On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that includes proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule on or after January 1, 2020. The CMS summary can be found here. There are several proposed changes that impact the Open Payments program, among other policies.
Open Payments
In the proposed rule, CMS intends to make some changes to the Open Payments program. It intends to codify provisions from the SUPPORT Act, proposes to address public comments received from the CY 2017 PFS proposed rule by changing the process for reporting data by adjusting the nature of payment categories, and proposes changes to standardize data on reported covered drugs, devices, biologicals, or medical supplies.
In its first proposed change, CMS references the October 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). The proposed rule implements Section 6111 of the SUPPORT Act by amended the definition of “covered recipient” with respect to information required to be submitted on or after January 1, 2022, to include physician assistants (PA), nurse practitioners (NP), clinical nurse specialists (CNS), certified registered nurse anesthetists (CRNA), and certified nurse midwives (CNM), in addition to the previously listed covered recipients of physicians and teaching hospitals.
CMS is further proposing to consolidate what it considers to be two duplicative categories related to the nature of payments made to covered recipients. Currently, there is a distinction between accredited/certified and unaccredited/non-certified continuing education programs.
The new category would likely read “Compensation for serving as faculty or as a speaker for a medical education program.” Thus, manufacturers would not need to distinguish between accredited and non-accredited faculty compensation. CMS is proposing to consolidate these categories and make the regulatory words match statutory language using the phrase “medical education programs.”
CMS is also proposing three additional categories that would operate prospectively and would not require the updating of previously reported payments or other transfers of value in three new areas: (1) debt forgiveness; (2) long-term medical supply or device loan; and (3) acquisitions.
New definitions include:
- long-term medical supply or device loan (91 or more days)
- short-term medical supply or device loan (90 days or less)
- certified nurse midwife
- certified registered nurse anesthetist
- clinical nurse specialist
- non-teaching hospital covered recipient
CMS further seeks to clarify the reporting requirements regarding drugs, biologicals, and medical supplies. Currently, when applicable manufacturers or applicable GPOs report payments or transfers of value related to specific drugs and biologicals, the agency requires names and NDCs to be reported to Open Payments. It has not currently required similar reporting for medical devices from the manufacturers. In the proposed rule, CMS cites recommendations from OIG and proposes that device identifiers(DI) be incorporated into Open Payments reporting that applicable manufacturers or applicable GPOs provide. It is not proposing a full unique device identifier (UDI).
Regarding drugs and biologics, CMS notes national drug codes (NDCs) have been required for both research and non-research payments. The agency writes that non-research payment NDC requirements were erroneously removed in the final 2015 rule. CMS proposes to correct the error to reiterate that NDCs are required for both research and non-research payments.
The adding of additional covered recipients will take effect starting in 2021. All other changes are proposed to take effect 60 days after the final rule is published. Often CMS comes out with the final rule on October 31st, so there is a small chance that these changes may be required for 2019 reporting.
On another note, CMS Open Payments proposes to substitute “physician” and refer to physician (and additional healthcare provider) covered recipients as “non-teaching hospital covered recipients.” (It is actually in the proposed rule)
The estimated burden of Open Payment reporting requirements, as outlined under Office of Budget and Management (OMB control number 0938-1237), is just over 1 million hours over the course of 1 year.
The total public burden of Open Payments is estimated over 3 million hours/annually “OMB control number 0938-1237: Frequency: Once; Affected Public: Private sector—Business or other for-profits; Number of Respondents: 227,157; Total Annual Responses: 457,454; Total Annual Hours: 3,099,297.”
According to Seth Whitelaw of Whitelaw Consulting “While the additional clarifications from CMS are welcome, there still remains ambiguity on how payments are characterized, especially with the new category for debt forgiveness. Therefore, now is a good time for covered entities to go back and examine their established Open Payments practices and processes to assure that they are in compliance and will remain so.”
Overall these seem like practical changes to the Open Payments program, we will have a full analysis in the September issue of Compliance Update.
CME
CMS intends to include additional text in current improvement activity IA_PSPA_28, “Completion of an Accredited Safety or Quality Improvement Program.” CMS states it wishes to add language to the activity description which outlines an example of an activity that could satisfy the improvement activity. The language highlights accredited continuing medical education in the proposed description.
Evaluation and Management Codes
CMS appears to have reversed course on a proposal to overhaul evaluation and management (E/M) codes that would have paid physicians the same amount for an office visit with a complex patient as a healthy one. We wrote about this issue last year. This accounts for roughly 20% of part B spending.
10 E/M codes (99201-99215) that account for roughly 20% of Part B spending. Come 2021, there will be a separate payment rate for each of the E/M codes, instead of a single amount for Levels 2 to 4, as had been previously finalized. CMS is aligning much of its forthcoming E/M policy with approaches that gained approval by the AMA’s CPT Editorial Panel earlier this year. That means CMS’s official policy is to significantly revise the E/M documentation guidelines by allowing providers to select a service based on medical decision-making or time. Providers would no longer have to factor in history and exam elements.
“Consistent with our goals of burden reduction, we are proposing to align our E/M coding with changes laid out by the CPT Editorial Panel for office/outpatient E/M visits,” said an updated CMS fact sheet.
“The CPT coding changes retain 5 levels of coding for established patients, reduce the number of levels to 4 for office/outpatient E/M visits for new patients, and revise the code definitions. The CPT changes also revise the times and medical decision making process for all of the codes, and requires performance of history and exam only as medically appropriate. The CPT code changes also allow clinicians to choose the E/M visit level based on either medical decision making or time,” according to the CMS.
CMS also has accepted the updated E/M valuations put forth by the AMA’s RVS update committee, Part B News describes. The new valuations, which would take hold in 2021, dramatically increase the work relative value units (RVU) for some of the E/M codes. For instance, the work RVUs for 99212 would rise from 0.48 to 1.18. Conversely, work RVUs for 99214, the most frequently reported office code, would fall from 1.50 to 1.18, according to the proposed fee schedule.
Quality Payment Program
CMS is proposing to streamline the Quality Payment Program by proposing a new framework called the MIPS Value Pathways (MVPs). Beginning in the 2021 performance period, it would move MIPS from its current state, which requires clinicians to report on many measures across the multiple performance categories, to a system in which clinicians will report much less. Under MVPs, clinicians would report on a smaller set of measures that are specialty-specific, outcome-based, and more closely aligned to Alternative Payment Models (APMs). In addition, MVPs would allow CMS to provide more data and feedback to clinicians.
Comments
Comments on the Physician Fee Schedule can be made from August 15, 2019 – September 27, 2019 on the Federal Register at this link https://www.federalregister.gov/documents/2019/08/14/2019-16041/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other