Health Care

The July 2018 cyber security newsletter issued by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) reminds health care providers and their business associates of the importance of properly disposing and destroying electronic devices and/or media that are no longer needed or that will be repurposed. 

At the end of July, CMS approved two Section 1332 State Innovation Waivers submitted by Wisconsin and Maine for the purpose of establishing state reinsurance programs. There has been a flurry of 1332 waiver activity recently as states have sought to stabilize their individual insurance markets through reinsurance programs.

Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”), including concerns around billing, federal oversight, and quality of care. The OIG made 16 recommendations to CMS to strengthen the hospice program; CMS only concurred with 6 of the recommendations.

On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018. 

States are increasingly looking for ways to improve stability in their individual insurance marketplaces. One way is through reinsurance programs – systems in which multiple insurance companies share risk by purchasing insurance policies from another party to limit the total loss the original insurer would experience in case of unusually high claims.

The first statistic comes from a recently published study by the Ponemon Institute, with sponsorship from IBM Security, entitled “2018 Cost of a Data Breach Study: Global Overview.”

Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the “Proposed Rule”) released by CMS earlier this month.

This week, the Senate is in session while the House is out on its August recess. The Senate could move the ball on opioids, but it is more likely that it focuses on nominations.

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.

This week, the House is looking at advancing several health care tax proposals, including permanent repeal of the medical device tax. They will also consider a proposal to delay the health insurance tax by two years.

Earlier this month, CMS proposed changes to the Medicare Physician Fee Schedule and Quality Payment Program with the goal of “modernizing Medicare and restoring the doctor-patient relationship.”

In an attempt to lower drug prices, CMS released a proposed rule last week to reduce payments for new drugs under the Part B program.

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S.

Timing is everything.  In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.

It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.

Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year.

The Tenth Circuit Court of Appeals has issued a significant decision, finding that a physician’s medical judgment about the medical necessity of heart procedures can be “false or fraudulent” under the federal False Claims Act (FCA). 

Some very good news for the telehealth community can be found amidst the more than 1,400 pages of the proposed Medicare Physician Fee Schedule for 2019(“Proposed Rule”) issued by CMS yesterday.

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.