Health Care

On Tuesday, President Obama signed the 21st Century Cures Act (the "Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises.

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP).

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5.  Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system.

A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%).

Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration.

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR's Phase 2 audit program.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS letterhead under the signature of OCR's Director Jocelyn Samuels and is being sent to HIPAA covered entities and their business associates.

There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016.

Republicans have been talking about remodeling the Medicaid program through block grants or per capita caps for years. Both block grants and per capita caps are designed to limit federal spending by providing a state with a set amount of federal money to fund its Medicaid program.

The Children’s Health Insurance Program (“CHIP”), created in 1997, helps states provide health care coverage to low-income children up to age 19 whose families fall above the Medicaid eligibility threshold but are unable to afford private insurance.

The Massachusetts Department of Public Health (DPH) continues its efforts to revise its regulations to comply with Executive Order 562, which requires all state agencies to review its regulations.

Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal government's strategy to try to reign in health care costs by reducing volume and promoting quality.

As we’ve previously reported, the FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications.

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.

As is well known, drug prices have been widely discussed nationally. They have been the subject of Congressional hearings and, in the case of Mylan, a high profile settlement.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act.  Repeal and Replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend. 

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. 

Last week, the OIG posted its Work Plan for 2017.  In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start.  Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act (ACA). Repeal and Replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act. Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend.