Based on the Snellen chart, ophthalmologists tell us that 20/20 vision is clearer than 20/21. And, based on several of this week’s leading stories, 2020 is making its move to bring some of this year’s leading stories into sharper relief.
F D A
The US Food and Drug Administration authorized the first COVID-19 vaccine for emergency use in the United States. Millions of doses of the Pfizer and BioNTech coronavirus vaccine, which has been found to be 95% effective, were shipped to distribution sites around the country this week. An emergency use authorization means that a medical product gets special authorization by the FDA to be used during an emergency. It is not a full approval. The drug’s manufacturers would have to file a separate application for its vaccine to be fully licensed by the FDA. The process of vaccination will take some time, and will take place in a staged sequence as outlined by the Centers for Disease Control and Prevention.
E L C T R L C L G E
Also this week, the 538 electors who make up the Electoral College gathered in all 50 states and the District of Columbia to formally cast their votes for president. The electoral votes confirmed Joe Biden as the 46th president and Kamala Harris as vice president. This confirmation comes days after the United States Supreme Court rejected a lawsuit to overturn Joe Biden’s Election Day vote count. The high court’s order rejected allegations by the state of Texas that five “swing states” committed voting improprieties, resulting in a flawed election. The suit was embraced by the president, 19 Republican state attorneys general, and 126 House Republicans.
S T I M U L S P K G
In a more bi-partisan way, negotiations toward a nearly trillion-dollar pandemic relief bill in Congress continue this week, with both Democrats and Republicans offering counter proposals. The measure is expected to include a $748 billion package boosting education, testing and vaccine distribution, the transportation sector, and other funding, as well as a more controversial $160 billion add-on of state and local funding married with a short-term liability shield for employers.
L I A B S H L D
The shielding of companies from virus-related lawsuits remains a contentious issue in the debate. Senate Majority Leader Mitch McConnell (R-KY) is urging lawmakers to drop aid for state and local governments and liability protections, and to proceed with a smaller bill without either. Senate Democratic Whip Dick Durbin (D-IL), who is seeking the party’s top post on the Judiciary Committee, is taking the lead on Democratic opposition to the GOP proposal in coronavirus relief negotiations. We’ll keep our eyes on these developments this week and report back to you in next week’s edition.
PAID ACT BECOMES LAW
As part of the newly enacted Continuing Resolution to fund the government, President Trump signed into law the Provide Accurate Information Directly (PAID) Act. The bi-partisan PAID Act unanimously passed the 116th Congress. This measure will require the Centers for Medicare and Medicaid Services (CMS) to expand its Section 111 Query Process to confirm, name, and identify whether an individual is currently (or has been during the preceding three-year period) enrolled in a Medicare Part C (Medicare Advantage) and/or Medicare Part D (Prescription Drug) plan. The PAID Act contains a one-year implementation plan. The Congressional Budget Office estimates that the PAID Act will result in savings of $30 million. The PAID Act will also bring increased clarity around claims by Medicare Advantage plans for “double damages” under Medicare's private cause of action provision. Your authors at The Way are proud to be among the advocates in this industry who have pushed for this good government reform.
HIPAA PRIVACY RULE REFORM
The Department of Health and Human Services (HHS) proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support patients’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the healthcare industry. The proposed HIPAA Privacy Rule would facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises such as the opioid crisis and COVID-19 public health emergencies. The agency also aims to reduce administrative burdens on HIPAA-covered healthcare providers and health plans while continuing to protect individuals’ privacy interests regarding their health information. HHS Secretary Alex Azar expects the proposed changes to the HIPAA Privacy Rule will, “break down barriers that have stood in the way of commonsense care coordination and value-based arrangements for far too long.” Comments on the proposed rule are due in February.
Making Our Way Around the Country
The White House issued an Executive Order (EO) aiming to reduce the burden of occupational licensing regulations to promote the free practice of commerce, lower consumer costs, and increase economic and geographic mobility. The EO states that licensing requirements have cost the U.S. an estimated 2.85 million jobs and over $200 billion annually in increased consumer costs. The initiative seeks occupational regulation reform throughout the United States, “building on occupational licensing reforms enacted most recently in Arizona, Florida, Iowa, Missouri, and South Dakota.” These state reforms were guided by six principles including: designated state governmental oversight; the least restrictive to competition sufficient to protect consumers; increased consideration for those applicants with criminal records; ease of administration for military spouses; and qualified state-to-state reciprocity. We’ll watch for legislation in the next legislative session around this initiative.
PHARMACY BENEFIT MANAGEMENT
The Supreme Court ruled on the case of Rutledge v. Pharmaceutical Care Management Association (PCMA). In its unanimous decision, the court held in favor of forty-five states, along with interest groups representing patients and community pharmacies, who seek to regulate pharmacy benefit managers. PBMs generally manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. With this ruling, states will have greater authority to regulate drug costs and utilization.
AIR AMBULANCE BILLING
The House Ways and Means Committee is leading a new air ambulance billing proposal, which differs from a previous “benchmark” approach advanced by the House Energy and Commerce Committee. This new proposal, which was formalized Friday night, calls for stakeholders to negotiate an agreed-upon rate or bring their dispute to a mediator. There is some pressure to act on this proposal during this Congress, as two of the key Republican champions of a surprise billing fix, Lamar Alexander (R-TN) and Energy and Commerce ranking member Greg Walden (R-OR) are retiring this year.
SOUNDS OF THE SEASON
In as much as our main story this week dealt with vision, we close with an auditory note. Today is thought to be the 250th anniversary of the birth of visionary composer, Ludwig von Beethoven, who famously said, “Music is like a dream. One that I cannot hear.” Beethoven’s stirring Ode to Joy, which appears in the fourth movement of his 9th Symphony, is featured prominently in one of the season’s more controversial selections to any list of the best holiday films. Stay safe, stay well, and stay connected.