Health Care Checkup: September 15, 2023

Health Care Checkup

September 15, 2023

THE BIG PICTURE: KEY CONGRESSIONAL DEVELOPMENTS

On Wednesday, President Joe Biden unveiled a slate of cancer moonshot program initiatives to advance the White House's goal of reducing the cancer rate by half over the next 25 years. The initiatives included $240 million in funding for the Advanced Research Projects Agency for Health, additional resources to help Americans quit smoking, and plans to improve cancer research and care for underrepresented communities and veterans.

What to Expect Next Week: The House and Senate are both in session next week with a lot of work to do. In addition to funding the government by September 30, Congress must reauthorize several health programs and pandemic response legislation.

The Senate is continuing to move to pass a minibus government funding package; a three-bill package that includes fiscal 2024 funding for Agriculture-FDA, Military Construction-VA, and Transportation-HUD. The Senate hit a snag as it tried to get consent to vote on ten bipartisan amendments to the minibus package. Senator Ron Johnson (R-WI) objected to advancing the appropriations bills as a full package. This block will require Senate leaders to work through this hurdle as they try to finalize the bill next week. Discussions will continue over the weekend on proceeding with amendments to the minibus. The Senate will resume debate Monday afternoon at 5:00 PM.

The Senate HELP Committee will hold a markup reauthorizing community health centers and other expiring health programs on September 21, with authorizations expiring on September 30. The House is expected to vote on reauthorization legislation of the Lower Costs, More Transparency Act (H.R. 5378) before the end of the month, which Sen. Cassidy has said the Senate should pass instead.

DEEP DIVE

Congressional:

House E&C Health Subcommittee Hearing on Generic Drug Shortages

On Thursday, the Energy and Commerce Committee Health Subcommittee held a hearing discussing five bills aimed at preventing drug shortages. The hearing followed the PAHPA reauthorization bills (H.R. 4421 and H.R. 4420), which passed along party lines in July, with Democrats objecting to a lack of provisions to address drug shortages. Thursday's hearing included a draft proposal of the Stop Drug Shortages Act from Republicans and legislation sponsored by Democrats, including the Drug Origin Transparency Act of 2023 from Rep. Anna Eshoo (D-CA), the Ensuring Access to Lifesaving Drugs Act of 2023 from Rep. Elissa Slotkin (D-MI), and the Drug Shortage Prevention Act of 2023 from Rep. Sara Jacobs (D-CA). The Republican draft focuses on the economics underpinning low-margin generic drug production, while the Democratic bills focus on more industry oversight by the FDA. The timing for a subcommittee markup is unclear. Rodgers said in an interview Wednesday that she was “open to all ideas,” but has not said she would incorporate any of the Democratic bills into her legislation. Read Mehlman Consulting’s hearing summary here.

Sanders, Marshall Deal to Reauthorize Community Health Centers Faces Opposition

On Thursday, Sen. Bernie Sanders (I-VT), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Sen. Roger Marshall, M.D. (R-KS), Ranking Member of the Subcommittee on Primary Health and Retirement Security, announced a markup of the Bipartisan Primary Care and Health Workforce Act on Thursday, September 21, after they have reached a deal on landmark legislation to address the primary care crisis in America and the major shortages of health care workers across the country. The legislation also increases funding for community health centers, the National Health Service Corps, and Teaching Health Centers. Ranking Member Cassidy opposed the legislation, stating the legislation lacks a specific plan or list of scored proposals to pay for the funding increases and creates new mandatory supplemental funding streams in sections 203, 205, and 206 that lack Hyde Amendment protections. See Sen. Cassidy’s press release here, Sen. Sanders’ markup announcement here, and a summary of the Bipartisan Primary Care and Health Workforce Act here.

House E&C Health Subcommittee Announces Hearing on Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology

On Tuesday, the Subcommittee on Health of the Committee on Energy and Commerce announced they will hold a hearing entitled “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology,” next Tuesday, September 19, at 10:00 AM focusing on the following legislation:

H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (Reps. Wenstrup, Bilirakis, Cardenas, Guthrie, Eshoo)
H.R. 2408, the Access to Innovative Treatments Act of 2023 (Reps. Barragan and Joyce)
H.R. 133, the Mandating Exclusive Review of Individual Treatments (MERIT) Act (Reps. Buchanan and Barragan)
H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (Reps. Arrington, Hudson, and Ruiz)
H.R. 1199, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (Reps. Dunn, Peters, Trahan, Blunt Rochester, Miller-Meeks, Tonko, Joyce, Kuster, and Bucshon)
H.R. 3842, the Expanding Access to Diabetes Self-Management Training Act of 2023 (Reps. Schrier, Bilirakis, DeGette, Bucshon, and Ruiz)
H.R. 4818, the Treat and Reduce Obesity Act (TROA) of 2023 (Reps. Wenstrup, Ruiz, and Miller-Meeks)
H.R. 1458, the Access to Prescription Digital Therapeutics Act of 2023 (Reps. Hern, Johnson, and Matsui)
H.R. 2880, the Protecting Patients Against PBM Abuses Act (Reps. Carter and Blunt Rochester)
H.R. 5074, the Kidney PATIENT Act of 2023 (Reps. Carter and Kuster)
H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program. (Rep. Malliotakis)
H.R. 5372, the Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 (Reps. Joyce and Peters)
H.R. 5376, the Share the Savings with Seniors Act (Reps. Miller-Meeks and Peters)
H.R. 5371, the Choices for Increased Mobility Act of 2023 (Rep. Joyce)
H.R. 5394, the Expanding Remote Monitoring Access Act (Reps. Balderson and Porter)
H.R. 5386, the Cutting Copays Act (Reps. McGarvey and Bilirakis)
H.R. 5393, the Transparency and Fairness for Pharmacies Act (Reps. Griffith and Carter)
H.R. 5389, the National Coverage Determination Transparency Act (Rep. Guthrie)
H.R. 5395, the Coverage Parity for Medicare Patients Act of 2023 (Rep. Harshbarger)
H.R. 5396, the Coverage Determination Clarity Act of 2023 (Rep. Bucshon)
H.R. 5392, the Timely Access to Coverage Decisions Act of 2023 (Rep. Dunn)
H.R. 5397, the Joe Fiandra Access to Home Infusion Act of 2023 (Reps. Fitzpatrick and Dunn)
H.R. 5385, the Medicare PBM Accountability Act (Reps. Landsman and Harshbarger)
H.R. 5388, the Supporting Innovation for Seniors Act (Rep. Balderson)
H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. (Rep. Sarbanes)

Read the hearing announcement and bills included in the hearing here.

Chairman Smith Announces Hearing on Reduced Care for Patients: Fallout from Flawed Implementation of Surprise Medical Billing Protections

On Tuesday, House Committee on Ways and Means Chairman Jason Smith (MO-08) announced the Committee will hold a hearing to examine the impact of the failure to fully implement the key patient protections from surprise medical bills contained in the No Surprises Act, signed into law on December 27, 2020. The hearing will take place on Tuesday, September 19, at 10:00 AM. Read the memo here.

Sanders Agrees to Confirmation Hearing for Biden's NIH Nominee

Late last week, Senate Health, Labor, Education and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT), agreed to hold a nomination hearing for Biden’s pick to lead the National Institutes of Health (NIH), Monica Bertagnolli, in October. Sanders had been delaying the hearing over concerns the Biden administration was not doing enough to lower the cost of prescription drugs. On Friday, Sanders said the administration's new contract with Regeneron, a drugmaker developing COVID-19 monoclonal antibodies, gives him hope that the administration is working to keep drug costs low. Read the press release here.

