content
  
  

LEGISLATION

ACA Repeal Update
With three separate bills the Senate Republican leadership failed its effort to repeal the Affordable Care Act (ACA). The leadership first attempted to pass a comprehensive repeal and replace bill, then moved to pass a repeal only bill, and finally pressed a minimal repeal and replace bill. Each version of these bills included provisions to eliminate the Prevention and Public Health Fund (PPHF) in fiscal year 2018 — the fiscal year that begins October 1, 2017 — which must have been the reason all three bills failed (not really).

Republican interest in repealing ACA has not dissipated and at this writing it is not clear what approach they will pursue next to accomplish that goal.

Federal Funding Update
No additional information to report.

HHS Operating Divisions Leadership Update
No additional information to report.

REGULATION

No additional information to report.

Washington Weekly
  

LEGISLATION

Federal Funding Update
This week the House Republican leadership moved appropriations bills that fund several federal agencies that support public health operations, including the Interior-Environment, State-Foreign Operations, and Labor-HHS measures. Detailed reports on these bills became available and add clarity to the impact of the House funding decisions. With a few notable exceptions described below, these appropriations bills largely reject the funding cuts sought by President Trump. To repeat, no Democratic member of the appropriations subcommittees or full committee voted for the bills, and this could set the stage for a shutdown showdown on Senate action.

The Interior bill includes funding for the Environmental Protection Agency, which had the largest reduction in spending from 2017 levels at $528 million. The bill does increase funding for Hazardous Substance Superfund by $27 million. Funding for Science and Technology (S & T) is cut $104 million, but it is unclear if President Trump’s proposal to eliminate the $10 million for Water Security is included; the committee agreed to President Trump’s request to increase S & T operations and administration by $11 million. The bill also increases overall operations and administration funding by $15 million but it cuts Environmental Programs and Management $234 million, and State and Tribal Assistance Grants are cut $239 million — with a $250 million cut to the clean water SRF, but the drinking water SRF funding is level.

Funding for the State Department and foreign operations global health activities had the second largest reduction with a cut from 2017 amounts of $404 million. The State–Foreign Operations bill maintains level funding for State Department PEPFAR work at $5.67 billion and cuts $404 million from USAID. The bill directs $82 million for global health security and emerging threats and includes $10 million for an Emergency Reserve Fund to respond to an emerging health threat.

As reported last week, the House Republican leadership on the appropriations committee has produced a bill to cut CDC by $198 million in fiscal year 2018 to help pay for a $1.1 billion increase for NIH. This funding cut will cause significant reductions in CDC’s support of critical public health programs.

TheLabor–HHS report indicates that while the CDC bill increases PHEP by $20 million, maintains level funding for HIV/AIDS Viral Hepatitis, STD, and TB; NCBDDD; and Global Health, it cuts NCEH by $56 million, IRD by $50 million, NCEZID by $33 million, and Public Health Scientific Services (PHSS) by $10 million. Within these reductions, funding for the Environmental Health Laboratory and newborn screening at NCEH is level though environmental tracking is cut $9 million as President Trump requested, NCEZID funding for AR is increased $3 million, food safety is increased $2 million, and level funding is provided for ELC, laboratory safety, AMD, and vector-borne. The $10 million cut to PHSS is another of the exceptions where the committee agreed with the President Trump’s cut of $7 million for Public Health Workforce.

While the bill cuts the Maternal and Child Health programs at HRSA by $10 million, it provides level funding for the newborn screening work done through both the Heritable Disorders and Universal Newborn Hearing programs.

On overall HHS funding, the bill cuts almost $22 million (36%) from the Office of the National Coordinator of Health Information Technology.   

Finally, the Agriculture appropriations bill provides level funding for FDA and its implementation of the Food Safety Modernization Act. The bill also includes interesting language on LDTs:

Laboratory Developed Tests.—The FDA’s draft guidance issued on October 3, 2014, titled ‘‘Framework for Regulatory Oversight of Laboratory Developed Tests’’ (LDTs), puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated. Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies and the FDA to find common ground on regulating LDTs. The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee maintains its position that FDA should suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

The House Budget Committee passed the Budget Resolution for fiscal year 2018, and there continue to be no documents are available. As reported the bill exceeds the budget caps for defense spending with a $73 billion increase and cut nondefense spending an additional $5 billion.

As a reminder, a group of moderate Republicans in the House has become so concerned about the process for 2018 that they’ve sent a letter to House Speaker Paul Ryan urging him to find a way to negotiate a bipartisan approach.

ACA Repeal Update
The Senate Republican leadership has announced that next week there will be a vote on whether the Senate will consider the revised version of their draft document that would repeal the Affordable Care Act (ACA).

As with the first version of the Senate leadership bill, the new version also eliminates the Prevention and Public Health Fund (PPHF) in fiscal year 2018 — the fiscal year that begins October 1, 2017. To refresh, the House of Representatives passed legislation that repeals the ACA and the first section of the House repeal bill eliminates the PPHF in fiscal year 2019. The PPHF provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants.

As a reminder, the initial version of the Senate bill has been scored by the Congressional Budget Office (CBO) who found that it would have a substantially similar impact on the number of people with health care insurance as the House counterpart. Further, a longer-term CBO assessment of the Medicaid provisions details additional cuts in Medicaid spending of 35% over the ten years from 2026 to 2036.

Because of the ongoing deliberations of the Senate bill, we continue to share the state-by-state fact sheets that document the impact of the repeal of the PPHF on each state produced by the Democrats on the Senate Health, Education, Labor and Pensions Committee. Again, if possible, it should be helpful to broadly disseminate the fact sheets to Members of Congress in your delegation to the extent you are able. Please contact us with any questions on this action.

HHS Operating Divisions Leadership Update
No additional information to report.

REGULATION

No additional information to report.

Laboratory Developed Tests
Please see description in Agriculture appropriations section above.

Washington Weekly
  

LEGISLATION

Federal Funding Update
The House Republican leadership on the appropriations committee has produced a bill to cut CDC by $163 million in fiscal year 2018 to help pay for a $1.1 billion increase for NIH. While there is only minimal information currently available on these cuts, it is clear that the bill cuts NCEZID by $79 million, NCEH by $74 million, and Public Health Scientific Services by $12 million. This amount of reduced spending will present significant reductions in CDC’s support of critical public health programs. The bill also cuts the Maternal and Child Health programs at HRSA by $10 million, but it is also not clear which programs are reduced at this time. No Democratic member of the appropriations subcommittee voted for the bill, and this could set the stage for a shutdown showdown once the Senate acts on the bill.

Overall, the House bill for all Labor-HHS activities is $3 billion lower than 2017 — which is hopefully the low water mark — despite the fact that the Budget Control Act prevents spending reductions on nondefense cannot be applied to the $68 billion in spending increases for defense. No similar activity on Labor-HHS has occurred in the Senate.

The House Budget Committee continues to pursue the Budget Resolution for fiscal year 2018, and there continues to be no documents available. Again, it is widely reported that the Republican Chair of the Committee, Diane Black (R-TN), is crafting a bill that will exceed the budget caps for defense spending with a $73 billion increase and cut nondefense spending an additional $5 billion.

As a reminder, a group of moderate Republicans in the House has become so concerned about the process for 2018 that they’ve sent a letter to House Speaker Paul Ryan urging him to find a way to negotiate a bipartisan approach.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request to you for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
The Senate Republican leadership released a revised version of their draft document that would repeal the Affordable Care Act (ACA). Republican Senators who previously announced their opposition continue to be opposed because of their assessment of the changes. Senator Rand Paul (R-KY) reportedly said the new version cements his opposition in part because it is “creating a brand-new insurance bailout superfund.” Senator Susan Collins (R-ME) has said she remains opposed to the size of the Medicaid cuts in the Senate bill.

As with the first version of the Senate leadership bill, the new version also eliminates the Prevention and Public Health Fund (PPHF) in fiscal year 2018 — the fiscal year that begins October 1, 2017. To refresh, the House of Representatives passed legislation that repeals the ACA and the first section of the House repeal bill eliminates the PPHF in fiscal year 2019. The PPHF provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants.

As a reminder, the initial version of the Senate bill has been scored by the Congressional Budget Office (CBO) which found that it would have a substantially similar impact on the number of people with health care insurance as the House counterpart. Further, a longer term CBO assessment of the Medicaid provisions details additional cuts in Medicaid spending of 35% over the ten years from 2026–2036.

