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December 13, 2021

This Week in Health Policy for December 13

This Week (December 13-17)

The Senate Health, Education, Labor and Pensions Committee holds a hearing on the nomination of Robert McKinnon Califf to be commissioner of the Food and Drug Administration.

  • Details: 10:00 AM EST on 12/14/2021
  • Witnesses: The nominee, Robert McKinnon Califf.
  • More information available here.

Last Week (December 6-10)

Health Care Highlights

Build Back Better negotiations continue in the Senate. Majority Leader Chuck Schumer (D-NY) said on the Senate floor Thursday (Dec. 9) that Democratic meetings with the Parliamentarian have concluded and bipartisan "Byrd bath" meetings, "where both sides are together and make their case to the parliamentarian and argue back and forth — we expect those to start next week." Roll Call reported earlier this week, "After text is completed, Republicans will propose Byrd challenges to various provisions they think have only a merely incidental impact on the budget. This triggers the formal parliamentarian review, also known as 'the Byrd bath,' in which Democratic and Republican staff will present arguments on why the provisions should or should not be included in the reconciliation package." Bill text and Congressional Budget Office (CBO) scores from five Senate committees — Banking, Commerce, Indian Affairs, Small Business, and Veterans' Affairs — have been published to date. Finance Committee Chairman Ron Wyden (D-OR) said Senate Democrats expect to release a "placeholder framework" for their version of the reconciliation package shortly.

President Biden touted the drug cost provisions in the Build Back Better Act during a speech on Monday (Dec. 6), highlighting the bill's $35 insulin cost cap, which is considered both one of the most popular drug pricing provisions of the bill and one the most vulnerable to being stripped, should Republicans challenge it based on budget rules. "We can agree that prescription drugs are outrageously expensive in this country," Biden said. "It doesn't need to be that way." Republicans oppose the partisan Build Back Better budget reconciliation bill, but capping insulin costs is a bipartisan policy; the Trump CMS created a demonstration that lets Medicare plans cap monthly insulin costs at $35. The president expressed his support for all the drug pricing provisions in the bill — including Medicare negotiation and inflationary rebate provisions — describing patients who had to take half their doses of medication or go without needed medications altogether because of high prices. He praised drugmakers for developing lifesaving products but said they're gouging consumers. "Nobody is standing up for the patients," Biden said. "Nobody has held the manufactures accountable — until now."

Scheduled cuts to Medicare suspended under provision to address debt limit. On Thursday (Dec. 9), the Senate approved a bill (S. 610) that will allow the Senate to increase the Federal debt limit by a simple majority vote. The process change was appended to a bill that includes relief from provider cuts scheduled to go into effect in 2022, which passed 59-34 under a 50-vote threshold after clearing an earlier procedural vote that required 60 votes and drew support from 14 Republicans. The measure would push into 2023 the balances on statutory "pay-as-you-go" scorecards that would have triggered 4% cuts to Medicare payments next year. It also would hit pause for three months, through March 31, on a 2% automatic cut to Medicare payments required under the Budget Control Act of 2011. Those cuts were most recently suspended through Dec. 31. The measure would also make other Medicare payment changes, including:

  • Increasing payments for physicians by 3% for calendar year 2022, following a 3.75% increase for 2021.
  • Eliminating a 15% reduction in payments for clinical diagnostic lab tests for 2022 and then extending the 15% reduction through 2025.
  • Delaying implementation of a radiation oncology payment model under a 2020 rule from the Centers for Medicare and Medicaid Services (CMS).

The House and Senate must vote on a separate bill to increase the debt limit, likely early next week. The process change was necessary because Republicans won't vote for an increase.

Senate passes measure disapproving vaccinate mandate for private sector. On Wednesday (Dec. 8), the Senate passed a measure disapproving the administration's vaccine requirement for private sector workers by a 52-48 vote, with Democratic Senators Joe Manchin (D-WV) and Jon Tester (D-MT) siding with Republicans in the measure. The vote was largely symbolic, as the Democratic-controlled House is unlikely to take up the resolution of disapproval and if passed, the administration would likely veto. Under the mandate, workers at companies with 100 or more employees would have to be vaccinated against COVID-19 or take tests weekly. A federal court has halted the administration's rule, while another federal court will hear a consolidated case against the mandate.

House members, Hospitals and doctors come out against surprise billing rules. This week, about 150 members of the House wrote Biden administration officials calling on them to amend a rule laying out how providers and insurers should resolve disputes over surprise billing "in order to align the law's implementation with the legislation Congress passed." The American Medical Association, American Hospital Association, and other parties filed also suit against the rule on Thursday (Dec. 9), claiming the new rule places a heavy thumb on the scale of an independent dispute resolution (IDR) process, unfairly benefiting commercial health insurance companies due to its presumption that median in-network rates are the fair price. Health insurers and providers are sharply split over the rule as doctors say they will be hurt by the rule but health insurers and employers argue it will prevent health-care price inflation. The rule and provision are set to take effect Jan. 1, 2022, with arbitrations expected to begin in the spring.

