The following LPG Weekly Healthcare Watch provides a summary update of legislative and regulatory healthcare activities from February 3 – February 9. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
Senate
On February 4, Sen. Roy Blunt (R-MO) called for continuing the delay in the implementation of the Trump administration’s modifications to the national liver distribution policy until the conclusion of ongoing litigation. Sen. Blunt argued that offering organs to the sickest patients within 500 nautical miles of the donor rather than to patients in their immediate community “could burden nearly half the country with increase costs and wait lists, while doing little to increase the total number of transplants or reduce mortality rates nationwide." However, some advocates estimate the policy will save 100 lives every year.
On February 4, it was reported that Sens. Sherrod Brown (D-OH), Bernie Sanders (I-VT), and Richard Blumenthal (D-CT) sent a letter to the Centers for Medicare & Medicaid Services (CMS) on January 28 calling for the Agency to address “upcoding” among Medicare Advantage (MA) plans. The authors cited a December Office of the Inspector General (OIG) report that concluded plan coding practices may have led to $6.7 billion in higher Medicare payments in 2017.
On February 5, the Veterans’ Affairs Committee held a hearing entitled VA MISSION Act: Update on the Implementation of the Community Care Network. Chairman Jerry Moran (R-KS) claimed a successful deployment of the Community Care Network (CCN) is critical to the MISSION’s Community Care Program. CCN has been implemented in four regions so far; lawmakers discussed how to improve the program before it is extended to new areas. Witnesses included: Richard Stone, MD, Executive in Charge, Veterans Health Administration (VHA); Adrian Atizado, National Legislative Director, Disabled American Veterans; Lt. Gen. Patricia Horoho, CEO, OptumServe; and David McIntyre, President & CEO, TriWest Healthcare.
On February 5, the Finance Committee (SFC) held a hearing to consider Sarah Arbes as the next Assistant Secretary of the U.S. Department of Health & Human Services (HHS). Arbes has served as the Principal Deputy of HHS Legislative Affairs for the past three years. Her candidacy was well received by both parties.
On February 5, the Senate voted to acquit President Donald Trump on two articles of impeachment. Sen. Mitt Romney (R-UT) was the only Republican to vote “guilty” on the abuse of power charge; however, only Democrats supported the obstruction charge.
House
On February 3, Reps. Terri Sewell (D-AL), Adrian Smith (D-NE), Tony Cardenas (D-CA), and John Shimkus (R-IL) introduced legislation to restrain the power of the Center for Medicare & Medicaid Innovation (CMMI), claiming the Center needs better accountability and transparency. H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act, would require the HHS Secretary to monitor the effects that a CMMI demonstration has on access to care, create an expedited congressional disapproval process for models, and make additional opportunities for public comment.
On February 5, the Ways & Means (W&M) Health Subcommittee held a hearing entitled More Cures for More Patients: Overcoming Pharmaceutical Barriers. Subcommittee Chairman Lloyd Doggett (D-TX) argued that if lawmakers pass policies giving manufacturers stronger incentives to create groundbreaking therapies, rather than focusing on small tweaks to existing drugs and follow-up therapies, then more cures will be available to more patients. Lawmakers heard from expert witnesses on how House Democrats’ drug package (H.R 3) would influence innovation, ways the Tax Cuts and Jobs Act of 2018 has impacted the pharmaceutical sector, tradeoffs of patient assistance programs, and why the Part D benefit should be redesigned. Members from both parties strongly supported passing a drug pricing package; however, Republicans pushed for their drug bill (H.R. 19) while Democrats stayed loyal to H.R. 3. Witnesses included: Juliana Keeping, Patient Advocate; Brad Setser, Senior Fellow for International Economics, Council on Foreign Relations; Ge Bai, Associate Professor of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health; Aaron Kesselheim, MD, Professor of Medicine, Harvard Medical School/Brigham and Women’s Hospital; and Tara O’Neill Hayes, Director of Human Welfare Policy, American Action Forum.
On February 5, the Energy & Commerce (E&C) Oversight & Investigations Subcommittee held a hearing entitled Vaping in America: E-Cigarette Manufacturers Impact on Public Health. Subcommittee Chair Diana DeGette (D-CO) argued the Food & Drug Administration’s (FDA) recent “flavor ban” does not sufficiently deter youth vaping because menthol flavored products remain available at gas stations and convenience stores and additional flavors can still be purchased at vape shops. She maintained that “industry caused this mess, and industry needs to be responsible for cleaning it up.” Witnesses included: K.C. Crosthwaite, CEO, JUUL Labs, Inc.; Ricardo Oberlander, President & CEO, Reynolds American Inc.; Ryan Nivakoff, CEO, NJOY, LLC; Antoine Blonde, President, Fontem U.S.; and Jerry Loftin, President, Logic Technology Development, LLC.
