FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway. Continue Reading

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus Provider-Based Departments Was Improper

On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for certain outpatient hospital services provided at certain off-campus provider-based departments (“PBDs”). Continue Reading

California Department of Managed Health Care Opposes AB 1249

On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the “Department”) released a letter of opposition (the “Letter”) to Assembly Bill 1249 (“AB 1249”). The Letter was addressed to Brian Maienschein of the California State Assembly, who is the lead author of AB 1249. Continue Reading

The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for the purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of their conclusion, with no other evidence to prove the falsity of the assessment.” U.S. v. AseraCare, Inc., No. 16-13004, at *3 (Sept. 9, 2019 11th Cir.) (“Op.”). Although the Court remanded the case to the district court to consider any such “other evidence” the Government might identify in the record, it also made clear that such evidence would need to “link” to specific claims submitted for payment, creating a substantial practical impediment to the Government’s ability to prove falsity in this and similar cases. See Op. at 56. Continue Reading

CMS Finalizes Rule Expanding its Authority to Deny and Revoke Medicare Program Enrollment, Among Other Changes

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule with comment period entitled, “Program Integrity Enhancements to the Provider Enrollment Process” (the “Final Rule”). The Final Rule, aiming to “address various program integrity issues and vulnerabilities by enabling CMS to take action against unqualified and potentially fraudulent entities and individuals,” significantly expands CMS’ ability to deny or revoke the Medicare enrollment of providers (e.g., hospitals, skilled nursing facilities, home health agencies, hospices, etc.) and suppliers (e.g., physicians, therapists, ambulance services, durable medical equipment suppliers, etc.) in ways that may create concerns even for providers and suppliers who are fully qualified and have not engaged in any fraudulent conduct. Continue Reading

Long-Term Care Providers and Corporate Compliance Programs: The Impending November 28, 2019 Deadline is Fast Approaching

A 2016 Final Rule from CMS created a new regulatory requirement for long-term care facilities, 42 C.F.R. § 483.85, that mandates such facilities have in operation, by November 28, 2019, a compliance and ethics program that is “reasonably designed to be effective in preventing and detecting criminal, civil, and administrative violations under the [Social Security] Act and in promoting quality of care.” The following eight components of a compliance and ethics program are required for all long-term care facilities’ operating organizations: Continue Reading

What’s the VA Got to Do With It? Military Medical Procurement Changes Reach the VA

There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics under the management of the Department of Defense (DOD), Defense Health Agency (DHA). But some may be unexpected, reaching all the way to Department of Veterans Affairs (VA) procurement, though the extent to which the VA will ultimately be affected is unclear. In the past few weeks, at least three major announcements were made regarding military healthcare: (1) DHA and the Defense Logistics Agency (DLA) signed a memorandum of agreement (MOA) regarding their respective rolls in DOD healthcare, (2) DLA gave the VA access to its medical/surgical prime vendor formulary indefinitely, and (3) the VA cancelled its long-anticipated prime vendor solicitation under the Medical/Surgical Prime Vendor (MSPV) 2.0 program. Is this all a coincidence? Probably not. Continue Reading

CMS Plans Updates to Star Ratings

On August 19, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced plans for two updates to its Overall Hospital Quality Star Ratings (“Star Ratings”). The first, in early 2020, to “refresh” the Star Ratings using the current methodology and the second, in 2021, to update the quality measurement methodology of the Star Ratings on CMS’s Hospital Compare website. The Star Ratings rate hospitals on a quality scale of one to five, summarizing a variety of measures reflecting common conditions hospitals treat. According to CMS Administrator Seema Verma, the goal of the changes is to empower patients to “make informed health care decisions, leading providers to compete on the basis of cost and quality.” Continue Reading

Eleventh Circuit Affirms Key Kickback Statute, Stark Law, and False Claims Act Principles in Dismissing Allegations Against HCA

On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas Bingham’s allegations. Bingham v. HCA (S.D. Fla. July 31, 2019) (“Op.”). In a well-reasoned opinion, the Court affirmed several key holdings:

  • There is no “remuneration”, for Federal health care program anti-kickback statute (“AKS”) purposes, unless a benefit is conferred for less than fair market value. In other words, as long as compensation to or from a referral source is consistent with fair market value, the AKS is not implicated.
  • With respect to the Stark Law, showing that a space lease arrangement effectuates an “indirect compensation arrangement” between a hospital and a referring physician requires a showing that the space, rental rates, or benefits under the lease correlate with the volume of the physician’s referrals to the hospital.
  • It may be appropriate for a court to strike allegations from an amended False Claims Act complaint if they are based on information uncovered by a relator during discovery.

These holdings should be welcomed by defendants of alleged AKS, Stark Law, and False Claims Act violations. Continue Reading

CMS Finalizes 2020 Hospice Rule: Big Changes Coming

On August 6, 2019, CMS finalized its 2020 hospice rule, including adopting, without substantial modification, two controversial and material changes to the hospice benefit:

  • Rebasing payment rates to shift about $500 million from routine care to enhanced levels of care including general inpatient, continuous, and respite care.
  • Adopting a requirement that, upon request (either at admission or later), hospices disclose in an extensive written addendum to patients (and other health care providers) any care that would be deemed unrelated to hospice care.

We reviewed these proposals in detail in prior blogs posts on rebasing and unrelated care disclosures; and, we submitted these comments to CMS.  In this blog, we will note the changes that CMS did make to these proposals and note some of the potential effects.

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