Because of the ongoing deliberations of the Senate bill, we continue to share the state-by-state fact sheets that document the impact of the repeal of the PPHF on each state produced by the Democrats on the Senate Health, Education, Labor and Pensions Committee. Again, if possible, it should be helpful to broadly disseminate the fact sheets to Members of Congress in your delegation to the extent you are able. Please contact us with any questions on this action.

HHS Operating Divisions Leadership Update
President Trump announced his intention to nominate Robert P. Kadlec of New York to be Assistant Secretary of Health and Human Services for Preparedness and Response. Currently, Dr. Kadlec is the Deputy Staff Director for the Senate Select Committee on Intelligence. Previously, he served as a Special Assistant to the President for Biodefense Policy for President George W. Bush.

REGULATION

Office of Information and Regulatory Affairs Nomination
Neomi Rao, an associate law professor at George Mason University has been confirmed by the Senate to lead the White House’s Office of Information and Regulatory Affairs (OIRA). OIRA is tasked with approving government data collection, oversees the federal rulemaking process and reviews draft regulations. Rao will be at the head of the Trump Administration’s effort to overhaul the government’s regulatory approach.

Laboratory Developed Tests
APHL met with the offices of Diana DeGette (D-CO) and Larry Bucshon (R-IN) this week to discuss laboratory developed tests (LDT) and the unique role of public health laboratories. Bucshon and DeGette are leading an effort to overhaul LDT regulation through legislation and have released a draft bill, the Diagnostic Accuracy and Innovation Act (DAIA). APHL discussed the fundamental public health principles needed in any LDT regulation as outlined in APHL’s LDT position statement. A second draft of DAIA is anticipated during the August recess, along with a hearing sometime in the fall. APHL will provide written feedback to both offices on the impact of LDT regulation to public health activities, including a public health surveillance exemption, increased flexibility during public health emergencies and preserving newborn screening services that may rely on LDTs.

Washington Weekly
  

IN THE NEWS

HHS Operating Divisions Leadership Update
On July 7, 2017, HHS Secretary Tom Price announced that Brenda Fitzgerald, MD will be the new Director of the Centers for Disease Control and Prevention. Dr. Fitzgerald had been the Georgia state health officer since 2011, and she begins serving as Director today and APHL looks forward to meeting with her shortly.

LEGISLATION

ACA Repeal Update
The Senate Republican leadership draft document of their proposal to repeal the Affordable Care Act (ACA) has been scored by the Congressional Budget Office (CBO) who found that it would have a substantially similar impact on the number of people with health care insurance as the House counterpart. Further, a longer-term CBO assessment of the Medicaid provisions details additional cuts in Medicaid spending of 35% over the ten years from 2026 to 2036. A number of Republican Senators have expressed concern about the impact of the repeal bill, causing the Republican Majority Leader Mitch McConnell to stop his effort to have the Senate vote on the bill prior to the Fourth of July Congressional recess.

The expression of concerns also has lead President Trump to suggest that a combined repeal and replace effort might not be best and it has caused the Republican Senate leadership to ask CBO for scores on variations of the original draft — though no details on those alternatives or the scores are yet available.

As a continuing reminder, the Senate leadership bill also eliminates the Prevention and Public Health Fund (PPHF) in fiscal year 2018 — the fiscal year that begins October 1, 2017. To refresh, the House of Representatives passed legislation that repeals the ACA and the first section of the House repeal bill eliminates the PPHF in fiscal year 2019. The PPHF provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants. Because of the ongoing deliberations of the Senate bill, the Democrats on the Senate Health, Education, Labor and Pensions Committee have compiled these state-by-state fact sheets that document the impact of the repeal of the PPHF on each state. It should be helpful to broadly disseminate the fact sheets to Members of Congress in your delegation to the extent you are able. Please contact us with any questions on this action.

While Congressional consideration of repeal legislation is far from over, it is becoming increasingly difficult to visualize a path forward for Senate approval of a bill that would be agreed to by the House and sent to the president.

Federal Funding Update
The House Budget Committee is pursuing the Budget Resolution for fiscal year 2018, and while no documents are available it is widely reported that the Republican Chair of the Committee, Diane Black (R-TN), is crafting a bill that will exceed the budget caps for defense spending with a $73 billion increase and cut nondefense spending an additional $5 billion. Such a budget resolution would break the law by violating the Budget Control Act (BCA) and it continues to remain unclear whether, or how, Congress will pursue changes in the BCA to allow the increased spending for defense without breaking the law. So far, we are not hearing chants of “lock her up.”

A group of moderate Republicans in the House has become so concerned about the process for 2018 that they’ve sent a letter to House Speaker Paul Ryan urging him to find a way to negotiate a bipartisan approach.

As a reminder, President Trump’s budget request that $54 billion be cut from fiscal year 2018 federal nondefense discretionary spending was released on May 23, 2017 and provides specific detail on the reductions in funding at the program, project and activity levels of federal spending, which is extremely useful in documenting the impact of those cuts from 2017 levels.

Cuts to CDC include: overall reduction of $1.2 billion; a cut of $186 million to HIV/AIDS, Viral Hepatitis, Sexually Transmitted Infections and TB; a cut of $136 million to Preparedness with $116 million coming from PHEP; a cut of $76 million to Global Health; a cut of $64 million to EZID, including the elimination of $40 million for ELC from the Prevention and Public Health Fund (PPHF) and $22 million from antibiotic resistance AR — and changing the funding source for the remainder of AR to the soon to be eliminated PPHF; a cut of $35 million to Birth Defects, Developmental Disabilities and Health; a cut of $30 million to Public Health Scientific Services accomplished by reducing the number of trained disease detectives and rapid outbreak responders; a cut of $60 million to Environmental Health, though the Environmental Health laboratory is level funded; however, there is an increase of $12 million for vector-borne activities and advanced molecular detection and food safety are level funded.

Cuts to FDA include: a cut of $71 million, $22 million internal and $49 million external, for implementation of the Food Safety Modernization Act.

Cuts to HRSA include: a cut of $35 million to the Maternal and Child Health Bureau achieved mostly by eliminating $18 million for universal newborn screening hearing and $14 million for heritable disorders.

Cuts to the State Department include: a cut of $2 billion to Global Health Programs for a funding level of $6.5 billion: $5 billion State and $1.5 billion USAID, no funding for Global Health Security but a redirection of $75 million in Ebola funding for these activities.

Cuts to EPA include: the elimination of funding ($10 million) for the water security program and moving some activities to the preparedness, response and recovery program which is cut $19 million. However, the Clean Water revolving loan fund is increased $2.6 million, and the Drinking Water fund is increased $1.6 million.

As a further reminder, the agreement on fiscal year 2017 spending includes robust funding for most federal agencies, including CDC, FDA, HRSA and EPA. Congress did not include the $18 billion in spending reductions sought by President Trump. Funding for most federal agencies is about level with 2016 amounts, though there are some programmatic increases and decreases in selected CDC activities as follows: AR + $3m; Food Safety + $2m; PH workforce - $2.2m; Global Public Health Protection + $3m; and overall CDC’s budget is down $13m; HRSA is up $88m; EPA is down $81m.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

ACA Repeal Update
The Senate Republican leadership produced a draft document of their proposal to repeal the Affordable Care Act (ACA) and it eliminates the Prevention and Public Health Fund (PPHF) in fiscal year 2018 – the fiscal year that begins October 1, 2017. To refresh, the House of Representatives passed legislation that repeals the ACA and the first section of the House repeal bill eliminates the PPHF in fiscal year 2019. The PPHF provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants. The Senate bill again demonstrates the strong interest in repealing ACA from President Trump and the Republican Congressional leadership.

Federal Funding Update
As a reminder, President Trump’s budget request that $54 billion be cut from fiscal year 2018 federal nondefense discretionary spending was released on May 23, 2017 and provides specific detail on the reductions in funding at the program, project and activity levels of federal spending, which is extremely useful in documenting the impact of those cuts from 2017 levels.

Cuts to CDC include: overall reduction of $1.2 billion; a cut of $186 million to HIV/AIDS, Viral Hepatitis, Sexually Transmitted Infections and TB; a cut of $136 million to Preparedness with $116 million coming from PHEP; a cut of $76 million to Global Health; a cut of $64 million to EZID, including the elimination of $40 million for ELC from the Prevention and Public Health Fund (PPHF) and $22 million from antibiotic resistance AR — and changing the funding source for the remainder of AR to the soon-to-be-eliminated PPHF; a cut of $35 million to Birth Defects, Developmental Disabilities and Health; a cut of $30 million to Public Health Scientific Services accomplished by reducing the number of trained disease detectives and rapid outbreak responders; a cut of $60 million to Environmental Health, though the Environmental Health laboratory is level-funded; however, there is an increase of $12 million for vector-borne activities and advanced molecular detection and food safety which are level-funded.

