The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) issued a Proposed Statement of Antitrust Enforcement Policy for Accountable Care Organizations (ACOs). The proposed Statement applies the antitrust laws to collaborations among independent health care providers that seek to participate as ACOs under the Medicare Shared Savings Program. Public comments on the proposed Statement must be received by May 31, 2011.
The Health Law team at von Briesen will be posting additional client bulletins with details on the FTC & DOJ proposed Statement for antitrust enforcement guidance.
The Centers for Medicare & Medicaid Services today released the long-awaited proposed regulations that would implement key provisions of last year’s healthcare reform legislation relating to shared saving programs, and in particular accountable care organizations (ACOs). CMS is promoting value-based purchasing programs as key components in its efforts to improve quality and lower the pace of growth in government expenditures. The Medicare shared saving program is intended to promote accountability for a patient population and coordinate items and services under Medicare parts A and B, as well as encourage investment in infrastructure and redesigned care processes for high quality and efficient service delivery.
The proposed rules cover a broad range of issues that are key to implementation of the shared saving program, including ACO eligibility and governance, procedures for establishing 3-year agreements with DHHS, the process for assigning Medicare fee-for-service beneficiaries to an ACO, measures for assessing quality and other reporting requirements, benchmarking and other considerations in the determination of shared savings, risk-based payment models, monitoring and termination of ACOs, and overlap with other shared saving initiatives such as physician group practice demonstration sites and the the new CMS Innovation Center.
The proposed rule also addresses coordination with other agencies on such key areas as waivers of CMP, antikickback and physician self-referral (”Stark”) laws; IRS guidance on tax-exempt organizations; and antitrust agencies relative to competition, price, access to care, and quality of care.
The proposed rule may be accessed at www.ofr.gov/OFRUpload/OFRData/2011-07880_PI.pdf. Public comments are due by May 30.
Also today, the Federal Trade Commission and the Antitrust Division of the Department of Justice issued a proposed statement of enforcement policy relating to entities that participate in ACOs, indicating that the agencies would employ a rule of reason analysis to ACOs meeting the requirements set forth in the policy. The analysis will focus on the ACO’s share of services in each ACO participant’s primary service area; the higher the PSA share, the greater the risk that the ACO will be anti-competitive.
The Health Law team at von Briesen will be posting additional client bulletins with details on the CMS proposed rules and proposed antitrust enforcement guidance.
The Office of Inspector General (OIG) has issued a favorable opinion regarding complementary transportation services. Advisory Opinion 11-02 examined a proposed arrangement to provide complementary transportation of patients to the hospital from physician offices located on, or contiguous to, the hospital campus. The transportation services would be provided by the hospital if physicians on the medical staff determine that a patient is in immediate need of treatment and there are no available private transportation options. The value of this transportation could be more than a nominal value, exceeding $10 per transport or $50 annually.
The OIG noted that the proposed arrangement potentially implicates the Anti-Kickback Statute and the civil monetary penalties law because the transportation could be offered to induce beneficiaries to obtain federally payable items or services from the hospital. However, the OIG determined that it would not impose sanctions based on a combination of factors:
- The proposed arrangement would not be limited to transportation of Federal healthcare program beneficiaries. Instead, eligibility for the transportation services would be determined by physicians according to the hospital’s written policy;
- The type of transportation – a van owned by the hospital and driven by an EMT employed by the hospital – would be reasonable;
- The hospital would only offer transportation services from physicians’ offices located on or contiguous to the hospital’s 108-acre campus, approximately ¼ of a mile;
- The hospital would not advertise the proposed arrangement;
- There is limited access to and availability of local public transportation; and
- The hospital would not claim, directly or indirectly, the cost of transportation on any Federal healthcare program cost report or claim, nor otherwise shift the cost to a Federal healthcare program.
You can access the March 24 Advisory Opinion here (pdf).
