Igor Gorlach

Igor Gorlach

Foley Hoag LLP

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New Rule Permits CMS to Revoke Medicare Billing Privileges for Providers/Suppliers with “Pattern or Practice” of Denied Claims

On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more

12/11/2014 - Billing Claims Processing Systems Clinical Laboratories CMS Final Rules Health Care Providers Health Insurance Healthcare

Massachusetts Enacts New Biosimilars Substitution Law

On June 23, 2014, Governor Deval Patrick signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (now Chapter 143 of the Acts of 2014). The new Act authorizes pharmacists to...more

6/26/2014 - Biosimilars Biotechnology Pharmaceutical Prescription Drugs

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

6/7/2014 - 340B Administrative Authority Affordable Care Act Covered Entities Dispute Resolution Drug Manufacturers FFDCA HRSA Orphan Drugs Permanent Injunctions PHRMA Popular Rulemaking Process Summary Judgment

FDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers

The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more

1/30/2014 - Biologics Drug Manufacturers FDA Healthcare Prescription Drugs

FDA is Soliciting Comments on Improving the Quality of ANDA Submissions

The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more

1/28/2014 - ANDA FDA Prescription Drugs

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

10/1/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps

The Physician Payment Sunshine Act Final Rule A Summary Of Key Provisions

On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act. The...more

2/8/2013 - Affordable Care Act CMS Drug Manufacturers Medicaid Medical Devices Medical Supplies Medicare Payment Records Physicians Sunshine Act Teaching Hospitals

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