Archives: Regulatory Developments

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SAMHSA Finalizes Changes to Rules for Disclosure of Substance Abuse Records to Support Health Care Operations

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule addressing the disclosure of substance use disorder patient records that is intended to facilitate health care activities while protecting patient privacy.  The final rule identifies the circumstances under which lawful holders of patient identifying-information may disclose such information to their contractors, … Continue Reading

CMS Mulling Changes to CLIA Personnel, Proficiency Testing Referral Rules

CMS is requesting information from the public on potential changes to longstanding Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel, histocompatibility, and related policies, which have not been comprehensively updated since 1992. With regard to personnel requirements, CMS seeks information that will enable it to revise the regulations to “better reflect current knowledge, changes in … Continue Reading

CMS Establishes New Rules for Medicare Shared Savings Program ACOs Impacted by Extreme/Uncontrollable Circumstances

CMS has just put on display an interim final rule with comment period to establish special policies to assess the performance year 2017 financial and quality performance of Medicare Shared Savings Program accountable care organizations (ACOs) affected by extreme and uncontrollable circumstances, such as Hurricanes Harvey, Irma, and Maria and the California wildfires.  CMS is … Continue Reading

Trump Administration Outlines Planned Regulatory — and Deregulatory — Actions for 2018

The Trump Administration has updated its “Unified Agenda of Regulatory and Deregulatory Actions,” which lists the scope and anticipated timing of pending and future regulations. In releasing the agenda, the Administration highlights its “ongoing progress toward the goals of more effective and less burdensome regulation,” including its plans to finalize three deregulatory actions for every … Continue Reading

CMS Extends Medicare Prior Authorization Program for Repetitive Scheduled Non-Emergent Ambulance Transport

CMS is extending for another year the Medicare prior authorization program for repetitive, scheduled non-emergent ambulance transport services rendered by ambulance providers in selected states. As previously reported, CMS began testing the three-year Medicare prior authorization model in New Jersey, Pennsylvania, and South Carolina on December 1, 2014. The agency extended the model to the … Continue Reading

CMS Scraps Cardiac/Hip Fracture Episode Payment Model, Downsizes CJR Program

The Centers for Medicare & Medicaid Services (CMS) has officially cancelled a planned program to require certain hospitals to participate in Medicare episode payment models (EPMs) for acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment procedures furnished in designated areas of the country, along with a Cardiac Rehabilitation (CR) Incentive Payment … Continue Reading

CMS Proposes Changes to Medicare Advantage, Part D Programs for 2019

CMS has issued a proposed rule to update the Medicare Advantage (MA) program and Part D prescription drug benefit rules for contract year 2019.  The proposed rule would, among many other things: Implement a Comprehensive Addiction and Recovery Act (CARA) provision that allows Part D plan sponsors to establish drug management programs that limit at-risk … Continue Reading

CMS Modifies Medicare Physician Quality Payment Program Rules for 2018

CMS has issued a final rule with comment period making changes to the Quality Payment Program (QPP) for 2018, the second performance year for the reformed physician payment framework mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). CMS is continuing its “slow ramp-up” of the QPP by building on the transition … Continue Reading

Medicare Home Health Payments to Drop by $80 Million under Final 2018 Rule

The final CMS calendar year (CY) 2018 Medicare home health prospective payment system (HH PPS) rule cuts Medicare payments by 0.4% ($80 million) in 2018 compared to 2017 levels, but CMS did not adopt a more sweeping case mix methodology reform proposal that would have reduced 2019 payments by almost $1 billion. Under the final rule, … Continue Reading

CMS Finalizes Medicare Physician Fee Schedule Update for 2018

Delays AUC Requirement until 2020, Cuts Off-Campus Hospital Department Payments The Centers for Medicare & Medicaid Services (CMS) has published its final Medicare physician fee schedule (PFS) rule for CY 2018. In addition to updating rates for 2018, the rule includes important policy changes, including an additional delay in implementation of appropriate use criteria (AUC) … Continue Reading

CMS Finalizes Medicare OPPS, ASC Rates and Policies for CY 2018

CMS has published a final rule updating Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2018. In addition to rate updates, notable policy changes in the rule include a deep ($1.6 billion) OPPS reimbursement cut for drugs obtained through the 340B drug … Continue Reading