Cuts to FDA include: a cut of $71 million, $22 million internal and $49 million external, for implementation of the Food Safety Modernization Act.
Cuts to HRSA include: a cut of $35 million to the Maternal and Child Health Bureau achieved mostly by eliminating $18 million for universal newborn screening hearing and $14 million for heritable disorders.

Cuts to the State Department include: a cut of $2 billion to Global Health Programs for a funding level of $6.5 billion: $5 billion State and $1.5 billion USAID, no funding for Global Health Security but a redirection of $75 million in Ebola funding for these activities.

Cuts to EPA include: the elimination of funding ($10 million) for the water security program and moving some activities to the preparedness, response and recovery program which is cut $19 million. However, the Clean Water revolving loan fund increased $2.6 million, and the Drinking Water fund is increased $1.6 million.

As previously reported, Congress will next turn to consideration of the budget for 2018, and the action will focus on the president’s proposal for tax cuts, cutting spending for nondefense by $54 billion and increasing spending on defense by $54 billion. The Congressional reception of the president’s budget request was tepid, and it continues to remain unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense.

As a further reminder, the agreement on fiscal year 2017 spending includes robust funding for most federal agencies, including CDC, FDA, HRSA and EPA. Congress did not include the $18 billion in spending reductions sought by President Trump. Funding for most federal agencies is about level with 2016 amounts, though there are some programmatic increases and decreases in selected CDC activities as follows: AR + $3m; Food Safety + $2m; PH workforce - $2.2m; Global Public Health Protection + $3m; and overall CDC’s budget is down $13m; HRSA is up $88m; EPA is down $81m.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

HHS Operating Divisions Leadership Update
No developments this week.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update
President Trump’s budget request that $54 billion be cut from fiscal year 2018 federal nondefense discretionary spending was released on May 23, 2017 and provides specific detail on the reductions in funding at the program, project and activity levels of federal spending, which is extremely useful in documenting the impact of those cuts from 2017 levels.

Cuts to CDC include: overall reduction of $1.2 billion; a cut of $186 million to HIV/AIDS, Viral Hepatitis, Sexually Transmitted Infections and TB; a cut of $136 million to Preparedness with $116 million coming from PHEP; a cut of $76 million to Global Health; a cut of $64 million to EZID, including the elimination of $40 million for ELC from the Prevention and Public Health Fund (PPHF) and $22 million from antibiotic resistance AR — and changing the funding source for the remainder of AR to the soon-to-be-eliminated PPHF; a cut of $35 million to Birth Defects, Developmental Disabilities and Health; a cut of $30 million to Public Health Scientific Services accomplished by reducing the number of trained disease detectives and rapid outbreak responders; a cut of $60 million to Environmental Health, though the Environmental Health laboratory is level-funded; however, there is an increase of $12 million for vector-borne activities and advanced molecular detection and food safety which are level-funded.

Cuts to FDA include: a cut of $71 million, $22 million internal and $49 million external, for implementation of the Food Safety Modernization Act.
Cuts to HRSA include: a cut of $35 million to the Maternal and Child Health Bureau achieved mostly by eliminating $18 million for universal newborn screening hearing and $14 million for heritable disorders.

Cuts to the State Department include: a cut of $2 billion to Global Health Programs for a funding level of $6.5 billion: $5 billion State and $1.5 billion USAID, no funding for Global Health Security but a redirection of $75 million in Ebola funding for these activities.

Cuts to EPA include: the elimination of funding ($10 million) for the water security program and moving some activities to the preparedness, response and recovery program which is cut $19 million. However, the Clean Water revolving loan fund increased $2.6 million, and the Drinking Water fund is increased $1.6 million.

As previously reported, Congress will next turn to consideration of the budget for 2018, and the action will focus on the president’s proposal for tax cuts, cutting spending for nondefense by $54 billion and increasing spending on defense by $54 billion. The Congressional reception of the president’s budget request was tepid, and it continues to remain unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense.

As a further reminder, the agreement on fiscal year 2017 spending includes robust funding for most federal agencies, including CDC, FDA, HRSA and EPA. Congress did not include the $18 billion in spending reductions sought by President Trump. Funding for most federal agencies is about level with 2016 amounts, though there are some programmatic increases and decreases in selected CDC activities as follows: AR + $3m; Food Safety + $2m; PH workforce - $2.2m; Global Public Health Protection + $3m; and overall CDC’s budget is down $13m; HRSA is up $88m; EPA is down $81m.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
The Senate continues to hold internal deliberations on how to modify the House-passed ACA repeal legislation but no details are available. To refresh, the House of Representatives passed legislation that repeals the ACA. As reported here frequently, the first section of the House repeal bill eliminates the Prevention and Public Health Fund which provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants. There is strong interest in repealing ACA from President Trump and the Republican Congressional leadership.

HHS Operating Divisions Leadership Update
No developments this week.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update
At 2:15 am Monday morning, the House of Representatives posted the text of a bipartisan (sic) agreement on federal spending for the remainder of federal fiscal year 2017. The Republican and Democratic leadership of the House and the Senate have enthusiastically endorsed the agreement, which is likely to be approved by the House on Wednesday and by the Senate on Thursday — a day before the continuing resolution expires. The White House has issued a statement that the president will sign the bill.

The agreement includes robust funding for most federal agencies, including CDC, FDA, HRSA and EPA. Congress did not include the $18 billion in spending reductions sought by President Trump. Funding for most federal agencies is about level with 2016 amounts, though there are some programmatic increases and decreases in selected CDC activities as follows: AR + $3m; Food Safety + $2m; PH workforce - $2.2m; Global Public Health Protection + $3m; and overall CDC’s budget is down $13m; HRSA is up $88m; EPA is down $81m.

As previously reported, Congress will next turn to consideration of the budget for 2018, and the action will focus on the president’s proposal for tax cuts, cutting spending for nondefense by $54 billion and increasing spending on defense by $54 billion. More detail on the specific funding cuts to CDC, FDA, HRSA, EPA and the State Department are expected to be available around May 22, 2017. It remains unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense and it is also unclear whether Congress will pursue the cuts in the proposal from President Trump absent the possibility of increased spending on defense.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, and here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
On Thursday, the House of Representatives passed legislation that repeals the ACA. As reported here frequently, the first section of the House repeal bill eliminates the Prevention and Public Health Fund, which provides CDC with almost $1 billion, 12%, of its annual budget and $40 million additional funding for ELC grants. While there is strong interest in repealing ACA from President Trump and the Republican Congressional leadership, it is not clear how the bill passed by the House will be received by the Senate. Scott Becker, executive director of APHL, was quoted today (May 5) in Politico that the loss of the $1 billion prevention fund would be a “big blow to public health in this country.”

HHS Operating Divisions Leadership Update
George Sigounas is the new Administrator of the Health Resources and Services Administration. Dr. Sigounas had been working at East Carolina University.

Reorganization of HHS
A report from Inside Health Policy detailed Secretary Price’s plan to “reimagine HHS.” In a recent speech to staff, Price outlined his plans to create an executive committee, a steering committee and five working groups to develop a strategic plan to reorganize the department. The reorganization is in response to a previous executive order requiring all federal agencies to improve efficiency, effectiveness and accountability. The strategic plan will be presented to the Office of Management and Budget by June 30 and major changes will require action from Congress. Inside Health Policy reports:

Price said the committees working on the broader HHS-wide reform plan will contain both political and career staff. "We will have an executive committee composed of both political and career leadership from the secretary's office and key staff divisions. There will be a steering committee which includes both political and career members from ASPE [Assistant Secretary for Planning and Evaluation], ASPR [Assistant Secretary for Preparedness and Response] and ASA [Assistant Secretary for Administration]. Those folks have been working hard for weeks now on the nuts and bolts of this process," Price said.

In addition, five working groups based on the major goals of HHS will be created, according to Price. "The real meat of this process moving forward will be five working groups we will form which will be divided into the major goals that this department has through our strategic plan. Those goals are the healthcare system, the public health system, economic and social well-being or the human services side, scientific advancement and then management and stewardship," Price said.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update
The Washington Weekly enjoyed spring break last week and returns to announce there will not be a shutdown on April 29, 2017, with some detail on the coming week. Congress has advanced, and the president is likely to sign, a one-week extension of the existing continuing resolution that has been funding 2017 federal government operations. Congress now has until May 5 to produce a complete funding measure for the remainder of 2017 — but they could also extend the deadline again.

