National Plan and Provider Enumeration System (NPPES) website, an applicable manufacturer must make a good-faith effort to obtain the NPI from the physician; a "good-faith effort" is requesting an NPI from a physician, checking the NPPES database, and calling the NPPES help desk. If a manufacturer cannot determine the physician's NPI or the physician does not have one, the space may be left blank.

CMS defines "teaching hospitals" as any institutions that received Graduate Medical Education payments under Medicare in the most recent year for which information is available. CMS will publish a list of all such hospitals annually, and manufacturers may rely on the list for the entire reporting year.

What Payments or Transfers of Value Must Be Reported?

The regulation requires manufacturers to report "direct and indirect payments or other transfers of value" to a covered recipient, or to a third party at the request of a covered recipient. It defines a "payment or other transfer of value" as "a transfer of anything of value." In determining reported value, CMS considers "value" to mean the discernible economic value on the open market in the U.S. All aspects of the value, such as taxes or shipping, should be included in the reported value. Beyond this, CMS declines to provide rules for calculating value. Manufacturers must make a reasonable, good-faith effort to determine the value of a payment or transfer of value, and may include the methodology used in a voluntary assumptions document that is submitted to CMS.

A payment made "at the request of" a covered recipient means that the covered recipient has directed the manufacturer to provide the payment to another entity or individual rather than receiving it personally—for example, a fee waived by a physician and then donated by a manufacturer to a charity on behalf of the physician. Such payments are to be reported under the name of the covered recipient, but the report also should include the name of the entity that received the payment, or, if an individual received it, the designation "individual" (so as to preserve the privacy of such individuals).

The rule sets forth a number of exclusions, which are described later in this alert.

What Are the Contents of the Report?

Manufacturers must report to CMS the following information regarding any payment to a covered recipient:

• Name
• Primary business address
• Physician specialty, license number, and NPI
• Amount of each payment
• Date of payment
• Related covered drug, device, biological, or medical supply
• Payment to physician with ownership interest
• Delayed publication
• Form of payment
• Nature of payment. The nature of each payment must be indicated using only one of the following categories:
  • Consulting fees
  • Compensation for services other than consulting, including serving as faculty or as a speaker at other than a continuing education program (discussed below)
  • Honoraria
  • Gift
  • Entertainment
  • Food and beverage (discussed below)
  • Travel and lodging (including the specified destinations)
  • Education
  • Research (discussed in next section)
  • Charitable contribution (discussed below)
  • Royalty or license
  • Current or prospective ownership or investment interest
  • Compensation for serving as faculty or as a speaker for an unaccredited medical education program (discussed below)
  • Compensation for serving as faculty or as a speaker for an accredited medical education program (discussed below)
  • Grant
  • Space rental or facility fees (teaching hospital only)

The rule elaborates further on the "nature" of payments to be reported in general and for certain of the above categories:

Payments with multiple categories: Only one nature may be indicated for each payment. If a payment could fit within several categories, the manufacturer should select the most suitable one, but should not bundle payments belonging to separate categories into a single payment. For example, a meal should be reported as a meal, even if it is associated with travel or a consulting contract.

Charitable contributions: This category should only be used where an applicable manufacturer makes a payment to a charity on behalf of a covered recipient, but not in exchange for any service or benefit. For example, if a physician requests that his or her consulting fee be paid to a charity, this should be reported not as a charitable contribution, but as a consulting fee with the physician as the covered recipient and the charity as the entity paid.

Meals and beverages: The cost of meals provided in a group setting must be divided by the total number of individuals who ate the meal (both physicians and non-physicians, such as office staff), with the resulting per-person cost reported for each physician who actually participated in the meal. Additionally, CMS is excluding the reporting of buffet meals, snacks, soft drinks, or coffee made generally available to all participants at large-scale conferences or similar events.

Payments for CME and speaker fees: Payments for CME that is accredited by the ACCME or other specified accrediting organizations are exempt from reporting if the manufacturer does not pay faculty directly and does not select or recommend individual faculty members. If a CME program is accredited, but the manufacturer directly pays or recommends the faculty, the payments must be reported as "Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program." If a program is not accredited, the payment is reported as "Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program." Finally, where a payment is made to a physician speaker at an event that is not continuing medical education (for example, a promotional speaker program), the payment should be reported as "Compensation for services other than consulting, including serving as faculty or as a speaker at other than a continuing education program."

"Other" Category Deleted: The final rule omits the "other" nature category in the proposed rule because it would dilute the usefulness of the "nature" categories. CMS cautions that all payments to covered recipients must be reported, and failure to identify a nature category could result in penalties. Therefore, manufacturers should select the nature category that most closely describes the payment.

