On Wednesday, the House of Representatives passed the CHOICE Arrangement Act (H.R. 3799) by a mostly party-line a 220-209 vote. The CHOICE Arrangement Act codifies a Trump Administration rule which allowed small businesses to reimburse employees for buying their own health insurance on the individual market. Read the statement by House Ways & Means Chairman Jason Smith (R-MO). Separately, the House passed H.R. 3801 the Employer Reporting Improvement Act, as amended and H.R. 3797 the Paperwork Burden Reduction Act, as amended.

The House Energy and Commerce Committee Subcommittee held a hearing Thursday examining the successes and remaining challenges of Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

The House Energy and Commerce Health Subcommittee held a hearing Wednesday to discuss reauthorization of the SUPPORT Act. Mehlman Consulting’s summary of the hearing can be found here.

President Joe Biden will sign an executive order today directing an array of federal agencies to explore new rules to make more forms of birth control available to more people at lower cost. The new order asks cabinet secretaries of several departments, including Defense, Treasury, Labor and Health and Human Services, to consider issuing guidance and binding rules to help people on Medicaid, Medicare and private insurance who use birth control. Read the full press release here.

Centers for Medicare & Medicaid Services (CMS) announced a proposal today on the Transitional Coverage for Emerging Technologies (TCET) pathway, as part of its commitment to fostering innovation while ensuring faster and more consistent access to emerging technologies. Additional information on today’s releases can be found here and here.

U.S. Senators Braun (R-IN), Hassan (D-NH), and Kennedy (R-LA) introduced S. 1869, the Site-based Invoicing and Transparency Enhancement (SITE) Act, to end exceptions to the 2015’s Bipartisan Budget Act site-neutral payment requirements. The press release can be found here.

U.S. Senators Tester (D-MT), Moore Capito (R-WV), Brown (D-OH), and Lankford (R-OK) introduced S. 1909, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. The bill is intended to ensure that all pharmacy price concessions are assessed at the point of sale and eliminate the retroactive nature of direct and indirect remuneration (DIR) clawback fees. Under the bill all pharmacy price concessions must be included at the point-of-sale so that an individual’s cost-sharing will reflect all possible discounts. The press release can be found here.

U.S. Senators Carper (D-DE) and Tillis (R-NC) introduced the Medical Supply Chain Resiliency Act, legislation that would authorize the President to engage in trade negotiations in order to ensure that critical medical goods and services are delivered safely, swiftly, and efficiently to patients in the United States and around the world. The press release can be found here.

Bipartisan lawmakers urge changes to Biden Administration proposed rule on prior authorization with more than 230 House Members and 61 senators releasing letters this week urging the Centers for Medicare & Medicaid Services (CMS) to make changes to a rule to require health insurance companies to modernize the way they process requests from providers to authorize treatments. Read more here.

Six senators, Thune (R-SD), Stabenow (D-MI), Moore Capito (R-WV), Baldwin (D-WI), Moran (R-KS), and Cardin (D-MD), released a letter calling for stakeholder feedback regarding the 340B Drug Discount Program. Within the letter, the Senators stated the goal of their efforts is to clear ambiguity in the program and the need to strengthen oversight and accountability of the program. Responses are due by July 28^th. Read the letter here.

Biden Administration misses the June 18th deadline, for the Office of the Director of National Intelligence to declassify Covid-19 origin intelligence, passed without information being made public. Congress unanimously passed the Covid-19 Origin Act of 2023, a bill to declassify intelligence on the origins of Covid-19, in March of this year. Read the full article here.

Pharmaceutical Research and Manufacturers of America (PhRMA) and others filed a lawsuit against the Biden Administration on Wednesday, arguing that the Inflation Reduction Act’s Drug Price Negotiation Program violates the Fifth and Eight Amendments. PhRMA joins a drug company Merck, the U.S. Chamber of Commerce and Bristol Myers Squibb in filling separate lawsuits against the Biden Administration. Read the more here.

U.S. Preventive Services Task Force (USPSTF) recommended for the first time, Americans ages 19 to 64 be screened for anxiety. In addition, the task force recommends that all adults get screened for depression, regardless of risk factors like family history or adverse life events. Read the article here.

