The following LPG Weekly Health Care Watch provides a summary update of legislative and regulatory health care activities from March 30– April 5. 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
The Senate stands in recess until at least April 20.
House
The House stands in recess until at least April 20.
REGULATORY UPDATE
On April 1, the Food & Drug Administration (FDA) requested drug manufacturers immediately remove certain prescriptions and over-the-counter heartburn medications from the market because of contamination concerns. Specifically, the FDA reports that ranitidine drugs, such as Zantac, may contain impurities of a carcinogen, N-Nitrosodimethlyamine.
CORONAVIRUS UPDATE
On March 29, President Donald Trump announced social distancing guidelines will be extended through April 30. On April 1, Surgeon General Jerome Adams said he believes the such guidance will extend beyond April.
On March 29, FDA issued an emergency use authorization (EUA) for the use of hydroxychloroquine and chloroquine, which have been used to treat malaria for decades, for the treatment of COVID-19. Specifically, FDA is allowing the drugs to be "donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.” As a condition of EUA, public health authorities must have a process in place for monitoring adverse event reporting and compliance so that all adverse events and medication errors associated with use of chloroquine and hydroxychloroquine are reported to FDA. According to two White House officials, the Administration is urging the Centers for Medicare & Medicaid Services (CMS) to find a reimbursement pathway for the experimental treatments.
On March 29, CMS sent a letter to hospitals on behalf of Vice President Mike Pence asking for information on testing, bed capacity, and medical supplies to be reported to the U.S. Department of Health and Human Services (HHS). CMS is collecting the information to better identify supply and bed capacity needs, as well as enhance COVID-19 surveillance efforts.
On March 29, former FDA commissioners Scott Gottlieb and Mark McClellan posted a white paper outlining a long-term pathway to recover from the pandemic. They propose dividing the response into four phases: 1) slow the spread through a broad shutdown; 2) reopen states gradually based on the risk of local spread and with continued measures to prevent mass gatherings and protect the vulnerable populations; 3) establish immune protections and lift physical distancing; and 4) invest in preparedness to ensure that America is ready to face the next infectious disease threat.
On March 30, Johnson & Johnson announced that the vaccine (Ad26 SARS-CoV-2) they are developing in partnership with the Biomedical Advanced Research & Development Agency may be ready for emergency use as soon as early 2021. Phase 1 trials for the vaccine are expected to launch no later than September.
On March 30, the Federal Communications Commission Chairman Ajit Pai announced a COVID-19 Telehealth Program, which would distribute $200 million appropriated in H.R. 748 to providers that need assistance purchasing telecommunications, broadband connectivity, and devices necessary for providing telehealth services. Notably, for-profit hospitals would not be eligible for the funds. Additionally, Commissioner Pai unveiled a final rule for a three-year Connected Care pilot program that would cover 85% of telehealth expenses incurred by low-income patients and veterans. The plan has received enough votes to ensure adoption.
On March 30, Ford and General Electric (GE) Healthcare announced plans to begin producing Airon Corp’s simplified ventilator by April 2. The manufacturers aim to produce 50,000 machines within the next 100 days and 30,000 a month thereafter.
On March 30, FDA issued guidance that temporarily expands permittable types of gowns, gloves and other apparel to be used as personal protective equipment (PPE) in health care settings.
On March 30, CMS issued an interim final rule (IFR) entitled, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. A press release is available here. Comments are due on June 1. The rule is effective retroactive to March 1, 2020, until the end of the Public Health Emergency (PHE) declaration. The IFR includes the following policies:
temporarily updating Medicare payment so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics, and federally qualified health centers are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks;
expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Part B;
making programmatic changes to the Medicare Diabetes Prevention Program and the Comprehensive Care for Joint Replacement Model, and program-specific requirements for the Quality Payment Program;
modifying the calculation of the 2021 and 2022 Part C and D Star Ratings;
amending the Medicaid home health regulations to allow other licensed practitioners to order home health services;
modifying "under arrangements" policy so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital;
adding an improvement activity to the MIPS Improvement Activities Inventory for the CY2020 performance period that promotes clinician participation in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection; and
altering applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing.
On March 30, CMS also announced “blanket waivers” that would affect a wide range of providers that serve Medicare beneficiaries as well as Medicare Advantage and Part D Prescription Drug Plans. According to CMS, these waivers, that include waivers of sanctions under the physician self-referral law (Stark Law) are intended ensure that sufficient health care items and services are available to meet the needs of Medicare beneficiaries in the emergency areas. CMS notes that these waivers do not require providers to submit a waiver request to a CMS Regional Office.
On March 31, the White House predicted between 100,000 and 240,000 U.S. deaths, if mitigation steps are implemented. If action is not taken, the death toll could reach two million.
On March 31, it was reported that the White House is calling for an EUA for the flu drug Avigan as a COVID-19 treatment, even though the FDA has not approved the drug for any indication. The drug is undergoing clinical trials in Japan.
On March 31, National Institute of Allergy & Infectious Diseases Director Anthony Fauci said the coronavirus task force is considering advising all Americans to wear face masks but are concerned about limiting supply for medical workers. On April 3, the President announced the Centers for Disease Control & Prevention (CDC) is planning to recommend wearing washable, cloth face coverings while in public.
On March 31, Surgeon General Adams and Assistant Secretary of Health Adm. Brett Giroir sent an open letter to health care workers providing technical guidance on how hospitals can split ventilators between two patients who are both either infected or free from the virus.
On March 31, the President Trump announced he will not approve a special enrollment period for HealthCare.gov. Twelve out of the 13 state-run exchanges have reopened their marketplaces.
On March 31, the American Hospital Association (AHA) sent a letter to HHS Secretary Alex Azar and CMS Administrator Verma asking for Medicare Administrative Contractors to “immediately” distribute H.R. 748’s $100 billion hospital fund to every hospital in the U.S. at the rate of $25,000 per bed and $30,000 per bed in “hot spots.”
On March 31, CDC reported that over 400 long-term care facilities across the U.S. are now combating COVID-19 cases.
On March 31, Sen. Rick Scott (R-FL) accused the World Health Organization of helping China "cover up" the full extent of the pandemic and called for a congressional investigation, as well as terminating U.S. funding to the organization.
On March 31, Fresenius Medical Care and DaVita announced a partnership to create and share a nationwide network of dialysis clinics that will focus on serving COVID-10 patients.
On April 1, FDA granted its first emergency use authorization for a COVID-19 antibody blood test, manufactured by Cellex. FDA noted that there is “reason to believe” that by analyzing antibodies in the blood, the test can determine if someone has been exposed to the virus. This type of test is widely viewed as a significant tool in curbing outbreaks because it can identify people who have recovered from infection and likely have some degree of protection from reinfection.
On April 1, Anthem announced that it would waive cost-sharing for all treatments related to COVID-19 through May 31. Anthem noted that the cost-sharing waiver would apply to all affiliated fully insured, Medicaid, and Medicare Advantage members. Anthem is the fourth major insurer to make this decision. Aetna, Humana and Cigna previously indicated that they would cover COVID-19 treatment without cost-sharing.
On April 1, it was reported that the European Union (EU) is interested in negotiating a regulatory deal with the U.S. that would set standards and streamline approval of potential future technologies (including pharmaceuticals and medical devices). Such an agreement was originally brought forth by the former Commission President Jean-Claude Juncker in 2018; now, the EU is arguing the deal could help both regions respond to the pandemic.
On April 1, CMS sent a letter to Life Care Center of Kirkland, a Washington state nursing home where the country’s first COVID-19 outbreak occurred. CMS levied a $611,325 fine and directed the provider to correct various safety deficiencies by September 16 or be terminated from the Medicare program.
On April 1, PEW Charitable Trusts posted a report urging states to ease opioid treatment guidelines to allow patients to take home medications during the COVID-19 pandemic.
On April 1, the AHA sent a letter to major insurers asking for expedited payment throughout the pandemic.
On April 1, the United Nations released a report outlining a “large-scale, coordinated and comprehensive multilateral response” to address the pandemic. The report calls on wealthy nations to take aggressive action and provide “maximum financial and technical support” to more vulnerable countries.
On April 1, President Trump suggested he may leverage Medicare and Medicaid to extend coverage to uninsured Americans, as an alternative to re-opening HealthCare.gov. The next day, Vice President Pence said that the Administration is considering using the $100 billion hospital relief fund included in H.R. 748 to cover treatment for the uninsured.