Research Payments

Under the final rule, payments for research are reported separately from other payments and transfers of value, using a different reporting format. "Research" includes basic and applied research, preclinical research, Phase I through IV studies, and investigator-initiated studies. If a payment falls within the definition of "research" and is subject to a written agreement, a protocol, or both, it is reported as research. Research-related payments that do not meet these requirements must be reported using other "nature" categories.

Manufacturers will not be required to attribute the entire research payment made to a facility to each principal investigator. Instead, the manufacturer will report each research payment once, identifying the name and address of the institution (whether or not a teaching hospital) or individual physician paid, the amount, the name of the study, the name of the related product, and information about each principal investigator. At their option, manufacturers may report explanatory information about the study. The requirements for reporting payments for pre-clinical studies are similar, but no associated product or study name need be reported.

The ACA requires CMS to delay publication of payments from manufacturers to covered recipients made (1) pursuant to a product research or development agreement or (2) in connection with a clinical investigation regarding a covered product. Delayed publication will apply to payments for both research and development, and clinical investigations, where they relate to a new product. However, where a new application of an existing product is concerned, publication will be delayed for a research and development payment but not for a clinical investigation payment. In other words, payments to clinical investigators will be entitled to delayed publication if the investigation is for a new product, but not if it is for a new indication of a currently marketed product. The only payments for "research" of new indications of marketed products that would be subject to delayed disclosure would be payments for non-clinical studies.

CMS clarifies that products for which approval or clearance will be sought under an abbreviated new drug application (ANDA) or a 510(k) notification are considered new products, rather than new applications of existing products.

Despite comments that CMS should not publish the payments until after FDA approval, licensure, or clearance, CMS stated in the preamble to the final rule that it believes "Congress clearly intended that all payments should be included on the public website, even if a product never received FDA approval, licensure or clearance."

For publication to be delayed, the manufacturer must indicate in its transparency report whether a payment is eligible for a delay in publication. The failure to indicate eligibility will result in the payment being posted publicly in the following year. The manufacturer also must continue to indicate annually that FDA approval, license, or clearance is pending, and subsequently must notify CMS if the FDA approves or clears the product.

Exclusions

Under the statute and the final regulation, the following payments are excluded from the reporting requirements:

(1) Transfer through a third party. No reporting is required for a transfer of value made indirectly to a covered recipient through a third party in cases where the applicable manufacturer does not know the identity of the covered recipient. Awareness of the identity of a recipient on the part of a legal agent acting on behalf of the manufacturer is attributed to the manufacturer itself.

(2) De minimis payments. Payments and transfers of value less than $10 are not reportable, unless the aggregate amount transferred to, requested by, or designated on behalf of a covered recipient exceeds $100 in a calendar year. Small items that are under $10 (such as pens and notepads) that are provided at large-scale conferences and similar large-scale events are exempted from the reporting requirements, and also do not need to be tracked for purposes of the $100 aggregate threshold.

(3) Samples. Product samples that are not intended to be sold, yet intended for patient use, including coupons and vouchers, are not reportable.

(4) Educational materials. Educational materials that directly benefit patients or are intended to be used by or with patients are not reportable. CMS has clarified that this exemption does not cover materials provided to physicians for their own education, nor does it cover marketing or promotional materials. This narrow interpretation imposes a considerable burden on manufacturers, which must report the value of all reprints and promotional materials provided to physicians if they exceed the de minimis threshold throughout the year.

(5) Devices for evaluation. Manufacturers need not report the loan of a covered device for a short-term trial period, not to exceed 90 days, or the provision of a limited quantity (i.e., 90 days of average use) of disposable or single-use devices or medical supplies, to permit evaluation of the covered device by the covered recipient. The exemption for disposable or single-use devices or supplies was added in the final rule.

(6) Warranty items. Items or services provided under a contractual warranty (including a service or maintenance agreement), including the replacement of a covered device, are not reportable where the terms of the warranty are set forth in the purchase or lease agreement for the covered device. The exemption applies even if the warranty period has expired.

(7) Charity care. Manufacturers are not required to report in-kind items used for the provision of charity care, defined as care for a patient who is unable to pay or for whom payment would be a significant hardship, where the covered recipient does not receive or expect to receive payment. This exemption does not include in-kind items provided to a charitable organization for the care of all of its patients, both those who can and cannot pay. Moreover, the exemption covers only in-kind items, not financial support for charity care.

(8) Covered recipient who is a patient. Reporting is not required for a payment or transfer of value to a physician who is a patient, research subject, or participant in data collection for research, and not acting in the professional capacity of a physician.

(9) Discounts and rebates are not reportable.

(10) Publicly traded securities. A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund is not reportable.

(11) Health care for employee. In the case of a manufacturer that offers a self-insured plan, payments for the provision of health care to employees under the plan are not reportable.

