Archives: Other Health Policy Developments

Subscribe to Other Health Policy Developments RSS Feed

Trump Administration’s Proposed FY 2019 Budget Targets Medicare, Medicaid for Savings, Seeks (Again) to Repeal/Replace ACA

The Trump Administration has released its fiscal year (FY) 2019 budget proposal, which includes extensive health policy provisions. While most of the President’s policy proposals for Department of Health and Human Services (HHS) programs would require Congressional approval, others are characterized as administrative proposals that presumably would not involve Congress. President Trump once again seeks … Continue Reading

CMS Cancels Another Pending CMS Innovation Project: the Direct Decision Support (DDS) Model

CMS will not proceed with its planned Direct Decision Support (DDS) innovation model “due to operational and technical issues with the proposed Model design.” When this model was announced in December 2016, it was expected to test a shared decision-making approach outside of the clinical delivery system. On February 2, 2018, CMS announced that it has … Continue Reading

VA and HHS Team Together to Combat Health Care Fraud, Waste, and Abuse

The Department of Veterans Affairs (VA) and the Centers for Medicare & Medicaid Services (CMS) have announced a partnership to leverage CMS’s program integrity tools to detect and prevent fraud within VA programs.  The collaboration will focus on applying state-of-the-art data analytics tools and best practices identified by CMS to VA claims payment processes.  In … Continue Reading

New “Granston Memorandum” Outlines Factors DOJ May Consider in Dismissing Qui Tam Cases Brought by Relators

A top Department of Justice (DOJ) official has recently issued a much-anticipated memo explaining the factors DOJ will consider when deciding whether to dismiss FCA suits brought by relators in qui tam cases. Specifically, the memo by Michael Granston, Director of the Commercial Litigation Branch within the DOJ Fraud Section sets forth seven non-exhaustive factors that … Continue Reading

ONC Proposes Trusted Exchange Framework for Health Information Networks

The Office of the National Coordinator (ONC) for Health Information Technology has released a draft trusted exchange framework that proposes policies, procedures, and technical standards to further Congressionally-mandated efforts to establish a nationwide, interoperable health system under the 21st Century Cures Act of 2016.  Currently, there are dozens of Health Information Networks (HINs) that operate … Continue Reading

Trump Administration Unveils Its First Bundled Payment Initiative — BPCI Advanced

The Trump Administration has rolled out its first CMS Innovation Center Medicare bundled payment initiative, the Bundled Payments for Care Improvement Advanced (BPCI Advanced). Under the new voluntary model, CMS will test whether bundled payments for 29 inpatient and 3 outpatient clinical episodes will lead to reduced Medicare expenditures while improving quality of care for … Continue Reading

CMS Clears the Way for States to Add Medicaid Work/Community Engagement Requirements

CMS has announced a new initiative allowing states to propose demonstrations to “improve Medicaid enrollee health and well-being through incentivizing work and community engagement.” Specifically, states may propose Section 1115 waivers to make participation in work or other community engagement a requirement for continued Medicaid eligibility or coverage for non-elderly, non-pregnant adult Medicaid beneficiaries who … Continue Reading

HHS Creates Conscience and Religious Freedom Division within OCR

On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).  The Division will focus on enforcement of (1) existing protections for health care providers who refuse to perform certain health care services on religious or moral grounds, and (2) laws that … Continue Reading

CMS Gives States Options for Complying with Cures Act Mandate to Cap Medicaid DME Rates

As previously reported, the 21st Century Cures Act prohibits federal financial participation (FFP) payments to the states for certain Medicaid durable medical equipment (DME) expenditures that exceed what Medicare would have paid for such items, either on a fee schedule basis or under competitive bidding.  The provision is effective January 1, 2018. CMS recently provided … Continue Reading

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any recommendations, it will seek to determine potential financial benefits to health care providers in ordering or referring health care services. The … Continue Reading

OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data

The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing information and FDA classification (e.g., innovator/brand or noninnovator/generic). The OIG determined that the “vast majority” of the drugs in the Medicaid rebate program were classified appropriately in 2016, but about 3% of these drugs (885 drugs) … Continue Reading

FDA Proposes Framework for Regulating Software as a Medical Device

The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. The … Continue Reading

OIG Highlights Recent Audit, Investigation, and Enforcement Accomplishments

The Office of Inspector General (OIG) of the Department of Health and Human Services has released its semiannual report for the period of April 1, 2017, through September 30, 2017. The report also includes aggregated data for all of fiscal year (FY) 2017.  For instance, during FY 2017, the OIG achieved: $4.13 billion in expected … Continue Reading

HHS Announces New Appeals Settlement Initiatives

The HHS Departmental Appeals Board (DAB) is inviting the public to submit recommendations for precedential Medicare Appeals Council (Council) decisions that will be binding on all CMS, HHS, and Social Security Administration components that adjudicate matters under CMS jurisdiction. The designation of precedential decisions was authorized by regulations adopted earlier this year; the DAB will … Continue Reading

OIG: Medicare Program Integrity at the Top of HHS Management Challenges

The OIG’s latest compilation of top HHS management and performance challenges flags vulnerabilities in key HHS health and social services programs, including includes the following: Ensuring Program Integrity in Medicare (addressing improper payments, fraud, payment policies, health care reforms, and health information technology). Ensuring Program Integrity in Medicaid (including compliance with fiscal controls, fraud prevention, … Continue Reading

CMS Finalizes Medicare Clinical Lab Fee Schedule for 2018

CMS has issued final 2018 Medicare clinical laboratory fee schedule (CLFS) rates, which are based on private payer data as mandated by the Protecting Access to Medicare Act of 2014 (PAMA).  A companion document explains changes the agency made in response to public comments on the September 2017 preliminary rates and clarifying its methodology.  In addition, … Continue Reading

CMS Releases 2018 HCPCS Update

The 2018 update to the alphanumeric Healthcare Common Procedure Coding System (HCPCS) files is now available on the CMS website.  The files include the Level II alphanumeric HCPCS procedure and modifier codes, their long and short descriptions, and information on Medicare coverage and pricing.  CMS also has begun posting application summaries for HCPCS applications discussed … Continue Reading

OIG Wants CMS to Track Medicare Costs from Device Failures

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices. The OIG also believes the lack of device information on claims data “impedes the ability … Continue Reading

Trump Administration Plan to Cut Off CSR Payments Withstands First Court Review

A Department of Health and Human Services (HHS) decision to discontinue ACA cost-sharing reduction (CSR) payments to insurers offering policies through ACA exchanges has cleared its first legal hurdle, with a U.S. district court declining to block the Administration’s action on an emergency basis. On October 12, 2017, the Trump Administration declared it was “immediately” … Continue Reading

Trump Executive Order Calls for “Healthcare Choice and Competition”

As legislative efforts to replace or reform the Affordable Care Act (ACA) sputter, President Trump has issued an executive order seeking to expand affordable health insurance choices, “to the extent consistent with law.” While the executive order itself does not modify current ACA statutory or regulatory requirements, it signals the Administration’s intent to: Facilitate the … Continue Reading
LexBlog