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December 14, 2020

Health Headlines – December 14, 2020


Surprise Billing Agreement Reached, May Be Enacted Before Year End – As members of Congress negotiate an end of year agreement on Fiscal Year 2021 federal spending and a potential COVID-19 relief package, there is a strong potential that surprise billing legislation may also be included.  On Friday, December 11, 2020, the bipartisan, bicameral leaders of the four health committees of jurisdiction announced they had reached a deal, releasing legislative text and a section-by-section summary. 

The agreement reached by House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR); House Ways and Means Committee Chairman Richard E. Neal (D-MA) and Ranking Member Kevin Brady (R-TX); House Education and Labor Committee Chairman Robert C. “Bobby” Scott (D-VA) and Ranking Member Virginia Foxx (R-NC); and Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) would:

  • Establish an independent dispute resolution (IDR) system for out-of-network surprise medical bills and not set benchmark pay rates.
  • Hold patients harmless from surprise medical bills, including those from air ambulance providers, by specifying they are only responsible for in-network payment rates.
  • Settle disputes between providers and insurers either through negotiation or through an IDR.  In the proposed IDR process, the parties would each submit an offer to an independent arbiter, who would consider median in-network rates, information related to the providers’ training an experience, market share of the parties, prior contracting history between the parties, and the complexity of services. 
  • Prohibit out-of-network providers from billing patients unless they notify patients 72 hours before receiving out-of-network services.
  • Direct the Secretary of HHS to establish a patient-provider dispute resolution process for uninsured individuals by January 1, 2022.
  • Require health plans to offer a price comparison tool for consumers.

The estimated $16 billion in savings from the surprise billing deal would be used to fund community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education Program through Fiscal Year 2024.

The White House Press Secretary issued a statement on December 11, 2020 noting “Congress should act swiftly to protect patients from surprise medical and air ambulance bills and send the compromise announced this afternoon to the President’s desk for signature.”  House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) each issued statements supporting inclusion of the deal in an end of year package.  However, Senate Majority Leader Mitch McConnell (R-KY) has not indicated he favors including surprise billing legislation in an end of year package.  The American Hospital Association expressed “significant concerns” with the deal and urged lawmakers to make several changes to the IDR as well as raised concerns with the billing process and transparency provisions. 

The legislative text of the December 11, 2020 agreement can be found here.  The section-by-section summary can be found here.  The AHA letter can be found here

Reporter, Allison Kassir, Washington, D.C., +1 202 626 5600, akassir@kslaw.com.

HRSA Implements Administrative Dispute Resolution Process for 340B Program – On December 10, 2020, HRSA issued a final rule (the Final Rule) implementing the 340B Drug Pricing Program administrative dispute resolution (ADR) process–an overdue mandate from the Affordable Care Act.   Under the Final Rule, disputes will be resolved by three-person ADR Panels, consisting of individuals from HRSA, CMS, and HHS Office of the General Counsel (HHS OGC).  The process will be governed by the Federal Rules of Civil Procedure (FRCP), to the extent possible, and the outcome will constitute a final agency decision that is precedential and binding. Claims may be brought by manufacturers, covered entities, and associations or organizations representing covered entities.  Claims may also be consolidated.  Given HRSA’s lack of general authority to interpret the 340B Program statute, the new ADR process will serve as an administrative tool for the government to provide interpretive guidance through publication of ADR decisions.  Although the Final Rule will become effective on January 13, 2021, an ADR Board and ADR Panels will need to be appointed before the ADR process becomes available for use by petitioners.

The Final Rule (published at 85 Fed. Reg. 80632) completes a ten-year rulemaking process to implement 42 U.S.C. § 256b(d)(3)(A), directing the HHS Secretary to create an ADR process for the 340B Program.  HRSA began the process with a 2010 advanced notice of proposed rulemaking (75 Fed. Reg. 57233) and proceeded with a notice of proposed rulemaking (81 Fed. Reg. 53381), before publishing the Final Rule, which codified an ADR process that is substantially similar to the process proposed in the 2016 proposed rule.  

The new ADR process (summarized below) will allow for the review and resolution of disputes and the creation of binding precedent.  One of the likely first uses for the process may be the resolution of the recent wave of disputes pertaining to the use of contract pharmacies by covered entities, as detailed by King & Spalding in the September 8 issue of Health Headlines

The new ADR process, codified at 42 C.F.R. §§ 10.20-10.24, is summarized below. 

