Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:

Continue Reading OIG Sends a Special Fraud Alert on Speaker Programs

On October 29, 2020, the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) issued a final rule requiring private-sector health insurers and self-insured health plans to disclose treatment prices and cost-sharing information with consumers.  The Transparency in Coverage rule comes in response to President Trump’s executive order aiming to increase transparency in the healthcare industry. It is slated to become effective on January 11, 2021.

The final rule contains three main parts: (1) requirements for plans and issuers to disclose estimated costs associated with covered items or services furnished by a particular provider; (2) requirements for plans and issuers to publicly disclose reimbursement rates; and (3) amendments to the medical loss ratio program rules to allow issuers to receive credit for enrollees’ savings. Each part is discussed below.

Estimated Costs

First, insurers and employer-sponsored health plans will be required to provide price estimates, including in-network and out-of-network negotiated rates, for health care items and services upon request.  The regulation requires these estimates beginning in 2023 for the 500 most “shoppable” items and services on an internet-based self-service tool (and in paper form, if requested by the participant, beneficiary, or enrollee).  Among the 500 “shoppable services” are mammograms, physician visits, colonoscopies, and various blood tests, biopsies, and X-rays, and the full list is specified in the regulations.  Then, beginning in 2024, price estimates for all remaining items and services offered, including procedures, drugs, durable medical equipment, must be disclosed. The price transparency requirements include disclosure of the following:

Continue Reading HHS Finalizes Health Plan Price Transparency Rule

On October 29, 2020, CMS issued the Home Health Prospective Payment System final rule [CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC], which permanently authorizes use of telecommunications technology as part of patient care under the Medicare home health benefit.[1]

The final rule is another regulatory step toward CMS recognizing the critical role of virtual care in the home health and other care settings, beyond the COVID-19 pandemic.[2]

Use of Telecommunications Technology in Home Health Services

In April 2020, CMS had initiated regulatory changes proposing to expand the use of telecommunication in the provision of home health services covered by Medicare.  CMS stated that its goal in expanding this permitted use of telecommunications technology in furnishing home health care is to “improve efficiencies, expand the reach of healthcare providers, allow more specialized care in the home, and allow home health agencies to see more patients or to communicate with patients more often.”

In the final rule, effective January 1, 2021, home health agencies (HHAs) will be able to use telecommunications – and receive reimbursement for home health services – under the following conditions:

Continue Reading HHS Approves Telecommunications for Providing Medicare Home Health Services, on a Permanent Basis, Effective January 1, 2021

Last week, the Office of the National Coordinator for Health Information Technology (ONC)  published an Interim Final Rule: Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency (Interim Final Rule) providing needed relief to entities working toward compliance.  In the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Rule), issued on May 1, 2020, ONC defines the entities that are subject to the rule’s provisions. ONC refers to these entities as Actors. Actors include health care providers, health IT developers of certified health IT, Health Information Exchanges (HIEs), and Health Information Networks (HINs). The Interim Final Rule provides these Actors with “additional flexibilities” to implement the provisions of the ONC Rule including updated compliance dates.  ONC explained that the extension is due to the outbreak of COVID-19 public health emergency; however, this will also provide ONC with additional time to provide answers to the numerous questions that the agency has received as Actors work toward compliance. ONC is accepting comments on this rule, as is typical for an interim final rule. These comments must be submitted to regulations.gov by January 4, 2021.

The Interim Final Rule extends “the applicability date for the information blocking provisions and compliance dates and timeframes for certain Program requirements, including compliance dates for certain 2015 Edition health IT certification criteria and Conditions and Maintenance of Certification requirements.” See CMS and ONC Enforcement Deadlines Chart for more information about compliance dates for the ONC Rule.

Information Blocking

Continue Reading ONC Issues Interim Final Rule Extending Compliance Dates for the Information Blocking and the ONC Health IT Certification Program

On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020.

As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)), HHS proposes to issue regulations to ensure (i) there is proper notice of any new guidance, and (ii) that the guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations.

This proposed rule appears to follow the Office of Management and Budget, “Final Bulletin for Agency Good Guidance Practices,” issued on January 25, 2007 (72 Fed. Reg. 3432) with respect to the significant guidance document that may, for example “adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or “materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof” and generally requires a 30 day notice and comment period.

