Mintz Levin - Health Law & Policy Matters

Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways

In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent…more
| Health

HHS Publishes Guidance on HIPAA and Cloud Computing

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below, the…more
| Health, Privacy, Science, Computers, & Technology

CMS Releases MACRA Final Rule, Easing 2017 Reporting Requirements

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The final rule marks the most significant reform to our…more
| Health

FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance

On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The draft guidance was prepared by the SaMD Working Group of the International…more
| Health, Science, Computers, & Technology

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate…more
| Health, Science, Computers, & Technology

Senate Bill Targets Part D DIR Fees

Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy…more
| Health

CMS releases Final Rule Overhauling Long-Term Care Facility Requirements

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”). This much anticipated rule…more
| Alternative Dispute Resolution (ADR), Health

Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”). DPH believes that believes the proposed…more
| Consumer Protection, Health

Massachusetts Dialysis Unit Licensing Proposed Regulations – Key Take-Aways

As we’ve previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s Executive…more
| Health

Billing Companies Beware – OIG Signals a Crackdown on Fraud and Abuse at All Levels

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for…more
| Civil Remedies, Health

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in…more
| Health, Science, Computers, & Technology

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable…more
| Health

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global…more
| Communications & Media Law, Health, International Law & Trade, Science, Computers, & Technology

Penalties For Health Care Law Violations Surge

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). Through an interim final rule, the…more
| Civil Remedies, Health

California Joins New York and Florida, Passes Out-Of-Network Legislation

Last month the California legislature passed AB-72, which amends the Health & Safety Code to address reimbursement for out of network (OON) providers who provide services at in-network facilities, such as hospitals and…more
| Alternative Dispute Resolution (ADR), Consumer Protection, Health
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701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

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