The final version of the COVID-19 relief bill has been published. Below are some of the healthcare-specific provisions, summarized by the MGMA. The legislation:
Temporarily suspends the 2% Medicare sequestration from Jan. 1 through March 31, 2021;
Increases Medicare payments across the board for CY 2021 from what was finalized in the 2021 Physician Fee Schedule (PFS) by adding $3 billion into the PFS and delaying payment of HCPCS add-on code G2211 for three years;
Freezes the 2020 qualifying participant thresholds required to achieve alternative payment model (APM) benefits such as the 5% lump sum bonus through 2023;
Delays the start date for the mandatory radiation oncology APM from July 1, 2021 until Jan. 1, 2022;
Extends the work geographic index floor under the Medicare program through Dec. 31, 2023;
Expands access to mental health services furnished through telehealth past the expiration of the COVID-19 public health emergency; and
Provides for the creation of 1,000 new Medicare-funded graduate medical education (GME) residency positions.
The surprise billing provision was discussed in yesterday’s blog.
About hospitals and healthcare systems
Monitoring for Hospital Price Transparency: A reminder that on January 1 CMS will start to monitor hospitals for compliance with price transparency.
Philadelphia health system merger clears latest FTC challenge: The merger is back on… “An appellate court on Dec. 21 denied the Federal Trade Commission's latest attempt to block a merger between Philadelphia-based Jefferson Health and Einstein Healthcare Network.”
Texas hospital pays $48M to settle false claims allegations: “Prosecutors allege that the hospital, which is partially physician-owned, and its subsidiary THHBP Management submitted claims to Medicare that resulted from illegal physician referrals and kickbacks.
In particular, prosecutors said the hospital violated Stark Law and the Anti-Kickback Statute by requiring physician owners to meet a 48 patient-contact requirement to maintain ownership in the hospital.”
About the public’s health
Johnson & Johnson Takes Big Step Forward With Its Vaccine Trial, Has Potential to Be Single Shot: “Johnson & Johnson took a big step forward this week as they announced their phase 3 trials are now fully enrolled with 45,000 people.” The vaccine does not require very low shipping/storage temperatures and, if proven effective, will require only one dose. It works by incorporating double stranded DNA in a modified adenovirus. The virus infects cells and releases the DNA, which causes manufacture of SARS CoV-2 spike proteins. These proteins provoke an immune response. See: How the Johnson & Johnson Vaccine Works for helpful graphics of tis process.
Trends in Overweight and Obesity Self-awareness Among Adults With Overweight or Obesity in the United States, 1999 to 2016: “Among study participants…, 33.5% were overweight and 34.5% were obese, although 41.3% of persons who were overweight and 9.7% of persons who were obese did not consider themselves to be overweight…
Among persons with obesity, being aware of their obesity… and health professionals' recommendation on losing weight… were independently associated with attempts to lose weight after adjustment for all [other] factors…[such as demographics, income and insurance status].”
Like many other conditions, self-realization of the problem is the first step toward successful treatment. That problem requires a different approach than just assuring compliance with treatment.
About pharma
FDA approves Riabni, third biosimilar to Rituxan: “The list price for rituximab-arrx in the United States will be $716.80 per 100 mg, or $3,584 for a 500-mg single-dose vial. This is 23.7% lower than the list price of its reference product, according to an Amgen press release.” This article is a reminder that biosimilars sell at a lower discount percentage than do generic small molecules.
Biogen Will Settle for $22 Million Over Alleged Drugs Kickback Scheme: “Biogen has agreed to a $22 million settlement to resolve allegations that donations it made to charities were kickbacks to Medicare patients for out-of-pocket costs associated with its multiple sclerosis medications.”
Myovant Sciences’ Oral Therapy for Advanced Prostate Cancer Wins FDA Approval: “A form of androgen deprivation therapy, Orgovyx lowers hormone levels that enable prostate cancer cells to grow. Unlike other treatments in this class, the drug doesn’t have to be injected or implanted under the skin.” Price was not available, but since it is taken orally, it will lower administration costs.
About health insurance
CMS Says 8.2M Americans Enrolled on ACA Federal Exchange for 2021: “The enrollment level is only slightly lower than the 2020 open enrollment season’s 8.3 million enrollment, even though there are fewer states on the federal exchange. Year-over-year plan selection trends rose by 6.6 percent from 2020, similar to its increase from 2019 (6.3 percent).
This year, New Jersey and Pennsylvania joined 12 states and the District of Columbia in shifting to a state-based platform for their state-based exchanges.”
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-F) Final Reg: “This final rule advances CMS’ efforts to support state flexibility to enter value-based purchasing arrangements (VBPs) with drug manufacturers for innovative, and sometimes costly drugs therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. It also creates minimum standards in state Medicaid DUR programs designed to reduce opioid-related fraud, misuse and abuse.
This final rule also revises regulations regarding:
How manufacturers should calculate the average manufacturer price (AMP) of a brand name drug when there is also a sale of an authorized generic;
How manufacturers should include the discount or rebates provided as part of their patient assistance programs in the calculation of ‘best price’ and AMP, including when they are impacted by pharmacy benefit managers (PBM) accumulator programs;
State and manufacturer reporting requirements to the Medicaid Drug Rebate Program (MDRP);
The definition of a CMS-authorized supplemental rebate agreement, to clarify that the rebates under such arrangements for MCO claims must be paid to the state;
The definition of line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, and innovator multiple source drug for purposes of the MDRP; and,
Coordination of benefits (COB) and TPL rules related to the special treatment of certain types of care and payment in Medicaid and Children’s Health Insurance Program (CHIP).”
Two Owners of New York Pharmacies Charged in $30 Million Covid-19 Health Care Fraud and Money Laundering Scheme: “An indictment was unsealed in federal court in Brooklyn… charging the two owners of over a dozen pharmacies in New York City and on Long Island, for their roles in a $30 million health care fraud and money laundering scheme in which they exploited emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic in order to submit fraudulent claims for expensive cancer drugs that were never provided, ordered or authorized by medical professionals.”
Oscar Health gearing up to go public: “The startup health insurer filed a draft registration statement on Form S-1 with the Securities and Exchange Commission (SEC). A potential initial public offering will undergo an SEC review…
Oscar's individual and family plans as well as small group and Medicare Advantage coverage will be available across 18 states and 286 counties next year. About 420,000 members were enrolled in its plans as of Sept. 30.”
About healthcare quality
Unnecessary C-sections are a problem in the US. Will publicizing hospital rates change that?: “The Joint Commission… plans to start publicly reporting next year on hospitals with high cesarean section birth rates. The news comes a few weeks after the Department of Health and Human Services unveiled an action plan to improve maternal health, which included reducing low-risk C-section delivery rate by 25%.
Since 1985, the World Health Organization has considered the ideal rate for C-section births to be between 10% to 15%.
However, the Centers for Disease Control and Prevention reports more than 31% of all deliveries in the U.S. were by C-section in 2018. Tricia Elliott, director of Quality Measurement at TJC, says some U.S. hospitals report C-section rates as high as 60%…
High C-section rates are not the problem, said Dr. William Grobman, professor of obstetrics and gynecology at Northwestern University's Feinberg School of Medicine. The problem is variation between hospitals – low C-section rates in some and high rates in others – with no improved outcome for mother and baby.”