Senators Continue Probe of Organ Recovery Organizations

Late last week, the Senate Finance Committee expanded its bipartisan investigation of the US organ donation system with requests for information from organizations that recover and help transplant human organs from deceased donors. The committee sent inquiry letters to eight organ procurement organizations (OPO), asking for information dating back to 2015 about potential conflicts of interest, and the personal financial interests and business relationships of OPO board members or executives with for-profit or non-profit organizations that conducts business with the OPO. OPOs have faced increased criticism from Congress over questionable spending practices, poor performance, and not making enough organs available for transplant. The letters were each signed by Finance Committee Chairman Ron Wyden (D-OR) and members Charles Grassley (R-IO), Ben Cardin (D-MD), and Todd Young (R-IN). Read the letters here.

House E&C Democrats Praise Biden Administration Push to Curb Short-Term Plans

On Monday, top Democrats on the House Energy and Commerce Committee, including Committee Ranking Member Frank Pallone (D-NJ), Health Subcommittee Ranking Member Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Member Kathy Castor (D-FL), praised a Biden administration proposal to rein in short-term health plans, branded by progressives as “junk plans," in a letter to HHS Secretary Xavier Becerra. The plans offer less expensive medical coverage but often provide fewer protections than required by the Affordable Care Act. Read the letter here.

Senator Warren Urges FTC to Fight ‘Sham’ Drug Patent Tactics Before Vote

Sen. Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) are putting pressure on the Federal Trade Commission (FTC) ahead of a Thursday meeting to take action against drugmakers for allegedly abusing the patent system to cut down competition and keep costs high. In a letter to FTC Chair Lina Khan, Warren and Jayapal wrote that the agency should move to “end Big Pharma’s routine exploitation” of the Food and Drug Administration process for listing drug patents and information of interest to competitors. That process involves the listing of drug information in the FDA’s “Orange Book,” a registry that chronicles patent exclusivity information behind drugs on the market, known officially as Approved Drug Products with Therapeutic Equivalence Evaluations. The request comes ahead of a Thursday FTC vote on whether to issue a policy over drugmakers’ “improper” listing of patents. Read the letter here.

Hospitals Urge Congress to Stop Medicaid Safety Net Funding Cuts

On Thursday, more than 250 safety net hospitals and health systems asked Congress to stop $8 billion in Medicaid cuts set to begin October 1, under the Affordable Care Act. The letter from America’s Essential Hospitals said the reductions in Medicaid disproportionate share hospital funding, which the hospitals receive to offset uncompensated costs incurred in caring for the uninsured, Medicaid beneficiaries, and other low-income and disadvantaged patients, would hamper their ability to help millions of patients. The hospitals said they provide more than $42 billion in uncompensated care each year and their need for DSH funding is greater now because expenses per patient have soared since the pandemic. Medicaid DSH funding is scheduled to be cut $8 billion in each of the fiscal years 2024 through 2027, an annual reduction equal to more than two-thirds of all federal DSH spending. The hospitals are urging Congress to halt at least the $16 billion in cuts for 2024 and 2025. Read the letter here.

Miller-Meeks, Ross, Carter, Peters Introduce the Share the Savings with Seniors Act

Late last week, Representatives Mariannette Miller-Meeks (R-IA), Deborah Ross (D-NC), Buddy Carter (R-GA), and Scott Peters (D-CA) today introduced the Share the Savings with Seniors Act, bipartisan legislation that ensures senior patients with chronic medical conditions directly benefit from the savings that plans and pharmacy benefit managers (PBMs) negotiate on their behalf. This legislation is the House companion to S.2474, the Share the Savings with Seniors Act introduced by Senators John Cornyn (R-TX), Tom Carper (D-DE), Thom Tillis (R-NC) and Sherrod Brown (D-OH). The Share the Savings with Seniors Act would require that patient cost-sharing for medicines used to treat certain chronic conditions is based on the net price the plan pays for the medicine for Part D plans. The requirement would not apply when patient cost-sharing is a fixed copay. Read the press release here, and the bill here.

