On March 23, the Centers for Medicare and Medicaid Services (CMS) approved Section 1135 waiver requests submitted by the California Department of Health Care Services (DHCS) as part of its response to the COVID-19 pandemic.  The waiver requests were submitted by DHCS on March 16 and March 19, 2020.

As discussed in a previous blog post, Section 1135 authorizes the U.S. Department of Health and Human Services to waive federal Medicare, Medicaid, and Children’s Health Insurance Program requirements in order to respond to a public health or national emergency. As of March 24, CMS had approved Section 1135 waivers related to the COVID-19 pandemic from 13 different states.

With the approval granted by CMS, DHCS is permitted to take the following actions in regards to its Medicaid program (Medi-Cal), effective retroactively to March 1 and to extend until the end of the public health emergency:

Continue Reading CMS Approves Medi-Cal Section 1135 Waivers

On March 23, 2020 CMS approved 11 more Section 1135 state Medicaid waiver requests for the following states: Alabama, Arizona, California, Illinois, Louisiana, Mississippi, New Hampshire, New Jersey, New Mexico, North Carolina, and Virginia. As with the prior waivers, CMS approved the requests in a handful of days from receiving them. The CMS press release on these waiver approvals is available here. For more discussions of Section 1135 waivers, see our prior coverage here.

Many states are looking to adapt their Medicaid programs to address new challenges related to COVID-19, including by increasing coverage and protection for Medicaid enrollees. The Centers for Medicare and Medicaid Services (CMS) has issued guidance on the types of measures that states can take to change their Medicaid programs.

In an FAQ addressed to state Medicaid and Children’s Health Insurance Program agencies, CMS addressed questions from states, saying that states may have flexibility to cover telehealth services, accelerate or relax prior authorization requirements, expand provider networks, extend Medicaid eligibility, and suspend copayments, although some of these measures may require CMS’ waiver of federal requirements or approval of changes to the state Medicaid plan.

On March 22, CMS released checklists and tools that guide Medicaid programs through the processes of seeking expedited approval of such changes and waivers, including section 1115 demonstration waivers, section 1135 waivers, Appendix K of section 1915(c) home and community-based services waivers, and disaster amendments to the state plan. In the associated press release, the Trump Administration indicated that the tools could be used by states to “access emergency administrative relief, make temporary modifications to Medicaid eligibility and benefit requirements, relax rules to ensure that individuals with disabilities and the elderly can be effectively served in their homes, and modify payment rules to support health care providers impacted by the outbreak.” CMS is providing states the options to request waivers effective retroactively to March 1.

Continue Reading CMS & State Medicaid Agencies Seek to Expand Enrollee Protections During COVID-19 Pandemic

On January 31, 2020, U.S. Department of Health and Human Services Secretary Alex Azar declared COVID-19 a public health emergency under Public Health Service Act Section 319. Subsequently, on March 13, 2020, President Trump declared COVID-19 a national emergency under Sections 201 and 301 of the National Emergencies Act. Doing so empowered Sec. Azar to temporarily waive or modify certain requirements for Medicare, Medicaid, and the Children’s Health Insurance program (CHIP) via Social Security Act Section 1135.

Section 1135 waivers are intended to ensure that enough health care items and services are made available to meet the needs of Medicare, Medicaid, and CHIP enrollees in an area affected by an emergency. Such waivers also may shield providers who furnish health care items or services in good faith from sanctions—absent any determination of fraud and abuse. For example, Section 1135 waivers may lift requirements that providers are licensed in the state where they are responding to the emergency if they have equivalent licensure in another state, thereby enabling the provider to be reimbursed for Medicare, Medicaid, or CHIP services. Likewise, 1135 waivers may waive Stark Law self-referral sanctions. An overview of Section 1135 waiver requirements and processes is available from CMS here.

This waiver authority is a critical component of state and federal governmental health programs’ response to emergencies such as the COVID-19 pandemic. The federal government has used this authority to:

CMS’s current emergencies webpage is updated regularly with additional waiver requests and grants and includes a fact sheet on the emergency declaration. As one would expect given the emergency, CMS is acting swiftly to review and approve state waiver requests. For example, Florida’s request was approved within three days and Washington’s within four. Some states, such as Arizona, have submitted requests for both an 1135 waiver and 1115 waiver to address COVID-19. We expect more waiver requests in the coming weeks as states and the federal government continue to explore solutions to the challenges of COVID-19.

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 Xavier Baker and Kevin Kroeker to discuss medical loss ratio requirements. The first episode provided background on what an MLR is and some of the history of MLR requirements, among other things. This episode touches on how the MLR is determined for plans and some of the compliance risks that can arise under MLR requirements.