Background

Continue Reading HHS Proposes a New Rule to Govern Release and Maintenance of Agency’s Guidance Documents

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Todd Rosenberg and Samuel Krause to discuss ERISA preemption of state regulation of pharmacy benefit managers (PBMs) in light of the upcoming U.S. Supreme Court hearing in Rutledge v. Pharmaceutical Care Management Association.

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On July 17th, the California Office of Administrative Law (“OAL”) approved an emergency regulation (effective until January 14, 2021) from the California Department of Managed Health Care (“DMHC”) that specifies COVID-19 diagnostic testing coverage requirements for California health care service plans. Medi-Cal managed care plans, Medicare Advantage plans, and specialized health plans are not subject to the regulation. The DMHC provided additional context to the emergency regulation in an all plan letter issued on July 23rd.

The regulation deems COVID-19 testing to be an urgent health care service during the California state of emergency. It also states that COVID-19 diagnostic testing is a medically necessary basic health care service for enrollees who are essential workers, regardless of whether the enrollee has symptoms of COVID-19 or a known or suspected exposure to a person with COVID-19. Essential workers are defined in the regulation to include a broad range of individuals working in the health care, emergency services, public transportation, congregate care, correctional, food service, and education sectors. Additionally, they include individuals who work in retail, manufacturing, agriculture, and food manufacturing that either have frequent interactions with the public or cannot regularly maintain at least six feet of space from other workers.

Between the regulation, all plan letter, and other applicable federal law, California health plans will need to comply with the following requirements for enrollees seeking COVID-19 testing:

Continue Reading Required Coverage of COVID-19 Testing for Essential Workers in California

On July 17, 2020, in a 2-1 decision, the  U.S. Court of Appeals for the D.C. Circuit upheld a Trump Administration rule that expands the scope of short-term limited duration insurance (STLDI) plans, affirming the lower court’s opinion that STLDI plans do not violate the Affordable Care Act. Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury , D.C. Cir. App., No. 19-05212 (July 17, 2020).

The rule’s genesis can be traced to an Executive Order issued in October 2017, which aimed to expand the availability of STLDI plans, seen by the Administration as more “appealing and affordable” than plans mandated by the ACA. The order tasked the Departments of Treasury, Labor, and Health and Human Services with expanding the duration of STLDI plans from three months to twelve. The changes also provide for renewals of those plans, which can amount to continuous coverage for up to three years.

Continue Reading Appeals Court Upholds Trump Administration’s Short-term, Limited Duration Insurance Policy Rule

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced a second round of regulatory waivers and rule changes in an interim final rule with comment (IFC) that added significant flexibilities for the coverage of telehealth services furnished by a broader set of eligible clinicians and in nontraditional health settings during the COVID-19 public health emergency. These additional changes further demonstrate CMS’s commitment to using telehealth to mitigate COVID-19 exposure risks to Medicare beneficiaries and its response to feedback regarding gaps in existing telehealth coverage and reimbursement rules.

Please click here to read the full alert, including our insights on whether these changes will remain after the COVID-19 emergency.

Potentially overlooked between the enactment of the Families First Coronavirus Response Act (the FFCRA) on March 18 and the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) on March 27, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument via teleconference on March 20 in Ass’n for Cmty. Affiliated Plans v. U.S. Dep’t of Treasury, No. 19-05212 (D.C. Cir. July 30, 2019). At issue in that case is the fate of a Trump Administration rulemaking expanding the scope of non-ACA compliant short-term limited duration insurance (STLDI) plans. Already controversial—with some arguing that STLDI plans increase access to health care, while others decry them as misleading consumers and destabilizing the individual insurance market—STLDI plans are of particular import given the COVID-19 pandemic.

As millions face unemployment, lose access to employer-sponsored health insurance coverage, and qualify to seek coverage via a special enrollment period, others may look to STLDI policies to obtain at least some coverage in the wake of COVID-19. But, as with ACA requirements such as essential health benefits and community rating, STLDI plans are not subject to the recently enacted zero-dollar cost-sharing and other coverage requirements for COVID-19 diagnostic testing.

Continue Reading Appeals Court Hears Argument on Short-term, Limited Duration Insurance Plan Rule; STLDI Plans are not Required to Provide $0 Cost-share of COVID-19 Diagnostic Testing