By: Kevin E. Raphael
As federal payors move away, with increasing speed, from fee-for-service payments toward value-based payment reforms, CMS and HHS-OIG released, on October 9, 2019, proposed Stark Law Exceptions and Anti-Kickback Statute Safe Harbors to better permit health care providers to engage in coordinated care reimbursed by these value-based payments. The proposed Rules remove “potential barriers to more effective coordination and management of patient care and delivery of value-based care that improves quality of care, health outcomes, and efficiency.” HHG-OIG proposed Rule at 5.
In summary, the proposed Rules create several new terms, all which define aspects of the value-based changes central to the proposed Rules’ purpose. The proposed Anti-Kickback Statute Rule creates six new Safe Harbors to the Anti-Kickback Statute, modifies four existing Safe Harbors, and provides clarification on certain statutory requirements. CMS’s proposed Stark Law Rule creates value-based Exceptions to Stark and provides additional guidance related to the Stark Law’s application to value-based care and clarifies its application to existing Exceptions. The proposed Rules, if adopted, will impact hospitals, physician groups, other care providers along the continuum of care, and vendors providing support services to healthcare providers, including EHR, security technology, and transport services. Importantly, the application of these proposed Rules is limited in many regards as to pharmaceutical companies, durable medical equipment distributors and suppliers, and laboratories. HHS-OIG is still contemplating whether to also exclude medical device manufacturers, PBMs and pharmacies from its proposed Rule’s application.
The government has solicited comments to these proposed Rules, and there is a 75-day deadline for interested parties to submit comments. After review of the comments, it is expected that final Rules will be published in 2020.
The Devil is in the Details:
I. The Anti-Kickback Statute Proposed Rule
A. The New Terminology
In order to integrate value-based care and value-based reimbursement into the existing Anti-Kickback Statute framework, HHG-OIG has defined six new terms, all of which play integral roles in the new Value-Based Safe Harbors created by the proposed Rule. These terms are:
B. New Safe Harbors
This proposed Safe Harbor will protect in-kind remuneration exchanged between qualifying VBE participants to further the coordination of care. The remuneration must be: (1) in-kind and not a cash payment; (2) used to engage in Value-Based Activity directly connected to the coordination and management of care for the TPP; and (3) cannot be funded, or result from contributions, by parties outside the VBE. In addition, the recipient of the care coordination must pay at least 15% of the cost for the in-kind remuneration received.
An example set forth in the proposed Rule contemplates a hospital and a skilled nursing facility (“SNF”) in a value-based arrangement, in which the hospital provides a behavioral health nurse to follow designated in-patients with mental health disorders who are discharged to the SNF. In turn, the SNF could provide staff to the hospital to help coordinate patients’ care through the discharge planning process or provide office space at the SNF for the nurse.
This Safe Harbor covers Value-Based Arrangements in which a VBE assumes substantial downside financial risk from a payor for providing coordinated care to a TPP. It would protect both monetary and in-kind remuneration.
“Substantial downside financial risk” means: (1) shared savings with a repayment obligation to the payor of at least 40% of any shared losses; (2) a repayment obligation to the payor under an episodic or bundled payment arrangement of at least 20% of total loss; (3) prospectively paid population-based payment for a defined subset of the TPP; or (4) a partial capitated payment from the payor for items and services for the TPP, reflecting a discount of at least 60% of the total expected fee-for-service payments for those items and services (based on historical expenditures).
This Safe Harbor addresses arrangements in which a VBE assumes the full financial risk from a payor for a TPP. “Full financial risk” means the VBE is financially responsible for the cost of all items and services covered by the applicable payor for each patient in the TPP and is prospectively paid by the applicable payor. Because the VBE would assume full financial risk, thereby lessening the traditional fee-for-service fraud and abuse risks, this Safe Harbor provides the most flexibility to the VBEs and the greatest ability to innovate with respect to the coordination of care.
This Safe Harbor protects arrangements under which a VBE participant furnishes patient engagement tools and supports to improve quality, health outcomes, and efficiency to the TPP. The tools must be in-kind preventive items/services, such as health-related technology or patient health-related monitoring, and must be furnished directly to the patient by the VBE participant. Cash and cash equivalents are not protected and all items must directly advance the patients’ compliance with a treatment regimen, follow-up plan, or disease management plan as determined by the patient’s provider, or advance the improvement in measurable outcomes for the TPP. The aggregate value cannot exceed $500 annually. Examples given in the proposed Rule of these types of services include providing support to improve patient safety during care transitions, or allowing providers to communicate more effectively with patients.
This Safe Harbor would protect remuneration among and between parties to arrangements under CMS-sponsored models, and permit remuneration in the form of incentives and supports provided by model participants to patients covered by that model. The Safe Harbor contains six safeguards to avoid intentional limitation of medically necessary care and to reduce inappropriate utilization of services.
This Safe Harbor removes barriers so parties can address the growing threat of cyberattacks on health care data. The Safe Harbor protects cybersecurity donations, while enforcing safeguards to ensure that referral sources do not become inappropriately tied to the donors. Several interesting notes to this Safe Harbor are: 1) the recipients cannot condition doing business with the donor on the receipt of the donation; 2) protected donors have to play a central role in the healthcare delivery structure; 3) there is no restriction on who can receive the donations; 4) patients can receive the donations with certain limitations; 5) the donations must be necessary and used predominately to implement and maintain effective cybersecurity; and 6) multifunctional technology and services are not protected by the Safe Harbor.
C. Modification of Existing Safe Harbors
While there are a number of changes to this Safe Harbor in the proposed Rule, the most impactful are:
a) the elimination of the prohibition on the donation of equivalent items or services;
b) the allowance of donations of replacement electronic health records technology;
c) the modification of the EHR Safe Harbor sunset provision; and
d) the limitation on the recipient cost-share requirement for small or rural physician practices.
