THIS WEEK’S DOSE
The House and Senate returned to session this week following the Thanksgiving holiday. Congress has just days to reach an agreement on a bill to keep the government funded beyond the December 16 expiration of the current stopgap continuing resolution (CR). Most expect that Congress will enact another short-term CR to buy more time before the end of the year, and the real question is whether lawmakers will need to return the week after Christmas to complete their work. As of press time, it remains undecided whether a year-end bill would be an omnibus FY 2023 appropriations package or a year-long CR, and to what extent such a package would include additional policy provisions—including the many pending healthcare extenders.
Preparing for the 118th Congress. In the House, both Republicans and Democrats are preparing for the new Congress by addressing rule changes within their caucuses and moving forward on new leadership. The most-watched leadership selection—Rep. McCarthy (R-CA) as speaker of the House—awaits a formal vote in Congress on January 3, 2023. Earlier this week Democrats formally elected their top three leaders for the new Congress: Rep. Jeffries (D-NY) will be the Democratic leader, Rep. Clark (D-MA) will be the Democratic whip, and Rep. Aguilar (D-CA) will be in charge of the Democratic Caucus. None of these three new leaders sit on a key health policy committee, so it remains to be seen how they will prioritize healthcare. In other key news, Republicans overwhelmingly rejected efforts from their Freedom Caucus ranks to eliminate use of earmarks in the 118th Congress, so that process is set to continue.
Senators Seek Input to Improve Care for Dual Eligibles. A bipartisan group of senators posted an open letter seeking feedback from healthcare stakeholders on efforts to improve coverage for individuals dually eligible for Medicare and Medicaid (dual eligibles).
The effort is led by Sen. Cassidy (R-LA), the incoming ranking member of the Health, Education, Labor and Pensions (HELP) Committee and member of the Finance Committee, which has jurisdiction over Medicare and Medicaid policy. Fellow Finance Committee Sens. Scott (R-SC), Cornyn (R-TX), Warner (D-VA), Carper (D-DE) and Menendez (D-NJ) also signed the letter, which requests specific information from stakeholders on shortfalls in the current system of care for dual eligibles, how to improve patient health outcomes, and the role of federal and state governments in dual eligibles’ care.
The senators indicated that responses will be used to inform their work in the new Congress to craft legislation to improve coverage for dual eligibles. The letter asks 11 specific questions, including the following:
- What are the shortcomings of the current system of care for dual eligibles? What specific policy recommendations do you have to improve coordination and integration between the Medicare and Medicaid programs?
- In your view, which models have worked particularly well at integrating care for dual eligibles, whether on the state level, federal level or both?
- If you believe a new unified system is necessary, what are key improvements we should prioritize?
- How can disruption be minimized for current beneficiaries should any changes to the current system of coverage be made?
- What is the best way to ensure that this system takes into account the diversity of the dually eligible population and is sufficiently targeted to ensure improved outcomes across each sub-group of beneficiaries?
- How does geography play a role in dual coverage? Are there certain coverage and care management strategies that are more effective in urban areas as compared to rural areas?
Interested stakeholders can submit feedback through January 13, 2023, by emailing email@example.com.
HHS Issues Proposed Rule on 42 CFR Part 2. On November 28, the US Department of Health and Human Services (HHS), including the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration, issued a proposed rule on the confidentiality of substance use disorder (SUD) patient records.
The regulations at 42 CFR Part 2 add different protections than those found in the Health Insurance Portability and Accountability Act (HIPAA) and are aimed at ensuring that individuals do not fear prosecution and are not deterred from entering SUD treatment. Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act required HHS to better align certain aspects of 42 CFR Part 2 with HIPAA and the Health Information Technology for Economic and Clinical Health Act. Section 3221 also required HHS to update the HIPAA Privacy Rule Notice of Privacy Practices requirements to address 42 CFR Part 2 protections and individual rights.
The November 28 proposed rule would permit the use and disclosure of SUD records based on a single prior consent given once by the patient, for all future uses and disclosures for treatment, payment and healthcare operations (rather than for every disclosure, as under current policy). Among its other provisions, the proposed rule would take the following actions:
- Expand prohibitions on the use and disclosure of 42 CFR Part 2 records in civil, criminal, administrative or legislative proceedings conducted by a federal, state or local authority against a patient, absent a court order or the consent of the patient
- Create two patient rights under 42 CFR Part 2 that align with individual rights under the HIPAA Privacy Rule:
- Right to an accounting of disclosures
- Right to request restrictions on disclosures for treatment, payment and healthcare operations.
