HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. FDA: COVID-19 TEST MAKERS SHOULD APPLY FOR FULL FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over. The agency has written and hopes to soon release a draft guidance that

will

CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any DRUGS ARE ONLY SECTOR NOT PART OF HISTORIC DROP IN HEALTH Drugs Are Only Sector Not Part Of Historic Drop In Health Care Costs. While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index . The first-ever drop in health care costs in

the

ASTHO ANALYSIS OF BIDEN ADMINISTRATION'S FY22 BUDGET Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday MO WALKS BACK PLANS FOR MEDICAID EXPANSION, SETTING STAGE Missouri Gov. Mike Parson (R) announced Thursday (May 13) that the state will formally withdraw its state plan amendments to expand Medicaid eligibility under the Affordable Care Act after legislators failed to appropriate funds for the expansion mandate passed by voters last summer, leaving stakeholders confident that legal action is

imminent.

HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response. While chair of the Senate Finance Committee in 2019, Grassley wrote a drug pricing bill with current

Chair Ron

FIVE NEW COMMISSIONERS NOMINATED TO MACPAC Five New Commissioners Nominated To MACPAC. The Government Accountability Office announced five new appointments -- with academic, insurance and federal and state government experience -- and two reappointments to the Medicaid and CHIP Payment and Access Commission on Monday (May 3). GAO also named a chair and vice chair

for the commission.

HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. FDA: COVID-19 TEST MAKERS SHOULD APPLY FOR FULL FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over. The agency has written and hopes to soon release a draft guidance that

will

CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any DRUGS ARE ONLY SECTOR NOT PART OF HISTORIC DROP IN HEALTH Drugs Are Only Sector Not Part Of Historic Drop In Health Care Costs. While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index . The first-ever drop in health care costs in

the

ASTHO ANALYSIS OF BIDEN ADMINISTRATION'S FY22 BUDGET Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday MO WALKS BACK PLANS FOR MEDICAID EXPANSION, SETTING STAGE Missouri Gov. Mike Parson (R) announced Thursday (May 13) that the state will formally withdraw its state plan amendments to expand Medicaid eligibility under the Affordable Care Act after legislators failed to appropriate funds for the expansion mandate passed by voters last summer, leaving stakeholders confident that legal action is

imminent.

HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response. While chair of the Senate Finance Committee in 2019, Grassley wrote a drug pricing bill with current

Chair Ron

FIVE NEW COMMISSIONERS NOMINATED TO MACPAC Five New Commissioners Nominated To MACPAC. The Government Accountability Office announced five new appointments -- with academic, insurance and federal and state government experience -- and two reappointments to the Medicaid and CHIP Payment and Access Commission on Monday (May 3). GAO also named a chair and vice chair

for the commission.

U.S. WILL SEND 500M DOSES OF PFIZER’S COVID-19 VACCINE TO The United States will purchase and donate half a billion doses of Pfizer’s COVID-19 vaccine to 92 low- and lower middle-income countries and the African Union through the end of 2021 and into the beginning of 2022, the Biden administration announced Thursday (June

10).

PWC PREDICTS 6.5% MEDICAL COST TREND FOR 2022 15 hours ago · The 2022 medical cost trend for commercial and self-insured employers will 6.5%, or slightly lower than 2021 yet still somewhat higher than the recent pre-pandemic rate, PwC’s Health Research Institute (HRI) predicts in its annual report dubbed Medical Cost Trend: Behind the Numbers . FTC MAPS OUT HOW IT COULD PROSECUTE DRUG REBATE WALLS The Federal Trade Commission provided a map for going after so-called drug rebate walls in a report delivered to Congress May 28 . FTC did not say it would sue over rebate walls, but two of the four commissioners, including the acting FTC chair, issued statements that are critical of the practice, and former FTC Policy Director David Balto said it’s noteworthy that the FTC report doesn’t LOBBYISTS SAY DEMOCRATS HAVE NEW PLAN FOR PASSING DRUG 3 hours ago · Democrats are considering adding Medicare drug price negotiation to the president’s American Families Plan and using budget reconciliation to pass it separately from the infrastructure bill, if a bipartisan deal is struck on infrastructure, drug and consumer lobbyists said. LAWSUIT PAUSED AFTER NEBRASKA HALTS TIERED MEDICAID 16 hours ago · A lawsuit seeking to get rid of a two-tiered benefits system for Nebraska’s Medicaid expansion population has been put on hold after the state decided to end the tiered system last week. GOTTLIEB, GIROIR DUKE IT OUT OVER FDA’S KRATOM RESPONSE Former FDA chief Scott Gottlieb and former HHS Assistant Secretary for Health Brett Giroir sparred over the safety of kratom and who’s to blame for the lack of strict scheduling, coming just minutes after FDA announced the seizure of $1.3 million worth of kratom-containing dietary supplements and bulk dietary ingredients. FDA NOT CLOSE TO LETTING STATES IMPORT DRUGS, HHS TELLS FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports. President Joe Biden supports drug imports, but HHS’ response to the lawsuit by the Pharmaceutical Research and BIDEN SEEKS TO BOOST FDA’S WORKFORCE, IT EFFORTS Biden Seeks To Boost FDA’s Workforce, IT Efforts. By Beth Wang / April 9, 2021 at 2:11 PM. Tweet. The Biden administration wants to enhance FDA’s “organizational capacity” as part of its larger goal of preparing the United States to respond to future public health crises. The president’s fiscal 2022 discretionary budget preview AHA STATEMENT ON UNITEDHEALTHCARE'S AGREEMENT TO PUT OFF 20 hours ago · Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more. HHS ASKS COURT TO DISMISS PHARMACIST SUIT OVER PBM FEES HHS wants the U.S. District Court for the District of Columbia to dismiss a lawsuit by independent retail pharmacists that targets the retroactive fees that pharmacy benefit managers charge. HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. FDA: COVID-19 TEST MAKERS SHOULD APPLY FOR FULL FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over. The agency has written and hopes to soon release a draft guidance that