ADR Panels Consisting of HRSA, CMS, and HHS OGC Representatives

ADR Board and Panel Composition.  The Secretary will establish a 340B ADR Board consisting of at least six members appointed by the Secretary, with equal numbers of members appointed from HRSA, CMS, and HHS OGC, from which ADR Panels of three members (one from each of HRSA, CMS, and HHS OGC) will be selected by HRSA.  Each ADR Panel will have the authority to review claims and make ADR decisions.  There will also be one ex-officio non-voting member chosen from the staff of the HRSA Office of Pharmacy Affairs (OPA) to facilitate the resolution of claims within a “reasonable timeframe.”  The Final Rule does not set a deadline for the assembling of the ADR Board or the ADR Panels.

ADR Panel Authority and Responsibilities.  The ADR Panels will review and evaluate information submitted by the parties, request additional information or clarifications, if necessary, evaluate a claim in a separate session from the parties, consult with OPA and the parties, and issue a final agency decision. 

Filing of Claims

Parties that May Initiate an Action.  Any covered entity or manufacturer may initiate an action for monetary damages or equitable relief against a covered entity or a manufacturer by filing a petition with HRSA, with a copy to opposing party. 

Minimum Threshold.  Any action must be for at least $25,000 in damages or seek equitable relief that will likely have a value of more than $25,000 during the year after the final decision. 

Types of Claims Eligible.  The following two types of claims are eligible for the ADR process: (i) claims by a covered entity that it has been overcharged by a manufacturer, including claims that a manufacturer has limited the covered entity's ability to purchase covered outpatient drugs at or below the 340B ceiling price; and (ii) claims by a manufacturer, after it has conducted an audit of a covered entity, that the covered entity violated the duplicate discount prohibition, the diversion prohibition, or else is not eligible for the 340B Program.

Required Documentation.  A petitioner party must provide documents sufficient to demonstrate its claim along with any other documentation requested by the ADR Panel.  A respondent party must respond within the deadlines set by the ADR Panel.   If respondent fails to respond, an ADR Panel may enter a default decision in favor of the petitioner.  In a proceeding for damages, the petitioner must still introduce evidence to support the claim for damages. 

Deadline to File a Claim.  Any action must be filed within three years of the date of the alleged violation, which is consistent with the record retention requirements for the 340B Program. 

Consolidation of Claims and Filing by a Trade Organization.  Covered entities may file claims of overcharges jointly against the same manufacturer for the same drug or drugs if each covered entity agrees to such filing and submits the required documentation.  An association or organization may file claims of overcharges by the same manufacturer for the same drug or drugs on behalf of multiple covered entities if each covered entity has documentation to support the allegations.  Similarly, manufacturers may request to consolidate claims brought by more than one manufacturer against the same covered entity if each manufacturer consents to consolidation, could individually file a claim against the covered entity, and possesses the required documentation.  Manufacturer claims may not be filed by associations or organizations representing manufacturers’ interests.   

Information Requests

Discovery by Covered Entity.  The ADR Panel may permit a covered entity a limited discovery (governed by FRCP) to obtain relevant information.

Information Requests by Panel.  The 340B Panel may request additional information from either party.  If a party fails to respond to a request, the ADR Panel, among other actions, may hold facts to have been established in the proceeding, preclude a party from presenting or contesting an issue, exclude evidence, or enter judgment or dismiss a proceeding.

Conduct of the ADR Proceeding

Conduct of ADR Proceeding.  The ADR Panel will determine the most efficient and practical form of the ADR proceeding and may issue instructions or guidance to govern the conduct of ADR proceedings.  The ADR process will be governed, to the extent applicable, by the FRCP and Federal Rules of Evidence, unless the parties agree otherwise and the 340B ADR Panel concurs.  When there are material facts in dispute, the ADR Panel will conduct an evidentiary hearing.

Final Agency Decision

Arriving at a Decision. The ADR Panel will determine whether the preponderance of the evidence supports the conclusion that a violation has occurred.  The agency decision will represent the decision of a majority of the ADR Panel’s findings regarding the claim.

Decision is Binding and Precedential.  The agency decision will constitute a final agency decision that is precedential and binding on the parties involved unless invalidated by a court.  The decisions will be published on HRSA’s website.  The ADR Panel’s decision will be submitted to the parties and HRSA for appropriate action.