HHS announces efforts to expand access to high-quality maternal health care. As part of Vice President Kamala Harris's Call to Action to Reduce Maternal Mortality and Morbidity, the U.S. Department of Health and Human Services (HHS) announced they are "taking steps to improve maternal health and support the delivery of equitable, high-quality care for pregnancy and postpartum care." CMS intends to propose a "Birthing-Friendly" designation aimed at driving improvements in perinatal health outcomes and maternal health equity. The designation would initially identify hospitals that provide perinatal care, are participating in a maternity care quality improvement collaborative, and have implemented recommended patient safety practices.

Energy and Commerce applauds House passage of health care bills. The House of Representatives passed a total of 15 health care bills initially advanced out of the Energy and Commerce Committee over the past two weeks, which was applauded by leaders on both sides of the aisle. This includes the popular and bipartisan Dr. Lorna Breen Health Care Provider Protection Act (H.R. 1667), legislation that would authorize grants for programs that offer behavioral health services for front-line health care workers, require HHS to recommend strategies to address health care provider burnout, and facilitate resiliency and launch a campaign encouraging health care workers to seek assistance when needed. "The COVID-19 pandemic has underscored just how essential it is to invest in our nation's public health by providing caregivers, providers, and patients with the resources and support they need. With the passage of these 15 bills, Congress is continuing its work to ensure the well-being of the American people by making necessary investments and providing support for frontline health workers and patients," E&C Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) said in a joint press release. Other bills passed included those aimed at funding public health and biomedical research, finding cures and treatments for ALS and other neurodegenerative diseases, advancing preventative care, bolstering public health education, combatting the ongoing substance abuse epidemic, increase access to life-saving vaccines, making critical improvements to maternal health care, and addressing social determinants of health.

FDA approves booster for older teens. On Thursday (Dec. 9), the Food and Drug Administration (FDA) advanced an emergency use authorization that allows 16- and 17-year olds to get booster doses at least six months after receiving their second Pfizer-BioNTech vaccine. The Centers for Disease Control and Prevention (CDC) quickly followed with a recommendation for the booster in the same age group. "We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series," said CDC Director Rochelle Walensky, M.D. The announcement makes millions of more Americans eligible for extra protection as scientists race to study the rapidly spreading omicron variant. More than 24%, or 48 million, of fully-vaccinated adults have received a booster as of Thursday, according to the Centers for Disease Control and Prevention.

NIH veteran tapped for acting director. A veteran and longtime second-in-command at the National Institutes of Health (NIH) will take over as acting director of the agency on Dec. 20 as Francis S. Collins ends his lengthy and distinguished tenure at the lead of the agency. In an largely expected move, HHS Secretary Xavier Becerra announced Lawrence A. Tabak's appointment as acting NIH director. Tabak has served as principal deputy director at the NIH since August 2010.

CMS announces payer-to-payer data exchange enforcement delay. On Wednesday (Dec. 8), CMS announced that health insurers won't be required to implement new rules intended to speed up their data-sharing efforts until the agency establishes a standardized way to share the data. The agency noted that "CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions" and does not expect to take action to enforce compliance until they are able to address certain implementation challenges. The rules were set to take effect next month.

Reports, Studies, and Journals

House of Representatives: Drug Pricing Investigation, Majority Staff Report. As Congress considers provisions in the Build Back Better Act to lower prescription drug prices in the United States, this report presents the findings of the Oversight Committee's nearly three-year investigation into pricing and business practices for branded prescription drugs.

The U.S. Surgeon General's Advisory: Protecting Youth Mental Health. This Advisory offers recommendations for supporting the mental health of children, adolescents, and young adults.

CDC: Community-Based Testing Sites for SARS-CoV-2 — United States, March 2020-November 2021. During March 19, 2020-April 11, 2021, the Community-Based Testing Sites (CBTS) program conducted 11,661,923 SARS-CoV-2 tests at 8,319 locations across the United States and its territories, including 3% administered through Drive-Through Testing, 87% through Pharmacies+ Testing, and 10% through Surge Testing.

Mathematica: Evaluation of the Independence at Home Demonstration. According to a report from consulting firm Mathematica, the Medicare demonstration designed to offer patients improved primary care at home and curb program costs hasn't made a meaningful dent in either goal, putting it at odds with analysis CMS, which has reported savings since the project launched six years ago.

Department of Health and Human Services: Medicare Beneficiaries' Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location. The analysis found that Medicare in-person visits dropped while telehealth visits increased significantly at the start of the pandemic. Subsequently, telehealth visits declined before plateauing by the end of 2020.


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