CMS Boosting Medicare ESRD Facility Payments by 0.5% for 2018

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare end-stage renal disease (ESRD) prospective payment system (PPS) rates and policies for calendar year 2018. CMS projects that the final rule will increase total Medicare payments to all ESRD facilities by 0.5% in 2018 (lower than the 0.8% increase forecast in the … Continue Reading

Final Medicare Provider Payment Rules in the Pipeline

The White House Office of Management and Budget (OMB) is reviewing several CMS rules that would finalize CY 2018 Medicare payment policies for various types of providers and suppliers. Specifically, OMB is reviewing final rules to update the hospital outpatient and ambulatory surgical center PPS; the Medicare physician fee schedule and physician Quality Payment Program; the … Continue Reading

Interim Final Rules Expand Contraceptive Coverage Exemption Based on Religious/Moral Beliefs

The Trump Administration has issued interim final rules to make it easier for employers and health insurance plans to qualify for an exemption from ACA rules mandating coverage of contraceptive services without cost sharing on the basis of religious or moral objections. The extent to which group health plans must cover contraceptive services in cases … Continue Reading

HRSA Delays Final 340B Penalty Rule until July 1, 2018; Additional Rulemaking in the Works

The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until … Continue Reading

Trump Administration Shelves Additional Obama Medicare/Health Plan Proposals

The Trump Administration has formally withdrawn a number of pending Department of Health and Human Services (HHS) proposals that never reached the final rule stage. This includes:  a controversial Part Medicare B drug payment innovation model; a proposal to protect same sex marriages in certain Medicare and Medicaid facilities (predating a related Supreme Court decision); … Continue Reading

CMS Corrects Final FY 2018 IPPS, LTCH, and SNF Payment Rules

CMS has released corrections to two major fiscal year (FY) 2018 Medicare payment rules. First, CMS has made numerous technical corrections to the FY 2018 inpatient prospective payment systems (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) final rule. CMS has corrected MS-DRG and MS-LTCH-DRG relative weights, budget neutrality adjustment factors, fixed-loss … Continue Reading

CMS Announces CY 2018 Amount in Controversy Thresholds for Medicare Appeals

CMS has released the calendar year (CY) 2018 amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The CY 2018 AIC threshold amounts are $160 for ALJ hearings (the same as 2017) and $1,600 for judicial review (compared to $1,560 in 2017).  These amounts … Continue Reading

Recently Released Enhanced Regulatory Initiatives for Drug Compounders

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key … Continue Reading

CMS Corrects Sunshine Act CMP Regulations due to Inflation Adjustment Error

CMS has just corrected an error in a 2016 rulemaking that inadvertently called for a 10-fold increase in certain “Sunshine Act” civil monetary penalties (CMPs). Under section 1128G of the Social Security Act, applicable manufacturers must report annually to CMS any payments or other transfers of value to covered recipients. In addition, the statute requires … Continue Reading

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties. As previously reported, while implementation of this rule has already been delayed until October … Continue Reading

CMS Issues Final FY 2018 Medicare Hospice Payment Update

CMS has finalized fiscal year (FY) 2018 Medicare hospice reimbursement rates and other updates to Medicare hospice policies. As mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), CMS is increasing FY 2018 hospice rates by 1% (approximately $180 million) for those hospices that submit required quality data; this update is reduced … Continue Reading

CMS Proposes Cancellation of Medicare Cardiac/Hip Fracture Episode Payment Models, Scale-Back of Mandatory CJR Participation

Signals Trump Administration’s About-Face on Obama-Era Mandatory Innovation Models The Centers for Medicare & Medicaid Services (CMS) has just released a proposed rule to cancel a significant — but still-pending — Obama Administration program that would require certain hospitals to participate in Medicare episode payment models (EPMs) for acute myocardial infarction (AMI), coronary artery bypass … Continue Reading

CMS Boosts Medicare Inpatient Psychiatric Facility Rates by $45 Million for FY 2018

CMS has published a notice with comment period updating prospective payment system (PPS) rates for Medicare services furnished by inpatient psychiatric facilities (IPFs) during fiscal year (FY) 2018.  CMS estimates that its policies will increase payments by $45 million (0.99%) compared to FY 2017 levels.  This increase is based on 1.25% payment rate update, offset … Continue Reading
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