On April 1, two Department of Homeland Security (DHS) officials claimed the SNS is nearly depleted of medical supplies and PPE. On April 2, the Federal Emergency Management Agency (FEMA) told the House Oversight Committee that there are 9,500 ventilators in the SNS and 3,200 more will become available by the week of April 13.
On April 2, the U.S. Department of Justice and HHS announced hoarded medical supplies, including 192,000 N95 respirator masks, 598,000 medical gloves, and 130,000 surgical masks, are being sent to New York and New Jersey. The supplies were secured by the Federal Bureau of Investigation as part of the Administration’s Hoarding and Price Gouging Task Force.
On April 2, the Pharmaceutical Research & Manufacturers of America (PhRMA) sent a letter to the U.S. Department of Transportation (DOT) advocating for making international flights a requirement for receiving the financial assistance included in H.R. 748. The trade groups argue that international flights are a necessary component of the pharmaceutical supply chain. The Associations for Accessible Medicines sent a similar letter to DOT on March 31.
On April 2, Speaker Nancy Pelosi (D-CA) tapped Majority Whip Jim Clyburn (D-SC) to lead a new committee tasked with overseeing the Administration’s implementation of the $2.2 trillion included in H.R. 748.
On April 2, the White House issued an order under the Defense Production Act (DPA) to help GE, Hill-Rom, Medtronic, ResMed, Royal Philips, and Vyaire Medical secure supplies to build ventilators by “removing obstacles in the supply chain.” In addition, the President claimed he has also signed “an elements of the [DPA] against 3M” authorizing FEMA to acquire as many N95 masks it deems necessary; however, 3M later argued it is already maximizing its efforts to produce as many masks as possible.
On April 3, Reps. Stephanie Murphy (D-FL) and John Katko (R-NY) introduce a bill to create a bipartisan commission to investigate how the government handled the pandemic, similar to what was done after Pearl Harbor and 9/11. The commission would begin in early 2021 and produce a report by March 2022.
Speaker Pelosi is pushing for a fourth package aimed at recovery. Democrats are already in the early stages of drafting legislation to aid health systems, protect frontline health care workers, and boost infrastructure, but some GOP lawmakers have argued that Congress should let the dust settle on the last package before moving forward. President Trump has supported calls for infrastructure reform.
On April 5, the U.S. had 324,052 confirmed COVID-19 cases resulting in 9,180 deaths, according to Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & 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
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
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 (IPPS) for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2021 Rates (CMS-1735); Proposed Rule; Received 1/30/20
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
FY 2021 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1737); Proposed Rule; Received 2/24/20
FY 2021 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1729); Proposed Rule; 2/24/20
FY2021 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1733); Proposed Rule; Received 3/3/20
FY 2021 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1731); Proposed Rule: Received 3/4/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20
Amendments to the HHS-operated Risk Adjustment Data Validation under the Patient Protection and Affordable Care Act's (ACA) HHS-operated Risk Adjustment Program (CMS-9913); Proposed Rule; Received 3/11/20
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage (CMS-1739); Proposed Rule; Received 3/12/20
Announcement of Calendar Year (CY) 2021 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies; Notice; Received 3/24/20
HHS-IHS
CY 2020 Reimbursement Rates; Notice; Received 3/2/20
HHS-HRSA
Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders; Final Rule; 3/16/20
REPORTS
Congressional Budget Office (CBO)
On April 1, CBO posted a presentation reviewing how CBO models firms' behavior in HISIM2 in its baseline budget projections.
On April 2, CBO released a preliminary estimate of H.R. 6201, the second COVID-19 emergency funding package geared at providing paid sick and family leave. CBO estimates that the law will cost $192 billion over the next decade; however, the agency cautions that this figure is subject to change based on the severity of the pandemic.
HHS Office of Inspector General (OIG)
On March 30, OIG posted a report entitled Iowa Did Not Comply with Federal and State Requirements for Major Incidents Involving Medicaid Members with Developmental Disabilities. OIG concludes that Iowa failed to ensure that community-based providers reported major incidents to the state and documented the resolution of reported major incidents to prevent or diminish chance of future occurrences; review Critical Incident Reports to determine trends, problems, and issues in service delivery; ensure that community-based providers reported all member deaths to the state; and report all major incidents to CMS.