Details on the content of the complete 2017 funding bill are closely held, but staff have indicated that there will not be surprising changes in funding levels and certainly not the $18 billion in cuts (CDC: $315 million, HRSA: $170 million, State: $2.3 billion, EPA: $247 million) to nondefense discretionary that President Trump requested. While funding decisions on 2017 are not completely resolved, it appears at this writing that there will not be a shutdown on May 6, 2017.

Congress will next turn to consideration of the budget for 2018, and the action will focus on the president’s proposal for tax cuts, cutting spending for nondefense by $54 billion and increasing spending on defense by $54 billion. It remains unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense and it is also unclear whether Congress will pursue the cuts in the Trump proposal absent the possibility of increased spending on defense.

We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, and here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
The White House staff have reportedly made progress working with the Conservative House Republican Freedom Caucus group on modifications to the House ACA repeal bill leading some to speculate that a vote in the House of Representatives is imminent. In an instructive comment, House Energy and Commerce Chair Greg Waldren, who authored the House repeal bill, has said, “Members have different ideas but I’m not aware of any changes at this point.” While interest in repealing ACA continues from President Trump and the Republican Congressional leadership, the next steps in legislative action are not clear.

HHS Operating Divisions Leadership Update
The Senate Health, Education, Labor and Pensions Committee advanced the nomination of Dr. Scott Gottlieb to be Commissioner of the Food and Drug Administration on a mostly partisan vote. In way of explanation the ranking democrat on that committee, Senator Patty Murray, said, “I have grown increasingly concerned about whether he can lead the FDA in an unbiased way given his unprecedented industry ties.”

The President announced his intention to nominate Brett Giroir of Texas to be an Assistant Secretary of Health at Health and Human Services. Dr. Giroir is the Chief Executive Officer of ViraCyte, a clinical trials company.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update
White House Office of Management and Budget Director Mick Mulvaney has been providing clarity on the Trump Administration’s thoughts on several matters, including funding for the remainder of federal fiscal year 2017. While first observing that no one wants a shutdown, when asked about the impact of a shutdown of federal government operations Mulvaney responded, “I think the government, if you measure it in terms of the dollars out the door, about 83 percent of the government stays open in a government shutdown.” Previous reports indicated that 850,000 federal employees were furloughed in the 2013 shutdown.

Mulvaney also resonated the White House interest in having Congress approve the 2017 supplemental funding increases of $30 billion for defense and $3 billion for homeland security coupled with $18 billion in cuts for nondefense in a radio interview stating, “If Congress has different ideas about how to accomplish [the administration’s] goals we are more than happy to talk about that. If they ignore them completely, then they have to face the fact that the president has to sign spending bills. (7:40)” In the clearest indication that President Trump will veto the 2017 appropriations bill, Mulvaney said “The president needs to see his priorities funded if he's going to be participating in signing these bills. (8:20)”

Again, Congress has gone on recess until April 25, 2017, leaving only four legislative days until the continuing resolution funding government operations expires at midnight on April 28.

As reported last week, the possibility of including defense and wall funding changes the likely possibility of passing a 2017 omnibus funding bill into one that appears to be headed to a shutdown on April 29. Other Republican leaders in the House and Senate continue to press for excluding defense and wall spending in the 2017 omnibus, but it is not clear how they will influence the decision making. The Democratic leadership will not accept increased funding for defense or the wall.

The two dominant shutdown possibilities continue to focus on Congressional inability to produce an omnibus funding bill for the President to sign because of the disagreement on defense and wall spending or Congress sending the President an omnibus funding bill that does not contain his spending for defense and the wall which he vetoes. There may well be an interim step where Congress sends the President a short-term extension of the continuing resolution in the hope that a resolution on spending will be reached.

As a continuing reminder, President Trump’s proposed federal fiscal year 2017 supplemental appropriations package increases Defense and Homeland Security spending by $33 billion while cutting nondefense discretionary spending by a net $15 billion ($18 billion cut with $3 billion increase for DHS) over the 5-month remainder of the 2017 budget cycle. The $18 billion cut averages to 4.5% for most agencies, and would cut CDC’s $7 billion budget by $315 million, HRSA by $170 million, State by $2.3 billion and EPA by $247 million. Again, federal government operations for 2017 — the fiscal year that began October 1, 2016 and runs until September 30, 2017 — are funded by a continuing resolution that ends April 28, 2017.

Again, it continues to be unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense and it remains unclear whether Congress will pursue the cuts in the Trump proposal absent the possibility of increased spending on defense. Nonetheless, Congressional rejection of both spending increases and cuts could increase the likelihood of President Trump vetoing appropriations bills that do not reflect his interests, which thereby increases the prospect for federal shutdowns.

The importance of ELC federal funding for food safety was the topic of this recent article that was posted online at Eater.com and this article in Modern Healthcare. We continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
No developments this week.

HHS Operating Divisions Leadership Update
No developments this week.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update
Congress has gone on recess until April 25, 2017, leaving only four legislative days until the continuing resolution funding government operations expires at midnight on April 28. As previously reported in the Washington Weekly, there have been multiple reports from key Members of Congress that the 2017 spending bills were nearing completion and that the development of those bills and their compilation into one omnibus measure was bipartisan. Also, as reported earlier, there were several instances where the Republican leadership of the House and Senate appropriations committees indicated that the 2017 funding measures would not include any elements of President Trump’s supplemental increases in spending for defense and the border wall, or his decreases in nondefense spending.

This week brought different comments from some Republican leaders that suggest there may be elements of the funding increases for defense and for the wall with House Appropriations Committee Chair Rodney Frelinghuysen reportedly suggesting that the funds for defense and the wall would be included in the 2017 bills stating, “I suspect the supplemental — the budget amendment, in fact — will be part of the package. Yes.”

The possibility of including defense and wall funding changes what had been expected to be a comparatively simple and likely possibility of passing a 2017 omnibus funding bill into one that is far less certain and increases the likelihood of a shutdown on April 29. Other Republican leaders in the House and Senate continue to press for excluding defense and wall spending in the 2017 omnibus, but it is not clear how they will influence the decision making. The Democratic leadership in the House and in the Senate have been quite clear that Democrats will not accept increased funding for defense or the wall.

At this writing there seems to be two shutdown possibilities: the first involves Congressional inability to produce an omnibus funding bill for the President to sign because of the disagreement on defense and wall spending, and the second involves Congress sending the President an omnibus funding bill that does not contain his spending for defense and the wall which he vetoes. There may well be an interim step where Congress sends the President a short-term extension of the continuing resolution in the hope that a resolution on spending will be reached.

As a continuing reminder, President Trump’s proposed federal fiscal year 2017 supplemental appropriations package increases Defense and Homeland Security spending by $33 billion while cutting nondefense discretionary spending by a net $15 billion ($18 billion cut with $3 billion increase for DHS) over the 5-month remainder of the 2017 budget cycle. The $18 billion cut averages to 4.5% for most agencies, and would cut CDC’s $7 billion budget by $315 million, HRSA by $170 million, State by $2.3 billion, and EPA by $247 million. Again, federal government operations for 2017 — the fiscal year that began October 1, 2016 and runs until September 30, 2017 — are funded by a continuing resolution that ends April 28, 2017.

A memo from the Chief Financial Officer of the Environmental Protection Agency details the possible effect of President Trump’s federal fiscal 2018 plans to increase defense spending by $54 billion and reduce nondefense spending by $54 billion. While State Revolving Funds spending in 2018 would increase by about $300 million, there are substantial reductions and program eliminations that produce a 31% cut in spending in all other areas. It is likely that similar memos exist, or are in production, for most federal agencies, including CDC, HRSA, FDA and the State Department.

Again, it continues to be unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense and it remains unclear whether Congress will pursue the cuts in the Trump proposal absent the possibility of increased spending on defense. Nonetheless, Congressional rejection of both spending increases and cuts could increase the likelihood of President Trump vetoing appropriations bills that do not reflect his interests, which thereby increases the prospect for federal shutdowns.

Again, as we continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
The Republican leadership of the House and the White House continue to meet on efforts to repeal the Affordable Care Act. House Republican Majority Leader Kevin McCarthy has indicated that while there is progress in the meetings, there is not yet a schedule for when the next legislative action to repeal will occur.

