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Significant Cuts Proposed to Medicare Payments for 340B Drugs

As part of the CY 2018 proposed updates to the Medicare Hospital OPPS, the US Department of Health and Human Services has proposed to decrease Medicare Part B payments to hospitals for 340B drugs by almost 30 percent. The cut...more

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

340B Program Rules to Remain Unclear

As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more

2/3/2017  /  HHS , OMB , Section 340B

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

OIG Issues Report on Medicare’s ‘2-Midnight Hospital Rule’

On December 19, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) “2-Midnight Rule.” The OIG concluded that...more

CMS Releases Medicare Outpatient Observation Notice Form

On December 8, 2016, the Centers for Medicare and Medicaid Services (CMS) published the Medicare Outpatient Observation Notice (MOON), which educates Medicare beneficiaries on the effect of outpatient status, particularly as...more

21st Century Cures: Congress Approves Legislation Expanding Hospital Site-Neutral Payment Exceptions and Making Other Payments...

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

CMS Releases CY 2017 Final Rule Implementing Changes to Outpatient Prospective Payment System

The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

CMS Proposed Rule Implements Limitations on Medicare Payments for Off-Campus Outpatient Hospital Departments

In Depth - Background - On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more

OIG Issues Report on Provider-Based Facilities, Urges CMS to Make Changes

In Depth - On June 16, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) oversight of billing by...more

6/28/2016  /  CMS , HHS , Hospitals , MedPAC , OIG , Provider Payments

Congress Considers Broader Hospital Site-Neutral Payment Exceptions and Other Payments Changes

In Depth - The House Ways and Means Committee next week is expected to consider and approve the Helping Hospitals Improve Patient Care Act of 2016, legislation that would create broader exceptions under much maligned...more

Program Integrity Changes to the Medicare Provider Enrollment Process

On March 1, 2016, the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) entitled “Medicare, Medicaid, and Children’s Health Insurance...more

MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more

CMS Finalizes Prior Authorization Program for Certain DMEPOS Items

On December 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing a prior authorization program for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)...more

OIG Reports on, Proposes Alternatives to Medicare Part B Reimbursement for 340B Drugs

In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more

CMS Finalizes Controversial Changes to "2-Midnight Rule" for Inpatient Stays

On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

CMS Addresses Current Position on Supervision and Practitioner Qualifications Under ‘Incident-To’ Billing Rules

Among the proposed changes to Medicare regulatory requirements related to billing and coverage of physician services set forth in the 2016 Medicare Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for...more

CMS Proposal Broadens Medicare Inpatient Reimbursement Eligibility Under the “2-Midnight Rule"

On July 1, 2015, the Centers for Medicare & Medicaid Services (CMS) released proposed updates to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for Calendar Year...more

Proposed Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more

House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program

The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more

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