On February 5, the Appropriations Energy & Water Development & Related Agencies Subcommittee held a hearing entitled The U.S. Department of Energy’s (DOE) Role in Advancing Biomedical Sciences. Subcommittee Chair Carolyn Kaptur (D-OH) called the hearing to examine how technology developed by the DOE can strategically be used to advance biomedical sciences and, in turn, “probe the medical unknowns.” Witnesses included: Mark Chance, MD, Director of the Center for Proteomics and Bioinformatics, School of Medicine, Case Western University; Narayanan “Bobby” Kasthuri, MD, Neuroscientist, Argonne National Laboratory; and Harold Varmus, Lewis Thomas University Professor, Weill Cornell Medicine.
On February 5, the Foreign Affairs Committee held a hearing entitled The Wuhan Coronavirus: Assessing the Outbreak, the Response, and Regional Implications. Democrats criticized the CDC and the State Department for failing to send officials to testify. They also feared the Administration’s travel restriction and quarantine policies could do unintended harm, including inviting prejudice against Asian Americans. Members from both parties raised concerns with the reluctance of the Chinese government to accept foreign aid. Witnesses included: Jennifer Nuzzo, Associate Professor & Senior Scholar, Center for Health Security, Johns Hopkins University; Jennifer Bouey, Senior Policy Researcher & Tang Chair in China Policy Studies, RAND Corporation; and Ron Klain, former White House Ebola Response Coordinator.
On February 5, the Foreign Affairs Committee held a hearing entitled Unique Challenges Women Face in Global Health. As described by Chairman Eliot Engel (D-NY), women live fuller, more prosperous lives when they have access to health care, including reproductive health and family planning services. Appropriations Chair Nita Lowey (D-NY) encouraged the Committee to take up her bill, the Global Health, Empowerment, and Rights (HER) Act, which would overturn the Mexico City policy. This so-called “global gag rule” bans U.S. aid to any non-governmental organization that provides abortion-related services. It has been reinstated and expanded under the Trump administration. Witnesses included: Jennifer Kates, Senior Vice President & Director of Global Health & HIV Policy, Kaiser Family Foundation, Sheba Crocker, Vice President for Humanitarian Policy & Practice, CARE; and Mulumba Moses, Executive Director, Center for Health, Human Rights & Development.
On February 6, the House voted 230-190 to pass H.Res. 826, a symbolic statement condemning the Trump administration’s new Healthy Adult Opportunity (HAO) initiative that gives states power to convert Medicaid funding into block grants. CMS Administrator Seema Verma contends that Democrats’ response to the proposal is an overreaction, noting that “only in Washington is an attempt to slow the growth of a program to the rate of inflation considered a devastating cut.”
On February 7, the W&M Committee released the Consumer Protections Against Surprise Medical Bills Act of 2020, bipartisan draft legislation aimed at protecting patients from surprise medical bills. The measure would let providers and payers engage in open negotiations to resolve out-of-network billing disputes. However, if they do not reach a solution within 30 days, then an independent arbiter would step in. HHS would have wide discretion to determine mediation rules. The proposal, summarized here, will be marked up on February 12.
On February 7, the Education & Labor (E&L) Committee also unveiled a plan to protect patients from surprise bills. H.R. 5800, the Ban Surprise Billing Act, would establish two mechanisms to resolve payment disputes between providers and payer. A benchmark rate would be used to resolve bills $750 or less ($25,000 for air ambulance services); for claims above this threshold, providers and payers could appeal to an independent arbiter. This matches the payment resolution method included in the E&C-HELP Committee proposal. E&L will mark up its proposal on February 11.
On February 7, House voted 257-149 to pass H.R. 5687, a bill to direct $4.7 billion disaster relief package to Puerto Rico. The Senate is not expected to pass the measure at this time.
The W&M Committee has been working on a hospice bill to address concerns raised by OIG in July 2019. Specifically, the measure is intended to improve education and training and to bring hospice into parity in terms of oversight programs that are present in the home health program. It is not driven by score, meaning the goal is not to have the bill save money to pay for other priorities. The Committee plans to mark up the stand-alone measure on February 12 and with the hopes of linking it to the May extenders package.