will

CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any DRUGS ARE ONLY SECTOR NOT PART OF HISTORIC DROP IN HEALTH Drugs Are Only Sector Not Part Of Historic Drop In Health Care Costs. While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index . The first-ever drop in health care costs in

the

ASTHO ANALYSIS OF BIDEN ADMINISTRATION'S FY22 BUDGET Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday MO WALKS BACK PLANS FOR MEDICAID EXPANSION, SETTING STAGE Missouri Gov. Mike Parson (R) announced Thursday (May 13) that the state will formally withdraw its state plan amendments to expand Medicaid eligibility under the Affordable Care Act after legislators failed to appropriate funds for the expansion mandate passed by voters last summer, leaving stakeholders confident that legal action is

imminent.

HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response. While chair of the Senate Finance Committee in 2019, Grassley wrote a drug pricing bill with current

Chair Ron

FIVE NEW COMMISSIONERS NOMINATED TO MACPAC Five New Commissioners Nominated To MACPAC. The Government Accountability Office announced five new appointments -- with academic, insurance and federal and state government experience -- and two reappointments to the Medicaid and CHIP Payment and Access Commission on Monday (May 3). GAO also named a chair and vice chair

for the commission.

HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. FDA: COVID-19 TEST MAKERS SHOULD APPLY FOR FULL FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over. The agency has written and hopes to soon release a draft guidance that

will

CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any DRUGS ARE ONLY SECTOR NOT PART OF HISTORIC DROP IN HEALTH Drugs Are Only Sector Not Part Of Historic Drop In Health Care Costs. While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index . The first-ever drop in health care costs in

the

ASTHO ANALYSIS OF BIDEN ADMINISTRATION'S FY22 BUDGET Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday MO WALKS BACK PLANS FOR MEDICAID EXPANSION, SETTING STAGE Missouri Gov. Mike Parson (R) announced Thursday (May 13) that the state will formally withdraw its state plan amendments to expand Medicaid eligibility under the Affordable Care Act after legislators failed to appropriate funds for the expansion mandate passed by voters last summer, leaving stakeholders confident that legal action is

imminent.

HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response. While chair of the Senate Finance Committee in 2019, Grassley wrote a drug pricing bill with current

Chair Ron

FIVE NEW COMMISSIONERS NOMINATED TO MACPAC Five New Commissioners Nominated To MACPAC. The Government Accountability Office announced five new appointments -- with academic, insurance and federal and state government experience -- and two reappointments to the Medicaid and CHIP Payment and Access Commission on Monday (May 3). GAO also named a chair and vice chair

for the commission.

U.S. WILL SEND 500M DOSES OF PFIZER’S COVID-19 VACCINE TO The United States will purchase and donate half a billion doses of Pfizer’s COVID-19 vaccine to 92 low- and lower middle-income countries and the African Union through the end of 2021 and into the beginning of 2022, the Biden administration announced Thursday (June

10).