On March 31, OIG issued a report entitled New York’s Oversight of Medicaid Managed Care Organizations Did Not Ensure Providers Complied with Health and Safety Requirements at 18 of 20 Adult Day Care Facilities Reviewed. OIG found that New York’s oversight of Medicaid managed care organizations did not ensure that 18 of the 20 adult day care services providers we reviewed complied with federal and state health and safety requirements. Specifically, OIG identified 476 instances of noncompliance with requirements for staff training, physical environment and safety, emergency preparedness, and staff health status.
On March 31, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Forbes Hospital. In their audit, OIG found that Forbes complied with Medicare billing requirements for 51 of the 100 inpatient and outpatient claims that were reviewed. However, the provider did not fully comply with Medicare billing requirements for the remaining 49 claims, all of which were inpatient, resulting in overpayments of $590,646 for CYs 2016 and 2017. OIG recommends that Forbes to refund this amount and take several steps to improve compliance.
On April 1, OIG published a report entitled States Could Do More to Prevent Terminated Providers From Serving Medicaid Beneficiaries. OIG reports that Nearly 1,000 terminated providers, or 11% of all terminated providers, were inappropriately enrolled in Medicaid or were associated with $50.3 million in Medicaid payments after being terminated for various forms of misconduct that posed a risk to beneficiaries. OIG outlined several ways CMS can empower states to address this area.
On April 1, OIG released a report entitled Twenty-Three States Reported Allowing Unenrolled Providers to Serve Medicaid Beneficiaries. Contrary to federal requirements, OIG found that 23 states had not enrolled all providers serving Medicaid beneficiaries in their respective Medicaid programs. In turn, beneficiaries were exposed to potentially harmful providers that had not been screened for fraud, waste, and abuse.
On April 3, OIG released a report entitled the National Institutes of Health (NIH) Has Acted to Protect Confidential Information Handled by Peer Reviewers, But It Could Do More. OIG’s study describes and assesses NIH's oversight of peer reviewers' handling of confidential information amid concerns about foreign threats to the integrity of U.S. medical research and intellectual property. OIG reviewed the agency’s policies and procedures to protect the confidentiality of the peer review process and take action against reviewers who disclose information. It also made several recommendations for NIH to more directly address concerns about foreign threats.
UPCOMING HEARINGS
Senate
None of note
House
None of note
OTHER HEALTH POLICY NEWS
On March 30, JAMA researchers concluded that biosimilar competition has caused Humira’s price to drop 82.8% in Demark.
On March 31, the U.S. Fifth Court of Appeals ruled that Texas can continue restricting abortions during the COVID-19 pandemic. Specifically, the Appeals Court stayed a U.S. district court decision that concluded Texas’ Executive Order (EO) labeling abortion as a “non-essential” procedure violated Roe v. Wade. The EO requires providers that perform abortions to pay a fine or face jail time. Ohio and Alabama have issued similar abortion restrictions.
On April 1, New York passed a budget that bans the sale of flavored vaping products and caps out-of-pocket insulin costs at $100 per 30-day supply
On April 2, U.S. District Judge James Boasberg granted a request from Michigan’s health department to pause the state’s work requirement lawsuit for the duration of the public health emergency. Michigan claims that proceeding with the lawsuit during the pandemic further strains the department’s workload.
On April 2, the Democratic National Committee said its July convention will be postponed until August because of the COVID-19.
On April 2, the Medicaid & CHIP Payment & Access Commission held a virtual public meeting on the following topics:
o Review of Chapters for June Report: Integrating Care for Dually Eligible Beneficiaries;
o Review of Chapter for June Report: Improving Participation in the Medicare Savings Programs;
o Review of Chapter for June Report: Coordination of Benefits with TRICARE;
o Review of Chapters for June Report: Medicaid's Role in Maternity Care; Substance Use Disorder and Maternal and Infant Health;
o Considerations in Designing Automatic Medicaid Financing Changes in Times of Crisis; and
o Medicaid's Response to the COVID-19 Pandemic
· On April 2, the Medicare Payment Advisory Commission held a virtual public meeting on the following topics:
o Realizing the Promise of Value-Based Payment in Medicare: An Agenda for Change
o Challenges Maintaining and Increasing Savings from Accountable Care Organizations;
o Realigning Incentives in Medicare Part D;
o Redesigning the MA Quality Bonus Program; and
o Improving Medicare's End-Stage Renal Disease Prospective Payment System.
· On April 3, Utah suspended its Medicaid work requirements, which were implemented in January along with a Medicaid expansion.