A press release from HHS on the proposed rule can be found here, and a fact sheet can be found here. Comments will be accepted through January 31, 2023.
CMS Issues Memo on Workplace Violence in Hospitals. On November 28, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to state survey agency directors regarding workplace violence in hospitals. The memo cites recent findings from the Bureau of Labor Statistics that healthcare workers accounted for 73% of all non-fatal workplace injuries and illnesses due to violence in 2018, and that this number has steadily grown since tracking of such events began in 2011.
CMS stressed that it is incumbent on hospital leadership to ensure adequate training, sufficient staffing levels, and ongoing assessment of patients’ aggressive behavior and indicators to adapt their care interventions and environment appropriately. The memo summarizes hospitals’ regulatory obligations with respect to emergency preparedness plans, risk assessment strategies and staff training efforts. CMS noted that it will continue to enforce the regulatory expectations that patients and staff have an environment that prioritizes their safety to ensure effective care delivery.
The CMS memo comes as lawmakers also seek to address the issue of hospital workplace violence. The SAVE Act (H.R. 7961), which has more than 50 bipartisan cosponsors, would help hospitals combat such violence by creating a new criminal offense for knowingly assaulting or intimidating hospital personnel during the performance of their official duties, and by authorizing grants for hospitals to initiate additional efforts to reduce hospital violence.
HHS OCR Issues Bulletin on Online Tracking Technologies and HIPAA. On December 1, HHS’s OCR issued a bulletin detailing the obligations of HIPAA covered entities and business associates when using online tracking technologies.
The bulletin notes that HIPAA rules apply when regulated entities collect through tracking technologies, or disclose to tracking technology vendors, information that includes protected health information (PHI). The bulletin states that regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA rules.
OCR stated that while it has always been true that regulated entities may not impermissibly disclose PHI to tracking technology vendors, because of the proliferation of tracking technologies collecting sensitive information, it is now more critical than ever for regulated entities to ensure that they disclose PHI only as expressly permitted by HIPAA.
The bulletin also clarifies that HIPAA rules do not apply to health information that an individual enters into a mobile app offered by an entity that is not regulated by HIPAA, even if the individual obtained that information from her medical record created by a regulated entity.
- Incoming House Majority Leader Scalise (R-LA) released the House calendar for 2023.
- The Senate HELP Subcommittee on Children and Families held a hearing titled “Caring for Our Kids: Supporting Mental Health in the Transition from High School to College.”
- The American Hospital Association, American Medical Association and other large healthcare groups sent a letter to congressional leadership urging lawmakers to prevent the impending 4% Medicare cut from the statutory Pay-As-You-Go Act of 2010 sequester from taking effect.
- Senate Finance Committee leaders released the committee’s fifth discussion draft to address mental health policy challenges, focused on improving parity. A summary of all mental health drafts released by the committee throughout the year, including the most recent parity provisions, is available here.
- CMS issued a request for information (RFI) on issues related to essential health benefits (EHB) under the Affordable Care Act (ACA). The RFI seeks input on a variety of topics related to the coverage of benefits in health plans subject to the EHB requirements of the ACA, and responses are due by January 31, 2023.
- The Advanced Research Projects Agency for Health (ARPA-H), the newly established agency within HHS to drive biomedical innovation, launched its website and Twitter account.
- HHS announced on November 22 that almost 3.4 million people nationwide have selected an Affordable Care Act Marketplace health plan since the 2023 Marketplace open enrollment period began on November 1. This is a 17% increase from the same time last year.
- HHS, through the Health Resources and Services Administration (HRSA), announced a new $350 million initiative for HRSA-supported health centers to increase COVID-19 vaccines in their communities, with a specific focus on underserved populations.
- HHS released a report on long COVID, offering insights and opportunities to support the patient community.
NEXT WEEK’S DIAGNOSIS
The House and Senate will both be in session as congressional leadership and top appropriators continue to seek an agreement on an end-of-year spending package. The Georgia Senate runoff election takes place December 6 and will decide whether Senate Democrats maintain a 50–50 majority (with Vice President Harris as the tiebreaking vote) or gain an outright, albeit narrow, 51–49 majority.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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