PWC PREDICTS 6.5% MEDICAL COST TREND FOR 2022 14 hours ago · The 2022 medical cost trend for commercial and self-insured employers will 6.5%, or slightly lower than 2021 yet still somewhat higher than the recent pre-pandemic rate, PwC’s Health Research Institute (HRI) predicts in its annual report dubbed Medical Cost Trend: Behind the Numbers . FTC MAPS OUT HOW IT COULD PROSECUTE DRUG REBATE WALLS The Federal Trade Commission provided a map for going after so-called drug rebate walls in a report delivered to Congress May 28 . FTC did not say it would sue over rebate walls, but two of the four commissioners, including the acting FTC chair, issued statements that are critical of the practice, and former FTC Policy Director David Balto said it’s noteworthy that the FTC report doesn’t LOBBYISTS SAY DEMOCRATS HAVE NEW PLAN FOR PASSING DRUG 2 hours ago · Democrats are considering adding Medicare drug price negotiation to the president’s American Families Plan and using budget reconciliation to pass it separately from the infrastructure bill, if a bipartisan deal is struck on infrastructure, drug and consumer lobbyists said. LAWSUIT PAUSED AFTER NEBRASKA HALTS TIERED MEDICAID 14 hours ago · A lawsuit seeking to get rid of a two-tiered benefits system for Nebraska’s Medicaid expansion population has been put on hold after the state decided to end the tiered system last week. GOTTLIEB, GIROIR DUKE IT OUT OVER FDA’S KRATOM RESPONSE Former FDA chief Scott Gottlieb and former HHS Assistant Secretary for Health Brett Giroir sparred over the safety of kratom and who’s to blame for the lack of strict scheduling, coming just minutes after FDA announced the seizure of $1.3 million worth of kratom-containing dietary supplements and bulk dietary ingredients. FDA NOT CLOSE TO LETTING STATES IMPORT DRUGS, HHS TELLS FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports. President Joe Biden supports drug imports, but HHS’ response to the lawsuit by the Pharmaceutical Research and BIDEN SEEKS TO BOOST FDA’S WORKFORCE, IT EFFORTS Biden Seeks To Boost FDA’s Workforce, IT Efforts. By Beth Wang / April 9, 2021 at 2:11 PM. Tweet. The Biden administration wants to enhance FDA’s “organizational capacity” as part of its larger goal of preparing the United States to respond to future public health crises. The president’s fiscal 2022 discretionary budget preview AHA STATEMENT ON UNITEDHEALTHCARE'S AGREEMENT TO PUT OFF 19 hours ago · Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more. HHS ASKS COURT TO DISMISS PHARMACIST SUIT OVER PBM FEES HHS wants the U.S. District Court for the District of Columbia to dismiss a lawsuit by independent retail pharmacists that targets the retroactive fees that pharmacy benefit managers charge. HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. WH: FDA NEEDS ADDITIONAL AUTHORITY TO COLLECT DRUG SUPPLY In a new supply chain report released Tuesday (June 8) , the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages. BECERRA PROMISES FLEXIBILITY ON PROVIDER RELIEF SPENDING HHS Secretary Xavier Becerra told House Ways & Means Committee members Tuesday (June 8) his department will provide some flexibility on the June 30 provider relief spending deadline, but he offered few other details on an extension that hospitals,

JOHN WILKERSON

John Wilkerson. John Wilkerson is a senior health group editor at Inside Health Policy, where he has covered the policy machinations of Congress and HHS since 2001.Currently, he writes and edits for Inside Drug Pricing.He works for tips, so pass some his way. CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any AMY LOTVEN | INSIDEHEALTHPOLICY.COM Amy Lotven. Amy Lotven is a senior editor for Inside Health Policy. Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday FDA NOT CLOSE TO LETTING STATES IMPORT DRUGS, HHS TELLS FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports. President Joe Biden supports drug imports, but HHS’ response to the lawsuit by the Pharmaceutical Research and INSIDEHEALTHPOLICY.COM A bipartisan group of House lawmakers hopes to tuck into the next coronavirus response package a newly introduced bill that would increase federal Medicaid matching funds (FMAP) by 1% for telehealth in states that cover those services. The Modernize Medicine Act, sponsored by Reps. Joe Kennedy (D-MA), Lisa Blunt Rochester (D-DE) and

former

SENATE MOVES CLOSER TO CONFIRMING BROOKS-LASURE AS CMS Senate Moves Closer To Confirming Brooks-LaSure As CMS Head. By Maya Goldman / May 12, 2021 at 2:47 PM. Tweet. The Senate voted 51 to 48 Wednesday (May 12) to advance the nomination of Chiquita Brooks-LaSure for CMS administrator after Sen. Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee, with Sen HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US CMS Revokes Trump Admin’s 10-Year Extension Of Texas 1115 Waiver. CMS Friday (April 16) revoked an 11th-hour move by the Trump administration to grant Texas a 10-year extension of its 1115 waiver that includes federal funding for the state’s uncompensated care funding pool that reimburses hospitals for caring for the uninsured. WH: FDA NEEDS ADDITIONAL AUTHORITY TO COLLECT DRUG SUPPLY In a new supply chain report released Tuesday (June 8) , the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages. BECERRA PROMISES FLEXIBILITY ON PROVIDER RELIEF SPENDING HHS Secretary Xavier Becerra told House Ways & Means Committee members Tuesday (June 8) his department will provide some flexibility on the June 30 provider relief spending deadline, but he offered few other details on an extension that hospitals,