Wisconsin recently expanded its peer review protection through the enactment of the Wisconsin Health Care Quality Improvement Act (WHCQIA). This new legislation is part of Wisconsin’s tort reform bill and revises Wisconsin’s current peer review statutes, Wis. Stat. §§ 146.37 & .38. In particular, WHCQIA broadens peer review protections for health care providers by, among other things, allowing related entities to share peer review information and explicitly protecting incident reports created as part of an organization’s peer review process. These helpful additions to state peer review protections not only ensure that related entities can work together in monitoring quality patient care, but also add comfort to peer review processes.
The revised statute will apply to disclosures and releases made on or after February 1, 2011, even if the peer review sessions took place prior to that date.
Read more…
The Centers for Medicare & Medicaid Services (CMS) published a final rule today regarding the imposition and collection of civil money penalties (CMPs) against nursing homes that are not in compliance with federal requirements of participation. The changes in the rule, mandated by section 6111 of the Patient Protection and Affordable Care Act, are effective January 1, 2012.
The final rule allows for reductions of CMPs by up to 50% for facilities that (1) self-report noncompliance before it is identified by CMS or the state and (2) correct the noncompliance within 10 days of its identification.
No reduction in CMPs is available for noncompliance that represents a pattern of harm, widespread harm, immediate jeopardy or results in the death of a resident. In addition, no reduction in CMPs is available for repeated deficiencies that resulted in a reduction in CMPs the previous year.
The rule provides for both an independent informal dispute resolution process and the establishment of an escrow account where CMPs are placed pending resolution of administrative appeals.
The published final rule is available here (pdf) (76 Fed. Reg. 15601).
On March 16, 2011, the U.S. Citizenship and Immigration Services (“USCIS”) issued a memorandum addressing the exemption of certain tax-exempt entities from the annual quota on H-1B petitions, known as the “H-1B cap.” Under current immigration law, non-profit entities that are related to or affiliated with an institution of higher education are exempt from the H-1B cap, meaning that they can obtain approvals of H-1B petitions even if the annual quota on H-1B petitions has been reached. This exemption has proved particularly useful for hospitals seeking to employ foreign physicians and for many residency programs.
Until recently, the USCIS routinely approved cap-exempt H-1B petitions filed by hospitals based on contractual affiliations with institutions of higher education, such as agreements to provide training to medical students or residents. However, in early 2011, the USCIS began denying petitions that were filed as cap-exempt unless the petitioner could show a direct ownership relationship between it and an educational institution. Most hospitals could not meet this requirement.
In the March 16 memo, the USCIS stated that it is currently reviewing its policy on H-1B cap exemptions for non-profit entities that are related to or affiliated with an institution of higher education. In the meantime, entities that have received approvals of H-1B petitions on a cap-exempt basis since June 6, 2006, will continue to be treated as cap-exempt absent a significant change in circumstances or clear error in the prior adjudication. The USCIS stressed that these are only interim measures, but also indicated that it will engage the public in developing any future guidance.
A copy of the USCIS memorandum can be found here.
The Office of the Inspector General for the U.S. Department of Health and Human Services has published a new guidance document for physicians on compliance with healthcare fraud and abuse laws. The document, A Roadmap for Physicians: Avoiding Medicare Fraud and Abuse, summarizes the five main federal fraud and abuse laws: the False Claims Act; the Anti-Kickback statute; the Physician Self-Referral Law (“Stark”), the Medicare exclusion statute; and the Civil Monetary Penalties (“CMP”) law. These materials then offer guidance on how physicians can comply with these laws in their relations with vendors, payers, and other providers. Examples include practical advice on such issues as coding, documentation, investments in health care business ventures, physician recruitment, and medical director arrangements. These materials may be found on the OIG website by following this link.
Daniel Levinson, HHS Inspector General, and Lew Morris, Chief Counsel to the Inspector General, both alluded to these new resources during testimony on March 2 before the U.S. Senate Committee on Finance, where they spoke on OIG’s collaboration with members of the private sector in their efforts to combat fraud. Messrs. Levinson and Morris also described two other ongoing initiatives aimed at strengthening the integrity of the Medicare and Medicaid programs, involving the targeting of “hot spots” with Medicare Fraud Strike Teams and increased utilization of exclusion and other tools when dealing with “untrustworthy” providers. This testimony is also accessible on the OIG website.
