Tag Archives: Centers for Medicare & Medicaid Services

CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion

The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a proposed arrangement under which a web-based diagnostic testing portal sought to provide referring physicians with free alerts related to test results.…

CMS Reverses Direction in Proposed Rule on Long Term Care Facility Arbitration Agreements

The Centers for Medicare & Medicaid Services (CMS) announced a Proposed Rule scheduled to be published in the Federal Register on June 8, 2017, revising its prior restrictions on binding arbitration provisions between long term care facilities and their residents set forth in a Final Rule published in October 2017.  Comments are due sixty days after publication of the Proposed Rule. In the Final Rule published last year, CMS had prohibited pre-dispute binding arbitration agreements and imposed requirements on facilities that asked residents to sign arbitration agreements.  The U.S. District …

CMS Proposes Delay of Home Health Agency Conditions of Participation

The Centers for Medicare & Medicaid Services (CMS) is proposing to delay the effective date for the revised Conditions of Participation (CoPs) for Home Health Agencies (HHAs).  The original effective date was July 13, 2017.  The proposed delay would extend the effective date for an additional six months, until January 13, 2018.  In a previously published post, we discussed the HHA CoPs.…

CMS Revises Process for Reporting Stark Law Violations and Posts New SRDP Forms

On March 28, the Centers for Medicare & Medicaid Services (CMS) revised the procedures and posted new forms for its Voluntary Self-Referral Disclosure Protocol (SRDP).  The SRDP is a mechanism established pursuant to the Affordable Care Act for health care providers and suppliers to facilitate settlement of violations of the physician self-referral law (Stark Law).

Under the Stark Law, physicians (or their immediate family members) who have a financial relationship with an entity are prohibited from making referrals to that entity for certain designated health services (DHS) that are payable …

CMS’ Final MACRA Rule Continues Transition Toward Value-Based Payments

On November 4, 2016, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule overhauls the methodology by which most physicians and certain other clinicians participating in Medicare will be reimbursed and marks a significant shift away from fee-for-service payments and toward value-based reimbursement. Under the Final Rule, CMS created the Quality Payment Program (QPP), which incorporates components of the Physician Quality Reporting System (PQRS), the Medicare Electronic Health …

FDA’s Program for Parallel Review of Medical Devices

On October 24, 2016, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a joint announcement of their plan to continue the Program for Parallel Review of Medical Devices.

The Program is a collaborative effort that is intended to reduce the time between FDA marketing approval and Medicare coverage decisions through the CMS National Coverage Determinations (NCD). The goal is to “ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population.”

The Program began in …

OIG’s 2016 Report on Provider-Based Facilities

On June 16, 2016, the Office of Inspector General (OIG), Department of Health and Human Services, issued a report on the Centers for Medicare & Medicaid Services’ (CMS) oversight of provider-based facilities.  In the report, the OIG concluded that although CMS is taking steps to improve its oversight, vulnerabilities nevertheless remain.

As part of its Bipartisan Budget Act of 2015, Congress had eliminated provider-based status for new off-campus outpatient departments of a provider. The Centers for Medicare & Medicaid Services’ (CMS) provider-based rules currently allow a hospital or health system …

CMS’s Mandatory Bundled Payment Program for Lower Extremity Joint Procedures

In January 2016, the Centers for Medicare & Medicaid Services (CMS) finalized the somewhat controversial, mandatory Comprehensive Care for Joint Replacement Model (CJR Model), which is a bundled payment program covering certain orthopedic procedures reimbursed by Medicare. The final rule implementing the CJR Model is effective on January 15, 2016, and the first model performance period begins on April 1, 2016. With the CJR Model, CMS aims to align various providers’ financial incentives by establishing a bundled payment system for CJR Procedures conducted in acute care hospitals located in 67 …

Significant Changes to The Stark Law in the 2016 Physician Fee Schedule

In the 2016 Medicare Physician Fee Schedule (PFS), the Centers for Medicare & Medicaid Services (CMS) made several important and provider-friendly revisions and additions to the physician self-referral law (Stark Law). The PFS created two new Stark exceptions—one for the recruitment of non-physician practitioners (NPPs) and one for timeshare arrangements. The PFS also made several clarifications and additional revisions to the Stark Law regulations.

NPP Recruitment Exception

The NPP recruitment exception allows hospitals, federally qualified health centers and rural health clinics to pay physicians to help them employ NPPs (includes …

Fraud And Abuse Waivers For ACOs

On October 29, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG), Health & Human Services issued a final rule (Final Rule) regarding waivers (ACO Waivers) of the physician self-referral law (Stark law), the federal Anti-Kickback Statute, and the Civil Monetary Penalties Law (CMP) provision relating to beneficiary inducements for Medicare accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP). The ACO Waivers waive the application of these fraud and abuse laws to certain ACO activities that are reasonably related …

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