Senator Marshall Introduces HHS COVID-19 Origin Transparency Act of 2023

On Monday, Senator Roger Marshall (R-KS) introduced the HHS COVID-19 Origin Transparency Act of 2023, legislation that would require the Department of Health and Human Services (HHS) to release all information and records related to the origins of COVID-19 to the public. Earlier this year, Congress passed the COVID-19 Origins Act of 2023, resulting in HHS releasing a summary report of HHS interpretations of the records. This bill would require the Secretary of HHS to publicly release all agency records related to COVID-19 in three separate categories – (1) unpublished HHS records, (2) all HHS records supplied to the Intelligence Community (IC) to augment its analysis, and (3) HHS declassified records. Read the press release here, and the bill here.

Senators Hassan, Braun, and Representatives Kuster, Harshbarger Introduce Bipartisan Bill to Lower Prescription Drug Costs by Cracking Down on Abuses of Medication Patent Process

On Wednesday, Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), as well as Representatives Annie Kuster (NH-02) and Diana Harshbarger (TN-01), introduced bipartisan, bicameral legislation, The Medication Affordability and Patent Integrity Act, to lower prescription drug costs by closing oversight gaps. Oversight gaps have led to incomplete coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), which drug manufacturers are able to use to extend the exclusivity period for a drug by submitting partial information for their initial patent, to help secure subsequent patents down the road. This increases their period of exclusivity and delays the availability of lower-cost alternatives. The Medication Affordability and Patent Integrity Act would require manufacturers to certify that they have not made inconsistent statements to the two agencies. Read the bill here, and the press release here.

Senators Manchin and Rubio Introduce Bipartisan Bicameral Legislation to Protect Healthcare Workers Against Workplace Violence

On Tuesday, Senators Joe Manchin (D-WV) and Marco Rubio (R-FL) introduced the Safety from Violence for Healthcare Employees (SAVE) Act, a bipartisan and bicameral legislation that would create stronger legal penalties for people who knowingly and intentionally assault or intimidate hospital employees. The legislation would protect healthcare workers from violence by creating new criminal penalties for acts of intentional assault. Read the bill here, and the press release here.

Reps. Carter, Krishnamoorthi, Rose, Dingell Introduce Bill Protecting Seniors’ Access to Their Local Pharmacy

On Wednesday, Reps. Earl L. “Buddy” Carter (R-GA), Raja Krishnamoorthi (D-IL), John Rose (R-TN), and Debbie Dingell (D-MI) introduced the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act, which would improve options and access to prescription drugs for seniors bringing pharmacy benefit managers (PBMs) in alignment with Medicare plans, allowing seniors to shop at their local pharmacy. The bill would modernize Medicare and enhance PBM accountability by preventing PBMs from discriminating against pharmacies that are willing to contract with them, helping seniors to seek care closer to home. Read the bill here, and the press release here.

Reps. Burgess, Murphy, and Sen. Barrasso Introduce Bill to Protect Medicare Part B Patients

On Tuesday, Reps. Michael Burgess (R-TX), Gregory Murphy (R-NC), and Senator John Barrasso (R-WY) introduced a bill to protect access to care for vulnerable Medicare patients being treated with Part B covered drugs, including treatments for cancer and other serious diseases. The Protecting Patient Access to Cancer and Complex Therapies Act, would lower reimbursements for providers and require drug manufacturers to send rebates directly to the government for the difference in costs. Read the bill here, and the press release here.

Reps. Dingell and Pallone Introduce Legislation to Strengthen Medicaid and CHIP, Provide Continuous Coverage for Enrollees

On Wednesday, Reps. Debbie Dingell (D-MI) and Frank Pallone, Jr. (D-NJ), Ranking Member of the House Energy and Commerce Committee, introduced the Stabilize Medicaid and CHIP Coverage Act to provide 12 months of continuous coverage for individuals receiving health care through Medicaid or the Children’s Health Insurance Program (CHIP). The Consolidated Appropriations Act of 2023 requires all states to provide 12-month continuous coverage to all children in Medicaid and CHIP beginning January 1, 2024. The legislation expands upon the progress made in that law to require 12-month continuous coverage to all adult Medicaid beneficiaries. Read the bill here, and the press release here.