REGULATORY UPDATE
On February 2, HHS Secretary Alex Azar notified Congress that he may need to shift up to $136 million from other Department accounts to help combat the evolving coronavirus epidemic. Secretary Azar said $75 million will be distributed to the CDC, $52 million the Office of the Assistant Secretary for Preparedness & Response (ASPR), and $8 million to the Office of Global Affairs. As of February 3, HHS had already spent $105 million on efforts to contain the virus. Top House appropriators responded by asking Secretary Azar to submit an emergency funding request to collect additional funds from Congress, rather than shifting resources from other HHS accounts. However, Azar contends that additional funding is not necessary at this time.
On February 5, the World Health Organization (WHO) announced it is seeking $675 million to address the outbreak, largely to help countries with low public health infrastructure. The U.S. government and the Bill & Melinda Gates Foundation have already donated $100 million each.
On February 5, CDC began shipping diagnostic test kits to public health laboratories in the U.S., allowing states to report confirmed cases without sending samples to CDC headquarters in Atlanta.
On February 7, the WHO predicted there will be a shortage of protective medical gear if the epidemic persists.
As of February 7, CDC confirmed 12 cases in the U.S., 31,000 worldwide, and at least 636 deaths.
On February 3, the Federal Trade Commission (FTC) and the FDA announced a joint partnership to address false or misleading promotions of biologic medicines that could undermine biosimilar competitors. The FTC and FDA will hold a public workshop on building a competitive marketplace for biosimilars on March 9.
On February 4, President Trump delivered his State of the Union address. He referenced SFC’s drug package (S. 2543) but did not explicitly endorse it. Specifically, he said "I have been speaking to Senator Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done and done properly.” He also promised that if Congress passes "bipartisan legislation that achieves the goal of dramatically lowering prescription drug prices,” then he would “sign it into law without delay." In addition, President Trump denounced Democrats’ “socialists” plans for single-payer health care and their efforts to extend coverage to undocumented populations. He also touted bipartisan efforts to improve kidney disease treatments, increase transparency, protect patients with pre-existing conditions, and mitigate the opioid epidemic. Despite rumors prior to the address, the President did not unveil a plan to lower out-of-pocket costs for diabetes medications and did not mention the International Pricing Index (IPI) Model.
On February 5, CMS released the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit (Part D) Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly proposed rule. Within Part D, CMS is proposing to (1) allow plan sponsors to establish a second, “preferred,” specialty tier at a lower cost-sharing threshold than the current specialty tier; (2) codify the existing maximum cost sharing for the highest specialty tier (between 25-33%); (3) codify a methodology to determine annually the specialty tier cost threshold using ingredient cost and increase the threshold when certain conditions are met; (4) require sponsors to permit tiering exceptions between the two specialty tiers; and (5) permit sponsors to determine which drugs go on either tier (subject to CMS formulary review and approval process). Additionally, CMS is proposing to require that each Part D plan implement a Real Time Benefit Tool that provides beneficiaries with patient-specific formulary and benefit information by January 1, 2022. CMS is also proposing to codify provisions of the 21st Century Cures Act that allow Medicare-eligible individuals with ESRD to enroll in MA plans beginning January 1, 2021. Comments on the proposed rule are due on April 6. A fact sheet is available here.
On February 5, CMS released the 2021 MA and Part D Advance Notice Part II. CMS plans to increase the payment to insurers by 0.93% in 2021, down from the 2.5% increase in 2020. The Notice includes proposals to change MA’s risk adjustment model and reliance on encounter data, as well as the MA and Part D star ratings programs. Notably, the Agency is seeking comment on whether to create a star rating measure that promotes biosimilar and generic utilization. CMS will not publish a Call Letter for 2021; instead, the guidance typically included in the annual Call Letter will be codified through the CY2021 and 2022 MA and Part D Proposed Rule. Comments are on Parts I and II of the Advance Notice are due on March 6 and the final rate announcement will be released on April 6. A fact sheet is available here.
On February 6, FDA released guidance to speed-up the approval process of applications from biosimilar manufacturers seeking to expand the use of their product to a secondary health condition. The Agency is aiming to shorten its expanded use application reviews from 10 months to six.
On February 6, it was reported that FDA’s Oncology Center for Excellence is working with Friends of Cancer Research and the American Society of Clinical Oncology on guidance to broaden the number of cancer patients eligible to join clinical trials. The guidance may be released later this year.
