Health Care E-Note November 2021

Articles / Publications

Helpful hints

OIG Updates Health Care Fraud Self-Disclosure Protocol ("SDP") 

On November 8, 2021, the OIG issued an updated SDP to providers, which included clarifications of existing guidance and increased the minimum settlement amounts OIG will accept. OIG originally published the SDP in 1998 to “establish a process for persons to voluntarily identify, disclose, and resolve instances of potential fraud involving Federal health care programs.” The OIG stated in the updated SDP that between 1998 and 2020, the agency resolved over 2,200 disclosures and recovered more than $870 million. The updated SDP touts the benefits of disclosing potential fraud, which include: (1) affording a presumption against the need for a corporate integrity agreement, (2) a lower multiplier on damages, (3) suspending the “60-day overpayment rule” upon acknowledgment of an SDP from the OIG, and (4) streamlining internal processes to reduce the average time for resolving a case to less than 12 months. The updated SDP notes that providers must acknowledge that the conduct reported is a potential violation, and cannot merely assert that OIG may consider the conduct a violation. The SDP also lists best practices for preparing a submission and explains when the SDP should be used (and not). Finally, the updated SDP states that the minimum settlement OIG will accept for submissions related to the federal Anti-Kickback Statute is $100,000, and the minimum settlement OIG will accept for all other submissions is $20,000.

For additional information: UPDATED: OIG'S Health Care Fraud Self - Disclosure Protocol (Nov. 8, 2021)

CMS Issues Calendar Year ("CY") 2022 Final Medicare Outpatient Prospective Payment System ("OPPS") Rule

On November 2, 2021, CMS finalized the Medicare payment rates for hospital outpatient and ambulatory surgical center (“ASC”) services in CY 2022 (“OPPS Final Rule”). One notable change under the OPPS Final Rule is an increase to the hospital price transparency regulation. Under CMS’ revised approach, the minimum annual penalty for non-compliance in CY 2022 will be $109,500 per hospital and the maximum annual penalty would be $2,007,500 per hospital (depending on the bed count of the hospital). Other notable elements of the OPPS Final Rule include: (1) CMS will use CY 2019 for 2022 ratesetting rather than CY 2020, in recognition of the impact of the COVID-19 public health emergency; (2) CMS is restoring the Inpatient Only List for the majority of procedures previously eliminated under the CY 2021 OPPS Final Rule, and is lifting the corresponding exemption of the restored procedures from the requirements of the “Two Midnight Rule”; (3) updates to the OPPS payment for drugs acquired through the 340(B) program; (4) changes to the process for adding procedures to the ASC Covered Procedures List; and (5) updates to the hospital and ASC Outpatient Quality Reporting programs to include additional measures and make certain voluntary measures mandatory going forward.

For additional information: "CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule" (CMS-1753FC) (Nov. 2, 2021)

CMS Issues Calendar Year ("CY") 2022 Medicare Physician Fee Schedule ("PFS") Final Rule 

On November 2, 2021, CMS issued the CY 2022 PFS Final Rule that implements certain policy changes for Medicare payments and other Part B issues. Notably, CMS extended the time period for certain services to remain on the telehealth services list through December 31, 2023 (which were temporarily added to the list as a result of the COVID-19 public health emergency), providing CMS with additional time to analyze whether the services should be permanently added to the list. CMS also amended the telehealth rule to allow the use of audio-only communications for mental health services furnished to established patients in their homes and clarified that mental health services include substance abuse disorder services. Other notable provisions of the 2022 PFS Final Rule include: (1) updates to billing for Evaluation/Management (“E/M”) visits, particularly as relates to split E/M visits in a facility; (2) physician assistants may now bill Medicare directly for their professional services, reassign their payments, and incorporate with other physician assistants to bill Medicare; (3) updates to the provision of services and reimbursement for rural health clinics and federally qualified health centers to promote access for underserved populations; (4) changes to the rules for billing therapy services provided by physical therapist assistants and occupational therapy assistants; (5) updates to the reimbursement for vaccine administration; and (6) updates to Medicare provider enrollment for certain independent diagnostic testing facilities and the process for rebutting suspension or deactivation of a provider’s enrollment.

For additional information: Calendar year (CY) 2022 Medicare Physician Fee Schedule Final Rule (Nov. 2, 2021)

Non-Medical Expansion States Facing Medicaid DSH and UC Cuts Under the Proposed Build Back Better Act (H.R. 5376)

Under the Build Back Better Act (“BBB”) published by the House Rules Committee on November 3, 2021, states that have elected not to expand Medicaid under the Affordable Care Act will face reductions to their statewide Medicaid Disproportionate Share Hospital (“DSH”) allotments and federal financial participation in Uncompensated Care (“UC”) programs starting in federal fiscal year (“FFY”) 2023. Under the BBB, for a non-Medicaid expansion state or a state that discontinues Medicaid expansion, the state’s annual DSH allotment will be reduced by 12.5% from what the state otherwise would have received, and the federal government will no longer participate in reimbursement to providers for uncompensated care furnished to patients who would otherwise have been covered under Medicaid expansion. If adopted, the BBB could result in a reduction of around $7.8 billion in federal funds in the DSH program alone over 10 years. Under the Affordable Care Act, states and participating hospitals have been facing DSH cuts since FFY 2014, but Congress has delayed implementation of the cuts several times (presently through FFY 2024). Hospital advocacy groups (including the American Hospital Association) and other stakeholders have urged Congress to remove these provisions of the BBB, especially in light of the impact to hospital providers from the COVID-19 public health emergency.