Rep. Fitzpatrick Introduces Bipartisan Fairness to Kids with Cancer Act

On Tuesday, Brian Fitzpatrick (R-PA) introduced the Fairness to Kids with Cancer Act of 2023 to adjust federal funding levels for pediatric cancer at a fairer percentage rate than the current system allows. The bipartisan legislation would ensure federal funds for pediatric cancer research match the same percentage of the number of Americans younger than eighteen years of age as part of the general population. Read the bill here, and the press release here.

Executive Branch:

White House Cancer Moonshot Announces New Actions and Commitments to End Cancer

On Wednesday, President Joe Biden unveiled a slate of cancer moonshot programs in tandem with a meeting of advisers across agencies who are in his Cancer Cabinet. The initiatives, which are meant to advance the White House's goal of reducing the cancer rate by half over the next 25 years, include more funding for the Advanced Research Projects Agency for Health, additional resources to help Americans quit smoking, and plans to improve cancer research and care for underrepresented communities and veterans. Some of the action items include:

$240 million for ARPA-H: The Advanced Research Projects Agency for Health will fund efforts to prevent, detect and treat cancer, such as tools to detect the disease early.
A biomedical data toolbox: ARPA-H, the National Institutes of Health and the National Cancer Institute will integrate their cancer datasets to make them more helpful to researchers.
A campaign to diversify clinical trials: A new nationwide network, ARPANET-H, will bring clinical trials to underserved communities.
Smoking cessation resources: A $15 million program will seek to reduce menthol and flavored tobacco use. Another drive aims to bring down smoking rates among underserved groups, including the American Indian, Alaska Native and Black communities.

Read the press release here.

CMS Announces Savings for Some People with Medicare on 34 Part B Prescription Drugs

On Wednesday, the Centers for Medicare & Medicaid Services (CMS) announced through the Inflation Reduction Act (IRA), the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Individuals with Medicare who take these drugs are expected to save between $1 and $618 per average dose starting October 1, 2023, depending on individual coverage. Under the IRA, individuals on Medicare may pay a lower coinsurance for some Part B drugs if the price of the drug increases faster than the rate of inflation. Wednesday’s announcement is the third quarterly update of Part B drugs subject to the IRA’s inflation rebate provisions. Read the press release here, and the fact sheet here.

CDC Launches Free COVID-19 Vaccine Program

On Thursday, the Centers for Disease Control and Prevention (CDC) launched a program allowing uninsured people to get free COVID-19 vaccines. The $1 billion Bridge Access Program will make vaccines available at health centers and 20,000 local pharmacies. The vaccines will be available at some locations starting this week, with distribution increasing in the coming weeks. The program is intended for the estimated 25 million to 30 million uninsured adults who otherwise would not have access to COVID-19 vaccines. The program is scheduled to end December 2024. Read the press release here.

DEA to Offer Additional Written Comment Period for Telemedicine Prescribing Rules

On Tuesday, the Drug Enforcement Administration said it will offer an additional written comment period for its telemedicine prescribing rules proposal, signaling it may again need to extend pandemic rules. Under the pandemic public health emergency, the agency allowed the prescribing of controlled substances sans an in-person visit. The agency proposed rolling back those eased rules in February, ahead of the emergency expiration in May. But it reversed course after a record 38,000 comments, many of them negative, and extended pandemic rules through November 11, for new patients and a year further for established ones. Given the tight time frame, the DEA’s additional written comment period signals the DEA is likely to issue another extension.

Federal Trade Commission Addresses the Orange Book and Drug Pricing

On Thursday, the Federal Trade Commission (FTC) voted unanimously to issue a policy statement on patents listed in the FDA’s Orange Book that the agency finds to be blocking generic drug competition. The FDA publishes annual records of approved drugs and patents pertaining to them, allowing generic companies to see which drugs’ patents might be expiring. Improper patents refer to those listed in the Orange Book that pertain to the drug cited, which could be erroneously used to prevent cheaper alternatives from coming to market. FTC Chair Lisa Khan noted that improper patents may have negatively affected the development of generics for brand-name drugs and medical devices for the past 30 years. Read the FTC statement here.