JOHN WILKERSON

John Wilkerson. John Wilkerson is a senior health group editor at Inside Health Policy, where he has covered the policy machinations of Congress and HHS since 2001.Currently, he writes and edits for Inside Drug Pricing.He works for tips, so pass some his way. CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any AMY LOTVEN | INSIDEHEALTHPOLICY.COM Amy Lotven. Amy Lotven is a senior editor for Inside Health Policy. Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET Last Procedural Vote Before Brooks-LaSure Confirmation Set For Monday. The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote on the nominee. Sen. Chuck Schumer (D-NY) filed cloture Thursday FDA NOT CLOSE TO LETTING STATES IMPORT DRUGS, HHS TELLS FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports. President Joe Biden supports drug imports, but HHS’ response to the lawsuit by the Pharmaceutical Research and INSIDEHEALTHPOLICY.COM A bipartisan group of House lawmakers hopes to tuck into the next coronavirus response package a newly introduced bill that would increase federal Medicaid matching funds (FMAP) by 1% for telehealth in states that cover those services. The Modernize Medicine Act, sponsored by Reps. Joe Kennedy (D-MA), Lisa Blunt Rochester (D-DE) and

former

SENATE MOVES CLOSER TO CONFIRMING BROOKS-LASURE AS CMS Senate Moves Closer To Confirming Brooks-LaSure As CMS Head. By Maya Goldman / May 12, 2021 at 2:47 PM. Tweet. The Senate voted 51 to 48 Wednesday (May 12) to advance the nomination of Chiquita Brooks-LaSure for CMS administrator after Sen. Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee, with Sen WH: FDA NEEDS ADDITIONAL AUTHORITY TO COLLECT DRUG SUPPLY In a new supply chain report released Tuesday (June 8) , the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages. BECERRA PROMISES FLEXIBILITY ON PROVIDER RELIEF SPENDING HHS Secretary Xavier Becerra told House Ways & Means Committee members Tuesday (June 8) his department will provide some flexibility on the June 30 provider relief spending deadline, but he offered few other details on an extension that hospitals, BRADY DOUBTS BIDEN’S TELEHEALTH COMMITMENT; BECERRA OFFERS House Ways & Means ranking Republican Kevin Brady (TX) suggested President Joe Biden’s fiscal 2022 budget ignores a need to continue telehealth coverage after the COVID-19 public health emergency, but HHS Secretary Xavier Becerra told lawmakers Tuesday (June 8) he does not intend to go backwards on such coverage, although the department could use some help from Congress. EMA PANEL RECOMMENDS APPROVING PFIZER'S COVID-19 VACCINE Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response. While chair of the Senate Finance Committee in 2019, Grassley wrote a drug pricing bill with current

Chair Ron

HHS ASKS COURT TO DISMISS PHARMACIST SUIT OVER PBM FEES HHS wants the U.S. District Court for the District of Columbia to dismiss a lawsuit by independent retail pharmacists that targets the retroactive fees that pharmacy benefit managers charge. BIDEN SEEKS TO BOOST FDA’S WORKFORCE, IT EFFORTS Biden Seeks To Boost FDA’s Workforce, IT Efforts. By Beth Wang / April 9, 2021 at 2:11 PM. Tweet. The Biden administration wants to enhance FDA’s “organizational capacity” as part of its larger goal of preparing the United States to respond to future public health crises. The president’s fiscal 2022 discretionary budget preview MO WALKS BACK PLANS FOR MEDICAID EXPANSION, SETTING STAGE Missouri Gov. Mike Parson (R) announced Thursday (May 13) that the state will formally withdraw its state plan amendments to expand Medicaid eligibility under the Affordable Care Act after legislators failed to appropriate funds for the expansion mandate passed by voters last summer, leaving stakeholders confident that legal action is

imminent.

CMS WON’T EXTEND NEXTGEN ACOS, BUT DIRECT CONTRACTING AN CMS Won’t Extend NextGen ACOs, But Direct Contracting An Option. CMS on Friday (May 21) said it will not extend the Next Generation Accountable Care Organization demonstrations beyond 2021, but it will allow participants in that demo to join the Global and Professional Direct Contracting (GPDC) Model in 2022, even though the agency had HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US Biden’s Budget Hints At Proposals To Extend Medicare Trust Find. President Joe Biden’s fiscal 2022 HHS budget-in-brief doesn’t include specific Medicare legislative proposals, but the president laid out a health care agenda that calls for extending the life of the Medicare Trust Fund by changing Medicare pay to private insurers -- which some lobbyists said is a reference to changing CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any INSIDEHEALTHPOLICY.COM A bipartisan group of House lawmakers hopes to tuck into the next coronavirus response package a newly introduced bill that would increase federal Medicaid matching funds (FMAP) by 1% for telehealth in states that cover those services.

