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340B Drug Pricing Program Omnibus Guidance Notice Published by HRSA

On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of permissible … Continue Reading

OMB Reviewing CMS Proposed Rule on PAMA Clinical Lab Test Payment Policy

CMS is finally taking steps to implement the Medicare clinical laboratory payment reforms mandated by the Protecting Access to Medicare Act of 2014 (PAMA).  Under PAMA, CMS must base Medicare payment rates for clinical laboratory tests on private payor rates beginning January 1, 2017. The statute requires that CMS establish the parameters for the private … Continue Reading

FDA Issues New Draft Guidance and Related Proposed Rule on Naming Biological Products

On August 28, 2015 the federal Food and Drug Administration (“FDA”) issued two important policies regarding naming biological products, including biosimilars. First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public … Continue Reading

CMS Publishes Corrections to Comprehensive Care for Joint Replacement Model Proposed Rule

On August 25, 2015, the Centers for Medicare & Medicaid Services (CMS) published technical and typographical corrections to its July 14, 2015 proposed rule to establish a Comprehensive Care for Joint Replacement Model. As explained in greater detail in our Client Alert, this initiative would provide a bundled payment to hospitals in selected geographic areas … Continue Reading

DOJ Win on ACA 60-Day Overpayment Rule in Kane v. Healthfirst FCA Case

In a post on our Life Sciences Legal Update blog here, we discuss the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case, which was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al. the court ruled in favor of … Continue Reading

CMS Issues Final FY 2016 Medicare IPPS/LTCH Rule

On July 31, 2015, the Centers for Medicare & Medicaid Services (CMS) released a major final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and the long-term care hospital prospective payment system (LTCH PPS) for fiscal year (FY) 2016. The official version of the rule will be published in the Federal … Continue Reading

CMS Finalizes Medicare IRF PPS Rates/Policies for FY 2016

On August 6, 2015, CMS published its final rule to update Medicare PPS rates for inpatient rehabilitation facilities for FY 2016, which begins October 1, 2015.  CMS estimates that rates will increase by 1.8% overall ($135 million) under the final rule compared to FY 2015 levels.  This increase reflects a 2.4% market basket update (using … Continue Reading

CMS Publishes Final FY 2016 Update to SNF PPS Rates, Policies

On August 4, 2015, CMS published its final rule updating Medicare skilled nursing facility (SNF) PPS rates and policies for FY 2016.  CMS projects that the final rule will increase overall payments to SNFs by $430 million, or 1.2%, as compared to FY 2015 levels.  This update reflects a 2.3% market basket increase that is … Continue Reading

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act … Continue Reading

CMS Publishes Final FY 2016 Medicare Inpatient Psychiatric Facilities PPS Rule

Today CMS published its final rule updating payment policies and rates for the Medicare Inpatient Psychiatric Facilities (IPF) Prospective Payment System (PPS) for FY 2016. The final rule provides a 1.5% increase to IPF PPS rates for FY 2016, which is expected to increase aggregate payments by $75 million compared to FY 2015 levels. This update … Continue Reading

Obama Administration Finalizes Regulations on ACA Coverage of Preventive Services, Including Contraceptive Services

The Obama Administration published final regulations on July 14, 2015 that implement Affordable Care Act requirements regarding coverage without cost sharing of certain preventive services, including contraceptive services. The regulations, jointly issued by the Departments of Health, Labor, and Treasury, finalize three earlier rulemakings:… Continue Reading

CMS Finalizes Medicare Hospice Wage Index/Rates for FY 2016

On August 6, 2015, CMS is publishing its final rule to update Medicare hospice payment rates and the wage index for fiscal year (FY) 2016.  CMS estimates that the final rule will increase overall payments to hospices by about 1.1%, or $160 million, in FY 2016.  This increase reflects a 1.6% hospice payment update percentage, … Continue Reading

CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

CMS has announced another 6-month extension of its current temporary enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs), subunits, and branch locations in designated metropolitan areas. The moratoria, which affect enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program, apply to: New ground ambulances in the Houston and Philadelphia metropolitan … Continue Reading

CMS Proposes Revisions to Stark Law Rules: Will they Provide Flexibility to Achieve Health Reform Goals?

The Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law.  The proposed changes, which are included in the annual proposed update to the Medicare physician fee schedule, are a summarized in a new Reed Smith Client Alert. … Continue Reading

Analysis of CMS’ Proposed Medicare “Comprehensive Care for Joint Replacement” Model

As promised in our July 21st post, our team has compiled a comprehensive analysis of the Centers for Medicare and Medicaid Services’ (CMS) proposed rule to establish a Medicare Comprehensive Care for Joint Replacement (CCJR) model, under which CMS would provide a bundled payment to hospitals for an episode of lower extremity joint replacement surgery. … Continue Reading

Final FY 2016 Medicare Payment Rules on the Horizon

Despite the recent flurry of activity on Medicare payment rules, more are in the pipeline. CMS has sent the final fiscal year (FY) 2016 Medicare skilled nursing facility, hospice, inpatient rehabilitation facility, and inpatient psychiatric facility payment rules to the White House Office of Management and Budget for final regulatory clearance. The FY 2016 final … Continue Reading

Medicare/Medicaid Requirements for Long-Term Care Facilities

On July 13, 2015, CMS issued a much-anticipated proposed rule seeking to consolidate the long-term care (LTC) facility participation requirements for the Medicare and Medicaid programs. This major proposal marks the first comprehensive changes to the LTC conditions of participation since 1991. As noted by CMS, the revisions are designed to align with current clinical … Continue Reading

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). … Continue Reading

FDA Requests RSVP for Public Meetings on PDUFA Reauthorization

The federal Food and Drug Administration (FDA) has issued a notice requesting that public stakeholders –including patient and consumer advocacy groups, health care professionals, and scientific and academic experts– notify FDA of their intent to participate in monthly consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). When the statutory authority … Continue Reading

Proposed CY 2016 MPFS Rule Takes First Steps in Implementing MACRA Reforms

On July 15, 2015, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to update the Medicare physician fee schedule (MPFS) for CY 2016 – the first rulemaking since the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repealed the sustainable growth rate (SGR) formula.  Under the proposed rule, the 2016 … Continue Reading

CMS Extends Medicare Prior Authorization for Power Mobility Devices Demonstration through August 2018

CMS has announced that it is extending its Medicare Prior Authorization for Power Mobility Devices (PMDs) demonstration for three years, through August 31, 2018. This demonstration was launched on September 1, 2012 in seven states that CMS describes as having “high levels of improper payments and incidents of fraud related to PMDs” – California, Illinois, Michigan, … Continue Reading

CMS Proposes $43 Million CY 2016 Medicare OPPS Rate Cut; Small Increase in ASC Payments

On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2016.  Perhaps most notably, CMS is proposing a -0.1% OPPS update for 2016, driven … Continue Reading

CMS Proposed Medicare Home Health PPS Rule Would Reduce HHA Payments by $350 Million in 2016

CMS has released its proposed calendar year (CY) 2016 Medicare home health prospective payment system (HH PPS) update, which CMS estimates would reduce overall Medicare payments to home health agencies (HHAs) by $350 million in 2016, compared with 2015 levels. This decrease reflects a 2.3% home health payment update percentage (derived from a 2.9% market basket … Continue Reading
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