This Week: Republicans try repeal-replace again... Grassley asks about hospital inspection records and opioids hearing planned.

House

Lawmakers Urge FDA to Rewrite “Deemed to be a License” Biosimilar Guide

On Sept. 20, the Congressional Diabetes Caucus chairs Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) sent a letter to FDA Commissioner Scott Gottlieb on revising the guidance for the Biologics Price Competition and Innovation Act’s provisions. The letter summarizes their position that existing policy discourages a lower price market for insulin products. In 2016, FDA laid out guidance that any biologic applications filed under the Food, Drug and Cosmetic Act that are still pending by March 23, 2020, the date of transition, will not receive approval and need to be resubmitted. The caucus chairs stated, “Insulins are the largest category of products impacted by the ‘deemed to be a license’ provision. The draft guidance issued last year, however, unnecessarily delays market entry for competitive products that could help lower the cost of insulin.” Further, the letter states, “The FDA should amend the guidance to streamline the transition…. We believe the draft guidance should be amended to streamline the transition to ensure patient access to more affordable biosimilar treatments, reflecting the Congressional intent of BPCIA.”

Senate

Graham-Cassidy Hearing and Maybe a Vote

Senate Finance Chair Orrin Hatch (R-UT) has called a committee hearing on the health care bill by Sens. Bill Cassidy (R-LA) and Lindsey Graham (R-SC) for Sept. 25. In addition, Senator Ron Johnson (R-WI), who chairs the Senate Committee on Homeland Security, had announced a hearing for the bill in his committee, but canceled his committee’s hearing once the Finance Committee hearing was scheduled.

The Congressional Budget Office announced it would release a “preliminary” analysis early this week that will only state whether the bill meets reconciliation instructions. CBO has stated that it won’t be able to say for several weeks, however, how the bill would affect the deficit, coverage numbers or cost of premiums. This means that Senate Majority Leader Mitch McConnell (R-KY) would have to bring it to the floor before senators know the projected impact if he wants to pass it through reconciliation. Those instructions expire Sept. 30.

Because of the deadline of Sept. 30, the majority leader and others are pushing to try one last time to move legislation to repeal and replace the Affordable Care Act. Sen. Rand Paul (R-KY) has said he will not vote for the bill. Pressure is being placed on Sens. John McCain (R-AZ), Lisa Murkowski (R-AK) and Susan Collins (R-ME), who voted “no” on the previous efforts to repeal and replace when the Senate considered it prior to the August recess.

On Sept. 19, a bipartisan letter from 10 governors urged the Senate to not consider the proposal. The letter was signed by Republican governors John Kasich of Ohio, Brian Sandoval of Nevada, Charlie Baker of Massachusetts and Phil Scott of Vermont. Other signers included independent Bill Walker of Alaska and Democratic governors John Hickenlooper of Colorado, Tom Wolf of Pennsylvania, John Bel Edwards of Louisiana, Terry McAuliffe of Virginia and Steve Bullock of Montana. In addition, the Republican governors of Maryland, New Jersey and New Mexico have stated their opposition to the legislation.

Grassley Asks Hospital Inspection Records Be Made Public

On Sept. 18, Senate Judiciary Chairman Chuck Grassley publicly asked CMS Administrator Seema Verma to release all hospital inspection records. According to recent news reported by the Wall Street Journal, hospitals have retained their accreditation regardless of violations that were deemed to cause serious injury or death. Specifically, Grassley stated, “The Joint Commission appears to be unable to aggressively enforce the necessary standards on all facilities. Making facility inspections reports public may go a long way to providing the necessary additional information for patients and their families to make informed decisions about where to seek care.” The Joint Commission is the accrediting agency for CMS.

To view the letter, click here.

HELP Hearing Oct. 5

The Health Education Labor and Pensions (HELP) Committee has announced a hearing for Oct. 5, “the Federal Response to the Opioid Crisis.” Witnesses will be:

  • Elinore F. McCance-Katz, M.D., Ph.D., assistant secretary for Mental Health and Substance Use, SAMHSA
  • Brenda Fitzgerald, M.D., director, Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry
  • Francis Collins, M.D., Ph.D., director, National Institutes of Health
  • Scott Gottlieb, M.D., commissioner, Food and Drug Administration

2. Regulations Open for Comment

CMS Proposes 2018 and 2019 Payment Changes for Medicare Home Health Agencies

The Centers for Medicare & Medicaid Services (CMS) on July 25 issued a proposed rule that would update payment rates and the wage index for home health agencies (HHAs) serving Medicare beneficiaries in 2018; it also proposes a redesign of the payment system in 2019. Comments are due Sept. 25, 2017.

