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On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals were operating under a joint operating agreement, constituted a single entity incapable of conspiring in violation of Section 1 of the Sherman Act. 
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On October 24, 2014, the Internal Revenue Service issued Notice 2014-67 (the “Notice”), which provides important guidance and increased flexibility for issuers and conduit borrowers of tax-exempt bonds regarding contracting with private parties in a manner that avoids “private use” by such parties of bond-financed facilities.
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As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs with a “geographic mean cost” of $100 or less.  
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Key Takeaways from OIG’s 2015 Work Plan

November 4, 2014 | Blog | By Kimberly Gold

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS programs and operations during the current fiscal year and beyond.
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The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). 
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The Contraception Coverage Controversy Continues…

October 31, 2014 | Blog | By Bridgette Keller

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e. no deductibles, coinsurance, or co-payments).
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Managing Antitrust Risks in Pre-Transaction Planning

October 30, 2014 | Blog | By Theresa Carnegie

Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”). In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation. 
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Last week, the Department Health and Human Services (HHS) announced that it will invest $840 million over the next four years to support 150,000 clinicians through a combination of incentives, tools, and information to encourage clinicians and other health care providers “to move from volume-driven systems to value-based, patient-centered, and coordinated health care services.”
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On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).
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Ebola Exclusions from Commercial Insurance Policies

October 29, 2014 | Blog | By Theresa Carnegie

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business insurers are beginning to specifically exclude ebola-related losses from their standard commercial insurance policies.
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On October 15, 2014, the New York State Department of Health (DOH) released proposed changes that will simplify the certificate of need (CON) process.
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ML Strategies Posts Weekly Health Care Update on October 27, 2014

October 28, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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In recent years, co-payment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Co-payment coupons are typically offered to commercially insured patients in order to reduce or eliminate out-of-pocket costs for specific brand name drugs with higher co-pays.
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Mintz’s Health Care Qui Tam Update

October 23, 2014 | Blog | By Kimberly Gold

Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases.
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Supreme Court Examines Boundaries of Antitrust Immunity

October 20, 2014 | Blog | By Theresa Carnegie

On October 14, 2014, the US Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services.
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William Gallagher Associates, a Boston-based insurance broker, has announced the rollout of a new policy to cover Ebola-related losses at hospitals and other healthcare providers involved in primary care emergency treatment.
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Front End Changes and, Again, More DIR Columns

October 17, 2014 | Blog | By Tara E. Dwyer

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members.
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Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over 150,000 claims) by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).
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Last Friday, the HHS Office of the Inspector General issued a highly anticipated proposed rule that provides new and modified regulatory safe harbors to the Anti-Kickback Statute, amends regulatory provisions related to enforcement of the Beneficiary Inducement Civil Monetary Penalty Law (CMP) provisions, and attempts to narrow the prohibitions covered by the Gainsharing CMP.
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ML Strategies Posts Weekly Health Care Update on October 13, 2014

October 15, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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