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Last week, the Center for Medicare & Medicaid Services (CMS) finalized long-awaited regulations on Interoperability and Patient Access (the “CMS Rule”) to require Medicare Advantage plans, Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state agencies, and Qualified Health Plan (QHP) issuers on federally-facilitated exchanges (“CMS Payers”) to provide patients easy access to their claims and encounter information, as well as certain clinical information, through third-party applications of their choice. On the same day, the Office of the National Coordinator for Health Information Technology finalized its rules on Interoperability, Information Blocking, and the ONC Health IT Certification Program (the “ONC Rule”) related to the 21st Century Cures Act (Cures Act). The CMS Rule and ONC Rule have far-reaching impacts.

As individuals and organizations covered by the rules are considering how they may facilitate their access to health information to support patients, health care providers, and others, it is important to understand when provisions in the rules will be effective and timing and what acts may constitute violations of these rules.  To help clients get familiar with these deadlines, we are providing this summary chart of compliance requirements and applicable deadlines to help your organization prepare for upcoming enforcement of the ONC Rule and the CMS Rule.  For legal advice tailored to the specific needs of your organization, please reach out to Jodi Daniel, head of the firm’s Digital Health Practice at jdaniel@crowell.com.

As you read the chart, you should keep the following in mind:

Continue Reading Compliance Reference Chart for ONC and CMS Interoperability Rules

The past week has seen daily action at the state and federal level that seeks to ensure that health plans and insurers are providing unrestricted access to testing for COVID-19 and for related services.  Health plans nationally have responded by adopting copayment and preauthorization waivers even where they have not been mandated.

Here are a few of the headlines:

On March 2, 2020, New York Gov. Andrew Cuomo announced he would require state health insurers to waive fees related to coronavirus testing in the state in order to avoid cost as a barrier to testing.  To implement his directive, Governor Cuomo announced that the New York State Department of Financial Services (“DFS”) will promulgate an emergency regulation that (i) prohibits health insurers from imposing cost-sharing on an in-network provider office visit or urgent care center when the purpose of the visit is to be tested for COVID-19 and (ii) prohibits health insurers from imposing cost-sharing on an emergency room visit when the purpose of the visit is to be tested for COVID-19.  In addition, DFS issued other COVID-19 guidance to New York insurers, including: (a) directing insurers to develop robust telehealth programs with their participating providers, and (b) directing insurers to verify that their provider networks are adequately prepared to handle a potential increase in the need for health care services, including offering access to out-of-network services where appropriate and required. Continue Reading Flurry of Regulatory Activity Driven by COVID-19 Anxiety Impacts Health Plan Requirements and Permissible Actions

In early February, two federal bills targeting surprise billing in healthcare advanced out of committee.  On February 11, the House Education and Labor Committee passed the Ban Surprise Billing Act (H.R. 5800), which was introduced by Chairman Rep. Bobby Scott (D. – Virginia) and Ranking Member Rep. Virginia Foxx (R. – North Carolina).  One day later, the House Ways and Means Committee unanimously advanced the Consumer Protections Against Surprise Medical Bills Act (H.R. 5826), led by Chairman Rep. Richard Neal (D. – Massachusetts) and Ranking Member Rep. Kevin Brady (R. – Texas).  Both bills would prohibit providers from balance billing patients for surprise medical bills and would limit patients’ cost-sharing to in-network amounts.  The two competing bills must be reconciled before the full House can vote on the issue.  Leaders hope to include the final product in a spending bill that must pass Congress by May 22.

Similar scopes of coverage

The competing bills are substantively similar in several ways.  Each bill applies to out-of-network emergency claims, to post-stabilization inpatient services provided to patients who are admitted to the hospital through the emergency room, and to non-emergency services provided at in-network facilities by out-of-network providers.  The Ban Surprise Billing Act also covers air ambulance services.  Additionally, both bills apply to all individual and group health plans (both fully- and self-insured) in the group and individual markets, but do not apply to federal programs such as Medicaid or the Federal Employees Health Benefits Program.  The Ban Surprise Billing Act also extends to grandfathered health plans.

Notice requirements Continue Reading Competing Surprise Billing Proposals Set to Collide in the U.S. House; States Test Different Solutions

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 Xavier Baker and Kevin Kroeker to discuss medical loss ratio. This episode touches on what an MLR is, some of the history of MLR requirements in health coverage, and some of the similarities and differences across markets. Stay tuned for Part 2.

Subscribe to Payers, Providers, and Patients – Oh My! at:

PodBean | SoundCloud | Apple Podcasts

Crowell & Moring has released its Regulatory Forecast 2020: What Corporate Counsel Need to Know for the Coming Year, a report that explores the impact of regulatory changes on the technology industry and other sectors, and provides insight into the house counsel can expect to face in the coming year.

For 2020, the Forecast highlights the driving forces behind the increased regulatory focus, including access to the data, online platforms, and cutting-edge technologies that define competitive advantage. It explores regulatory trends in antitrust, environment and natural resources, and public affairs.

The health care section, “Will Health Care be Healthier in 2020,” discusses the profound impact that court challenges and new proposals could have on the Affordable Care Act, Medicaid and the Stark Law.

Be sure to read the full report and follow the conversation on social media with #RegulatoryForecast.