Archives: Regulatory Developments

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CMS Reverses Course in Pre-Dispute Arbitration Agreement Ban

In a clear turnabout from its previous position, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on June 5, 2017 that would lift the agency’s ban on pre-dispute arbitration agreements in the long term care (LTC) setting. By contrast, less than nine months earlier, CMS prohibited LTC facilities from entering into … Continue Reading

CMS Extends Comment Period on SNF Case Mix Methodology ANPRM

CMS is extending the comment period on its May 4, 2017 advance notice of proposed rulemaking (ANPRM) discussing plans to revise the basis for the Medicare skilled nursing facility (SNF) prospective payment system (PPS).  As previously reported, the ANPRM set forth the outline of CMS’s plan to replace the current RUG-IV case-mix classification methodology with … Continue Reading

As ACA Repeal/Replace Debate Drags On, Trump Seeks Advice on How to Make Improvements to Health Care Markets

In a tacit acknowledgement of the hurdles ahead for enactment of Affordable Care Act (ACA) repeal/replace legislation, the Trump Administration is soliciting suggestion for changes that could be made within the current legal framework to improve health insurance markets and meet Administration reform goals. In particular, the Department of Health and Human Services (HHS) is … Continue Reading

HRSA Pushes Back 340B Rule Implementation Until October 1, 2017

Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017.  The rule initially was scheduled to go into effect … Continue Reading

CMS Delays Start Date for Medicare Cardiac/Hip Fracture Episode Payment Model Until 2018; Parallel CJR Changes Also Pushed Back

The Centers for Medicare & Medicaid Services (CMS) is delaying until January 1, 2018 implementation of mandatory Medicare episode payment models (EPMs) for acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment procedures furnished in designated geographic areas.  Conforming changes to the Comprehensive Care for Joint Replacement (CJR) program also are being … Continue Reading

Deadline Extended: Hospitals and Other Non-Federal Entities Given Another Year to Comply with New OMB Procurement Standards

The Office of Management and Budget (OMB) recently announced that it is giving hospitals and other non-federal entities that receive federal assistance an additional year to comply with revised procurement standards for grants and federal funding. While the deadline has been extended until December 25, 2017, federal grant recipients should be taking steps to ensure compliance … Continue Reading

CMS Proposes 1% Update to Medicare IRF PPS Payments for FY 2018

CMS has published a proposed rule to establish FY 2018 Medicare prospective payment system (PPS) rates for inpatient rehabilitation facility (IRF) services.  CMS estimates that IRF PPS payments would increase by 1.0% overall ($80 million) under the proposed rule compared to FY 2017 levels.  As mandated by the  Medicare Access and CHIP Reauthorization Act of … Continue Reading

CMS Proposes FY 2018 Update to Medicare Hospice Payment Rules; Solicits Ideas for Hospice Program Improvements

CMS has published a proposed rule to establish fiscal year (FY) 2018 Medicare hospice reimbursement rates, update hospice quality programs, and request public input on ways to improve the Medicare hospice program. The proposed rule would increase FY 2018 hospice rates by 1% (approximately $180 million), as mandated by the Medicare Access and CHIP Reauthorization … Continue Reading

CMS Proposes IPPS/LTCH Payment and Policy Changes for FY 2018; Requests Comments on Broader Policy Issues

CMS has published 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) 2018. CMS also solicits public comments on a range of policy issues related to physician-owned hospitals, inpatient and outpatient payment differentials for similar services, and ways … Continue Reading

CMS Simultaneously Releases Proposed Rule to Update SNF PPS for FY 2018 & Advance Notice of Proposed Rulemaking (ANPRM) to Replace RUG-IV Case-Mix Methodology as Early as FY 2019

CMS has issued its proposed rule to update Medicare skilled nursing facility (SNF) prospective payment system (PPS) rates and policies for FY 2018, while at the same time soliciting comments regarding a forthcoming and potentially ground-breaking proposed rule to replace the SNF PPS RUG-IV case-mix classification methodology, which forms the basis for SNF payment, with … Continue Reading

CMS Signals Potentially Big Changes Ahead for Medicare SNF Payment Policy

Using unusually blunt language, the Medicare Payment Advisory Commission (MedPAC) recently noted that it “is increasingly frustrated with the lack of statutory or regulatory action” to lower Medicare skilled nursing facility (SNF) payments and revise the payment system to link payments to patients’ characteristics and costs of care.  It appears, however, that the Centers for … Continue Reading

