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Ken is a partner in the Corporate Practice Group in the firm's Los Angeles office and a member of the Healthcare Team.

“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”[1]

On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule (“Privacy Rule”) to disclosures and requests for information regarding COVID-19 vaccination status. In a frequently-asked-questions format, the Guidance sets forth a series of workplace-related scenarios involving the confidentiality of an employee’s vaccination status, an employer’s ability to obtain vaccination information from its employees, and the confidentiality of such information.


Continue Reading HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance

On October 4, 2021, the California Senate Bill 650 (“SB 650”), also known as the Corporate Transparency in Elder Care Act of 2021, was signed by Governor Gavin Newsom. As described below, SB 650 is designed to provide the public with greater transparency as to skilled nursing facility (“SNF”) ownership and finances.

Continue Reading What Price Transparency? California SB 650 Shines Light on Skilled Nursing Facility Ownership while Creating New Reporting Burdens for California Skilled Nursing Facilities

On October 4, 2021, California Governor Gavin Newsom signed California bill SB-664 “Hospice licensure: moratorium on new licenses” (the “Bill”) into law.  The Bill, which passed the California Assembly on September 8, 2021 and the California Senate on September 9, 2021, imposes a moratorium on the California Department of Public Health (the “Department”) issuing new hospice licenses on or after January 1, 2022.  Under the California Hospice Licensure Act of 1990, a person, political subdivision of the state, or other governmental agency must obtain a license from the Department to provide hospice services to an individual who is experiencing the last phase of life due to a terminal disease.  The moratorium will end either three hundred and sixty five (365) days from the date the California State Auditor publishes a report on hospice licensure or when the provisions of the Bill are repealed on January 1, 2027, whichever is sooner.  The Department may grant an exception to the moratorium upon making a written finding that an applicant for a new license, or with a license application pending on January 1, 2022, has shown a ‘demonstrable need’ for hospice services in the area.  However, the Bill does not affect the Department’s ability to renew existing licenses.

Continue Reading New California Law Imposes Moratorium on New Hospice Licenses

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower Drug Costs Now Act, proposes to grant the U.S. Department of Health and Human Services (“HHS”) the authority to negotiate directly with pharmaceutical companies in order to lower drug prices in Medicare Part B and Medicare Part D (the “Proposal”).  The Proposal would require that 125 brand-name drugs that cost Medicare the most to be subject to negotiation by Medicare, with a cap on the price for each drug set at 120% of the average price paid in six other countries.  The Proposal is part of a $3.5 trillion budget proposal that, as of this writing, faces an uncertain future in Congress.  While not a novel idea, the Proposal is controversial and faces strong opposition from pharmaceutical companies in particular.

Continue Reading Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act (“FCA”) by knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Sutter Health’s contracted Medicare Advantage (“MA”) Plans.[1]  The Sutter Health settlement is the largest FCA settlement ever paid by a health care provider for alleged MA fraud.

Continue Reading Sutter Health Settles Medicare Fraud Case For $90 Million: The Largest Settlement For Medicare Advantage Fraud

On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure purposes.  Notably, the Infrastructure Bill is paid for in part through changes to several healthcare policies, including delaying a Medicare Part D rebate rule for an additional three years and reducing Medicare payment amounts to providers.  The Infrastructure Bill’s changes to healthcare policies provide a mixed impact to health care industry stakeholders, with both expected benefits and burdens to providers, payers, and drug manufacturers.

Continue Reading The Infrastructure Investment and Jobs Act: Potential Impact on Healthcare Policy and Spending

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020 (“Interim Final Rule”).  As described in our December 2020 blog post, the Interim Final Rule established a seven-year nationwide, mandatory MFN Model that would test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals.  The MFN Model, originally set to begin January 1, 2021, would have tied the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries and remove incentives to use higher cost drugs, in order to determine whether this could “control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.”  Had the Interim Final Rule been implemented, Medicare Part B reimbursement would have been significantly reduced starting January 1, 2021.

Continue Reading Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While Keeping the “Most Favored Nations” Drug Reimbursement Program on the Sidelines

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies.

Continue Reading 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation

In its June 2021 physician supply and demand report, “The Complexities of Physician Supply and Demand: Projections From 2019 to 2034” (the “Report”), the Association of American Medical Colleges (“AAMC”) highlights the ongoing concern of physician shortages in the United States.  According to the Report, the U.S. faces a potential physician shortage of between 37,800 to 124,000 doctors by 2034. While an improvement from AAMC’s June 2020 report, the COVID-19 pandemic highlighted the consequences of failing to address this problem, as medical schools and teaching hospitals were forced to graduate medical students early, and hospitals scrambled to call up retired physicians and to pay steep travel and relocation rates, all to address the public health emergency.
Continue Reading Congressional Action in the Face of Mounting Concerns Regarding Current and Future Physician Shortages

On May 21, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that the Next Generation Accountable Care Organization (“ACO”) Model (“NGACO Model” or “Model”), set to end December 31, 2021, will not be extended after receiving a one-year extension due to COVID-19.  The decision comes as a surprise to NGACO participants and other industry groups who have been calling on CMS to revisit its decision and closely consider the Model’s merits and potential as a permanent program option.  Industry stakeholders, such as the National Association of ACOs (“NAACOS”), expressed initial disappointment with CMS’ decision to end the program, but were later able to find some reprieve with CMS’ decision to “allow Next Gen ACOs a limited opportunity to apply for Direct Contracting . . . . starting next year.”

Continue Reading CMS’ Next Generation Accountable Care Organization (NGACO) Model Set To End in December 2021

The Biden Administration’s American Rescue Plan Act of 2021 (H.R. 1319) (the “Act”) could present an opportunity for the growth of utilization of ambulatory surgery centers (“ASCs”), continuing the trend of migration of inpatient procedures to the outpatient setting.  This shift toward the outpatient setting initially began prior to the COVID-19 public health emergency, but was accelerated by the pandemic’s effect on hospitals, likely continuing the substantial increase in investment in the ASC marketplace.
Continue Reading Biden’s American Rescue Plan Follows Trend Toward Outpatient Setting, Increase in ASC Investment