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Kathleen M. Stratton is Special Counsel in the Corporate Practice Group in the firm’s Washington D.C. office.

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.”
Continue Reading CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

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

On July 16, 2019, the Congressional Budget Office (“CBO”) released a Cost Estimate for Senate Bill S. 1895, the “Lower Health Care Costs Act.” The bipartisan bill, introduced June 19, 2019, intends to end surprise medical bills, reduce the prices of prescription drugs, improve transparency in health care costs, and increase public health awareness and access to health information.
Continue Reading CBO Report Shows Senate’s Bipartisan Bill on Surprise Billing, Drug Prices, Transparency, and More Would Result in Deficit Decrease

On July 11, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced a proposed rule for home health agency Medicare reimbursement that would increase payments by an aggregate 1.3% for 2020, amounting to $250 million. In doing so, CMS would begin a transition to payments that are value-based, implementing the Patient-Driven Groupings Model (“PDGM”), an alternate case-mix payment methodology. In the PDGM, home health agencies are paid for 30 rather than 60-day episodes of care, and reimbursement is based on patient characteristics rather than the number of therapy visits provided. In a statement from CMS administrator Seema Verma regarding the proposed rule, she said the PDGM will reward “value over volume.” The proposed changes to reimbursement also include a one-year phasing out of pre-payments for home health services, known as Requests for Anticipated Payment. These proposed changes reflect a significant shift in the manner in which home health agencies historically have been reimbursed.
Continue Reading CMS Proposes New Home Health Agency Rule Including Potential Changes to Reimbursement, Coverage, Quality, and More: CMS Accepting Comments until September 9, 2019

Quality Improvement Programs

The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change involves a clarification regarding the accreditation “deeming” standard for Medicare Advantage (“MA”) quality improvement programs. The second change, also related to accreditation, simply proposes the deletion of language regarding the soon to be eliminated requirement that MA organizations (“MAOs”) conduct quality improvement projects.
Continue Reading Blog Series Part 4: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021