Health Care

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit health system in southeast Texas.

Our ML Strategies colleagues, Eli Greenspan, Katie Weider, and Rodney Whitlock, have published a new edition of the Health Care Weekly Preview. This edition covers upcoming hearings in the House, including one before the House Ways & Means Committee regarding expiring Medicare programs, as well as changes to Medicare’s payment system.

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.

By now, you may have heard about the global ransomware attacks affecting health care and other organizations throughout the world, in particular the United Kingdom, but also in the United States. The ransomware variant, called “Wanna Decryption” or “WannaCry” works like any other ransomware: once it is inadvertently installed, it locks up the organization’s data until ransom is paid.

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now.

In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, the “minibus” refers to a handful of policy provisions tied together in one piece of legislation. 

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.

The Trump administration is considering releasing a rule to ease the burden that small practices are facing in trying to comply with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), according to a recent report in The Hill.

Patient assistance programs have been a staple within the health care industry for over a decade. These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, co-payments, deductibles, premiums, or other related services.

Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here).  On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz. 

RAlthough telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies.

Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.

ML Strategies has provided a Spring Cheat Sheet previewing the coming months in health care policy in the 115th Congress. The Cheat Sheet addresses attempts to amend the American Health Care Act, funding for the federal government, the heath insurance marketplace, FDA user fee acts, and the health care minibus.

Today, our colleagues at ML Strategies provided another installment of their Health Care Weekly Preview. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.

Earlier this week, the Mintz Levin privacy team  updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws, with updates from New Mexico, Tennessee, and Virginia.  As the privacy team reports, with New Mexico enacting a data breach notification law, only Alabama and South Dakota remain the only states without data breach notification laws.

Next week, the Massachusetts House will continue the budget process and debate over 1000 amendments that members filed to the House Ways and Means Committee’s proposed $40.3 billion FY2018 budget.

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico.

Welcome to Spring Break! That time of the year where college kids head to a beach somewhere, families pack up for some tourist trap to spend lots of money, and Congress gets out of DC and goes back home.  This is also a time to consider where we are and where we are heading in terms of health care policy.