Reporters, Igor Gorlach, Houston, +1 713 276 7326, igorlach@kslaw.com and Travis Jackson, Los Angeles, +1 213 443 4374, tjackson@kslaw.com.   

HHS Announces Proposed Changes to the HIPAA Privacy Rule – On December 10, 2020, the HHS Office of Civil Rights (OCR) announced proposed modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.  Among other changes, the proposed rule would shorten the required response time to 15 days for a covered entity to provide PHI to a patient.  In a press release, HHS stated that the changes would “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.”

Notably, the proposed rule would shorten the required response time for covered entities to provide PHI requested by a patient to no later than 15 calendar days (from the current 30 days) with the opportunity to extend for no more than 15 additional calendar days (from the current 30-day extension).  The proposed rule also includes the following proposed changes aimed at making PHI more easily accessible to patients:

  • Allowing individuals to take notes or use other personal resources to view and capture images of their PHI;
  • Reducing the identity-verification burden on individuals exercising their access rights;
  • Requiring covered healthcare providers and health plans to respond to certain records requests received from other covered healthcare providers and health plans when directed by individuals pursuant to the right of access; and
  • Clarifying the scope of permitted uses and disclosures for individual-level care coordination and case management.

The proposal would amend the HIPAA Privacy Rule to increase permissible disclosures of protected health information and improve care coordination.  According to HHS, the proposed modifications include “strengthening individuals’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or threatening circumstances, such as the Opioid and COVID-19 public health emergencies; and reducing administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals’ health information privacy interests.”

OCR encourages comments from “all stakeholders” including HIPAA covered entities, consumer advocates, health information technology vendors, health care professional associations, government entities, and patients and their families.

Public comments are due 60 days after publication of the proposed rule in the Federal Register. The proposed rule is available here.  The press release from HHS is available here.

Reporter, Elizabeth Han, Houston, 713-276-7319, ehan@kslaw.com 

Federal Court Rejects FTC Challenge to Hospital Merger in PennsylvaniaOn December 8, 2020, a federal court in Pennsylvania rejected a challenge by the Federal Trade Commission (FTC) and the State of Pennsylvania to block a $599 million merger of two hospital and healthcare systems in Philadelphia: the fourteen-hospital Thomas Jefferson University (Jefferson) and the three-hospital Albert Einstein Healthcare Network (Einstein).  The court found that the FTC had failed to meet its burden to prove that the merger would result in an increase in prices to insurers and less competition in the relevant geographic market.  The FTC has requested the federal district court and the U.S. Court of Appeals for the Third Circuit grant a temporary injunction while it appeals the decision.  If the emergency motions are denied, the merger could complete as soon as December 21, 2020.

Einstein’s flagship hospital, Einstein Medical Center Elkins Park, is a safety net hospital, as it has one of the highest percentages of government-insured inpatients—87% or more—among large hospitals in the United States.  Because of its poor payer mix, Einstein sought a strategic partner to improve its financial situation.  On September 14, 2018, Jefferson and Einstein entered into a System Integration Agreement, pursuant to which Jefferson would become Einstein’s sole member and ultimate parent. 

Earlier this year, the FTC and the Pennsylvania Office of Attorney General (together, the Government) sought a preliminary injunction in federal court to block the merger between the two systems pending an administrative investigation by the FTC to determine whether the merger would violate Section 7 of the Clayton Act.  The Government contended that if the merger were permitted to go forward, the transaction would substantially lessen competition in the Philadelphia area.

After a six-day evidentiary hearing, the district court denied the Government’s request for a preliminary injunction, holding that the Government did not properly define the relevant geographic market for healthcare services in Philadelphia and therefore did not meet its burden to block the merger.  The court defined the healthcare industry market as represented by a “two-stage model of competition.” 

In the first stage, hospitals compete to be included in an insurer’s hospital network.  In the second, hospitals compete to attract individual members of the insurers’ plans.  The court held that the first stage of competition—focusing on insurers as the payers in the market—is more important because insurers will most directly feel the impact of any increased price of care.  This is referred to as the “commercial reality” of the uniquely structured healthcare industry.  As a result of this “commercial reality,” the insurers’ perspective is “extremely important” in deciding whether a proposed merger will affect competition for healthcare in a proposed geographic market. 

The second stage of the competition model—where patients choose to receive healthcare—is relevant to the extent patient choices and behavior affect the bargaining leverage that hospitals and insurers possess when negotiating network agreements and reimbursement rates.  But this is less important than the insurers’ perspective as the payer, and thus the relevant geographic market must be assessed “through the lens of the insurers.”

Through this framework, the Government had the burden to prove that the insurers would face a price increase in the Government’s proposed markets should the merger occur.  The district court held that the Government failed to meet its burden.  The court reasoned that the FTC was far too focused on the second stage—where patients go to attend care—rather than whether the insurers would be forced to pay increased prices as a result of the merger.  The court noted that the geographic region has only four major commercial health insurance providers, and one of them Independence Blue Cross, has more than 50% market share.  Although the Government put forth expert calculations and testimony from two of the larger payers in the market in support of its contention that the insurers would face increased prices, the court found the testimony “neither unanimous, unequivocal nor supported by the record as a whole.”  Moreover, the consolidation of the insurance payers in the market led the court to conclude that the testimony from the Government’s experts’ and insurers’ that insurers would have to succumb to a price increase was “not credible.”  The court therefore denied the request for a preliminary injunction.

The FTC has appealed the decision to the U.S. Court of Appeals for the Third Circuit and has requested a temporary injunction of the merger pending the resolution of its appeal.  Pursuant to agreement of the parties, the district court entered an order (available here) extending a previous temporary injunction of the merger from December 15 to December 21, 2020 pending resolution of the FTC’s requests for a further injunction pending appeal.  If the requests are denied, the merger could be complete as soon as December 21, 2020.

The district court’s December 8, 2020 opinion is here.  The FTC’s emergency motion with the district court is here, and its emergency motion with the Third Circuit is here

Reporter, John Carroll, Washington, D.C., +1 202 626 2993, jdcarroll@kslaw.com and Ariana Fuller, Los Angeles, +1 213 443 4342, afuller@kslaw.com.

HHS Releases New Frequently Asked Questions Regarding CARES Act Provider Relief Funds – This month, HHS released over twenty new and modified Frequently Asked Questions (FAQs) regarding payments distributed to providers via the CARES Act Provider Relief Fund.  The FAQs cover a wide range of topics, including payments received in error, permissible uses of funds, calculating “expenses attributable to coronavirus not reimbursed by other sources,” and more.

The new FAQs broadly discuss the following general categories: (1) returning payments; (2) terms and conditions; (3) auditing and reporting requirements; (4) ownership structure and financial relationships; (5) use of funds; and (6) vaccine distribution and administration. Particularly significant is that the FAQs explain that if a provider received a greater payment than expected and believed it was made in error, the provider should contact the Provider Support Line and seek clarification.  This is a change from HHS’ previous FAQ (modified on October 28, 2020) that stated: “if you believe you have received an overpayment and expect that you will have cumulative lost revenues and increased costs that are attributable to coronavirus during the COVID-19 public health emergency that exceed the intended calculated payment, then you may keep the payment.”  Additionally, the FAQs explain that if a provider returns its payment to HHS, it must also return any accrued interest associated with the amount returned if the payments were held in an interest-bearing account.

The FAQs also provide additional clarity on the use of funds.  Providers can use funds on expenses incurred to secure and maintain adequate personnel (e.g., hiring bonuses and retention payments, childcare, transportation, etc.) if these expenses were newly incurred after the Public Health Emergency declaration and they were necessary to secure and maintain adequate personnel.  Additionally, the FAQs explain that funds can be used to pay taxes (except for Nursing Home Infection Control Distribution payments), and the funds can be used on outsourced or third-party vendor services that enable sustained access to healthcare services and daily operations (e.g., food and patient nutrition services, facilities management, etc.) if they are attributable to coronavirus.

Furthermore, HHS explains how providers should calculate “expenses attributable to coronavirus not reimbursed by other sources.”  The FAQ states, in relevant part:

Providers can identify their healthcare related expenses, and then apply any amounts received through other sources, such as direct patient billing, commercial insurance, Medicare/Medicaid/Children’s Health Insurance Program (CHIP), or other funds received from the Federal Emergency Management Agency (FEMA), the Provider Relief Fund COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured, and the Small Business Administration (SBA) and Department of Treasury’s Paycheck Protection Program (PPP) that offset the healthcare related expenses. Provider Relief Fund payments may be applied to the remaining expenses or costs, after netting the other funds received or obligated to be received which offset those expenses. The Provider Relief Fund permits reimbursement of marginal increased expenses related to coronavirus. For example, assume the following:

A $5 increase in expense or cost to provide an office visit is calculated by pre-pandemic cost vs. post-pandemic cost, regardless of reimbursement source:

  • Pre-pandemic average expense or cost to provide an office visit = $80
  • Post-pandemic average expense or cost to provide an office visit = $85

Examples of reimbursed amounts may include, but not be limited to:

  • Example 1Medicaid reimbursement: $70 (Report $85-$80 = $5 as expense attributable to coronavirus but unreimbursed by other sources)
  • Example 2Medicare reimbursement: $80 (Report $85-$80 = $5 as expense attributable to coronavirus but unreimbursed by other sources)
  • Example 3Commercial insurance reimbursement: $85 (Report $5, commercial insurer did not reimburse for $5 increased cost of post-pandemic office visit)
  • Example 4 Commercial insurance reimbursement: $85 + $5 insurer supplemental coronavirus-related reimbursement (Report zero since insurer reimbursed for $5 increased cost of post-pandemic office visit)
  • Example 5COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured: $80 (Report $5 as expense attributable to coronavirus but unreimbursed by other sources)

Finally, the FAQs explain that relief fund payments may be used to support expenses associated with the distribution of a COVID-19 vaccine licensed or approved by the FDA that have not been reimbursed from other sources or that other sources are not obligated to reimburse (which include, but is not limited to, Medicare, Medicaid, and CHIP).  If reimbursement does not cover the full expense of administering vaccines, funds may be used to cover the remaining associated costs.  Funds may also be used ahead of an FDA-licensed or approved vaccine becoming available–this may include using funds to purchase additional refrigerators, personnel costs to provide vaccinations, transportation costs not otherwise reimbursed.

The complete FAQ document is available here.

Reporter, Ahsin Azim, Washington, D.C., +1 202 626 9262, aazim@kslaw.com

United States Supreme Court Passes on Review of  FCA Dismissal from Fifth Circuit Involving Alleged Medicare Overbilling – On December 7, 2020, the United States Supreme Court declined review of the U.S. Court of Appeals for the Fifth Circuit’s affirmation to dismiss a $61.8 million False Claims Act case alleging Medicare overbilling against a Texas hospital system.  The lawsuit, initially brought by relator Integra Med Analytics (Integra) against Baylor Scott & White Health (Baylor), alleged that Baylor engaged in a scheme to overbill Medicare by fraudulently increasing the use of certain “secondary” diagnosis codes for complications and comorbidities, which result in higher Medicare reimbursement on the claim.  The Supreme Court’s decision not to undertake review of the Fifth Circuit’s decision signals that the nation’s highest court has no aims to alter the legal landscape of the False Claims Act’s pleading standard at this time.

The underlying lawsuit alleged, among other things, that Baylor enacted a scheme through trainings and other initiatives to fraudulently increase the use of secondary diagnosis codes for complications or comorbidities, evidenced in part with statistical analysis comparing Baylor to its peer institutions.  The district court, however, found that such allegations could not survive a motion to dismiss because “such a scheme is not in and of itself one to submit false claims and is equally consistent with a scheme to improve hospital revenue through accurate coding of patient diagnoses in a way that will be appropriately recognized and reimbursed by CMS commensurate with the type and amount of services rendered.”  The Fifth Circuit agreed; finding that the facts pleaded are consistent with both the claimed misconduct and a legal and “obvious alternative explanation” that Baylor was “ahead of most healthcare providers” in accurately coding these scenarios.

In its petition for review before the Supreme Court, Integra noted that the Fifth Circuit’s decision “signals an impossible standard for FCA relators relying in part on statistical analyses, as they would need to anticipate and rule out every possible alternative explanation . . . .”  But, the Supreme Court’s denial of Integra’s petition for review signals its intention to leave the pleading standard landscape for False Claims Act cases undisturbed.

The case is U.S., Ex Rel. Integrated Med v. Baylor Scott, et al., U.S., No. 20-581 (petition denied Dec. 7, 2020).  The Supreme Court’s list of cert denials from December 7, 2020 is available here. The Fifth Circuit’s opinion is available here.  Previous coverage from King & Spalding of this case can be found here

Reporter Michael L. LaBattaglia, Washington, D.C., +1 202 626 5579, mlabattaglia@kslaw.com.