On February 6, Georgia Gov. Brian Kemp (R) asked CMS to pause its review of their 1332 waiver request to allow people to receive employer contributions on top of federal subsidies to purchase private insurance in the individual marketplace. Later that day, Gov. Kemp applauded the Administration for releasing the HAO initiative.
On February 7, Arkansas Gov. Asa Hutchinson (R) expressed intent to pursue a partial Medicaid block grant under CMS’s HAO demonstration.
On February 10, the White House is expected to unveil the President’s budget request for FY2021.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT AND BUDGET (OMB)
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments (CMS-3337-P); Proposed Rule; Received 6/6/2019
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/2019
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
Comprehensive Care for Joint Replacement Model Three Year Extension and Modifications to Episode Definition and Pricing (CMS-5525-P); Proposed Rule; Received 8/22/2019
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Strengthening the Program Integrity of the Medicaid Eligibility Determination Process (CMS-2421-P); Proposed Rule; Received 12/20/2019
Interoperability and Patient Access (CMS-9115-F); Final Rule; Received 9/26/2019
Preadmission Screening and Resident Review–Update (CMS-2418-P); Proposed Rule; Received 10/31/2019
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482-P); Proposed Rule; Received 12/27/19
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2021 Rates (CMS-1735); Proposed Rule; Received 1/30/2020
Advance Notice of Methodological Changes for Calendar Year (CY) 2021 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies (Part II); Notice; Received 12/13/2019
SHHS-FDA
Institutional Review Boards; Cooperative Research; Proposed Rule; Received 10/31/2019
HHS-OIG
Civil Monetary Penalties Law Notice of Proposed Rulemaking; Proposed Rule; Received 1/23/2020
HHS-ONC
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program; Final Rule; Received 10/28/2019
HHS-HRSA
Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program Eligibility Guidelines; Notice; Received 11/8/2019
REPORTS
Government Accountability Office (GAO)
On February 7, GAO released a report entitled Defense Health Care: Plans Needed to Ensure Implementation of Required Elements for TRICARE's Managed Care Support Contracts. In 2016, Congress required the Department of Defense (DoD) to develop a strategy to improve TRICARE that addressed 13 specific elements related to health care delivery, including provider networks, telehealth services, and referrals, among others. GAO found that DoD has only implemented six of these elements so far; it recommends for the Department to outline a strategy to complete the remaining elements.
Congressional Budget Office (CBO)
CBO is expected to release a cost estimate of S. 2543, the Prescription Drug Pricing Reduction Act of 2019 very soon.
Office of Inspector General (OIG)
On February 3, OIG posted a report entitled Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder. OIG claims that access to buprenorphine services remains difficult in many locations, despite increases in the number of waivered providers. Of the 1,000 countries most at risk to insufficient access, over half did not have adequate capacity to treat patients with buprenorphine in office settings. Therefore, OIG recommends that the Substance Abuse & Mental Health Services Agency target its efforts to increase the participation of waivered providers in high-need counties.
On February 4, OIG issued a report entitled Missouri Medicaid Fraud Control Unit (MFCU): 2018 Onsite Inspection. During fiscal years 2016-18, OIG found that the Missouri MFCU generally complied with applicable laws, regulations, policy transmittals. However, they also found several ways the MFCU could improve adherence to federal performance standards.
On February 6, OIG posted a report entitled New York Claimed Tens of Millions of Dollars for Opioid Treatment Program (OTP) Services That Did Not Comply with Medicaid Requirements Intended To Ensure the Quality of Care Provided to Beneficiaries. OIG estimates that New York improperly claimed at least $39.3 million in Federal Medicaid reimbursement for OTP services during CYs 2014-2017. It recommends that New York (1) refund $39.3 million to the Federal Government, (2) ensure that providers comply with Federal and State requirements for providing and claiming reimbursement for OTP services, and (3) implement procedures to detect and prevent duplicate claims for OTP services.
UPCOMING HEARINGS
Senate
Judiciary Committee
February 11, 10:00 a.m., 226 Dirksen Senate Office Building
The Infant Patient: Ensuring Appropriate Medical Care for Children Born Alive
Details will be forthcoming.
