Drug Pricing Blueprint Tracker

On May 11, the Department of Health and Human Services released a blueprint entitled American Patients First, which contains many high-level policy priorities to reduce the prices of prescription medicines. The NHC submitted comments on the blueprint on July 16. Since this time, many of the high-level priorities in the blueprint have been developed into specific policies, either through efforts by the Administration, or Congressional legislation. In order to help health care stakeholders keep track of the status of these policies and be able to weigh in on them, the NHC has developed this Drug Pricing Blueprint Tracker. 

Updated Sept. 26, 2018

Policy Name

Summary

Form

Alignment with NHC Domains and Values

How to Comment

FDA Guidance to Promote Generic Drug Access On September 13, the FDA released 42 new guidances and 12 revised guidances to support drug makers in developing generic versions of products; of the 42 new guidances, 14 are for products without generic competition FDA Guidance Aligns: The NHC supports efforts to increase access and price competition through the development of generic alternatives. N/A
Patient Right to Know Drug Prices Act - S. 2554

Know the Lowest Price Act - S.2553
 

On September 17, the Senate passed a bill banning the use of gag clauses in private insurance buy a vote of 98 - 2

On September 4, the Senate passed S. 2553. The bill would ban gag clauses, allowing pharmacists to tell patients if a cash price for their Rx is cheaper than insurance

On September 25, the House passed both bills.

Legislation Aligns: NHC supports efforts to increase price transparency for consumers; dissolving the gag clause would give patients information they need to make informed decisions about their health care.  N/A

Indication-Based Formulary Design Beginning in Contract Year (CY) 2020

On August 29, CMS issued a memo to Part D plan sponsors to announce that plans may include indication-based formulary designs in plans beginning in contract year (CY) 2020. This policy would allow the plan to cover specific drugs for certain approved indications and exclude coverage for other approved indications.

CMS Memo

Potentially Aligns: While this new policy could result in an increase in the number of drugs covered on formularies and increase competition, it would allow plans to exclude coverage of drugs for certain indications thus creating barriers to patient access. The ease with which patients can access information on these formulary limitations is critical.

N/A

Drug Price Disclosure in Direct to Consumer (DTC) Prescription Drug Advertising

On August 23rd, the Senate passed H.R. 6157, an $856.9 billion measure that includes funding for the Departments of Labor and HHS (LHHS), as well as the Departments of Defense (DOD and Education. The measure includes an amendment, sponsored by Senators Durbin (D-IL) and Grassley (R-IA) that would appropriate $1 million and direct the HHS Secretary to require manufacturers to disclose drug prices in direct-to-consumer (DTC) advertising.

Legislation

Potentially Aligns: The NHC supports drug pricing transparency but believes patients could be deterred or discouraged from seeking certain therapies if a high list price is disclosed.  Any pricing disclosure should include clear and understandable details explaining the difference between the list price and patient’s out of pocket costs.

N/A

Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP

On August 24, the Department of Health and Human Service’ Office of the Inspector General (HHS OIG) issued a request for information (RFI) seeking feedback on potential changes to the Anti-Kickback Statute (AKS) safe harbors and beneficiary inducement civil money penalties to promote care coordination and facilitate value-based care in federal health coverage programs. Specifically, the RFI focuses on value-based coverage and contracting, beneficiary engagement to improve adherence and outcomes, and the availability of technology solutions to improve access to and the protection of patient treatment information.

Request for Information

Potentially Aligns: Aligns with some patient advocacy positions, (e.g. promoting care-coordination, value-based care, increased access to data, etc), however the expansion of safe harbors without adequate protections could potentially lead to fraud and abuse.

Link

Deadline: Oct. 26, 2018

Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage

On August 7, CMS issued a memo to notify Medicare Advantage (MA) plans that they may implement step therapy for Part B-covered drugs beginning in January 2019. MA plans that also offer prescription drug coverage would be allowed to manage across both Part B and Part D drugs in applying step therapy.

CMS Memo

Does Not Align: Potential access barriers and burdens placed on patients. 