JOHN WILKERSON

John Wilkerson. John Wilkerson is a senior health group editor at Inside Health Policy, where he has covered the policy machinations of Congress and HHS since 2001.Currently, he writes and edits for Inside Drug Pricing.He works for tips, so pass some his way. AMY LOTVEN | INSIDEHEALTHPOLICY.COM Amy Lotven. Amy Lotven is a senior editor for Inside Health Policy. BIDEN’S HHS TO ENFORCE ‘GAG RULE’ UNTIL NEW TITLE X RULE The Biden administration told the Supreme Court it will continue to enforce the Trump-era so-called gag rule until it is replaced with a version the Biden HHS proposed in mid-April and expects to finalize by early fall before 2022 Title X funding is awarded in December. SENATE MOVES CLOSER TO CONFIRMING BROOKS-LASURE AS CMS The Senate voted 51 to 48 Wednesday (May 12) to advance the nomination of Chiquita Brooks-LaSure for CMS administrator after Sen. Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee, with Sen. Susan Collins (R-ME) and Sen. Jerry Moran (R-KS) joining Democrats to vote in favor of the motion. FOWLER AIMS TO REFOCUS CMMI ON BROADER HEALTH Innovation center chief Liz Fowler asked accountable care organizations for patience as the Center for Medicare and Medicaid Innovation evaluates its models, and indicated the center needs to focus on transforming the health care system, not just certifying

models to be

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote

on the nominee.

FORMER FDAER DOUBTS WOODCOCK WILL BE FDA CHIEF, OTHERS NOT FDA drug center director Janet Woodcock has been pegged as a potential front-runner for the full-time commissioner position ever since she

was

HOME | INSIDEHEALTHPOLICY.COMNEWSTOPICSFDA WEEKINSIDE DRUG PRICINGHEALTH EXCHANGE ALERTABOUT US Biden’s Budget Hints At Proposals To Extend Medicare Trust Find. President Joe Biden’s fiscal 2022 HHS budget-in-brief doesn’t include specific Medicare legislative proposals, but the president laid out a health care agenda that calls for extending the life of the Medicare Trust Fund by changing Medicare pay to private insurers -- which some lobbyists said is a reference to changing CRAPO, BRADY: MEDICARE TRUST FUND REPORT DELAYED Senate Finance Committee ranking Republican Mike Crapo (ID) and House Ways & Means ranking Republican Kevin Brady (TX) say that, after a note from the Treasury Department, they are concerned the Medicare Hospital Insurance Trustees Report may not be released for months -- but the Republicans say they need accurate information on the pandemic’s effect on the trust fund before any INSIDEHEALTHPOLICY.COM A bipartisan group of House lawmakers hopes to tuck into the next coronavirus response package a newly introduced bill that would increase federal Medicaid matching funds (FMAP) by 1% for telehealth in states that cover those services.

JOHN WILKERSON

John Wilkerson. John Wilkerson is a senior health group editor at Inside Health Policy, where he has covered the policy machinations of Congress and HHS since 2001.Currently, he writes and edits for Inside Drug Pricing.He works for tips, so pass some his way. AMY LOTVEN | INSIDEHEALTHPOLICY.COM Amy Lotven. Amy Lotven is a senior editor for Inside Health Policy. BIDEN’S HHS TO ENFORCE ‘GAG RULE’ UNTIL NEW TITLE X RULE The Biden administration told the Supreme Court it will continue to enforce the Trump-era so-called gag rule until it is replaced with a version the Biden HHS proposed in mid-April and expects to finalize by early fall before 2022 Title X funding is awarded in December. SENATE MOVES CLOSER TO CONFIRMING BROOKS-LASURE AS CMS The Senate voted 51 to 48 Wednesday (May 12) to advance the nomination of Chiquita Brooks-LaSure for CMS administrator after Sen. Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee, with Sen. Susan Collins (R-ME) and Sen. Jerry Moran (R-KS) joining Democrats to vote in favor of the motion. FOWLER AIMS TO REFOCUS CMMI ON BROADER HEALTH Innovation center chief Liz Fowler asked accountable care organizations for patience as the Center for Medicare and Medicaid Innovation evaluates its models, and indicated the center needs to focus on transforming the health care system, not just certifying

models to be

LAST PROCEDURAL VOTE BEFORE BROOKS-LASURE CONFIRMATION SET The Senate is slated to vote Monday (May 24) at 5:30 P.M. on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next CMS administrator, the last procedural hurdle before a final vote

on the nominee.