(12) Payments for non-medical services. Where a physician is also a licensed non-medical professional, a payment to the physician is non-reportable if it is solely for the non-medical professional services of the individual.

(13) Payments for services in judicial proceeding. Manufacturers need not report a payment to a physician if the payment is solely for the services of the physician with respect to a civil or criminal action or an administrative proceeding.

(14) Personal relationship. A payment to a physician is not reportable if it is made solely in the context of a personal, non-business-related relationship.

Reports on Physician Ownership and Investment Interests

In addition to transparency reports, the ACA requires manufacturers and GPOs to separately report information on ownership or investment interests in such entities held by physicians or their immediate family members.

CMS finalized its proposed definition of "applicable GPO" as an entity that operates in the United States and purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply for a group of individuals or entities, but not solely for use by the entity itself. CMS states that this definition includes purchasers and physician-owned distributors of covered drugs, devices, biologicals, and medical supplies, but does not include bulk purchasers for commonly owned entities.

An "immediate family member" is defined as one of the following:

• Spouse
• Natural or adoptive parent, child, or sibling
• Stepparent, stepchild, stepbrother, or stepsister
• Father-, mother-, daughter-, son-, brother-, or sister-in-law
• Grandparent or grandchild
• Spouse of a grandparent or grandchild

An ownership or investment interest in a manufacturer or GPO may include stock, stock options (when exercised), partnership shares, loans, and bonds. However, an ownership or investment interest does not include any publicly traded security or mutual fund. Manufacturers and GPOs need not report indirect ownership or investment interests held by physicians or their immediate family members about which the manufacturers or GPOs did not know.

Manufacturers and GPOs must report the following information for each physician ownership or investment interest:

• Manufacturer's or GPO's name
• Physician owner or investor's:
  • Name
  • Specialty
  • Primary business street address
  • NPI
  • State professional license number for at least one state where the physician maintains a license, and the state(s) in which the license is held
• Whether the ownership or investment interest is held by the physician or an immediate family member of the physician
• Dollar amount invested
• Value and terms of each ownership or investment interest
• Any payments or other transfers of value provided to the physician owner or investor, including:
  • Amount of payment or other transfer of value in U.S. dollars
  • Date of payment or other transfer of value
  • Form of payment or other transfer of value
  • Nature of payment or other transfer of value
  • Name(s) of related covered drugs, devices, biologicals, or medical supplies
  • NDCs of related covered drugs and biologicals, if any
  • Name of entity that received the payment or other transfer of value, if not provided to the physician owner or investor directly
  • Statement providing additional context for the payment or other transfer of value (optional)

To avoid duplicative reporting, manufacturers should report the payments provided to physician owners or investors in the report for payments, and should note that the covered recipient receiving the payment or other transfers of value is a physician owner or investor. Additionally, an individual may be both a covered recipient and a physician owner or investor. A manufacturer should only report a payment once, regardless of whether it is required to be reported as a payment or an ownership interest.

Report Submission and Correction

Manufacturers and GPOs must submit their reports for the preceding calendar year electronically to CMS by March 31, 2014, and by the 90th day of each calendar year thereafter. Only manufacturers that made a payment to a covered recipient or had a physician owner or investor in the previous calendar year need to register and submit a report to CMS. Similarly, only GPOs with a physician owner or investor are required to submit a report. In other words, even if an entity meets the definition of "applicable manufacturer" or "applicable GPO," it need not register or submit a report if it has no payments or other transfers of value to report.

A manufacturer under common ownership with separate entities that are also applicable manufacturers may, but is not required to, file a consolidated report of all payments, and physician ownership or investment interests, for all entities. All manufacturers with payments to report must register individually, even if they intend to be part of a consolidated report submitted by another manufacturer. Manufacturers submitting data as part of a consolidated report that will be submitted by another manufacturer may indicate during registration that they intend to be part of the report submitted by another manufacturer. The entity submitting the consolidated report must indicate all of the manufacturers for which it is reporting.

An authorized representative must submit a signed attestation at the time of data submission certifying the truthfulness, accuracy, and completeness of the data submitted to the best of the signer's knowledge and belief. An entity submitting a consolidated report must attest on behalf of itself and each of the other manufacturers included in the report. While the attestation must be provided at the time of data submission, it also must be provided any time the data is changed or updated. Data without an attestation will not be considered an official submission. For a manufacturer with payments or other transfers of value to report, if covered products represent less than 10 percent of total (gross) revenue for the preceding year, the attestation must indicate that fact.

CMS will not grant submission extensions, and any late data will be considered a failure to report, which may be subject to penalties.