House of Representatives Passes Legislation to Provide Health Benefit Choices and Flexibility for Small Businesses  

On Wednesday, the House passed the CHOICE Arrangement Act (H.R. 3799) by a mostly party-line a 220-209 vote. The CHOICE Arrangement Act codifies a Trump Administration rule which allowed small businesses to reimburse employees for buying their own health insurance on the individual market. House Ways & Means Chairman Jason Smith (R-MO) said in a statement that “This bill gives small businesses the opportunity, if they so choose, to shed the administrative burden of managing traditional insurance coverage. At the same time, it gives workers more options for their own health care and makes that coverage portable.” Read the statement. Separately, the House passed two other less controversial bills regarding employer health benefit reporting by voice vote. These are: H.R. 3801 Employer Reporting Improvement Act, as amended (Sponsored by Rep. Smith (R-NE) / Ways and Means Committee) and H.R. 3797 – Paperwork Burden Reduction Act, as amended (Sponsored by Rep. Smith (R-MO) / Ways and Means Committee).

On Thursday, the House Energy and Commerce Committee’s Subcommittee on Oversight held a hearing to examine the successes and remaining challenges of Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. The hearing, entitled “MACRA Checkup: Assessing Implementation and the Challenges that Remain for Patients and Doctors,” will feature the following witnesses:

On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing Wednesday to discuss reauthorization of the SUPPORT Act. Health subcommittee members considered 28 bills, most of them bipartisan, to improve mental health and addiction treatment services, to allow federal funds to pay for test strips that can detect drugs like fentanyl and the horse tranquilizer xylazine that dealers often mix it with, and to train more health providers to treat people with substance use disorder. Mehlman Consulting’s summary of the hearing can be found here. Witnesses featured at the hearing included:

Today, President Joe Biden will sign an executive directing an array of federal agencies to explore new rules to make more forms of birth control available to more people at lower cost. The new order asks cabinet secretaries of several departments, including Defense, Treasury, Labor and Health and Human Services, to consider issuing guidance and binding rules to help people on Medicaid, Medicare and private insurance who use birth control. It also includes efforts to boost access for the uninsured, including support for the Title X family planning program and assistance obtaining over-the-counter contraception. The order also aims to address widespread reports of insurance companies violating the Affordable Care Act’s mandate that all forms of FDA-approved contraception be available to patients without cost-sharing. Read the full press release here.

Today, the Centers for Medicare & Medicaid Services (CMS) announced a proposed a Transitional Coverage for Emerging Technologies (TCET) pathway as part of its commitment to fostering innovation while ensuring faster and more consistent access to emerging technologies. The proposed procedural notice outlines the new expedited Medicare coverage pathway. The TCET pathway, which is voluntary and applies to certain FDA-designated Breakthrough Devices, supports innovation by providing an efficient, predictable, and transparent coverage review process while developing robust safeguards for the Medicare population. In addition, CMS released three proposed guidance documents: 1) Coverage with Evidence Development; 2) Evidence Review and 3) Clinical Endpoints Guidance for Knee Osteoarthritis. Additional information on today’s releases can be found here and here.

U.S. Senator Mike Braun (R-IN), Maggie Hassan (D-NH), and John Kennedy (R-LA) introduced S. 1869, the Site-based Invoicing and Transparency Enhancement (SITE) Act. The SITE Act would end exceptions to the 2015’s Bipartisan Budget Act site-neutral payment requirements. It would also prevent off-campus emergency departments from charging higher rates than on-campus emergency departments when standalone emergency facilities are near a hospital campus. The bill also requires that health systems establish, and bill using a unique National Provider Identifier number for each off-campus outpatient department and directs HHS to treat outpatient departments as subparts of the parent organization and to issue these subparts unique provider identifiers. The bill removes liability for services rendered for payers that are not billed in accordance with this section’s requirements. The SITE Act would also respond to nursing shortages through reinvesting $100M in savings from this bill into a national nurse training program, which bill sponsors say would create 20,000 training positions annually and establish a graduate nursing education program to provide payments for qualified advanced practice registered nurse (APRN) training costs. The press release can be found here.