FDA Committee Votes Against Effectiveness of Cold Drug Ingredient

Food and Drug Administration expert advisers on nonprescription medicines voted unanimously today that current scientific data doesn’t support the effectiveness of a common ingredient in over-the-counter cold drugs. The committee’s vote provides the FDA with an opening to withdraw phenylephrine-containing pill products, available in 10-milligram doses, from the market. Industry representatives argued that newer studies the FDA analyzed before today’s meeting were inadequate to support changes to phenylephrine’s status. FDA spokesperson Cherie Duvall-Jones stated if regulators decided to take the next step, the agency would have to issue a proposed order amending its over-the-counter rules for cough and cold drugs to remove phenylephrine as a safe and effective ingredient for OTC cold pills. Read the briefing here.

FDA Approves Updated Covid Shots from Pfizer, Moderna

On Monday, the FDA approved updated COVID-19 shots, which generate immunity against the XBB.1.5 subvariant of Omicron, paving the way for individuals to receive shots later this month. The FDA cleared the new vaccines for everyone, including children as young as 6 months. Manufacturers report that their shots generate immunity against the XBB subvariants of the virus, per the FDA’s June recommendation, as well as the newer EG.5 and FL.1.5.1 subvariants, which currently account for more than 30 percent of cases in the U.S. The vaccine makers also said their shots generate immunity against BA.2.86, a strain circulating globally that appears to have a higher number of mutations and is being monitored by the World Health Organization. Read the press release here.

HHS Announces Details of Partnership with Regeneron to Develop Life-Saving Monoclonal Antibodies

Late last week, the Department of Health and Human Services (HHS) announced new details of its agreement with Regeneron to extend its public-private partnership to develop monoclonal antibodies as part of Project NextGen enhancing preparedness for COVID-19 strains and variants. As part of HHS’ commitment to lowering drug costs, the agreement included a clause that any new Regeneron product commercialized will have list price in the United States equal to or less than its retail price in comparable markets globally. Read the press release here.

Legal & Other:

HHS Files Reply in Support of Request to Dismiss Drug Price Negotiation Lawsuit

Late last week, the Department of Health and Human Services filed a reply in support of its request to dismiss the drug price negotiation challenge from the US Chamber of Commerce and some of its state affiliates. The action is the department’s first move since the Centers for Medicare & Medicaid Services released the list of the 10 Medicare Part D drugs subject to price negotiations starting in 2026. The government argued the case should be dismissed because the plaintiffs’ alleged injuries are speculative, they lack associational standing, their case is not ripe because prices have yet to be finalized, and the multiple lawsuits brought by individual companies that are pending in several courts “renders an association suit unworkable.” The next step in the case is the oral argument set for September 15, where Judge Michael J. Newman will hear the chamber’s motion for a preliminary injunction, as well as the Biden administration’s motion to dismiss the case. Read the case here.

Judge in PhRMA Drug Price Suit to Rule on HHS Motion to Dismiss

On Tuesday, a federal judge ruled on its motion to dismiss litigation over Medicare’s drug price negotiation program from a leading pharmaceutical industry group. Judge Robert Pitman for the US District Court for the Western District of Texas wrote the attorneys on behalf of the Department of Health and Human Services demonstrated “good cause” when they argued the court should modify the existing scheduling order and rule first on whether the groups behind the lawsuit lack standing. The National Infusion Center Association filed the lawsuit in June along with drug industry group the Pharmaceutical Research and Manufacturers of America and the Global Colon Cancer Association.

The organizations are behind one of eight lawsuits currently challenging drug pricing provisions of the Inflation Reduction Act that allow Medicare to negotiate the prices of some of the drugs it spends the most on. Read the case here.