The statute requires that, following submission of the reports, CMS must providemanufacturers, GPOs, covered recipients, and physician owners and investors with the opportunity to review the data for at least 45 days prior to publication on the public website. If a covered recipient or physician owner or investor disagrees with the data, he can initiate a dispute, and applicable manufacturers or GPOs may begin resolving the dispute and correcting the data. After the end of the 45-day review-and-correction period, manufacturers and GPOs will have an additional 15 days to correct data for the purposes of resolving disputes, after which they may submit, and provide attestation for, the updated data to CMS to finalize the submission. Payments or ownership or investment interests that cannot be resolved by the end of the 15-day resolution period will be marked as "disputed," but the manufacturer's or GPO's most recent attested data subject to the dispute will be the only information published.

The 45-day review-and-correction period and 15-day dispute-resolution period will not be the only opportunities to dispute the contents of the public website. CMS will allow physicians and teaching hospitals, and physician owners and investors, the opportunity to sign in to the system to review or dispute officially submitted and attested transactions any time during the year. Any disputes resolved outside the 45- and 15-day time periods, however, will not be reflected on the public website until the next update of the data.

Civil Monetary Penalties

If a manufacturer or GPO fails to submit the required information, it may be subject to penalties of not less than $1,000, but not more than $10,000, for each payment or ownership or investment interest not reported. The maximum penalty that can be assessed for failure to report is $150,000 each year. For knowing failures, a manufacturer or GPO will be subject to penalties of not less than $10,000, but not more than $100,000, for each payment or ownership or investment interest not reported. The maximum penalty for a knowing failure to report is $1,000,000 each year. The penalties imposed on each manufacturer or GPO are aggregated separately, and subject to separate aggregate totals for failures to report and knowing failures to report, with a maximum combined total of $1,150,000.

The factors that CMS will consider in determining the amount of a penalty include, but are not limited to, the following:

• The length of time the manufacturer or GPO failed to report
• The amount of payment or other transfer of value or the value of the ownership or investment interest the manufacturer or GPO failed to report
• The level of culpability
• The nature and amount of information reported in error
• The degree of diligence exercised in correcting information reported in error

For consolidated reports, the manufacturer that submits the consolidated report will be required to attest on behalf of all the entities included in the consolidated report, and therefore will be subject to the maximum penalties for each individual manufacturer included in the report. The submitter of the consolidated report therefore could be subject to a penalty greater than $1,000,000 depending on the violations of the manufacturers for whom it submitted the report and attested as to the data.

HHS, CMS, the Office of the Inspector General (OIG), or their designees have the right to audit or inspect manufacturers or GPOs to assess their compliance with the requirement to provide timely, complete, and accurate submissions of the information. In order to facilitate the auditing and inspection process, manufacturers and GPOs must maintain books, records, and documents to enable an audit or inspection for a period of at least five years from the date the payment or other transfer of value, or ownership or investment interest, is published on the website.

CMS Website

The statute requires CMS to publish the data collected from manufacturers and GPOs on a publicly available website by June 30 of each year. Due to the timing of the final rule, the first publication will be in June 2014 for data collected in 2013.

In the preamble to the final rule, CMS stated that it plans to engage stakeholders regarding the content of the website, since it recognizes that stakeholders and the public must be part of the website-development process. CMS will ensure that the website "accurately and completely describes the nature of relationships between physicians and teaching hospitals, and the industry, including an explanation of beneficial interactions," and that it will clearly state that disclosure on the website "does not indicate that the payment was legitimate nor does it necessarily indicate a conflict of interest or any wrongdoing."

Annual Reports

CMS must submit annual reports to Congress and the states. The annual report is due to Congress on April 1 of each year, and must include aggregated information on each manufacturer and GPO submitted during the prior year, as well as any enforcement actions taken and penalties paid. The state reports will be state-specific.

Relation to State Laws

The ACA preempts any state or local laws requiring the reporting of the same type of information regarding payments made by applicable manufacturers to covered recipients. However, this does not prevent a state from collecting this information for public-health surveillance, investigation, or other public-health purposes or health oversight. The public-health goal must be one other than transparency in order for the state reporting to avoid preemption.

State and local governments may require the reporting of information other than that required under the ACA. The additional information may include other types of information (except payments that fall below the $10 individual or $100 aggregate thresholds), or payments to health care providers other than physicians and teaching hospitals.

Conclusion

Manufacturers and GPOs must begin tracking payments to physicians and teaching hospitals, as well as physician ownership and investment interests, starting on August 1, 2013, in order to report them to CMS by March 31, 2014. They would be well advised to implement systems, practices, and procedures to accomplish these tasks in the six or so months remaining.

Please contact David Hoffmeister, Farah Gerdes, or Jon Nygaard in Wilson Sonsini Goodrich & Rosati's life sciences/FDA and healthcare practice with any questions about the Physician Payment Sunshine Act.

¹ Generally, this alert will refer to "payments or transfers of value" simply as "payments."

² Henceforth in this alert, "manufacturers" will mean "applicable manufacturers."