HHS Operating Divisions Leadership Update
The Senate Health, Education, Labor and Pensions Committee held a confirmation hearing for Dr. Scott Gottlieb to be Commissioner of the Food and Drug Administration on April 5. The committee vote advancing Dr. Gottlieb’s nomination has not been scheduled.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

Federal Funding Update

Monday, March 27 marked twelve legislative days remaining until the current continuing resolution expires at midnight on April 28. Curiously, the 100th day of the Trump administration, April 29, seems at this writing more likely than not to coincide with a shutdown of the federal government.

APHL’s attention now turns and increases commensurately to preserving $1.6 billion ($315 million in 2017 + $1.3 billion in 2018) in CDC funding, as the effort to maintain the $1 billion CDC receives from the Prevention and Public Health Fund (PPHF) is on temporary hiatus.

Once again, President Trump’s proposed federal fiscal year 2017 supplemental appropriations package increases Defense and Homeland Security spending by $33 billion while cutting nondefense discretionary spending by a net $15 billion ($18 billion cut with $3 billion increase for DHS) over the 5- month remainder of the 2017 budget cycle. Details on CDC, HRSA, State and EPA can be found in the snips below taken from the full table; the $18 billion cut averages to 4.5% for most agencies, and would cut CDC’s $7 billion budget by $315 million, HRSA by $170 million, State by $2.3 billion and EPA by $247 million. Again, federal government operations for 2017 — the fiscal year that began October 1, 2016 and runs until September 30, 2017 — are funded by a continuing resolution that ends April 28, 2017.

FY17_TrumpReductions_A.jpg FY17_TrumpReductions_B.jpg FY17_TrumpReductions_C.jpg FY17_TrumpReductions_D.jpg FY17_TrumpReductions_E.jpg FY17_TrumpReductions_F.jpg FY17_TrumpReductions_G.jpg FY17_TrumpReductions_H.jpg FY17_TrumpReductions_I.jpg

President Trump’s federal fiscal 2018 plans to increase defense spending by $54 billion and reduce nondefense spending by $54 billion would cause a reduction of CDC’s budget by at least $1.3 billion if the 18% cut to HHS is applied evenly to all operating divisions. Additional details on President Trump’s 2018 budget request, including his proposal for significant tax reform, are expected in the middle of May.

In addition to the reductions at CDC, the spending level for the Food and Drug Administration (FDA) would be reduced $1 billion or 37% of its $2.7 billion in budget authority — though the Trump proposal increases taxes (in the form of user fees) by $1 billion to cover this reduction. Congress has not been receptive to initiatives that increase FDA user fees, and it remains unclear whether this may change.

Finally, the 2018 budget plan cuts State Department funding 28%, and funding for the Environmental Protection Administration (EPA) is reduced by 31% or $2.6 billion.

It continues to be unclear whether Congress will pursue changes in the Budget Control Act to allow the increased spending for defense. Also unclear is whether Congress will pursue the cuts in the Trump proposal absent the possibility of increased spending on defense. Nonetheless, Congressional rejection of both spending increases and cuts could increase the likelihood of President Trump vetoing appropriations bills that do not reflect his interests, which thereby increases the prospect for a federal shutdown.

Again, as we continue to press the importance of the service public health laboratories provide for their communities and the people who inhabit them, here is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

ACA Repeal Update
No developments this week.

HHS Operating Divisions Leadership Update
No developments this week.

REGULATION

No developments this week.

Washington Weekly
  

LEGISLATION

ACA Repeal Update
In an action-packed end of the week, efforts to repeal the Affordable Care Act (ACA) derailed. In a series of startling developments​, after the House Republican leadership pulled the Thursday night vote on their ACA repeal bill, the American Health Care Act (H.R. 1628) — when it was clear they did not have the votes to pass the bill — President Trump issued the ultimatum that if they did not vote on Friday the entire effort to repeal ACA would end. House floor consideration of the bill began at 11:21 a.m. (ET) Friday and about two and a half hours later Speaker Ryan went to the White House to inform President Trump that there were not enough Republican votes to pass the bill. Nonetheless, the Republican House leadership continued the debate on the bill with the aim of holding a vote at 4:00 p.m. (ET) and then pulled the bill from further consideration at 3:30 p.m. (ET).

Earlier in the week President Trump said Republicans would lose their congressional offices if they didn’t vote for the bill, but Republican support remained distant even after the bill was modified by a technical amendment and a policy amendment. The Republican leadership provided section-by-section descriptions of the technical and policy amendments, and the Budget Committee produced a report on the earlier bill.

A new Congressional Budget Office statement on the impact of the revised bill details how the new version will cost $186 billion more than the earlier version, reducing the 10-year savings by 55% to $151 billion. The bill was further amended to allow states to determine the “essential services” required for health plans and to create a new one-time $15 billion infusion for the Patient and State Stability Fund states with a suggestion to provide maternity coverage and newborn care and mental health and substance abuse treatment in fiscal year 2020.

Again, the first section of the bill eliminates the Prevention and Public Health Fund (PPHF) effective in federal fiscal year 2019, and the bill contains no provisions on replacing that source of funding for public health programs.

It is unclear what will happen next on repeal, and what action the Senate may take. Speaker Ryan plans to have the bill passed by Congress in early April.

APHL continues to express its concern on the need to replace the funding provided by the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 was the source of almost $1 billion of CDC’s $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. The Atlantic magazine recently produced an article on this subject and former CDC Director Tom Frieden wrote on public health funding cuts in Time magazine, as did the Raleigh News Observer. APHL will continue to join governmental and nongovernmental public health organizations to urge Congress to assure funding for the programs supported by the PPHF.

Leaving no communication method unused, the podcast on the experiences of APHL members during our Annual Hill Day visits can be heard here, and this is a reminder of our request for additional material to develop a podcast on the importance of continuing funding for ELC.

Federal Funding Update
President Trump’s proposal for a federal fiscal year 2017 supplemental appropriations package that increases Defense and Homeland Security spending by $33 billion while cutting nondefense discretionary spending by a net $15 billion ($18 billion cut with $3 billion increase for DHS) over the 5-month remainder of the 2017 budget cycle does not seem to have received much support in Congress. If applied evenly to the remainder of nondefense discretionary, the $18 billion cut averages to 3.5% — which would cut CDC’s $7 billion budget by $245 million. Many of the Defense items targeted for spending increases were already funded in the House and Senate appropriations bills for DoD and will not likely receive double funding. Additionally, House appropriations chair Rodney Frelinghuysen has reportedly said there is no timetable for additional consideration of the supplemental package and in a town hall teleconference with his constituents he voiced strong support for spending for CDC.

Again, federal government operations for 2017 — the fiscal year that began October 1, 2016 and runs until September 30, 2017 — are funded by a continuing resolution that ends April 28, 2017. It is unclear how Congress address the proposal that exceeds the 2017 defense budget cap of $551 billion by $25 billion. It continues to be difficult to see how this supplemental request helps avoid a shutdown of federal operations on April 29.

Trump’s federal fiscal 2018 plans to increase defense spending by $54 billion and reduce nondefense spending by $54 billion also seems not to be finding much support in Congress. As the Washington Weekly first reported last week, a reduction of this magnitude would reduce CDC’s budget by at least to $1.3 billion if the 18% cut to HHS is applied evenly to all operating divisions.

APHL has learned that while redirected CDC funds would likely be the source of funding for the creation of the emergency response fund in the Trump budget request, the response fund amount of $500 million reported in last week’s Washington Weekly was in error as no amount has yet been specified for the emergency response fund.

In addition to the reductions at CDC, the spending level for the Food and Drug Administration (FDA) would be reduced $1 billion or 37% of its $2.7 billion in budget authority — though the Trump proposal increases taxes (in the form of user fees) by $1 billion to cover this reduction. Congress has previously not accepted initiatives to increase FDA user fees, and it remains unclear how this may change.

Finally, the 2018 budget plan cuts State Department funding 28%, and funding for the Environmental Protection Administration (EPA) is reduced by 31% or $2.6 billion. 

Additional details on President Trump’s 2018 budget request, including his proposal for significant tax reform, are expected in the middle of May.

HHS Operating Divisions Leadership Update
No developments this week.

REGULATION

Laboratory Developed Tests
Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) of the House Energy and Commerce Committee released a discussion draft of the Diagnostic Accuracy and Innovation Act that builds on previous efforts by the Diagnostic Test Working Group (DTWG) to develop a risk-based framework for regulating laboratory developed tests (LDTs). Previous proposals by DTWG, a group of industry stakeholders, offered an alternative regulatory scheme to FDA’s draft guidance to oversee LDTs. Late last year, FDA delayed plans to implement their guidance.