Coming Soon: Proposed 2018 Medicare Payment Rules

CMS has sent several major proposed Medicare 2018 payment rules to the White House Office of Management and Budget (OMB) for regulatory clearance before publication in the Federal Register. OMB has already cleared the proposed fiscal year (FY) 2018 acute inpatient prospective payment system/long-term care hospital prospective payment system (PPS) rule; it could be released … Continue Reading

CMS Clarifies Medicaid DSH Rules for Treatment of Third Party Payments in Calculating Uncompensated Care Costs

CMS has published a final rule intended to codify its existing interpretation of how third-party payments are considered in the calculation of Medicaid uncompensated care costs for the purpose of making Medicaid disproportionate share hospital (DSH) payments. Under the final rule, CMS specifies that uncompensated care costs for purposes of calculating hospital-specific DSH limits are … Continue Reading

CMS Considering 6-Month Delay of Obama Administration Home Health COP Rule

As previously reported, in January 2017 the Obama Administration finalized major changes to the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in Medicare and Medicaid. The rule is currently scheduled to go into effect July 13, 2017, except that the requirement to implement data-driven performance improvement projects is effective … Continue Reading

Price, Verma Taking a Fresh Look at Obama Administration’s EPM/CJR Final Rule; Changes Pushed Back to at Least October 1, 2017

HHS Secretary Thomas Price and CMS Administrator Seema Verma have signaled that the Trump Administration is eyeing changes to one of the last major Medicare policies issued by the Obama Administration.  Specifically, CMS is delaying a January 3, 2017 final rule that established mandatory Medicare episode payment models (EPM) for acute myocardial infarction, coronary artery … Continue Reading

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated.  The January 5, 2017 final rule … Continue Reading

Regulatory “Freeze” Thaws for HHS: Medicare FY 2018 IPPS/LTCH Rulemaking Process Gets Underway

The Centers for Medicare & Medicaid Services (CMS) is moving ahead on its annual Medicare hospital payment update rule – and it actually is ahead of last year’s pace.  Specifically, on March 8, 2017 CMS sent to Office of Management and Budget (OMB) for regulatory clearance its proposed rule updating the Medicare hospital inpatient prospective … Continue Reading

CMS Proposes Changes to Stabilize ACA Health Insurance Markets

At the same time Republican Congressional leaders are attempting to develop legislation to repeal and replace the Affordable Care Act (ACA), CMS has published a proposed rule that is intended to help stabilize the Affordable Insurance Exchanges for 2018. According to CMS, “[t]he health and competitiveness of the Exchanges, as well as the individual and … Continue Reading

Trump Temporarily Tables Effective Date of the New Episode Payment Model Rule – But No Change to July 1, 2017 Implementation

As mandated by the Trump Administration’s regulatory review policy, CMS is delaying the effective date of its January 3, 2017 final rule establishing mandatory Medicare episode payment models (EPM) for acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment procedures furnished in designated geographic areas.  Specifically, CMS is extending the effective date … Continue Reading

Reed Smith Client Alert: OIG Finalizes Expanded Exclusion Authorities under ACA

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs. Specifically, the final rule expands OIG’s … Continue Reading

OIG Finalizes Expanded Exclusion Authorities under ACA

On January 12, 2017, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a final rule to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs (“Final Rule”).  The Final Rule, which implements Affordable Care Act authority, was issued with an … Continue Reading

CMS Proposes Stringent New Medicare Standards for Providers and Suppliers of Prosthetics and Custom-Fabricated Orthotics

CMS has issued a proposed rule that would set forth qualifications that providers and suppliers must meet in order to furnish, fabricate, or bill for prosthetics and custom-fabricated orthotics under the Medicare program. The very prescriptive rule comes more than a decade after the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 directed CMS … Continue Reading

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act.  In particular, the final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; … Continue Reading

CMS Finalizes Rule to Reduce Medicare Appeals Backlog

In the face of growing scrutiny and now judicial pressure, the Centers for Medicare & Medicaid Services (CMS) published a final rule on January 17, 2017 implementing certain administrative and procedural actions in an effort to reduce the significant Medicare appeals backlog. The final rule comes on the heels of intense criticism from various branches … Continue Reading
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