NHC Blog: Two Wrongs Don’t Make a Right

N/A

CY2019 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule

On July 25, 2018 CMS released the proposed OPPS/ASC rule which included an RFI on implementing a new version of the previously suspended Competitive Acquisition Program (CAP) model. CMS is soliciting comments on the optimal method to implement the model to reduce expenditures and improve quality of care. The rule also proposes to:

  • Expand payment policies for Part B drugs acquired through the 340B program to non-excepted off-campus provider-based departments (PBDs)
  • Expand site neutral policies to outpatient clinic visits.

 

CMS Proposed Rule

Potentially Misaligns: The NHC supports efforts to address the rising cost of prescription drugs but will not support a potential modified Competitive Acquisition Program (CAP) model that poses potential risks to patient access to drugs. Specific access concerns include timely distribution of drugs and allowing venders to use step therapy or utilization management measures

 

NHC Comment Letter

Link

Deadline: Sept. 24, 2018

FDA Workgroup on Focused Drug Importation Policy Options

On July 19, FDA Commissioner Scott Gottlieb announced that the agency will form a work group to explore various policy frameworks that could support importation of drug products from foreign countries.

FDA Workgroup

Potentially Misaligns:  The NHC supports increased choice, competition, and access to more affordable drugs. However, the NHC will not support any importation measures that compromise drug safety

N/A

Biosimilars Action Plan: Balancing Innovation and Competition

On July 18, the FDA released the Biosimilars Action Plan, which outlines the agency’s thinking and upcoming actions to help spur biosimilar development and uptake in the US. FDA Commissioner Scott Gottlieb expanded on the plan the same day during his remarks at the Brookings Institution. The plan is divided into 4 key areas: Efficacy of Development, Providing Clarity for Manufacturers, Providing Educational Resources, and Reducing Gaming to Delay Competition.

FDA Action Plan

Aligns: The NHC supports measures to strengthen the biosimilars market.

N/A

CY2019 Medicare Physician Fee Schedule and Quality Payment Program Proposed Rule

On July 12, 2018 CMS released the proposed CY2019 MPFS rule, which included proposed changes to the QPP. The rule proposes to:

  • Reduce Wholesale Acquisition Cost (WAC)-based payments for Part B drugs to WAC plus 3% and allow Medicare Administrative Contractors the authority to pay at WAC plus 3% as well
  • Maintain its CY 2018 payment Relatively Adjuster of 40% of the amount that would have been paid under the Hospital Outpatient Prospective Payment System. This would apply to non-excepted departments paid under MPFS

 

In addition, CMS seeks input on barriers preventing providers and suppliers from informing patients of out-of-pocket costs, and changes that could be made to increase transparency for patients regarding out-of-pocket costs.

CMS Proposed Rule

Potentially Aligns:  Seeks input on efforts to increase transparency for patients regarding out-of-pocket cost.

Link

Deadline: Sept. 10, 2018

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities and Medical Product Communications That Are Consistent with the FDA-Required Labeling

On June 12, FDA issued 2 guidances intended to support communication

between manufacturers and payers, which the agency indicates may help spur the adoption of

value-based purchasing (VBP) arrangements. The first guidance addresses drug and device manufacturer communications with formulary committees and health plans and how manufacturers can share safety, effectiveness, and cost effectiveness information that may not have been included as part of the FDA’s regulatory review. The second guidance, which is not limited to payor communications, provides clarity on how the FDA evaluates medical product communications that present information that is not contained in the FDA-required labeling for the product but that may be consistent with that labeling.

FDA Guidance

Potentially Aligns:  Promotes Value-based purchasing (VBP) arrangements.

N/A

Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement

On May 31, FDA issued 2 draft guidances outlining new policies for the agency’s Risk Evaluation and Mitigation Strategies (REMS) requirements, Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement. According to the agency, the guidances will simplify the REMS process and reduce burdens for generic product manufacturers in the regulatory process.

FDA Draft Guidance

Aligns: Promotes access and competition.

N/A