Senate Aging Committee
February 12, 9:30 a.m., 366 Dirksen Senate Office Building
There’s No Place Like Home: Home Health Care in Rural America
Witnesses included: LeighAnn Howard RN, DNP, CHFN-K, Director Home Health and Specialty Programs, Northern Light Home Care & Hospice; William Dombi President, National Association for Home Care & Hospice; Warren Hebert, DNP, RN, CAE, FAAN, Assistant Professor & CEO, Loyola University and Home Health Care Association of Louisiana; and Francis Adams, Home Care Worker
Senate Finance Committee
February 13, 9:30 a.m., 215 Dirksen Senate Office Building
The President’s Fiscal Year 2021 HHS Budget
HHS Secretary Azar will testify.
House
Education & Labor Committee
February 11, 10:15 a.m., 2175 Rayburn House Office Building
Markup on Surprise Billing Legislation
Members will consider H.R. 5800, the Ban Surprise Billing Act.
Education & Labor Workforce Protections Subcommittee
February 11, 2:00 p.m., 2175 Rayburn House Office Building
Balancing Work, Health, and Family: The Case for Expanding the Family and Medical Leave Act
Details will be forthcoming.
Energy & Commerce Health Subcommittee
February 12, 10:00 a.m., 2123 Rayburn House Office Building
Protecting Women’s Access to Reproductive Health Care
Members will consider H.R. 2975, the Women's Health Protection Act of 2019
Witnesses include: Holly Alvarado, Advocate; Teresa Stanton Collett, JD, Professor of Law; Georgette Forney, President of Anglicans for Life, Co-founder of the Silent No More Awareness Campaign; Nancy Northup, President & CEO, Center for Reproductive Rights; and Yashica Robinson, Medical Director, Alabama Women's Center for Reproductive Alternative.
Ways & Means Committee
February 12, time TBA, 1100 Longworth House Office Building
Markup on Surprise Billing and Hospice Legislation
Members will consider the H.R._, the Consumer Protections Against Surprise Medical Bills Act of 2020 and a yet-to-be introduced hospice bill by Reps. Jimmy Panetta (D-CA) and Tom Reed (R-NY)
Secretary Azar is expected to testify before the W&M and E&C Committees on the President’s FY2021 HHS budget proposal during the last week of February.
OTHER HEALTH POLICY NEWS
On February 3, the Trump administration and the GOP attorney generals suing to overturn the Affordable Care Act (ACA) asked the Supreme Court not to consider their case, Texas v. Azar, in the fall. The Court already rejected a requested by the Democratic attorney generals defending the constitutionality of the ACA to consider the suit on an expedited basis this spring. On February 21, the Court will decide whether (and when) to hear the case or return it to a Texas district court.
On February 3, the Iowa Democratic Caucus was held, with Sen. Bernie Sanders and former Mayor Pete Buttigieg finishing at the top. Next to winning the general election, health care was the top issue among participants. Out of all caucus-goers, 40% claimed health care was their main priority, 70% supported a single-payer plan, and 90% supported a public option.
On February 4, the 75 organizations claiming to represent fiscal conservatives and free market activists sent President Trump and GOP lawmakers a letter arguing against tackling drug prices by way of government “price controls.” The authors claim that "whether it is called price fixing, rate setting, subsidy capping, or inflation capping, government price controls have wormed their way into the health care reform plans of too many of our friends in Washington."
On February 4, the Campaign for Sustainable Rx Pricing announced a seven-figure advertisement campaign to pressure policymakers to pass drug-pricing legislation. The ads will run in nine presidential and Senate “battleground” states
On February 5, executives from Epic and 60 health systems sent Secretary Azar a letter asking the Trump administration to modify proposed new rules aiming to make it easier for patients to access their own health care data. The authors claim the rules would be overly burdensome for providers and could threaten patient privacy; therefore, they are requesting for the regulations to be narrowed and be implemented more slowly.
Democratic lawmakers in Colorado are anticipated to introduce public option legislation in the coming weeks. The proposal is expected to mirror Gov. Jared Polis’ (D) plan, which would cap payments to hospitals and make Medicaid payment contingent upon participating in the public option program.
The Abigail Alliance, a trade association that promoted the federal right-to-try law, is working on draft state legislation to ensure insurers cover experimental drugs. In 2018, President Trump signed legislation, dubbed “right-to-try,” that allows patients to require access to certain drugs with a pending FDA approval directly from manufacturers, but such treatments are rarely covered. Their model legislation would require insurers to cover federally eligible experimental therapies "on a basis no less favorable than hospice and palliative care."
On February 10, the White House will meet with the National Governors Association to discuss drug pricing proposals.