Yesterday, the Government Accountability Office (GAO) released a report of testimony before the Subcommittee on Oversight and Investigations from the House of Representatives Committee on Energy and Commerce. The report and testimony provided the GAO’s 2011 High-Risk Series update on the Medicare program – the first GAO high-risk update on the program since 2009. The GAO report notes that CMS estimates improper payments for fiscal year 2010 Medicare fee-for-service and Medicare Advantage totaled almost $48 billion.
The report outlines the GAO’s specific recommendations for CMS in order to address four significant challenges to the Medicare program:
Challenge 1: Reform and refine Medicare’s payment methods to achieve efficiency and savings
- GAO Recommendation: Although CMS has implemented payment reforms and provided feedback to physicians on resource use, CMS need to enhance its feedback to ensure that physician fees recognize efficiencies when certain services are furnished together. CMS should target services with the greatest potential for savings, including oxygen and imaging services. The GAO recommends front-end approaches to better ensure appropriate payments, such as revisions to locality payments and prior authorization requirements for imaging services.
Challenge 2: Improve program management
- GAO Recommendation: The GAO reports pervasive internal control deficiencies in CMS’s management of contracts that increased the risk of improper payments. CMS should clarify the roles and responsibilities for implementing contractor oversight responsibilities, clear a backlog of contracts that are overdue for closeout, and finish its investigation of over $70 million in questionable payments.
Challenge 3: Enhance program integrity
- GAO Recommendation: CMS should develop an adequate process to address vulnerabilities to improper payments identified by Recovery Audit Contractors (RAC). CMS should also address additional GAO recommendations designed to reduce improper payments, including one recommendation to conduct postpayment reviews of claims submitted by home health agencies with high rates of improper billing.
Challenge 4: Improve oversight of patient care and safety
- GAO Recommendation: Weaknesses in survey methodology and guidance for surveillance could understate care quality problems. While the GAO also reported that CMS’s current approach for funding state surveys of Medicare-participating facilities is ineffective, the GAO acknowledged the steps taken by CMS to implement nursing home oversight recommendations.
For a summary of these recommendations and to view the full GAO testimony report, please click here.
Today, the OIG announced two new additions to its Most Wanted Health Care Fugitives List. The list, originally released in early February, is described by the OIG as “the first-ever list of individuals sought by authorities on charges of health care fraud and abuse.” The list is meant to increase public awareness of health care fraud, waste, and abuse and involve the public in tracking the fugitives. The interactive list provides the public with photographs and profiles of each fugitive as well as status updates as fugitives are captured.
The OIG’s February press release reports that the ten most-wanted health care fugitives’ fraudulent activities have cost taxpayers an alleged $124 million. Although the list documents only the ten most wanted fugitives, the OIG is seeking over 170 fugitives on charges related to health care fraud and abuse.
The Most Wanted Health Care Fugitives List, including today’s additions, is available here.
In a memorandum to their legislative colleagues, Representative Dr. Erik Severson, Representative John Nygren and Senator Dr. Pam Galloway announced that they are co-sponsoring legislation that would make statements of apology or condolence by a health care provider inadmissible in a court action or administrative hearing. The bill is LRB-0769.
Their memorandum states:
“The goal of this bill is to provide medical professionals with the ability to express condolences or apologies to patients or their families without fear of frivolous malpractice lawsuits. Currently, saying “I’m sorry” could be construed as an admission of guilt in the court system. However studies have shown that the simple act of saying “I’m Sorry” results in families being less likely to file lawsuits. Unfortunately medical professionals have become reluctant to express apology, condolence, or sympathy for fear of suit, despite their personal feelings.
This bill has been introduced with bipartisan support in the last several sessions. A version of this legislation was even passed through the full legislature in 2005, but was vetoed by Governor Jim Doyle. Laws similar to our proposed Doctor Apology Bill have been passed in 35 other states across the nation, showing the importance of allowing medical professionals to express their concerns without fear of damaging and frivolous litigation.”
The deadline for additional co-sponsors is March 9. We will monitor the progress of this bill through the legislative process.
