Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 18, 2017.  This week’s preview focuses on the prognosis for the Graham-Cassidy bill to block grant ACA funding to states, including potential roadblocks imposed by Senators John McCain (AZ), Susan Collins (ME) and Lisa Murkowski (AK). The Weekly Preview also touches on the discord between Senators Lamar Alexander (TN) and Orrin Hatch (UT), who chair the HELP and Finance committees, respectively.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 11, 2017.  This week’s preview focuses on Congress’ efforts to stabilize the ACA marketplaces, as well as the proposal from Senators Lindsey Graham (SC) and Bill Cassidy (LA) to use block grants to fund Medicaid expansion and private insurance subsidies.

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

Our colleagues at ML Strategies have provided their Fall Health Care Preview for Fall 2017.  This preview focuses on what to expect for the rest of 2017 by examining the following questions:

  1. How will the health care minibus provisions move?
  2. Will a market stabilization package come together?
  3. Will cost-sharing reductions (CSR) payments continue to be made or formally authorized?
  4. Will ACA “repeal and replace” be resurrected yet again?

This preview is a must read for those seeking to navigate the health care policy landscape in the remaining months of 2017.

Over the past month, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program and Medicare Therapy Caps. In this post we will go into detail on the structure, funding, and outlook of the “primary care cliff,” and specifically the three programs relating to community health centers. This is part of an ongoing series we are doing on the potential riders of a health care minibus. The “minibus” refers to a handful of policy provisions tied together in one piece of legislation. This minibus will carry a number of provisions into law, although the number of riders onboard the minibus, and when the minibus leaves the station, remains to be seen.  Continue Reading Community Health Center Fund: A Minibus Rider

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health.  Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.  The DOS rules are important to laboratories and hospitals because they dictate which party must bill Medicare for certain laboratory testing performed on stored specimens collected during a hospital procedure but ordered after the patient has left the hospital.  If revisions are ultimately finalized, the proposal could have significant business implications for independent laboratories and hospitals.

Continue Reading CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit. However, these laws continue a pattern in which each state’s telemedicine laws use different definitions for what constitutes telemedicine and imposes disparate restrictions on telemedicine providers. This lack of uniformity imposes an ongoing challenge for telemedicine providers.

The Texas law, passed by the state legislature on May 12, 2017, permits telemedicine providers to establish a valid patient-provider relationship via telemedicine and without the need a prior in-person visit. This law follows a long and arduous court battle between the Texas Medical Board and Teladoc Inc. A summary of the case can be found here. At the crux of the controversy were Board regulations that prohibited physicians from establishing a valid physician-patient relationship in the absence of an in-person visit.  Continue Reading Holdout States Loosen Restrictions on Telemedicine but Obstacles Remain

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.  Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?