The Diagnostic Accuracy and Innovation Act establishes a new category and regulatory structure for FDA for in vitro clinical tests (IVCTs) such as test kits, platforms and LDTs. This removes the regulation from devices, drugs or biologics category. The act outlines test development and manufacturing under FDA’s jurisdiction and calls for the creation of a new center to oversee these activities. CLIA will exclusively oversee laboratory operations and the activities that are necessary to run an IVCT.

Tests intended for public health surveillance will not be impacted by the act.

Over the next week, APHL will develop a more detailed summary and analysis of the proposed bill.

Washington Weekly
  

LEGISLATION

Federal Funding Update
President Trump announced his plans to increase defense spending by $54 billion and reduce non-defense spending by $54 billion in federal fiscal year 2018. As the Washington Weekly first reported in the March 3 edition, a reduction of this magnitude would reduce CDC’s budget by almost $1 billion in 2018. Now that Trump has provided brief details on his 2018 budget request, the details in his request suggest that the cut to CDC would increase to $1.3 billion if the 18% cut to HHS is applied evenly to all operating divisions. Further, the Trump budget request would create a $500 million emergency response fund within HHS without specifying the source of those funds — which could be a redirection of CDC funding. If the emergency fund is created from CDC funds, then the effective reduction for CDC programs would be $1.8 billion in 2018. When coupled with the almost $1 billion cut to CDC’s budget from the elimination of the PPHF in 2019, the total cut to CDC in 2019 would be $2.8 billion or 33% of the $7 billion 2016 CDC budget.

Continuing our reminder, with the increasingly curious exception of fully funding the PPHF for all of fiscal year 2017, all other federal government operations are funded by a continuing resolution that ends April 28, 2017. Democratic Senators sent a letter to the Republican leadership of the Senate this week suggesting that decisions on federal spending must occur in a bipartisan manner to avert shutdown of the federal government, a possibility first reported in the January 17 APHL Federal Legislative update.

ACA Repeal Update
Ryancare 2.0 — which is headed toward being called Trumpcare (and occasionally Obamacare Lite in the interim) — has been approved by the House Budget Committee and will shortly be approved by the full House. Again, the first section of Ryancare 2.0/Trumpcare/Obamacare Lite (RTO) also eliminates the Prevention and Public Health Fund (PPHF) effective in federal fiscal year 2019 and the bill contains no provisions on replacing that source of funding for public health programs.

The Congressional Budget Office (CBO) statement on the implications of Speaker Ryan’s RTO bill documents the increase in the number of uninsured Americans and other impacts, but it appears to have no effect on the likelihood the bill will be passed.

Once passed by the House, it is possible that the Senate will bypass any committee consideration of the repeal bill and instead have the full Senate pass the House bill immediately and without change. This would be possible because the requirement for the Senate to consider a reconciliation bill is not debatable, and once it is being considered only 20 hours of debate are allowed.

Recent reports on statements from Senator Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor and Pensions Committee seem to lend credibility to this possibility as he has indicated he is currently "focusing on amending it while it's still in the House." "I'm doing all that I can to make the House bill as good as it can be," Alexander reportedly said. "We've been working for the last six weeks with the House committees and a bicameral staff. That's the most effective way for me to improve the bill right now." The rigorous work of the Senator with the House suggests that there may be little or no way to improve the bill once it arrives in the Senate, possibly because the Senate will simply pass the House bill unchanged.

Speaker Ryan plans to have the RTO bill passed by Congress in early April.

APHL continues to express its concern on the need to replace the funding provided by the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC’s $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. It is increasingly apparent that the comments from Republican Congressional offices — that program funding cuts would be resolved under regular order procedures for federal spending — could be an indication that they in fact have no intention of taking action to replace the lost funding which could account for their lack of concern about the rigidity of the existing restrictions on federal spending that will prevent $1 billion from other sources being moved into CDC’s budget. APHL will continue to join governmental and non-governmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF.

HHS Operating Divisions Leadership Update
At the end of last week, President Trump announced the nomination of Dr. Scott Gottlieb to be Commissioner of FDA. The February 17 issue of the APHL Washington Weekly reported on the possible nomination of Dr. Gottlieb, a former FDA official under the Bush Administration, whose significant personal holdings in pharmaceutical companies led him to recuse himself from FDA actions related to those companies and noted there are reports that he is supported for the position by large pharmaceutical companies.

This week, President Trump announced that Eric Hargan will again serve as Deputy Secretary of the Department of Health and Human Services, a position he held under the Bush Administration, and Hargan most recently provided guidance on health issues for the Governor of Illinois.

IMPACT OF HIRING FREEZE ON FEDERAL ADVISORY COMMITTEES

CLIAC Meeting Delayed
Earlier this week, APHL learned that the HHS Policy Team will not approve CDC’s Special Government Employees for Federal Advisory Committees or other review committees. The immediate impact of this decision was the postponement of CDC’s Clinical Laboratory Improvement Advisory Committee, which was scheduled to hold a meeting in mid-April. Because of the restriction on CDC’s ability to approve new members to CLIAC, including those who are also APHL members, they will not be able to reach the required quorum.

EXECUTIVE ORDERS

Comprehensive Plan for Reorganizing the Executive Branch
On March 13, the administration released an executive order instructing the Office of Management and Budget (OMB) to reorganize government functions to improve efficiencies, effectiveness and eliminate unnecessary agencies, offices and programs. The order instructs heads of agencies to submit plans to OMB within 180 days to increase effectiveness and reorganize. Given the impact of potential budget cuts combined with the directive from this executive order, there could be significant impacts on APHL’s federal partners. A notice in the Federal Register will be published by the OMB Director to gather input from the public to suggest areas for improvement in the Executive Branch. APHL will provide feedback as necessary.

REGULATION

No significant regulatory updates this week.

Washington Weekly
  

LEGISLATION

ACA Repeal Update
The second version of House Speaker Paul Ryan’s draft bill to repeal the ACA (referred to as “Ryancare 2.0”) can be read here, and a section-by-section description produced by the Energy and Commerce Committee can be found here. The first section of Ryancare 2.0 also eliminates the Prevention and Public Health Fund (PPHF) effective in federal fiscal year 2019 and the bill contains no provisions on replacing that source of funding for public health programs.

Both the Energy and Commerce Committee and the House Ways and Means Committee approved their portions of the ACA repeal legislation and reported them to the House Budget Committee which will now assemble one bill that will meet the requirements for consideration under the rules for “reconciliation.” Again, the 2017 budget resolution contains the reconciliation instructions for the repeal of ACA, and the reconciliation process is being utilized to limit the debate on the repeal measure in the Senate which will likely lead to it being passed by Congress and signed into law.

Speaker Ryan plans to have the bill passed by Congress in early April.

There is still no Congressional Budget Office (CBO) statement on the budget implications of the various elements of Speaker Ryan’s repeal bill.

APHL continues to express its concern on whether healthcare repeal will eliminate the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC’s $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. In meetings with Congressional staff this week during the APHL Hill Day, APHL members heard expressions of great concern from Democratic offices that insufficient action was being contemplated on addressing the $1 billion hole that will be created in CDC’s budget with repeal of the PPHF, and non-specific assurances from Republican offices that it would be resolved under regular order procedures for federal spending — assurances that seem to ignore the rigidity of the existing restrictions on federal spending that render those assurances moot. APHL will continue to join governmental and nongovernmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF.

As a reminder APHL’s Executive Director, Scott Becker, published a blog post about the potential loss of ELC funds through the ACA repeal. In the post, Becker explains the critical nature of ELC funding to public health laboratories and a #SaveELC effort. In the coming weeks, APHL will provide information on how you, public health laboratorians, can communicate and share the stories of your important work to elected officials to #SaveELC.

HillDay2017REV.pngAPHL Hill Day 2017
On Monday, March 6, four APHL members participated in an annual advocacy day on Capitol Hill. Jennifer Rakeman-Cagno (NYC), Denise Toney (VA), Chris Whelen (HI) and Sara Vetter (MN) spent the day meeting with staff members from authorizing and appropriations committees to discuss the funding needs of public health laboratories. Much of the discussion was focused on the Prevention and Public Health Fund (PPHF) that is jeopardized in the repeal of the Affordable Care Act. APHL members passed out advocacy materials and shared stories of the importance of this funding in their laboratory operations. 

ASTHO Hill Event
On Tuesday, March 7, APHL member Joanne Bartkus participated in the ASTHO Hill briefing on “The Power of State and Territorial Public Health Agencies — Celebrating 75 Years of Protecting and Promoting America’s Health.” Dr. Bartkus presented on the Minnesota experience in the 2016 Zika response, and emphasized the importance of the ELC funding provided by the PPHF.