FORMER FDAER DOUBTS WOODCOCK WILL BE FDA CHIEF, OTHERS NOT FDA drug center director Janet Woodcock has been pegged as a potential front-runner for the full-time commissioner position ever since she

was

EU PROPOSES TRIPS WAIVER ALTERNATIVE TO ADDRESS VACCINE 9 hours ago · The European Union on Friday (June 4) proposed an alternative to the widely debated waiver of certain World Trade Organization intellectual property obligations -- of which the bloc remains critical -- outlining instead an initiative to limit export restrictions on COVID-19-related products, encourage expanded production of vaccines and facilitate intellectual property flexibilities, including FDA RELEASES FACT SHEETS ON FY 2022 BUDGET FOR FOOD SAFETY 7 hours ago · Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more. FDA PLANS JUNE 9 PHARMACY COMPOUNDING ADVISORY COMMITTEE 6 hours ago · Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more. EMA PANEL RECOMMENDS APPROVING PFIZER'S COVID-19 VACCINE Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news

and much more.

DRUGS ARE ONLY SECTOR NOT PART OF HISTORIC DROP IN HEALTH While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index . FORMER HHS SECRETARY ALEX AZAR JOINS ASPEN HEALTH STRATEGY 10 hours ago · Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more. HRSA THREATENS TO FINE DRUG MAKERS OVER 340B RESTRICTIONS The Health Resources and Services Administration threatened to fine drug makers that continue to restrict discounts to hospitals and clinics that dispense 340B drugs through multiple contract pharmacies, and HRSA said drug makers must refund hospitals. CMS WON’T EXTEND NEXTGEN ACOS, BUT DIRECT CONTRACTING AN CMS on Friday (May 21) said it will not extend the Next Generation Accountable Care Organization demonstrations beyond 2021, but it will allow participants in that demo to join the Global and Professional Direct Contracting (GPDC) Model in 2022, even though the agency had previously said it would not accept additional direct contracting applications for next year . HHS ASKS COURT TO DISMISS PHARMACIST SUIT OVER PBM FEES HHS wants the U.S. District Court for the District of Columbia to dismiss a lawsuit by independent retail pharmacists that targets the retroactive fees that pharmacy benefit managers charge. GRASSLEY ASKS HOUSE DEMS UNEASY WITH H.R. 3 TO WORK ON Sen. Charles Grassley reached out to the 10 House Democrats who recently expressed their uneasiness with House Democrats’ government drug price negotiation bill, H.R. 3, but the Iowa Republican said he’s not received a response.

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BREAKING DRUG PRICING NEWS MANDATORY FAVORED NATION PILOT CUTS DOCTOR PAY, LIMITS RX ACCESS Trump administration officials announced Friday (Nov. 20) a pilot that, starting Jan. 1, mandates seven years of deep Medicare pay cuts to doctors nationwide and that is projected to make fewer drugs available to seniors. HHS TOSSES FDA’S UNAPPROVED DRUGS INITIATIVE FOR PRICING REASONS

2021 TRANSITION

MCCLELLAN: BIDEN ADMIN SHOULD MAKE FDA AN INDEPENDENT AGENCY Former FDA chief Mark McClellan says the Biden administration should consider making FDA an independent agency, separate from HHS, and he asserts the discussion should be a priority for Congress and the administration in 2021 due to concerns the Trump White House exerted political pressure over FDA’s COVID-19 decisions.

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STAKEHOLDERS DIVIDED ON HOW HHS-FDA RELATIONS WILL SHAKE OUT

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LUJAN GRISHAM SAYS SHE HASN’T DISCUSSED HHS ROLE WITH TRANSITION

TEAM

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OMB CLEARS STARK, ANTI-KICKBACK STATUTE REFORMS

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HEALTH EXPERTS FROM BOTH PARTIES TALK BIDEN 2021 AGENDA, LAME DUCK

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INDUSTRY: BIDEN ADMIN MUST RESTORE TRUST IN FDA’S SCIENTIFIC

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AMA SIGNALS SUPPORT FOR LIMITED PUBLIC OPTION; BACKS AUTO-ENROLLMENT

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OMB QUICKLY REVIEWED FINAL REBATE RULE HHS SAID IT KILLED LAST YEAR More 2021 Transition Coverage → EXCLUSIVE, RELIABLE HEALTH POLICY REPORTING, JUST WHEN IT MATTERS MOST. NOW IS THE TIME TO TRY _INSIDE HEALTH POLICY_.

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CMS Changes Organ Procurement Organizations’ Conditions For

Coverage

CMS on Friday (Nov. 20) finalized changes to Organ Procurement Organizations’ Medicare and Medicaid Conditions for Coverage, moving away from self-reported measures and setting up a 12-month review period during the organization’s four-year recertification cycle. CMS To Expand Ambulance Prior Authorization After COVID-19 CMS plans to expand the non-emergency ambulance prior authorization demonstration across the country once the pandemic ends. In the meantime, the agency will continue the demonstration in states where it is already underway. ACHP Wants Telehealth Expanded, COVID-19 Tests Funded In Lame Duck The lobby representing community-based health plans is asking Congress to immediately extend access to telehealth services at least through 2022 to provide certainty through the public health emergency. End-Of-Year Omnibus Instead Of CR Would Be Good For FDA The Alliance for a Stronger FDA says a fiscal 2021 omnibus spending bill, instead of another continuous resolution, would be good news for FDA as it would likely give the agency an increase of around $40 million over fiscal 2020 levels, whereas if Congress signs another continuing resolution it would leave FDA with the same funding levels

as fiscal 2020.