U.S. Senators Jon Tester (D-MT), Shelley Moore Capito (R-WV), Sherrod Brown (D-OH), and James Lankford (R-OK) introduced legislation to reform direct and indirect renumeration (DIR) fees between PBMs and pharmacies. S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act, aims to ensure that all pharmacy price concessions are assessed at the point of sale and eliminate the retroactive nature of direct and indirect remuneration (DIR) clawback fees. It redefines “negotiated price” under statute to include all pharmacy price concessions at the point-of-sale so that an individual’s cost-sharing will reflect all possible discounts. Further it aims to improve transparency in price concessions and fees, by requiring prescription drug plans and Medicare Advantage drug plans to report any pharmacy price concession or incentive payment they apply after the point-of-sale to a pharmacy. The press release can be found here.

U.S. Senators Tom Carper (D-DE) and Thom Tillis (R-NC) introduced the Medical Supply Chain Resiliency Act, legislation that would authorize the President to engage in trade negotiations in order to ensure that critical medical goods and services are delivered safely, swiftly, and efficiently to patients in the United States and around the world. This legislation would combat shortages of medical products and supplies by strengthening supply chain resiliency and safeguarding against future health crises. The legislation would allow the President to negotiate with a group of “trusted trading partners,” countries with a demonstrated commitment to global health security, rule of law, and transparency to ensure that health care providers and patients can access life-saving medical products. The press release can be found here.

More than 230 House Members and 61 senators released letters this week urging the Centers for Medicare & Medicaid Services (CMS) to make changes to a rule that, when finalized, would require health insurance companies to modernize the way they process requests from providers to authorize treatments. Lead by Senator John Thune (R-SD) and Rep. Suzan DelBene (D-WA), the bipartisan group of lawmakers are urging CMS to include in any final rule some key provisions from the Improving Seniors’ Timely Access to Care Act which include 1) real-time prior authorization for routine matters 2) A 24-hour deadline for Medicare Advantage plans to answer prior authorization request for ‘urgently needed care’ and 3) more detailed transparency metrics. Read more here.

A bipartisan group of six senators, John Thune (R-SD), Debbie Stabenow (D-MI), Shelley Moore Capito (R-WV), Tammy Baldwin (D-WI), Jerry Moran (R-KS), and Ben Cardin (D-MD), released a letter calling for stakeholder feedback regarding the 340B Drug Discount Program. The 340B program requires that drug manufacturers who participate in Medicaid provide certain non-profit health care providers, hospitals, and clinics (covered entities) a discount on outpatient drugs. Within the letter, the Senators stated the goal of their efforts is to clear ambiguity in the program and the need to strengthen oversight and accountability of the program. Responses are due by July 28^th. Read the letter here.

A June 18th deadline, for the Office of the Director of National Intelligence to declassify Covid-19 origin intelligence, passed without information being made public. Congress unanimously passed the Covid-19 Origin Act of 2023, a bill to declassify intelligence on the origins of Covid-19, in March of this year. Senator Hawley (R-MO), who sponsored the bill, tweeted Tuesday for the intelligence to be released “now”. The Office of the Director of National Intelligence and the White House did not respond to a query about the delay. Read the full article here.

On Wednesday, the Pharmaceutical Research and Manufacturers of America (PhRMA) and others filed a lawsuit against the Biden Administration arguing that the Inflation Reduction Act’s Drug Price Negotiation Program violates the Fifth and Eight Amendments. In a press conference, James Stansel, PhRMA’s general counsel stated that “HHS could literally choose any number under the maximum and manufacturers would be forced to accept that price. And unfortunately, HHS has taken the most extreme and aggressive decision at every turn”. PhRMA joins a drug company Merck, the U.S. Chamber of Commerce and Bristol Myers Squibb in filling separate lawsuits against the Biden Administration. Read the more here.

The U.S. Preventive Services Task Force (USPSTF) recommended for the first time that Americans ages 19 to 64 be screened for anxiety. USPSTF is made up of independent health experts who practice in a variety of fields that range from family medicine, pediatrics to gynecology. In addition, the task force recommends that all adults get screened for depression, regardless of risk factors like family history or adverse life events. Read the article here.

None. House and Senate are not in session for the next two weeks and will reconvene July 10^th (Senate) and July 11^th (House & Senate).