HHS Operating Divisions Leadership Update
No news this week.

REGULATION

FDA RIDT Reclassification Regulation Update
In previous Washington Weekly editions, we have reported on a regulatory freeze that was put into place shortly after the new administration came into office. Recently we received clarification that FDA’s RIDT Reclassification will continue to move forward with a delayed effective date, and will now go into effect on March 20, 2017. FDA plans to move forward with implementation on this date and APHL’s Influenza Program is in the process of developing materials for public health laboratories and clinical partners on the changes. 

Washington Weekly
  

LEGISLATION

ACA Repeal Update
Just as the Washington Weekly was about to post today, APHL received a copy of the House ACA repeal legislation. The first section of the bill eliminates the Prevention and Public Health Fund (PPHF), but delays the elimination until federal fiscal year 2019. APHL will provide a more detailed analysis in next week’s publication.

Also this week, the US Conference of Mayors joined several governors in expressing opposition to the proposal to block grant Medicaid in the House blueprint presented by House Speaker Ryan. Again, House Republican leaders shared a 19-page blueprint document on repeal of the ACA that includes sections on overall reform for Medicaid along with unspecified changes to the tax treatment of health benefits that are provided through the workplace, though it remains unclear whether these changes apply to all individuals who get health insurance coverage through their employment or some subset of those individuals. Senator Susan Collins (R-ME) articulated her concern about the impact of those changes on employer-provided health insurance plans.

There is still no Congressional Budget Office (CBO) report on the budget implications of the various elements that could be included in a repeal bill — which implies that legislative language of some sort has been created and submitted to CBO for a budget score. Additionally, there are reports that Senate Republican staff are engaged in a dialogue with the Senate Parliamentarian to ensure that the legislation they are drafting complies with the requirements for reconciliation — and Senator Lamar Alexander told the winter meeting of the National Governors Association, “We’re not writing the bill in public. We’re writing the bill together, so it’ll be changing a lot as it goes along,” another indication that legislation has been drafted.

Finally, the White House indicated that there will also be a proposal to repeal ACA from the Trump Administration that will be sent to Congress in mid-March.

To repeat, the continued delay in considering repair, repeal, replace legislation continues to also complicate consideration of the 2018 budget resolution — once another budget resolution is adopted, the reconciliation provisions of the previous budget resolution are no longer actionable. The 2017 budget resolution contains the reconciliation instructions for the repeal of ACA, and the reconciliation process is being utilized to limit the debate on the repeal measure in the Senate.

APHL continues to express its concern on whether healthcare repeal will eliminate the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC’s $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. APHL will continue to join governmental and nongovernmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF. In meetings with key Democratic Senate offices this week, there was no indication that any coordinated effort to modify or oppose the legislative action to repeal the ACA is being developed. Those offices expressed concern about the impact of the funding cuts that would occur with elimination of the PPHF, but provided no information on a systematic plan to address the cuts through insisting on modifications to the repeal bill that would preserve the PPHF.

As a reminder again, funding for the rest of the federal government — including all CDC activity not funded by the PPHF — only runs through April 28, 2017 and this week the Republican leadership of the House indicated that work on 2017 appropriations will occur after the President’s Day break. The delay in producing a 2018 budget resolution could also result in a delayed process for consideration of the 2018 appropriations bills. President Trump this week said that the current federal budget is a mess and that he would do more with less, which could indicate he is developing a budget that includes substantial reductions in federal spending.

As a reminder, APHL’s Executive Director, Scott Becker, published a blog post about the potential loss of ELC funds through the ACA repeal. In the post, Becker explains the critical nature of ELC funding to public health laboratories and a #SaveELC effort. In the coming weeks, APHL will provide information on how you, public health laboratorians, can communicate and share the stories of your important work to elected officials to #SaveELC.

HHS Operating Divisions Leadership Update
As HHS Secretary Tom Price continues to get settled into his new position, there is nothing new to report on leadership at HHS or the operating divisions this week.

REGULATION

Impact of Regulatory Freeze Still Uncertain
APHL continues to seek clarification on the impact of the regulatory freeze on two recent regulations that were published in the Federal Register shortly before the new administration took office. The regulatory freeze delayed the effective dates of the Common Rule and a final order that reclassified antigen-based rapid influenza virus detection systems from class I to class II. Regarding the Common Rule, APHL reached out to HHS and were told to contact the White House, which APHL then did and the response from the White House was that they could not provide guidance on our questions. Similar uncertainty was expressed by FDA regarding the influenza reclassification final order.

Washington Weekly
  

IN THE NEWS

APHL’s Executive Director, Scott Becker, recently published a blog post about the potential loss of ELC funds through the ACA repeal. In the post, Becker explains the critical nature of ELC funding to public health laboratories and a #SaveELC effort. In the coming weeks, APHL will provide information on how you, public health laboratorians, can communicate and share the stories of your important work to elected officials to #SaveELC.

LEGISLATION

ACA Repeal Update
Congress continues to slip past the January 27, 2017 deadline for committees to report legislation that would repeal and replace the Patient Protection and Affordable Care Act (ACA). This week, there were reports that Representative Michael C. Burgess, chair of the health subcommittee of the Energy and Commerce committee, said the subcommittee could consider repeal "in the next several weeks," but that the week following the President's Day recess is "a little quick." Meanwhile, the Freedom Caucus — the group of very conservative Republicans in the House — has made it clear they want the House to pass a repeal bill that is as strict as the 2015 version of repeal which also defunded Planned Parenthood for one year, and then move to replacement, increasing pressure for the House to act.

House Republican leaders shared a 19-page blueprint document on repeal of the ACA that also refers to legislative activity occurring after the President’s Day recess. That document includes sections on overall reform for Medicaid along with unspecified changes to the tax treatment of health benefits that are provided through the workplace, though it remains unclear whether these changes apply to all individuals who get health insurance coverage through their employment or some subset of those individuals. House Speaker Paul Ryan indicated that he is anticipating a Congressional Budget Office (CBO) report on the budget implications of the various elements that could be included in a repeal bill — which implies that legislative language of some sort has been created and submitted to CBO for a budget score.

Newly confirmed HHS Secretary Tom Price met with Senate Republicans and reportedly outlined plans to work with them to develop legislation that would repeal and replace the ACA, rather than presenting a proposal that was created by the Trump Administration. It is not clear if this approach will add to the delay in passing the repeal bill.

The continued delay in producing repair, repeal, replace legislation continues to also complicate consideration of the 2018 budget resolution — again, once another budget resolution is adopted the reconciliation provisions of the previous budget resolution are no longer actionable. As a reminder, the 2017 budget resolution contains the reconciliation instructions for the repeal of ACA, and the reconciliation process is being utilized to limit the debate on the repeal measure in the Senate.

APHL continues to express its concern on whether healthcare repeal will eliminate the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC’s $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. APHL will continue to join governmental and nongovernmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF.

To repeat from last week’s Weekly, funding for the rest of the federal government — including all CDC activity not funded by the PPHF — only runs through April 28, 2017 and this week the Republican leadership of the House indicated that work on 2017 appropriations will occur after the President’s Day break. The delay in producing a 2018 budget resolution could also result in a delayed process for consideration of the 2018 appropriations bills.

HHS Operating Divisions Leadership Update
With HHS Secretary Tom Price in place it is likely that additional leadership positions in the operating divisions, like the Centers for Disease Control and Prevention, the Food and Drug Administration and the Health Services and Resources Administration. This week attention on a potential nominee for the FDA focused on Dr. Scott Gottlieb, a former FDA official whose significant personal holdings in pharmaceutical companies led him to recuse himself from FDA actions related to those companies. There are reports that he is supported for the position by large pharmaceutical companies.

REGULATION

House Energy and Commerce Committee Leadership Seeks Clarification for FDA
Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) sought clarification from the Office of Management and Budget (OMB) on the hiring freeze that was imposed by the Administration on January 23, 2017. The letter asks for further information on whether the federal hiring freeze applies to the Food and Drug Administration (FDA) and argues that recruitment of top scientists is needed to fulfill its mission. Additionally, at risk under the freeze are the implementation of the 21st Century Cures Act (PL 114-255) and FDA’s commitments under the user fee agreements which must be modified this year. The representatives requested additional guidance from OMB.

Regulatory Freeze Executive Order: Reprint and Update
On January 20, 2017 the White House issued a memorandum for the heads of executive departments and agencies on a regulatory freeze. The memorandum allows the new Administration time to review any new or pending regulations with the exception of "emergency situations or other urgent circumstances relating to health, safety, financial or national security matters."

