Archives: Regulatory Developments

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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

OIG Reports on Impact of “High-Priced Drugs” on Medicare Part D Catastrophic Coverage Spending

At the request of Congress and others, the Office of Inspector General (OIG) conducted a review of “high-priced drugs” (defined by OIG as exceeding $1,000 per month) and their impact on the Medicare program.  The OIG found that 2015 federal payments for Part D catastrophic coverage, which is triggered when a beneficiary’s out-of-pocket costs exceed … Continue Reading

President Trump’s Regulatory Review to Impact Recent Health Rules

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff … Continue Reading

CMS Finalizes Tighter Rules for New Medicaid Managed Care Pass-Through Payments

CMS has finalized without change its proposed rule to block states from adopting or increasing Medicaid managed care “pass-through” payments to hospitals, nursing facilities, and physicians beyond those in place when pass-through payment transition periods were established in a May 6, 2016 final Medicaid managed care rule.  As we previously reported, CMS considers pass-through payments … Continue Reading

Obama Administration Finalizes Changes to Home Health Conditions of Participation

CMS has finalized extensive changes to the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced flexibility while focusing on “a patient-centered, data-driven, outcome-oriented process that promotes high quality patient care at all times for all patients.” … Continue Reading

SAMHSA Releases Final and Supplemental Proposed Rules on Substance Abuse Records Privacy Protections

A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. SAMHSA explains in the preamble that it the agency “wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from health system delivery … Continue Reading

CDC Issues Final Quarantine Rule to Strengthen Control of Communicable Diseases

The Centers for Disease Control and Prevention (CDC) has issued a final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate. The regulation is intended to both aid public health responses to outbreaks of new or re-emerging communicable diseases and provide due … Continue Reading

CMS Again Extends HHA/Ambulance Enrollment Moratoria in Selected States

The Centers for Medicare & Medicaid Services (CMS) is extending for six months its current moratoria on the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollment of new nonemergency ground ambulance suppliers and home health agencies (HHAs) in selected states, effective January 27, 2017.  The temporary moratoria on new HHA enrollment (including new subunits … Continue Reading

OIG Issues Annual Solicitation of Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is inviting public recommendations for new or modified safe harbor provisions under the federal anti-kickback statute.  The OIG also invites suggestions for new OIG Special Fraud Alerts to provide guidance to health care providers regarding “practices OIG finds potentially fraudulent … Continue Reading

CMS Corrects Final 2017 OPPS/ASC Rule, Results in Slight Payment Increase

CMS has published a notice correcting technical errors in its November 14, 2016 final rule with comment period updating the Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center payment systems for 2017.  Among many other things, CMS is correcting the OPPS weight scaler, which very slightly increases OPPS rates that are adjusted … Continue Reading

CMS Issues Final Mandatory Episode Payment Models for Cardiac and Orthopedic Cases, Plus New Cardiac Rehabilitation Incentive Payment Model and CJR Program Refinements

In the waning days of the Obama Administration, the Centers for Medicare & Medicaid Services (CMS) has unveiled a lengthy and complex final rule to establish mandatory Medicare bundled payment programs for acute myocardial infarction (AMI), coronary artery bypass graft (CABG), and surgical hip/femur fracture treatment (SHFFT) procedures furnished in designated geographic areas.  The rule … Continue Reading

CMS Announces New Medicare Prior Authorization Requirements for Two Types of Power Wheelchairs

Beginning in March 2017, CMS is phasing in new Medicare prior authorization (PA) requirements for two types of power wheelchairs under a policy adopted in a final rule issued late in 2015. As previously reported, CMS finalized regulations to require Medicare PA for certain durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) items that … Continue Reading

CMS Issues Final ACA Benefit and Payment Policies for 2018; Questions Loom Over Implementation

On December 16, 2016, CMS released its Affordable Care Act (ACA) Notice of Benefit and Payment Parameters final rule and the final Annual Letter to Issuers for the 2018 plan year. Notably, the final rule revises the risk adjustment methodology to “further promote stable premiums in the individual and small group markets.” The final risk … Continue Reading

OIG Issues CMP, Anti-kickback Safe Harbor Final Rules

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule). … Continue Reading

Conflict of Interest Concerns Prompt New CMS Restrictions on Dialysis Facility Payment of Beneficiary Health Plan Premiums; Allows Plans to Reject Third-Party Payments

Citing “differences between providers’ and suppliers’ financial interests and patients’ interests” that “may result in providers and suppliers taking actions that put patients’ lives and wellbeing at risk,” CMS is imposing stringent new requirements on Medicare-certified dialysis facilities that seek to make payments of premiums for individual market health plans. By way of background, earlier … Continue Reading
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