For additional information: H.R. 5376, Rules Committee Print (Nov. 3, 2021)"Congress urged to remove hospital cits from social spending bill," American Hospital Association (Nov. 1, 2021)

For more information on these "Helpful Hints" topics, please contact Rachel Gilbert in the firm's Greenville, SC office. Rachel may be reached at (864) 552-9329 or


CMS Issues COVID-19 Health Care Staff Vaccination Interim Final Rule 

On November 4, 2021, the Centers for Medicare & Medicaid Services (“CMS”) announced its interim final rule regarding vaccination requirements for eligible staff of certain health care providers. The rule, which became effective on November 5, 2021, is expected to apply to approximately 76,000 health care providers and cover over 17 million health care workers across the United States. Read more.

Written by Angie Smith, Howard Bogard 

Contact Angie at (205) 458-5209 or Contact Howard at (205) 458-5416 or


New COVID-19 Vaccination and Testing Rules Webinar Recording 

Recorded on November 9th, Angie Smith, Mike Rich, Amy Jordan Wilkes, and Scott Williams summarized the new COVID-19 vaccine mandate for health care workers; guidance for federal contractors with respect to vaccine mandates and other COVID-19 safety protocols; and OSHA’s new Emergency Temporary Standard requirements on COVID-19 vaccination and testing. Listen to the recording here. 

Speakers: Angie SmithMike Rich, Amy Jordan WilkesScott Williams.

Contact Angie at (205) 458-5209 or Contact Mike at (251) 345-8216 or Contact Amy at (205) 458-5358 or Contact Scott at (205) 458-5436 or

Birmingham Medical News: Interaction of HIPPA and Employer Vaccine Mandates

Reprinted with permission from Birmingham Medical News (Published November 11, 2021)

As we approach various deadlines for COVID-19 vaccine mandates, both in the private and the public sector, there appears to be confusion over when vaccine information may be shared with employers and what obligations employers have, if any, under The Health Information Portability and Accounting Act (“HIPAA”) to protect such information once obtained. To address some of that confusion, the Health & Human Services Office for Civil Rights (“OCR”) has issued guidance entitled “HIPAA, COVID-19 Vaccination, and the Workplace.” Read the full article here.

Written by Kelli Carpenter Fleming. Contact Kelli at (205) 458-5429 or

Birmingham Medical News: J-1 Waivers and the Employment of Foreign Physicians in Alabama - October 2021:

Reprinted with permission from the Birmingham Medical News (Published October 18, 2021)

Health care providers across the United States continue to face an acute shortage of physicians particularly in Medically Unserved Areas (“MUAs”) and Health Professional Shortage Areas (“HPSAs”), which areas are determined by the United States Public Health Service and which include certain areas in and around Alabama. Foreign medical graduates (“FMG”) in J-1 visa status are often seeking physician employment opportunities in designated shortage areas in order to fulfill certain immigration requirements. Read more.

Written by Melissa Azallion Kenny. Contact Melissa at (843) 785-2171 or

November 19 Webinar: Hiring, Retraining Staff, and Employee Retention

Join us for the next Burr Morning show where we will discuss hiring, retraining staff, and employee retention. Information and registration for this webinar is available here.

Speakers: Dent Morton, (205) 458-5208,, William Wasden, (251) 345-8230,,  Amy Jordan Wilkes, (205) 458-5358,


10 States Sue to Block Health Care Worker Vaccine Mandate (Source: NPR, 2021-11-11)

Hospital Safety Grades Remain Similar to Pre-Pandemic (Source: Healthcare Dive, 2021-11-10)

Hospitals Seeing Massive Shortages in Drugs, Medical Devices (Source: HealthDay, 2021-11-04)

Despite More Investments, Firms Unable to Stop Cyberattacks (Source: HealthIT Security, 2021-11-08)

Burr & Forman Health Care E-Note is a monthly e-mail service provided by Burr & Forman LLP. The physical address for correspondence related to this newsletter is: 171 17th Street, NW, Suite 1100, Atlanta, GA 30363. (404) 815-3000. This electronic newsletter is provided to clients and friends of Burr & Forman. The information described is general in nature, and may not apply to your specific situation. Legal advice should be sought before taking action based on the information discussed. Applicable State Bar or Attorney Regulations May Require This Be Labeled as "Advertising."
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