Pressure Mounts To Train Nursing Home Staff In COVID-19 Control CMS is urging more nursing homes to use the agency’s voluntary infection control training as COVID-19 related deaths for residents near 100,000 and stakeholders and lawmakers pressure CMS to step up its support for long-term care facility staff. Drug Makers Likely To Sue If Interim Final Rule Used For Favored

Nation Scheme

If the Trump administration uses an interim final rule to put in place the president’s plan to base Medicare reimbursement on international drug prices, drug makers will surely sue, drug lobbyists say. Stakeholders Worry Trump’s CMS May Reverse Course On MFAR Rule Some stakeholders and lobbyists worry the Trump administration will issue a controversial Medicaid supplemental pay rule before leaving office -- despite CMS Administrator Seema Verma’s statement in September that CMS was scrapping the rule -- as Verma recently said CMS was slowing down its work on the rule in order to get it right but still stood behind the rule’s goals. HHS Uses Artificial Intelligence In Bid To Scrub 185,000 Pages Of

Regs

HHS unveiled a proposed rule Tuesday (Nov. 17) that aims to clean up 185,000 pages of regulatory code by removing outdated regulations, correcting nearly 100 citations, axing erroneous language, and fixing misspellings and typographical errors after the department used artificial intelligence and natural language processing to discover the inconsistencies.

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CORONAVIRUS

Our complete coverage of COVID-19

INSIDE DRUG PRICING

STUDY PROJECTS 1.1M DEATHS FROM SENIORS NOT TAKING PILLS DUE TO COSTS If drug prices continue to rise at current rates without Medicare coverage changes, more than 1.1 million seniors are projected to die over the coming decade because they skip medications due to costs, according to a study by West Health Policy Center and Xcenda, the research arm of the drug distributor AmerisourceBergen. BIDEN’S BUY-AMERICAN PLEDGE COULD HURT GENERIC DRUG INDUSTRY

FULL COVERAGE →

NOT A SUBSCRIBER? Contact customer service at ihp@iwpnews.com or 703-416-8505. For a free trial, contact Steve Reilly at sreilly@iwpnews.com. HEALTH REFORM DEBATE New Coalition To Push Open Enrollment; 804K Sign Up During Week 2 State exchanges, consumer advocates and health care stakeholders on Thursday launched Get Covered 2021, a new effort urging Americans to protect themselves and their families from COVID-19 by wearing masks and getting insured. Molina Takes Hit In Exchange Business In Third Quarter Dem Health Leaders Demand CMS Reverse GA Medicaid, 1332 Waivers 818K Sign Up For ACA Plans In First Week Of Open Enrollment Groups Partner To Boost Exchange Sign-Ups, Week 1 Enrollment Data MIA Appeals Court Rejects Request For Full Panel Review Of CSR Case More Health Reform News →

DOCUMENTS

Wyden Statement On Reforms To Organ Donation And Procurement

Standards

CMS Finalizes Policy To Increase Available Lifesavings Organs By Holding Organ Procurement Organizations Accountable HHS Moves To Withdraw FDA's Unapproved Drugs Initiative Guidance FDA Announces Advisory Committee Meeting To Discuss Pfizer COVID-19

Vaccine Candidate

FDA Approves First Treatment For Hutchinson-Gilford Progeria Syndrome And Some Progeroid Laminopathies Reactions To HHS' Stark, Anti-Kickback Reforms

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2021 TRANSITION

LONG-AWAITED STARK, ANTI-KICKBACK RULES CMS, OIG FINALIZE LONG-AWAITED STARK, ANTI-KICKBACK REFORMS HHS on Friday (Nov. 20) finished physician self-referral, or Stark, and anti-kickback reforms that have been in the works for much of the administration’s tenure, and key stakeholders immediately praised the final rules for protecting value-based care.

