This Week: Congress focuses on organizing for the next Congress and the continuing resolution; previews of drug pricing legislation for the next Congress; CMS issues controversial guidance concerning how states can use subsidies.

Congress

House

• Incoming House chairmen Ask Trump Officials for Documentation on Plan for Bypassing Key Requirements of the ACA

Senate

• Senators Ask CMS to Move on Direct-to-Consumer Advertising by End of Year
• Sanders, Khanna Release Drug-Pricing Bill Blending Republican and Democratic Ideas
• Sen. Merkley Proposes Bill to Sell Drugs at Reference Price

Administration

• CMS: Efforts to Improve Patient Safety, Quality of Care in Nursing Homes
• Trump Administration Approves Kentucky Waiver a Second Time for Medicaid Work Requirements
• CMS Releases New 1332 Waiver Concepts That Shift ACA Requirements
• CMS: Modernizing Part D & Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses
• CMS: New Online Tool Displays Cost Differences for Certain Surgical Procedures
• FDA Moves to Publish Names of Devices with Old Predicates as Part of 510(k) Reform
• HRSA to Put 340B Ceiling Price Rule into Effect Jan. 1

Congress

House

Incoming House chairmen Ask Trump Officials for Documentation on Plan for Bypassing Key Requirements of the ACA

Reps. Pallone (D-NJ) and Richard Neal (D-MA), incoming chairmen of the House Energy and Commerce and House Ways and Means Committee, respectively, have asked Trump officials to provide documents and answers to questions about a plan, for which additional guidance was released on Nov. 30, to give states more options to bypass key requirements of the Affordable Care Act. States would be permitted to use subsidies for plans other than those that meet ACA requirements.

Senate

Senators Ask CMS to Move on Direct-to-Consumer Advertising by End of Year

On Nov. 16, incoming Senate Finance Committee Chairman Charles Grassley (R-IA) and Senate Democratic Whip Sen. Dick Durbin (D-IL) asked the Trump administration to finalize a proposal requiring drug manufacturers to disclose list prices in direct-to-consumer advertising, by the end of the year. The senators also called on the Department of Health & Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to adopt additional drug-price disclosure measures.

Sanders, Khanna Release Drug-Pricing Bill Blending Republican and Democratic Ideas

On Nov. 20, Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) unveiled a prescription drug-pricing bill that mixes Republican and Democratic proposals. The proposal expands the Trump administration’s international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug manufacturers’ exclusivity if their drug prices are deemed excessively high. Sanders and Khanna plan to introduce the bill in the next session of Congress.

Sen. Merkley Proposes Bill to Sell Drugs at Reference Price

On Nov 29, Sen. Jeff Merkley (D-OR) proposed a bill to force prescription drug manufacturers to set prices at or below an international reference price based on 11 other countries, or get kicked out of Medicare, Medicaid and Affordable Care Act exchanges. The Department of Health & Human Services’s (HHS) secretary would determine reference prices for both brand and generic drugs.

Administration

CMS: Efforts to Improve Patient Safety, Quality of Care in Nursing Homes

On Nov. 20, the Centers for Medicare & Medicaid Services (CMS) announced a three-year initiative that is meant to improve residents’ quality of life by equipping nursing home staff, administrators and stakeholders with technical tools and assistance to enhance resident care. This CMPRP series will include a release of online “toolkits” as part of the initiative.

Find the first CMPRP toolkit here.

Trump Administration Approves Kentucky Waiver a Second Time for Medicaid Work Requirements

On Nov. 20, the Trump administration approved Kentucky’s Medicaid waiver to impose work requirements on some enrollees. The program was previously blocked in court and this is the second time the administration has approved the waiver.

In its re-approval, the Centers for Medicare & Medicaid Services (CMS) said it determined the Kentucky project still advanced Medicaid’s purpose of providing coverage in part because it promotes enrollee health and financial independence. The waiver takes effect April 1 and will be rolled out gradually.

CMS Releases New 1332 Waiver Concepts That Shift ACA Requirements

On Nov. 29, the Centers for Medicare and Medicaid Services (CMS) released four new waiver concepts designed to help states understand options for pursuing a Section 1332 waiver under the Affordable Care Act (ACA). The regulations include an accounts-based system that lets states direct public funds into a consumer account for the purchase of coverage and other health expenses. Other concepts include waiving the premium tax credits to create a new state-level subsidy program, an “adjusted plan” concept that, used in tandem with the accounts system, could subsidize consumer purchase of non-ACA-compliant plans. The waiver concepts follow new guidance on Section 1332 waivers that CMS released in late October of this year.

Read the released waiver concepts here.

CMS: Modernizing Part D & Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses

On Nov. 26, the Centers for Medicare & Medicaid Services (CMS) proposed policies for 2020 that give Medicare Advantage and Part D plans more tools to negotiate lower drug prices and increase transparency. CMS’s proposals include letting Part D plans exclude drugs in protected classes from Part D formularies when their makers raise prices faster than inflation or when drug companies make new formulations of drugs already on the market.

Read the proposed regulation here.

CMS: New Online Tool Displays Cost Differences for Certain Surgical Procedures

On Nov. 27, the Centers for Medicare & Medicaid Services (CMS) launched a new online tool for consumers to compare Medicare payments and copayments for certain procedures that are performed in both hospital outpatient departments and ambulatory surgical centers. The Procedure Price Lookup tool displays national averages for the amount Medicare pays the hospital or ambulatory surgical center and the national average copayment amount a beneficiary with no Medicare supplemental insurance would pay the provider.

Find the Procedure Price Lookup tool here.

FDA Moves to Publish Names of Devices with Old Predicates as Part of 510(k) Reform

On Nov. 26, the FDA announced a consideration to publish online the names of devices cleared using predicate devices that are 10 years old or older—this is part of an effort to modernize the FDA’s medical device clearance process after recent reports of safety issues.

HRSA to Put 340B Ceiling Price Rule into Effect Jan. 1

The Health Resources and Services Administration (HRSA) finalized a regulation to push up implementation of the 340B ceiling price and penalties rule to Jan. 1, 2019. The HRSA said the action will not interfere with the Department of Health and Human Services’ (HHS) overall drug-pricing strategy and that the HRSA can continue with additional 340B rulemaking after the ceiling price and penalties regulation has been put in place.