Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

Federal health policy is an early focus for Congressional committees.  In addition to several hearings held in January, Congressional hearings in February have concentrated on the Affordable Care Act (ACA) and primary care, including the following: A House Energy and Commerce Committee hearing on the Texas v. United States court case challenging the constitutionality of the ACA and its potential impact on individuals with pre-existing conditions. A House Education and Labor Committee hearing entitled…
The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have proposed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing (PT) regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992.  The proposed rule would, among other things, revise the list of analytes requiring PT and update the scoring criteria for acceptable laboratory performance.  Comments…
On February 14, 2019, CMS is hosting an educational call on new opioid policies for Medicare drug plans.  The call will focus on improved safety alerts when opioid prescriptions are dispensed at the pharmacy, and drug management programs for individuals at-risk for misusing or abusing “frequently abused drugs” (opioids and benzodiazepines).  The target audience for the call includes physicians, physician assistants, nurses, nurse practitioners, dentists, case managers, and other interested stakeholders.  To register, visit the…
Late yesterday, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule to amend the anti-kickback safe harbors[1] in response to perceived risks that rebates paid by pharmaceutical manufacturers to payors and pharmacy benefit managers (PBMs) may contribute to pharmaceutical list price inflation and not benefit patients and payors.  The proposed rule would (i) remove safe harbor protection for drug manufacturer rebates to Part D…
The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.  HHS states that the change would enable covered entities to clearly distinguish whether a prescription fill for a Schedule II drug is a “partial fill” (i.e., less than the full…
The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D Payment Modernization Model (Part D Model), which will be tested by the CMS Center for Medicare and Medicaid Innovation.  CMS unveiled the Part D Model on January 18, 2019, at the same time the agency released details on extensive revisions to its current Medicare Advantage Value-Based Insurance Design (VBID) model. On January 31, 2019, CMS provided additional detail on…
The Centers for Medicare & Medicaid Services (CMS) is making extensive revisions to its Medicare Advantage (MA) Value-Based Insurance Design model in order “to contribute to the modernization of Medicare Advantage through increasing choice, lowering cost, and improving the quality of care for Medicare beneficiaries.” By way of background, the VBID innovation model was launched in 2017 to test how MA plans in seven states can use health plan design elements (e.g., supplemental benefits, disease…
The Centers for Medicare & Medicaid Services (CMS) has issued new guidance on what date of service (DOS) should be billed for various Medicare Part B services.  For radiology services, CMS offers the option of reporting the DOS of either the date when the radiology study was performed on the patient or the date of the professional interpretation when a “global” claim is submitted for payment for both components. When the technical component (TC) or…
As the new 116th Congress gets underway, four House and Senate committees are holding hearings to examine health policy issues, including two hearings focusing on prescription drug prices.  Specifically, the following hearings are all scheduled for January 29, 2019: A Senate Finance Committee hearing on “Drug Pricing in America: A Prescription for Change, Part I,” which will feature testimony from economists, a patient advocate, and others. A House Committee on Oversight and Reform…
The Centers for Medicare & Medicaid Services (CMS) has finalized a major restructuring of the Medicare Shared Savings Program, dubbed “Pathways to Success.”  According to CMS, the program changes “are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles.”  Most notably, CMS is accelerating the schedule for accountable care organizations (ACOs) to transition to two-sided risk models, under which the ACO…