CMS is planning a slight pay cut for home health agencies in 2018, by reducing Medicare payments to the agencies by 0.4 percent next year, saving the federal government an estimated $80 million. That change is driven in part by CMS’s planned phase out of a provision boosting pay rates for certain home health services delivered to rural patients. The agency is also floating a series of changes to the payment methodology beginning in 2019, which could result in a pay cut of up to 4.3 percent. That would translate to as much as $950 million in reduced Medicare payments to home health agencies.

Under the proposed rule, the home health payment update percentage for HHAs that submit the required quality data for the Home Health Quality Reporting Program would be 1 percent in 2018. The proposed rule also includes proposals to refine the HH PPS case-mix adjustment methodology, including a change in the unit of payment from 60-day episodes of care to 30-day periods of care, to be implemented for periods of care beginning on or after Jan. 1, 2019. Additionally, the proposed rule includes proposals for the Home Health Value-Based Purchasing Model and the Home Health Quality Reporting Program.

To view the proposed rule, click here.

For more information on the Home Health Prospective Payment System, click here.

3. Administration

CMS: Home Health Agencies: Quality of Patient Care Star Rating Algorithm Call

During this call, CMS will talk about modifications and proposed changes to the way the Quality of Patient Care star rating is calculated, including the removal of the influenza measure. CMS presents the rationale, proposed timing and impact of the changes. A question-and-answer session follows the presentation.

The call is scheduled for Tuesday, Oct. 10 from 2-3 p.m. ET.

To register for the call, click here.

CMS Innovation Center New Direction RFI: Submit Comments by Nov. 20

On Sept. 20, the CMS Innovation Center issued a request for information, seeking information on a new methodology to develop patient-centered care and also to experiment with market-driven reforms that empower beneficiaries as consumers, to provide more choice and transparency.

Comments can be submitted by clicking here.

4. States

New Jersey: Christie-led Opioid Commission Announces Public-Private Partnership With Pharma

On Sept. 18, New Jersey Republican Gov. Chris Christie announced a partnership between the NIH and the pharmaceutical industry in order to fast track a pain medication without opioids and treatment options. The press conference, held in Trenton, was a part of the president’s commission on opioid addiction, chaired by the New Jersey governor. Kellyanne Conway, NIH representatives, FDA representatives and PhRMA were all in attendance. Prior to the conference, 14 pharmaceutical companies met, several of which have been a part of state-based lawsuits over deceptive marketing tactics related to opioid use. The third meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis will be held on Wednesday, Sept. 27 in Washington.

For more information on the President’s Commission on Combating Drug Addiction and the Opioid Crisis, click here.

5. Reports

Graham-Cassidy: Kaiser and Averlere Analysis Reports States Would Lose Billions

An analysis from the Kaiser Family Foundation, released Sept. 19, estimates that states would lose $160 billion over a decade if Graham-Cassidy were enacted. Those cuts come largely from states that expanded Medicaid, like California, which stands to lose $56 billion. In all, 35 states would see reduced federal support. The bill wouldn’t spare all nonexpansion states. Florida stands to lose $9.7 billion over a decade. Kaiser’s analysis also highlights a relatively overlooked implication of Graham-Cassidy: The plan’s restrictions would go beyond Obamacare by cutting funding for nearly every state’s traditional Medicaid program. The bill imposes a cap on federal funding for the program, resulting in a $15 billion reduction in 2027 alone. Only Montana and Alaska would be spared from traditional Medicaid cuts through a carve-out included in the bill.

To view the report, click here.

In addition, a new analysis from Avalere finds that the Graham-Cassidy proposal to repeal and replace the Affordable Care Act (ACA) would lead to a reduction in federal funding to states by $215 billion through 2026 and more than $4 trillion over a 20-year period.

To view the report, click here.