FOCUS ON COVID-19

FDA VACCINE ADVISERS WILL REVIEW PFIZER’S COVID-19 VACCINE DEC. 10 FDA’s vaccine advisory committee will meet on Dec. 10 to discuss Pfizer and BioNTech’s COVID-19 vaccine, the agency announced Friday (Nov. 20), the same day the companies submitted an emergency use authorization request for their vaccine. CMS NURSING HOME GUIDE DISCOURAGING HOLIDAY LEAVE SPARKS QUESTIONS STATES, PROVIDERS HOPE COVID-19 RELIEF WISHLIST PART OF POSSIBLE

OMNIBUS

FDA GRANTS EUA TO BARICITINIB-REMDESIVIR COMBO FOR COVID-19 FDA REMOVES LANGUAGE ON DECLINING TO REVIEW LDT EUAS FROM WEBSITE SLAOUI: PEOPLE SHOULD HAVE EQUAL ACCESS TO PFIZER’S, MODERNA’S

VACCINES

PUBLIC CITIZEN: PFIZER USED GOVT. TECHNOLOGY IN ITS COVID-19 VACCINE SLAOUI: COVID-19 VACCINE TRIALS WILL BE UNBLINDED, BUT QUESTION IS

WHEN

FDA: FIRST FULL AT-HOME COVID-19 TEST TO BE FOLLOWED BY SIMILAR EUAS PHARMACISTS HOPE TO PARLAY COVID-19 VACCINE WIN INTO PROVIDER STATUS

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EXCLUSIVE 340B NEWS

LILLY TO HRSA: CO-PAY COUPONS BETTER FOR PATIENTS THAN 340B Eli Lilly indicated in a letter to the Health Resources and Services Administration that its co-pay coupons are more helpful for patients than the 340B program, shortly after CMS finalized a proposal to let Obamacare plans exclude brand drug makers’ coupons from out-of-pocket calculations even when there are no generics available. HRSA TOLD LILLY IN JUNE TO RETHINK 340B CONTRACT PHARMACY LIMITS, BUT DIDN’T OUTRIGHT SAY ILLEGAL

THE VITALS

BCBSA Data Show Precipitous Drop In Childhood Vaccinations CMS To Retire 8 Compare Sites In December, Transition To Care Compare HHS Seeks Proposals To Reduce Hypertension In Pregnant Women KFF: Average Employer Premiums Have Grown 4% In 2020 Coons Says Barrett Mum On ACA Opinion In Phone Meeting CMS Offers Grants To Transition Medicaid Beneficiaries To HCBS DC Exchange Loosens Small Biz Enrollment Policy Through 2022

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Inside CMS

HHS’ Reg Work Continues Post Election, But Many Polices Still At OMB Stakeholders Worry Trump’s CMS May Reverse Course On MFAR Rule HHS Pulled In Different Directions On Provider Relief Reporting

Policies

Provider Groups Pressure Trump To Work With Biden Transition Team

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Health Exchange Alert HHS’ Reg Work Continues Post Election, But Many Polices Still At OMB Dem Health Leaders Demand CMS Reverse GA Medicaid, 1332 Waivers 818K Sign Up For ACA Plans In First Week Of Open Enrollment Roberts, Kavanaugh Questioning Signals SCOTUS Might Not Toss ACA

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FDA Week

HHS Directs FDA To Review Voluntary EUA Applications For COVID-19 LDTs FDA: Only N95s Nearly 100% Effective, But Cloth Masks Still Helpful Slaoui: COVID-19 Vaccine Trials Will Be Unblinded, But Question Is

When

FDA Will Publicize EUA Data, Information As GAO Calls For Transparency Download PDF | Read More →

Inside Drug Pricing

OMB Reviews Drug Rebate Ban Final Rule; Moderna Unveils Good News On

Vaccine

Patients Back Bill To Delay HHS Rule That Undermines Copay Coupons ICER Lowers Recommended Price For COVID Drug Remdesivir Public Citizen: Pfizer Used Govt. Technology In Its COVID-19 Vaccine

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Medicare

CMS, OIG Finalize Long-Awaited Stark, Anti-Kickback Reforms CMS Changes Organ Procurement Organizations’ Conditions For

Coverage

Mandatory Favored Nation Pilot Cuts Doctor Pay, Limits Rx Access

Congress

McClellan: Biden Admin Should Make FDA An Independent Agency States, Providers Hope COVID-19 Relief Wishlist Part Of Possible

Omnibus

End-Of-Year Omnibus Instead Of CR Would Be Good For FDA

Food Safety

Generic Drug Labeling, Orphan Drug Bills Among 10 Passed By House CSPI: FDA Cell-Based Seafood Plan Must Align With Cell-Meat Efforts FDA Proposes Rule To Improve Food Traceability

Medical Devices

FDA Removes Language On Declining To Review LDT EUAs From Website FDA: First Full At-Home COVID-19 Test To Be Followed By Similar EUAs HHS Directs FDA To Review Voluntary EUA Applications For COVID-19

LDTs

Budget

H.R. 3 Placed On Senate Calendar, But It’s Likely A Spending-Bill

Shell

White House Wants Extenders In Fiscal 2021 Continuing Resolution House Appropriations Passes Labor-HHS Spending Bill

Rx Drugs

Mandatory Favored Nation Pilot Cuts Doctor Pay, Limits Rx Access HHS Tosses FDA’s Unapproved Drugs Initiative For Pricing Reasons FDA Vaccine Advisers Will Review Pfizer’s COVID-19 Vaccine Dec. 10

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