ALSO IN THE NEWS

King & Spalding Client Alert:  Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud – As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely aware that the U.S. Department of Justice (DOJ) has promised to intensify its enforcement activity in this space. This alert provides an update on two of DOJ’s recent enforcement actions and public statements related to clinical trials. It also suggests steps that compliance officers can consider to position their companies as favorably as possible to prevent enforcement actions if the government comes knocking.  The full King & Spalding Client Alert is available here . 

King & Spalding Webinar – The World Changed in 2020: What This Means for Healthcare Fraud Enforcement and You – On December 16, 2020, from 12:30 – 1:30 p.m. ET, King & Spalding attorneys Amy Garrigues, Mike Paulhus, Stephanie Johnson, Ethan Davis, and Lee Nutini will lead a discussion on the government’s new priorities in healthcare fraud enforcement in a year like no other.

This discussion will include the following areas related to fraud and abuse enforcement:

  • The CARES Act and other pandemic legislation and related enforcement;
  • Increased governmental focus on telemedicine / telehealth enforcement;
  • Evolving procedural trends in FCA enforcement, including developing definitions of falsity and knowledge;
  • Updates to DOJ guidelines for evaluating compliance programs; and
  • Practical tips on proactive compliance strategies to mitigate risk.

Registration for the event is free. Click here to sign up.

King & Spalding Webinar – 2021 Outlook for California Healthcare Providers – On December 17, 2020, from 12:00 – 1:00 p.m. ET, King & Spalding attorneys John Barnes, Travis Jackson, and Kyle Gotchy will lead a discussion on how California will usher in 2021 with a number of new laws designed to respond to COVID-19, increase access to healthcare, and promote transparency in healthcare pricing.  Key topics include:

  • California’s strategy to combat COVID-19, including PPE stockpiles, nursing home staffing requirements and outbreak notification obligations;
  • State measures designed to promote access to care, such as mental health parity requirements and scope of practice changes for nurse practitioners;
  • Pricing transparency measures adopted by the state including California’s effort to collect data on the amount state-regulated health insurers pay for specific medical services;
  • Responses by California to the potential repeal of the Affordable Care Act and the effect of the 2020 election on federal health policy.

Registration for the event is free.  Click here to sign up.

King & Spalding Webinar – Recalculating:  Major Stark, Anti-Kickback and CMP Final Rules Changes are Taking Us in a New Direction

EVENT DETAILS

Part One
Thursday, January 7, 2021
1:00 P.M. – 2:30 P.M. ET

Part Two
Thursday, January 14, 2021
1:00 P.M. – 2:30 P.M. ET

Part Three
Thursday, January 21, 2021
1:00 P.M. – 2:00 P.M. ET

CMS and OIG recently finalized the most significant changes to the Stark Law rules, the Anti-Kickback Statute (AKS) safe harbors and the Beneficiary Inducements CMP regulations that the agencies have adopted in recent years. The final rules address value-based arrangements, introduce major changes to other key Stark Law concepts and definitions, address the donation of cybersecurity technology and services, and create flexibility to provide patient incentives in value-based arrangements and with respect to telehealth. Click here to read King & Spalding’s Client Alert highlighting the key proposals.

We are hosting a three-part webinar series to discuss these changes in greater detail, described below. We will cover new flexibilities and limitations created by these final rules, as well as how they may impact enterprise risk and future enforcement actions.

  • In Part One, we will discuss the changes to fundamental Stark Law concepts such as taking into account the volume or value of referrals or other business generated, fair market value, commercial reasonableness and the definition of indirect compensation arrangements. We also will address changes to the definition of “group practice,” writing requirements, changes to several commonly used compensation exceptions and new provisions related to cybersecurity technology and related services.
  • In Part Two, we will discuss changes related to value-based arrangements and patient incentives. This will include the new AKS safe harbors and Stark Law exception for value-based arrangements, modifications to existing AKS safe harbors and Stark Law exceptions to address value-based arrangements, new AKS safe harbors for patient incentives, revisions to the local transportation safe harbor and the warranties safe harbor and a new telehealth exception to the Beneficiary Inducements CMP.
  • In Part Three, we will explore how future enforcement theories and litigation of False Claims Act cases with Relators and the Department of Justice may evolve based primarily on changes to the Stark Law concepts of indirect compensation arrangements, taking into account the volume or value of referrals, fair market value, and commercial reasonableness.

Registration is coming soon.  You do not have to be a client to attend, and there is no charge.  We hope you will be able to join us.