2. Personal Services and Management Contracts (42 CFR § 1001.952(d))
Among the more impactful changes are: 1) the requirement that aggregate compensation be set in advance would be replaced with the requirement that the methodology for determining compensation be set in advance; 2) the elimination of the requirement that a contract specify schedule, length, and exact charge for part-time work; 3) the proposed protection for “Outcome-Based Payments.” “Outcome-Based Payments” are defined as those from a principal to an agent that: (1) reward agent improving/maintaining improvement of a patient or population health by achieving one or more outcome measures that effectively and efficiently coordinate care across the care settings, or (2) achieve one or more outcome measures that appropriately reduce payor costs while improving, or maintaining the improvement of, quality care for patients, such as shared savings payments, shared losses payments, gainsharing payments, and episodic or bundled payments.
The proposed Rule would expand the existing Safe Harbor for warranties to include bundled items and related services, such as product support and educational services. HHS-OIG provides examples of services that may be protected under the proposed expanded Safe Harbor.
The mileage limit for patients residing in rural areas would increase to 75 miles and the distance limit on transportation of discharged patients would be eliminated. The Safe Harbor is intended to offer greater protection to hospitals and physician practices in rural areas, so they can arrange the transport of patients to necessary medical appointments.
D. Clarification of Bipartisan Budget Act of 2018 (“BBA”) Requirements
The proposed Rule amends the CMP (Civil Monetary Payment Law) definition of remuneration to exclude telehealth technologies furnished to certain in-home dialysis patients. However, this applies only to providers currently treating a patient for end-stage renal disease. The proposed Rule also applies the BBA definition of “remuneration” related to all ACO Beneficiary Incentive Programs.
II. Proposed Rule Regarding The Stark Law
A. New Exceptions
First, the proposed Rule incorporates the new value-based terminology set forth in the Anti-Kickback Statute proposed Rule. There are minor differences in certain of the new value-based terms, but for the most part the definitions in the proposed Stark Rule track those in the proposed Anti-Kickback Statute Rule. There are also three new value-based Stark Exceptions and two other new Exceptions:
This Exception applies to a Value-Based Arrangement where a Value-Based Enterprise has assumed full financial risk from a payor for the cost of all covered patient care and services for a defined population for the duration of the VBE arrangement.
This Exception applies to a Value-Based Arrangement under which a physician accepts meaningful downside financial risk for failure to achieve the Value-Based Purposes of the Value-Based Enterprise during the entire term of the arrangement.
This Exception applies broadly to any Value-Based Arrangement where additional requirements are met, including: 1) the Value-Based Arrangement is set forth in writing, signed by the parties, and includes descriptions of certain details of the arrangement; and 2) any performance or quality standards against which receipt of remuneration will be measured are both objective and measurable.
All three of these Exceptions apply to compensation arrangements, including indirect compensation arrangements, but do not apply to other financial arrangements.
This Exception is intended to cover small payments to a physician for items and services the physician provides to an entity on a short-term or infrequent basis. The remuneration must not be determined in any manner that takes into account the value or volume of referrals or other business generated by the physician and the compensation must be commercially reasonable.
This Exception would protect donations of cybersecurity technology for the same policy reasons underlying the proposed Anti-Kickback Statute Safe Harbor.
B. Additional Stark Law Guidance
CMS also provides guidance requested by stakeholders on terminology and concepts that are lynchpins of the Stark Law. These include:
C. Changes to the Scope and Application of the Stark Law
CMS has added, deleted or revised a number of the existing Stark Law Exceptions. In brief, CMS proposes the following changes:
There are several other proposed additions, modifications or revisions to other Stark Exceptions that are of limited applicability or are technical in nature.
The proposed Rules are a meaningful and comprehensive effort by both CMS and HHS-OIG to respond to criticisms and commentary from the healthcare industry about the difficulties that the current Stark Law and Anti-Kickback Statute create for providers in the current healthcare environment and in moving towards value-based care. These proposed Rules offer significant opportunities for various healthcare entities to more closely work together to provide value-based care and to share value-based payments. The proposed Rules are expected to be fully in effect sometime in late 2020.
Michael A. Morse will be participating in an American Health Law Association webinar on Wednesday, June 10th to discuss Fraud and Abuse in the Age of Coronavirus: Current and Future Federal Criminal and Civil Enforcement Actions. In this informative program, speakers will cover the potential criminal and civil exposures, the ongoing government response to monitor… Read more »Read More
On May 6, 2020 the U.S. Department of Education (DOE) released the long-awaited final Title IX regulations. The Final Regulations provide specific guidance to colleges and universities on how they must respond to allegations of sexual misconduct and other Title IX covered conduct. The Final Rule goes into effect on August 14, 2020. The Final… Read more »Read More
Pietragallo Gordon Alfano Bosick & Raspanti, LLP Partner Pamela Coyle Brecht will present “The False Claims Act Update” at the Pennsylvania Bar Institute’s (PBI) A Day in Health Law program on October 28, 2020 in Philadelphia, Pennsylvania. A Day on Health Law is a one-day, six-hour spin-off of PBI’s annual Health Law Institute. The Health… Read more »Read More
Partner Michael A. Morse will be speaking at the Health Care Compliance Association‘s 6th Annual Healthcare Enforcement Compliance Conference in November. During the four day conference, attendees will hear first‑hand from government officials about regulatory changes, expectations, and key priorities in the Healthcare Enforcement sector. Attendees can further gain the knowledge and skills needed to… Read more »Read More