Archives: Regulatory Developments

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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

CMS Proposes Updates to Medicare Hospice Wage Index/Rates for FY 2016

CMS published a proposed rule on May 5, 2015 that would update Medicare hospice payment rates and the wage index for fiscal year (FY) 2016. CMS estimates that the proposed rule would increase overall payments to hospices by about 1.3%, or $200 million, in FY 2016. This increase reflects a 1.8% proposed FY 2016 hospice payment … Continue Reading

Final Rule Implements HIV Organ Policy Equity Act

On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs from … Continue Reading

CMS Clarifies FY 2016 IPPS/LTCH Proposed Rule Comment Deadline

CMS has published a correction notice that clarifies that the comment deadline for the FY 2016 Medicare inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS proposed rule is June 16, 2015 (as the agency announced when the rule was released). The version of the rule published in the Federal Register on April 30 incorrectly stated … Continue Reading

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading

CMS Issues Proposed Rule to Update FY 2016 IPPS, LTCH PPS Rates, Policies

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) is publishing its proposed rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2016.  CMS will accept comments on the proposed rule until June 16, 2015. The … Continue Reading

CMS Releases Proposed FY 2016 Medicare Inpatient Psychiatric Facilities PPS Update

CMS issued a proposed rule on April 24, 2015 that would update FY 2016 Medicare payment policies and rates for the Inpatient Psychiatric Facilities (IPF) PPS. The proposed rule also would update quality measures and reporting requirements under the the IPF Quality Reporting Program, under which facilities report on quality measures or are subject to … Continue Reading

CMS Proposes FY 2016 Update to SNF PPS Rates, Policies

On April 20, 2015, CMS published its proposed rule updating Medicare skilled nursing facility (SNF) PPS rates and policies for FY 2016. CMS projects that the proposed rule would increase overall payments to SNFs by $500 million, or 1.4%, compared to FY 2015 levels. This update would be attributed to a 2.6% market basket increase that … Continue Reading

CMS Proposes Updates to EHR Meaningful Use Rules

CMS published a proposed rule on April 15, 2015 that would modify the Medicare and Medicaid Electronic Health Record (EHR) Incentive program to reduce complexity, simplify reporting requirements, and align Stage 1 and Stage 2 objectives and measures with Stage 3. Notably, CMS proposes to change the Medicare and Medicaid EHR Incentive Program reporting period … Continue Reading

CMS Proposes 1.7% Increase in Medicare IRF PPS Payments for FY 2016

On April 23, 2015, CMS released its proposed rule to update Medicare prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) for FY 2016, which begins October 1, 2015. CMS estimates that rates would increase by 1.7% overall ($130 million) under the proposed rule compared to FY 2015 levels. This proposed increase reflects a … Continue Reading

CMS Proposes Mental Health Parity Rules for Medicaid Managed Care/Alternative Benefit Plans, CHIP Coverage

CMS has published a proposed rule that would apply provisions of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) to Medicaid beneficiaries who receive services through managed care organizations or alternative benefit plans and to the Children’s Health Insurance Program (CHIP). In general, such programs will be required to meet the mental health … Continue Reading

CMS Proposes Extension of Enhanced Funding for Certain Medicaid Eligibility & Enrollment Systems

On April 16, 2015, CMS published a proposed rule that would revise the definition of Medicaid mechanized claims processing and information retrieval systems to include Medicaid eligibility and enrollment (E&E) systems, which would make enhanced federal financial participation (FFP) available for such systems on an ongoing basis (current regulatory authority for such enhanced funding expired … Continue Reading

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading
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