POLICY BRIEFINGS


HHS Moves to Waive Regulations for Certain Drugs and Devices


The U.S. Department of Health and Human Services (HHS) has released two policies aimed at increasing transparency and reducing unnecessary drug and medical device regulations. The first measure would require the Food and Drug Administration (FDA) to publish a report detailing the timeframes for generic drugs approvals, and whether FDA review was completed within the 180-day period required by law. The second policy would make permanent the FDA’s decision to waive premarket review requirements for certain medical devices in response to the COVID-19 pandemic. The change would apply to seven types of surgical and examination gloves, as well as 83 different types of class two medical devices and one device that is not classified – equipment including sterilizers, digital imaging software, face masks, ventilators, thermometers, and medical gowns, as well as more complex products such as infusion pumps, digital devices for psychiatric disorders, and fetal monitoring devices. HHS hopes to avoid unnecessary delays in patient access caused by premarket review of these devices.


HHS Lifts Restrictions on Buprenorphine Prescribing


The U.S. Department of Health and Human Services (HHS) has announced new guidelines that will make it easier for physicians to prescribe buprenorphine to treat opioid addiction. HHS plans to eliminate the requirement that doctors obtain an “X” waiver, which requires them to complete nearly 24-hours of training before being allowed to prescribe the drug. Some health care providers have raised concerns that the prescribing requirements restrict access to the treatment in the midst of the opioid epidemic.


Hart Health Strategies COVID-19 Resources


Hart Health Strategies Inc. continues to update the following resources related to the coronavirus pandemic. Please remember to clear your cache to ensure you download the most recent documents.


Upcoming Congressional Committee Activity


Senate Select Committee on Intelligence hearing to examine the expected nomination of Avril Haines to be Director of National Intelligence; 10:00 a.m., WEBEX; January 19

Senate Finance Committee hearing to consider the anticipated nomination of the Honorable Janet L. Yellen to Secretary of the Treasury; 10:00 a.m., 215 Dirksen Bldg.; January 19

Senate Homeland Security and Governmental Affairs Committee hearing to examine the expected nomination of Alejandro N. Mayorkas, to be Secretary of Homeland Security; 10:00 a.m., 342 Dirksen Bldg.; January 19

Senate Foreign Relations Committee hearing to examine the expected nomination of Antony J. Blinken, of New York, to be Secretary of State; 2:00 p.m., 301 Russell Bldg.; January 19

Senate Armed Services Committee hearing to examine the expected nomination of Lloyd J. Austin III, to be Secretary of Defense; 3:00 p.m., G50 Dirksen Bldg.; January 19

Senate Commerce, Science, and Transportation Committee hearing to examine the expected nomination of Peter Buttigieg, of Indiana, to be Secretary of Transportation; 10:00 a.m., 253 Russell Bldg.; January 21

Senate Veterans’ Affairs Committee hearing to examine the expected nomination of Denis R. McDonough, to be Secretary of Veterans Affairs; 3:00 p.m., 106 Dirksen Bldg.; January 27


Recently Introduced Health Legislation


H.R.238 — To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits for lung cancer screenings for certain individuals without the imposition of cost sharing; Sponsor: Rep. Boyle, Brendan F. [D-PA-2]; Committees: House - Energy and Commerce

H.R.253 — To expand and enhance existing adult day programs for younger people with neurological diseases or conditions (such as multiple sclerosis, Parkinson’s disease, traumatic brain injury, or other similar diseases or conditions) to support and improve access to respite services for family caregivers who are taking care of such people, and for other purposes; Sponsor: Rep. Lee, Barbara [D-CA-13]; Committees: House - Energy and Commerce

H.R.254 — To amend the Public Health Service Act to create a National Neuromyelitis Optica Spectrum Disorder Consortium to provide grants, coordinate synergistic research, and targeted therapy with respect to the causes of, and risk factors associated with, neuromyelitis optica spectrum disorder, and for other purposes; Sponsor: Rep. Lee, Barbara [D-CA-13]; Committees: House - Energy and Commerce

H.R.259 — To amend the Public Health Service Act to address the increased burden that maintaining the health and hygiene of infants and toddlers places on families in need, the resultant adverse health effects on children and families, and the limited child care options available for infants and toddlers who lack sufficient diapers, and for other purposes; Sponsor: Rep. Lee, Barbara [D-CA-13]; Committees: House - Energy and Commerce; Ways and Means

H.R.265 — To amend title XI of the Social Security Act to eliminate the general Medicaid funding limitations for territories of the United States, and for other purposes; Sponsor: Rep. Sablan, Gregorio Kilili Camacho [D-MP-At Large]; Committees: House - Energy and Commerce

H.R.280 — To direct the Secretary of Health and Human Services to carry out a pilot program to test the feasibility and outcomes of integrating a substance use disorder and behavioral health treatment locator tool into the prescription drug monitoring programs of 5 eligible States; Sponsor: Rep. McKinley, David B. [R-WV-1]; Committees: House - Energy and Commerce

H.R.295 — To waive high deductible health plan requirements for health savings accounts; Sponsor: Rep. Budd, Ted [R- NC-13]; Committees: House - Ways and Means

H.R.311 — To provide for quality assurance of COVID-19 reimbursements and reporting; Sponsor: Rep. Posey, Bill [R- FL-8]; Committees: House - Energy and Commerce; Judiciary

H.R.312 — To provide a Federal income tax credit for State income taxes paid by individuals temporarily providing certain health or emergency services in the State, and to provide a corresponding reduction in Federal highway funds to the State; Sponsor: Rep. Posey, Bill [R-FL-8]; Committees: House - Ways and Means; Transportation and Infrastructure

H.R.315 — To amend the Coronavirus Aid, Relief, and Economic Security Act to extend the temporary suspension of Medicare sequestration, and for other purposes; Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House – Budget

H.R.316 — To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19; Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House - Energy and Commerce; Financial Services

H.R.317 — To amend the Public Health Service Act to establish a health insurance Federal Invisible Risk Sharing Program; Sponsor: Rep. Schweikert, David [R-AZ-6]; Committees: House - Energy and Commerce

H.R.318 — To amend title XVIII to provide coverage and payment for certain tests and assistive telehealth consultations during the COVID-19 emergency period, and for other purposes; Sponsor: Rep. Schweikert, David [R-AZ-6]; Committees: House - Energy and Commerce; Ways and Means



January 19, 2021: | Page 1 Page 2 Page 3 Page 4

SERVICES




BRIEFING ARCHIVE


 -  2021


 +  2020


 +  2019


 +  2018