Health Care

In its February 20, 2015 Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter, CMS addressed a variety of issues relating to its Star Ratings system.

The Federal Trade Commission (“FTC”) on Monday completed its review of Novartis AG’s (“Novartis”) proposed $16 billion acquisition of GlaxoSmithKline’s (“GSK”) oncology drug portfolio with an announced consent decree that requires limited divestitures of BRAF- and MEK-inhibitor drugs used to treat melanoma, ovarian, colorectal, non-small cell lung, and other cancers.

On February 25, 2015, in a 6-3 decision authored by Justice Kennedy, the Supreme Court upheld the Federal Trade Commission’s decision finding that the North Carolina Board of Dental Examiners, although a state agency, was not exempt from federal antitrust laws when it sent 47 official cease-and-desist letters to non-dentist teeth whitening service providers.

On February 25, 2015, in a 6-3 decision authored by Justice Kennedy, the Supreme Court upheld the Federal Trade Commission’s (FTC) decision finding that the North Carolina Board of Dental Examiners (Board), although a state agency, was not exempt from federal antitrust laws when it sent 47 official cease-and-desist letters to non-dentist teeth whitening service providers.

Last week, the Centers for Medicare & Medicaid (CMS) released its 2016 Advance Rate Notice and draft Call Letter (2016 Call Letter) for the Medicare Advantage (MA) and Medicare Part D programs.

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

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations.

The U.S.’s pursuit of lower health care costs and higher quality health care services has included the incentivizing of new organizational structures and payment models that trigger long standing concerns about maintaining competition in the health care system.

The Centers for Medicare & Medicaid Services (CMS) recently announced a one-year delay in finalizing the long-awaited and closely watched rule addressing the 60-day deadline to return Medicare and Medicaid overpayments (the “60-day rule”).

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.

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services Act, Section 733 of ERISA and Section 9832 of the Internal Revenue Service Code. 

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations that Fox Hollow violated the False Claims Act (FCA) by causing certain hospital clients to submit false claims to the Medicare program.

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year 2016.

The District of Columbia Circuit Court of Appeals handed the Federal Trade Commission a critical win on January 30, 2015 by affirming the Commission’s January 2013 decision holding POM Wonderful LLC in violation of the FTC Act for its deceptive advertisements alleging pomegranate juice and supplements could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.

On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the physician practices as members of the corporations’ consolidated tax group for U.S. federal income tax purposes.

On February 10, 2015, in United States v. Patel (Case No. 14-2607), the Seventh Circuit Court of Appeals ruled that a physician makes a “referral” within the meaning of the federal health care programs Anti-Kickback Statute (AKS).

The New York State Department of Financial Services (the "Department") recently released a "Report on Cyber Security in the Insurance Sector" (the "Report").

In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit recently upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion of an efficiencies defense.

In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion of an efficiencies defense based on integrated care and risk-based reimbursement.

The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations.