This week CMS continued its rapid response—average approval takes less than a week—to review and approve Social Security Act Section 1115(c) Appendix K and Section 1135 waivers to facilitate state Medicaid programs’ efforts to address the COVID-19 pandemic. CMS approved waiver applications from Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts,
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New York State Department of Health Seeks Additional 1135 Waivers From CMS To Alleviate Strain On Medicaid Managed Long-Term Care Plans and Other MCOs As Well As PACE Organizations Amidst Coronavirus Outbreak
New York State is now considered the nation’s epicenter of the coronavirus outbreak, far surpassing all other states in confirmed COVID-19 cases. Managed long-term care plans (“MLTCPs”) and other Medicaid managed care organizations (“MCOs”) are facing unprecedented financial and other challenges addressing the care needs of their members as COVID-19 continues to ravage more and more New Yorkers. Earlier this week, the New York State Department of Health (“DOH”) acted to secure regulatory relief from the federal government for MLTCPs and MCOs as well as Programs of All-Inclusive Care to the Elderly (“PACE”) Organizations from the growing financial stress brought about by the coronavirus outbreak.
In recognition of the challenges faced by health care providers and payors alike, on March 13, 2020, the Secretary of Health and Human Services, invoking Section 1135 of the Social Security Act authorized the Centers for Medicare and Medicaid Services (“CMS”) to waive application of certain federal laws to ensure that sufficient health care items and services are available to meet the needs of Medicaid patients and plan members during the coronavirus public health emergency. On March 23, 2020, DOH requested additional waivers from federal regulations under Section 1135 that impact among others, MCOs and MLTCPs, including:…
Continue Reading New York State Department of Health Seeks Additional 1135 Waivers From CMS To Alleviate Strain On Medicaid Managed Long-Term Care Plans and Other MCOs As Well As PACE Organizations Amidst Coronavirus Outbreak
CMS Approves Medi-Cal Section 1135 Waivers
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:…
CMS Approves 11 More 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…
CMS & State Medicaid Agencies Seek to Expand Enrollee Protections During COVID-19 Pandemic
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.…
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HHS, States use Section 1135 Emergency Waivers to Meet COVID-19 Challenges
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.…
Flurry of Regulatory Activity Driven by COVID-19 Anxiety Impacts Health Plan Requirements and Permissible Actions
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
OMB Concludes Review of Proposed Rules for Modernizing Physician Self-Referral and Anti-Kickback Regulations
As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law.
These regulations were the subject of two Requests for Information…
11th Circuit Issues Long-Awaited Opinion in AseraCare Affirming that Mere Differences in Reasonable Clinical Judgement Cannot Be False Under the FCA and Remanding for New Trial and Consideration of Full Record
In a long-awaited opinion, on September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit in United States v. Aseracare, Inc., et al, unanimously vacated AseraCare’s False Claims Act (FCA) victory and remanded the case for further proceedings. While this might seem a victory only for the Government at first blush, the opinion contains key takeaways for defendants that will likely reach far beyond just this case.
Importantly, even though the Eleventh Circuit vacated the district court’s grant of summary judgment to AseraCare, it affirmed the district court’s conclusion that a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for purposes of the FCA, when there is only a reasonable disagreement between medical experts as to the accuracy of that conclusion, with no other evidence to prove the falsity of the assessment. The Eleventh Circuit also concluded, however, that the Government should have been allowed to rely on the entire record, not just the trial record, to prove otherwise. The Government was precluded from doing so, the Court found, due to an earlier decision by the district court to bifurcate proceedings into two phases: one on falsity, and the other on the remaining elements of the FCA.
In affirming the district court’s holding regarding clinical judgment, the Eleventh Circuit remarked that it appears to be the “first circuit court to consider the precise question at issue here,” and is an extraordinary move that provides hospice facilities, hospitals, and providers more generally with a degree of assurance that a reasonable disagreement between clinicians in a courtroom, without other evidence of objective falsehood, does not create a jury question and cannot serve as the basis for an action under the FCA: “While there is no question that clinical judgments must be tethered to a patient’s valid medical records, it is equally clear that the law is designed to give physicians meaningful latitude to make informed judgments without fear that those judgments will be second-guessed after the fact by laymen in a liability proceeding.”…
Continue Reading 11th Circuit Issues Long-Awaited Opinion in AseraCare Affirming that Mere Differences in Reasonable Clinical Judgement Cannot Be False Under the FCA and Remanding for New Trial and Consideration of Full Record
Podcast: Some Potential Impacts of Legal Challenges to the ACA
In the latest episode of Payers, Providers, and Patients – Oh My!, Troy Barsky and Alice Hall-Partyka talk with Joe Records and Payal Nanavati about how recent litigation challenging the constitutionality of the Affordable Care Act may impact providers and payers. The discussion focuses on the authority for innovative health care models and…