Archives: Regulatory Developments

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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

CMS Issues Additional ACA Medicaid and CHIP Eligibility, Appeals, Enrollment Regulations

CMS has published a final rule that implements various Medicaid and Children’s Health Insurance Program (CHIP) eligibility, appeals, and related administrative changes under the Affordable Care Act (ACA) that were proposed in January 22, 2013 but not included in a July 15, 2013 rule finalizing selected provisions. According to CMS, the rule will support “modernization … Continue Reading

Out with the Old Rules? Will Trump and Republicans Target Health Care Regulations for Reversal in the New Year under Congressional Review Act?

The Congressional Review Act (CRA) has been used to overturn only one final rule in 20 years, but that situation may be about to change.  According to a new Congressional Research Service (CRS) analysis, a “specific set of circumstances” will occur when President-elect Trump is sworn in, namely, turnover in White House party control when … Continue Reading

CMS Proposes Restrictions on New Medicaid Managed Care Pass-Through Payments

CMS is proposing to prohibit states from adopting new or increased “pass-through” payments to hospitals, nursing facilities, and physicians under their Medicaid managed care contracts beyond those in place when the pass-through payment transition periods were established in a May 6, 2016 final Medicaid managed care rule. CMS considers pass-through payments to be amounts that … Continue Reading

CMS Publishes Final Rule Updating 2017 Medicare Physician Fee Schedule Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (MPFS) for calendar year (CY) 2017.  In addition to updating MPFS rates and policies, the final rule makes numerous other Medicare policy changes, including updates to Stark Law regulations related to unit-based compensation and new enrollment requirements for providers and … Continue Reading

CMS Finalizes Medicare OPPS, ASC Rates and Policies for 2017

CMS has published its final rule with comment period updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for CY 2017.  CMS will accept comments on a limited number of provisions until December 31, 2016. Major provisions impacting outpatient hospital department services include the … Continue Reading

Obama Administration Releases Regulatory Agenda – But Changes Expected Under Trump Administration

The Obama Administration has updated its regulatory agenda, listing the anticipated timing of pending and future regulatory actions, including a number of Department of Health and Human Services regulations. Note, however, that with the transition to the new Trump Administration, federal regulatory priorities can be expected to change.  Indeed, a new Administration often triggers a … Continue Reading

CMS Proposes Updated Fire Safety Standards for Dialysis Facilities

CMS has issued a proposed rule that would require certain dialysis facilities participating in Medicare or Medicaid to meet updated fire safety standards.  The proposed fire safety rule, published November 4, 2016, would apply only to dialysis facilities that do not provide one or more exits to the outside at grade level from the treatment … Continue Reading

FY 2018 Federal Financial Participation Matching Amounts Published

The Department of Health and Human Services (HHS) has published the FY 2018 Federal Medical Assistance Percentages (FMAP), Enhanced FMAP, and disaster-recovery FMAP adjustments.  These amounts will be used to determine federal matching amounts for state expenditures for Medicaid, the Children’s Health Insurance Program, and certain other medical and other social services, applicable from October … Continue Reading

CMS Delays Expanding Medicaid Rebate Program, Price Reporting Requirements to Territories Until 2020

CMS has announced that it is delaying until April 1, 2020 its controversial change in the definitions of “States” and “United States” included in the February 1, 2016 Medicaid covered outpatient drug final rule with comment period.  Specifically, in that rulemaking CMS defined “States” and “United States” to include the U.S. territories (American Samoa, the … Continue Reading

CMS Seeks Input on Ways to Accelerate Medicaid Home and Community-Based Services

CMS is requesting public input on policy options it can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries.  Note that while supporting increased availability of quality HCBS services has been a priority for the Obama Administration, it is unclear what priority future HHS and CMS leadership in the Trump … Continue Reading

CMS Finalizes Two-Track System to Implement MACRA Medicare Physician Payment Policy Changes

Temporary Transition Policies Reduce Threat of Negative Adjustments in 2019, But Adds to Complexity On November 4, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a sweeping final rule reforming the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  Beginning … Continue Reading

Medicare Dialysis Payments to Increase by $80 Million in CY 2017

CMS has published its final rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) rates and policies for CY 2017. CMS expects the rule to increase overall Medicare payments to ESRD facilities by 0.73 percent in 2017 compared with CY 2016 levels, for an aggregate increase of $80 million. This update … Continue Reading
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