Tag Archives: Stark

CMS Proposes Medicare Physician Fee Schedule Update for 2017

The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2017. The proposed rule contains numerous Medicare payment and policy proposals, including consideration of potentially misvalued codes, revisions to diagnostic imaging policies, updates to Stark Law regulations, and new enrollment … Continue Reading

CMS Proposes Extension of Medicare Self-Referral Disclosure Protocol Lookback Period to Six Years

CMS has published a notice inviting comments on a revised Medicare Self-Referral Disclosure Protocol (SRDP), which is a vehicle for providers and suppliers to voluntarily self-disclose actual or potential violations of the physician self-referral statute (known as the “Stark Act”).  Under the currently-approved process, a party must provide a financial analysis of overpayments arising from … Continue Reading

CMS/OIG Finalize Fraud Authority Waivers for Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP)

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the Shared Savings Program” and “reduce burden on ACOs, ACO participants, and ACO providers/suppliers.”  Specifically, the rule allows ACOs, ACO participants, … Continue Reading

CMS Proposes Revisions to Stark Law Rules: Will they Provide Flexibility to Achieve Health Reform Goals?

The Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law.  The proposed changes, which are included in the annual proposed update to the Medicare physician fee schedule, are a summarized in a new Reed Smith Client Alert. … Continue Reading

GAO Highlights Medicare Program Risks and Recommends Program Integrity Actions

The Government Accountability Office (GAO) has released its latest update to its “High-Risk Series” reports, which again lists Medicare as a high-risk program, in part because of the program’s substantial size and scope, and its wide-ranging effects on beneficiaries, the health care industry, and the U.S. economy. The latest report highlights five areas of particular … Continue Reading

OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

Today the OIG and CMS published a joint notice continuing the effectiveness of fraud and abuse law waivers granted in 2011 in connection with the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs).  By way of background, in … Continue Reading

Ways and Means Committee Seeks Comments on Medicare Program Integrity Bill

The Chairman of the House Ways and Means Subcommittee on Health is seeking comments on a draft bill, the Protecting Integrity in Medicare Act of 2014, that is “aimed at combating fraud, waste and abuse in the Medicare program.” The bill covers a range of Medicare and Medicaid policies, from establishing new alternative sanctions for … Continue Reading

OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG's expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted. Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG's proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.… Continue Reading

California Weighs Further Curtailment of Physician Self-Referrals

This post was written by Paul Pitts. California State Senator Ed Hernandez, O.D., Chair of the Senate Health Committee, has introduced legislation that would close an exception in state law that currently permits physicians to provide advanced imaging, anatomic pathology, radiation therapy, and physical therapy within their office or the office of their group practice.  … Continue Reading

Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

As previously reported, the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) published final rules in December amending Anti-Kickback Statute (AKS) and Stark Law regulations permitting certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services.  Reed Smith has prepared a … Continue Reading

Final Rules Issued Extending Protections of Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the "sunset" provisions).… Continue Reading

GAO Examines Self-Referral of Anatomic Pathology, IMRT Services

The Government Accountability Office (GAO) has issued two reports on trends in physician referrals to entities in which the provider or the provider’s family members have a financial interest – both of which conclude that financial incentives are likely a major factor driving increases in referrals. In the first report, “Medicare: Action Needed to Address … Continue Reading

Bill Introduced to Narrow Stark Exception for In-Office Services

This post was also written by Rachel Golick. A new bill introduced in the House on August 1, 2013 by Congresswoman Jackie Speier (D-CA) and Congressman Jim McDermott (D-WI) would dramatically narrow the in-office ancillary services (IOAS) exception to the Stark law for physician groups performing imaging, pathology radiation therapy and physical therapy services. The … Continue Reading

CMS, OIG Propose Extension of Electronic Health Record Donation Protections

This post was written by Jennifer Pike. CMS and the OIG have proposed new rules to extend existing protections that allow hospitals to donate electronic health record (EHR) technology to physicians who refer patients to their facilities. By way of background, in 2006, CMS established an exception to the Stark self-referral law to allow hospitals … Continue Reading

Obama Administration’s Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

Today, the Obama Administration released its proposed federal budget for fiscal year 2014. As widely reported, the budget incorporates an offer the President made to Congress in December 2012 to achieve nearly $1.8 trillion in additional deficit reduction over the next 10 years, including $401 billion in health savings (the Administration observes that this level of … Continue Reading

GAO Report Examines Medicare Costs From Self-Referrals of Advanced Imaging Services

A recent GAO report examines the growing prevalence of physician self-referral (referral to the physician’s own practice) for advanced imaging services (e.g., magnetic resonance imaging (MRI) and computed tomography (CT) services) and its effect on Medicare spending. The GAO reports that while the number of both self-referred and non-self-referred advanced imaging services increased from 2004 through … Continue Reading

CMS Releases Information on Physician Self-Referral Prohibition Exception Process for Physician-Owned Hospitals

The final CY 2012 Medicare Outpatient Prospective Payment System (OPPS) final rule implemented a statutory mandate that CMS develop an exceptions process related to the ACA’s prohibition on expanding an existing physician-owned hospital’s facility capacity. The rule provided that in order to be eligible for an exception, the physician-owned hospital must satisfy eligibility criteria to … Continue Reading

Self-Disclosure Protocol Under Stark Act

As mandated by Section 6409 the ACA, CMS has released its Medicare self-referral disclosure protocol (SRDP). The SRDP sets forth a process to enable providers and suppliers to self-disclose actual or potential violations of the physician self-referral statute (known as the “Stark Act”). Under the SRDP, providers or suppliers would submit all information necessary for CMS to … Continue Reading

House Approves Stark Legislation to Enhance Medicare Fraud Authorities

On September 23, 2010, the House of Representatives approved H.R. 6130, the Strengthening Medicare Anti-Fraud Measures Act. The legislation, which was introduced by Reps. Pete Stark and Wally Herger, Chairman and Ranking Member of the House Ways and Means Health Subcommittee, would allow the OIG to exclude certain corporate executives from doing business with Medicare … Continue Reading

FTC/CMS/OIG Workshop on Accountable Care Organizations (Oct. 5, 2010)

On October 5, 2010, the FTC, CMS, and the OIG are holding a workshop on accountable care organizations (ACOs). These organizations, authorized by the ACA, are designed to deliver high-quality and efficient health care services to consumers. The workshop is intended to assess how the variety of possible ACO structures in different health care markets … Continue Reading

CMS Proposes CY 2011 HOPPS/ASC Rates, Revises 2010 Rates

On July 2, 2010, CMS released its proposed rule updating the Medicare hospital outpatient prospective payment system (HOPPS) and the ambulatory surgical center (ASC) payment system rates and policies for calendar year (CY) 2011. The official version of the rule is scheduled to be published in the Federal Register on August 3, 2010. Comments on … Continue Reading
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