Health Care

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. 

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 month, the Centers for Medicare & Medicaid Services (CMS) announced important changes to the Recovery Audit Program.

On March 7, 2014 the Federal Trade Commission (FTC) issued a policy paper as part of its on-going effort to urge state legislators to open health care markets to a broader range of providers. 

Cybersecurity is of increasing importance to health care organizations, given the growing trend of enforcement and increasing penalties. President Obama's Executive Order 13636: Improving Critical Infrastructure Cybersecurity included "the incapacity or destruction of [] systems and assets [that] would have a debilitating impact.

The Federal Trade Commission (FTC) has a well-established role in promoting competition in the health care industry through enforcement, study and advocacy. To that end, the agency actively urges the opening of health care markets to a broader range of providers.

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.

Following an onslaught of criticism, CMS told Congress today that it will not move forward with certain controversial provisions of its proposed rule on the Medicare Advantage and Medicare Part D prescription drug program.

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in China, went into effect.

Triple-S Management Corp. (“Triple-S”), a Puerto Rico-based health insurer, has been fined $6.8 million by the Puerto Rico Health Insurance Administration (“PRHIA”) following a Health Insurance Portability and Accountability Act ("HIPAA") breach by its subsidiary, Triple-S Salud Inc. (“TSS”), involving more than 13,000 beneficiaries.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and Office for the National Coordinator for Health Information Technology (ONC) issued model Notices of Privacy Practices (NPPs) in Spanish.

The FDA recently proposed guidance for the submission of materials disseminated through real-time social media promotions ("Interactive Promotional Media") for postmarketing reporting purposes.

As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). 

Citing the need to complement a portfolio of pilot projects that focus mostly on primary care and the inpatient setting, CMS released a Request for Information (RFI) on February 11th, seeking input on potential payment and care delivery models that focus on outpatient specialty care and complex/chronic disease management care.

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for Fiscal Year 2014 on January 31, 2014. The Work Plan provides insight into the OIG’s priorities by providing a brief description of the activities it will initiate and continue during fiscal year 2014. 

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism from multiple industry stakeholders.

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the Physician Payments Sunshine Act (the “Act”).

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to permit CLIA-certified laboratories to provide copies of completed test reports to patients upon request.