Archives: Regulatory Developments

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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

FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will not be enforced until November 1, 2015. This means dispensers have an additional four months to establish a commercially-viable and operational system that … Continue Reading

CMS Proposed 2016 Medicare Payment Rules in the Pipeline

CMS recently sent several major proposed Medicare CY 2016 payment rules to the White House Office of Management and Budget (OMB) for regulatory clearance – the last step before publication in the Federal Register. Specifically, OMB is reviewing proposed rules to update the Medicare physician fee schedule, the hospital outpatient PPS/ambulatory surgical center payment update, … Continue Reading

CMS Releases CY 2016 ESRD PPS Proposed Rule

On June 26, 2015, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2016. CMS anticipates that the proposed rule would increase overall Medicare payments to ESRD facilities by 0.3% ($20 million) compared with CY 2015 payments. … Continue Reading

CMS Revises, Expands ACO “Investment Model” Opportunities

As previously reported, CMS announced a Medicare Shared Savings Program/Accountable Care Organization (ACO) “Investment Model” last fall to better coordinate care in rural and underserved areas where inadequate access to capital could hinder infrastructure development needed for successful population care management. On June 25, 2015, CMS announced that it is modifying the eligibility criteria for … Continue Reading

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” … Continue Reading

Administration Releases Final ACA Summary of Benefits and Coverage and Uniform Glossary Rule

On June 12, 2015, the Internal Revenue Service, Employee Benefits Security Administration, and Centers for Medicare & Medicaid Services released final regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary requirements for group health plans and health insurance coverage in the group and individual markets under the Affordable Care Act. The regulations … Continue Reading

CMS Adopts Changes to Medicare Shared Savings Program/ACO Regulations

On June 9, 2015, CMS published a final rule revising the regulations governing the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form Accountable Care Organizations (ACOs) to provide cost-effective, coordinated care to Medicare beneficiaries. According to CMS, the Shared Savings Program now … Continue Reading

HHS Issues Spring 2015 Regulatory Agenda

The Administration has updated its regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, 340B drug pricing policies, and changes to fraud and abuse authorities, among many others.… Continue Reading

CMS Proposes Overhaul of Medicaid/CHIP Managed Care Rules

CMS has published a proposed rule that would update Medicaid and Children’s Health Insurance Program (CHIP) managed care regulations to more closely align with Medicare Advantage (MA) and private health plan standards and to strengthen quality safeguards. The proposed rule, which represents the first major revisions to Medicaid and CHIP managed care standards in more … Continue Reading

CMS Finalizes Changes to Deeming Authority Survey, Certification, and Enforcement Rules

CMS has published a final rule that revises survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs), effective July 21, 2015. Among other things, the rule: revises standards for application and re-application procedures for national accrediting organizations; extends certain provisions that are applicable to Medicare-participating providers to Medicare-participating suppliers; modifies requirements … Continue Reading

HHS Solicits Comments on Use of Health Plan Identifier in E-Health Transactions

Today HHS published a request for public comments regarding the health plan identifier (HPID), including the requirements regarding health plan enumeration, and the requirement to use the HPID in electronic health care transactions. Specifically, HHS is seeking information regarding the following: The HPID enumeration structure outlined in the September 5, 2012 HPID final rule, including … Continue Reading
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