Archives: Other Health Policy Developments

Subscribe to Other Health Policy Developments RSS Feed

New CMS Guidance for ADLT Lab Tests and ADLT Application Released

CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to Medicare Act of 2014 (PAMA). As previously reported, the June 23, 2016 final PAMA rule established the framework for basing Medicare clinical laboratory fee schedule (CLFS) payment on private insurance payment amounts, with … Continue Reading

New HHS Advisors Appointed to Develop Strategy on Drug Pricing, Opioid Policy

HHS Secretary Alex Azar has appointed two advisors to help advance Department strategy to address prescription drug pricing and the opioid crisis. Daniel M. Best, the new Senior Advisor to the Secretary for Drug Pricing Reform, is charged with leading the HHS initiative to lower the cost of prescription drugs. He recently served as Corporate … Continue Reading

CMS Gives Providers More Time to Consider Low Volume Appeals (LVA) Initiative Participation

CMS has extended until June 8, 2018 the deadline to submit an expression of interest (EOI) for the Low Volume Appeals Initiative. As previously reported, the LVA option is available for providers, physicians, and suppliers with fewer than 500 total Medicare Part A or Part B claim appeals pending at the Office of Medicare Hearings … Continue Reading

MedPAC Calls for Medicare Post-Acute Care and Physician Payment Reforms, Recommends Medicare Payment Updates

The Medicare Payment Advisory Commission (MedPAC) has issued its annual recommendations to Congress on updates to Medicare fee-for-service payment system rates, many of which overlap recommendations made in previous years. For instance, MedPAC continues to call for implementation of a unified prospective payment system (PPS) for post-acute care (PAC) providers, including skilled nursing facilities (SNFs), … Continue Reading

MACPAC Recommends Changes to Medicaid Managed Care, Telehealth, and DSH Policy

The Medicaid and CHIP Payment and Access Commission’s (MACPAC) March 2018 Report to Congress examines three aspects of Medicaid policy:  managed care, telehealth, and disproportionate share hospital (DSH) payments.  First, MACPAC proposes statutory changes to allow states to require all beneficiaries to enroll in Medicaid managed care programs, along with changes to Section 1915(b) waiver … Continue Reading

OIG Evaluates Risks of Relying on Unverified Patient Lists in Home Health Surveys

The Department of Health and Human Services, Office of Inspector General, has issued a new Risk Alert focusing on the home health agency (HHA) survey process.  The alert specifically examined whether HHA-supplied patient lists during surveys may omit certain patients from review and thereby present opportunities to conceal fraudulent activity or health and safety violations. Upon … Continue Reading

CMS Appoints Ombudsman to Handle Pharmaceutical/Technology Industry Concerns

James Bailey is the new CMS Medicare Pharmaceutical and Technology Ombudsman, a role Congress established in the 21st Century Cures Act to help expedite resolution of industry Medicare reimbursement concerns. The Ombudsman’s office is charged with fielding questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers, and other stakeholders regarding Medicare coverage, coding, and payment … Continue Reading

New “MyHealthEData” Initiative Focuses on Putting Patients in Charge of their Medical Records

The Trump Administration has launched a new MyHealthEData initiative intended to make it easier for Medicare beneficiaries and other health consumers to control their medical data and share it with their choice of providers. The government-wide initiative, led by the White House Office of American Innovation, seeks to “break down the barriers that prevent patients … Continue Reading

CMS Releases Proposed 2019 Medicare Advantage/Part D Reimbursement Methodologies and Policies

CMS is seeking comments on its proposed updates to the methodologies used to pay Medicare Advantage (MA) and Part D plan sponsors for 2019.  This year CMS released its 2019 Advance Notice and Draft Call Letter in two parts.  In late 2017, CMS released proposed changes to the Part C risk adjustment model (Part I … Continue Reading

Trump Administration Proposes Rules to Expand Short-Term, Limited Duration Insurance Plans

The Trump Administration has issued a potentially highly-significant proposed rule intended to expand the availability of short-term, limited duration insurance policies that are exempt from Affordable Care Act (ACA) qualified health plan standards.  Under the proposed rule, issued by the Departments of Treasury, Labor, and Health and Human Services (the “Departments”), the maximum duration of … Continue Reading

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.… 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
LexBlog