Related to public health laboratories, three regulations were published in the Federal Register prior to inauguration. While APHL believes that these regulations are subject to a 60-day delay in original effective date, they are likely not subject to the 2 for 1 Regulatory Executive Order (see last week’s Washington Weekly), however confirmation of this is still being sought. 

  • On January 12, 2017 the Food and Drug Administration issued a final order (21 CFR 866) reclassifying antigen-based rapid influenza virus detection systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. The original effective date was February 13, 2017 and will now be March 21, 2017 to allow for review, however this has not been confirmed by FDA.
  • On January 19, 2017 the Centers for Disease Control and Prevention issued the final rule (42 CFR 73) not to finalize the proposed changes to the list of select agents and toxins. Other changes finalized amendments to address toxin permissible limits and the inactivation of select agents, biosafety regulations and clarified regulatory language around security, training, incident response and records. The original effective date was February 21, 2017 and will now be March 21, 2017 to allow for review. UPDATE: A Federal Register notice dated February 16, 2017 confirms the effective date of March 21, 2017.
  • On January 19, 2017 the Department of Health and Human Services (HHS) and 15 other agencies issued the final rule (10 CFR 745) on the body of regulations that protect human subjects involved in research known as the Common Rule. APHL believes the Common Rule would fall under the exclusion described in #4 above because a statutory deadline was imposed by the enactment of the Newborn Screening Saves Lives Reauthorization Act of 2014 (PL 113-240), however this has not been confirmed by HHS. PL 113-240 required the Secretary of HHS to update the Common Rule with respect to informed consent and the use of dried blood spots two years after enactment. 
Washington Weekly
  

LEGISLATION

ACA Repeal Update
Congress continues to slip past the January 27, 2017 deadline for committees to report legislation that would repeal and replace the Patient Protection and Affordable Care Act (ACA). Congressional leaders are standing by their new goal for the bills of March 2017 along with the possibility of multiple bills instead of one as envisioned by the 2017 budget resolution reconciliation instructions. This approach is slowing the consideration of the 2018 budget resolution because as soon as subsequent budget resolution is adopted the reconciliation provisions of the previous budget resolution are no longer actionable. Again, the reconciliation process is being utilized to limit the debate on the repeal measure in the Senate  a protection that does not exist if multiple bills are advanced.

APHL continues to express its concern on whether healthcare repeal will eliminate the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC's $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. Recently, Republican offices in the Senate have been communicating in coalition meetings and in separate meetings with others that CDC will not face a $1 billion shortfall if the PPHF is eliminated  which is a very encouraging message even though it is not yet clear how this will be accomplished. APHL will continue to join governmental and nongovernmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF.

To repeat from last week's Weekly, funding for the rest of the federal government — including all CDC activity not funded by the PPHF — only runs through April 28, 2017 and there has been no visible progress on that front, raising the possibility of a federal government shutdown in spring. The delay in producing a 2018 budget resolution could also result in a delayed process for consideration of the 2018 appropriations bills.

HHS Secretary Price Approved
Congressman Tom Price (R-GA) was approved by the Senate to be Secretary of the Department of Health and Human Services on February 10, 2017. There is no indication that there has been progress in selecting a new Director of CDC.

REGULATION

2 for 1 Regulation Executive Order
Interim guidance was issued by the Office of Information and Regulatory Affairs to implement the Trump Administration's Executive Order on "Reducing Regulation and Controlling Regulatory Costs." As we reported last week, this "2 for 1" Executive Order requires agencies to repeal two existing regulations for every one new regulation put in place. The interim guidance states that agencies may comply with these requirements by issuing two "deregulatory" actions for every new action that imposes costs such that the net cost of the new regulation is no greater than zero. As simple as this may seem, Lisa Soronen, executive director of the National Conference of State Legislatures State and Local Legal Center, points out in a blog post that deregulating is as much of a drawn out process as implementing new regulations as outlined in the Administrative Procedures Act. Agencies repealing regulations must go through the same steps of issuing a notice in the Federal Register, soliciting comments and responding to them before officially repealing. This process can be lengthy and would only be more cumbersome if the repealed regulation is complex. Additionally, the Administrative Procedures Act requires agencies to be thoughtful and have reason to repeal a regulation. According to Soronen, "eliminating regulations for the sake of meeting a numerical of cost-based quota is not likely to satisfy this standard."

Also clarified in the interim guidance is that the Executive Order applies to significant regulatory actions issued between January 20, 2017 and September 30, 2017. Food Safety News reports that food safety rules are likely to emerge unscathed from the "2 for 1" Executive Order because federal food safety agencies had not planned on issuing major regulations during this time anyway. What remains to be seen, however, is if the Administration's regulatory reform will be continued beyond September 30, 2017.

HHS Releases Memo on Exemptions to Hiring Freeze
The Department of Health and Human Services (HHS) released a broad memo identifying which positions are considered exempt from the hiring freeze. Department heads were allowed to exempt positions that were necessary to meet national security or public safety responsibilities. Notable to public health, there is a "Public Health Safety and Emergencies" category that broadly addresses HHS' legal authority to prepare and respond to public health emergencies such as pandemic influenza, Ebola and Zika. They also mention public health safety programs such as food, drug and medical device safety. In a more detailed attachment, occupations listed include microbiologist epidemiologist, medical officer, environmental health and safety, health scientist safety specialist- Bio-risk, medical technologist and medical technicians. Positions that will require preapproval through HHS include public health advisors and health science administrators.

Washington Weekly
  

Welcome to the first installment of the APHL Washington Weekly, our attempt to capture the myriad developments in federal activity that have an impact on public health laboratories and public health. We will continue to bring you these reports as long as there continues to be a steady stream of actions to report on, and we will begin each issue with legislative updates followed by regulatory updates.

LEGISLATION 

ACA Repeal Update
While a primary goal of the Trump Administration and the Republican leadership of the House of Representatives and the Senate has been to repeal and replace the Patient Protection and Affordable Care Act (ACA), recently there has been an added emphasis on repair. Most notably, the January 27, 2017 deadline for Congressional committees to report legislation that would take these actions passed with no bills written or considered. Congressional leaders set a new goal for the bills of March, 2017 with some leaders suggesting that there could be multiple bills instead of one as envisioned by the budget resolution reconciliation instructions. Again, the reconciliation process is being utilized to limit the debate on the repeal measure in the Senate — a protection that would not exist if multiple bills were advanced. 

A continuing concern of APHL is whether healthcare repeal will eliminate the Prevention and Public Health Fund (PPHF) — which in fiscal year 2017 provided almost $1 billion of CDC's $7 billion operating budget and $40 million for the Epidemiology and Laboratory Capacity grant program. APHL has joined governmental and nongovernmental public health organizations to urge Congress not to eliminate the PPHF until it acts to assure funding for the programs supported by the PPHF. 

Funding for the rest of the federal government — including all CDC activity not funded by the PPHF — only runs through April 28, 2017 and to date there has been no visible progress on that front, raising the possibility of a federal government shutdown in spring. The debate on finishing the spending bills for 2017 has become increasingly complicated by proposals from the Trump Administration to spend $13–$15 billion on a wall along the border with Mexico and to increase defense spending by $27 billion. Once the spending decisions for 2017 are finalized, Congress must turn its attention to funding issues for fiscal year 2018, which starts in nine months on October 1, 2017. As we move closer to that date there may be a clearer path on the healthcare repeal effort and whether the PPHF is eliminated and CDC spending faces a $1 billion shortfall.
 
HHS Secretary Nomination Advances
The nomination of Congressman Tom Price (R-GA) to be Secretary of the Department of Health and Human Services was approved by the Senate Finance Committee on February 1, 2017 after the Committee suspended its rules for a quorum. The quorum rule was suspended because no Democrats were present or voting and there was not a quorum. Congressman Price's nomination now moves to the Senate floor where the Senate will confirm him.

REGULATION

Executive Orders
On January 30, 2017, the Trump administration released the executive order: Reducing Regulation and Controlling Regulatory Costs. The order directs that for every one new regulation issued, a minimum of two existing regulations must be rescinded. The media and White House press conference have reported the executive order as focused on reducing regulations on small businesses; however, the executive order is broadly written addressing "the heads of all agencies." The executive action could have implications for federal partners who regulate activities important to public health.

Executive Memorandum
A federal civilian hiring freeze was issued to heads of executive departments and agencies on January 23, 2017 by an executive memorandum. The hiring freeze outlines that no vacant positions can be filled nor new positions created. A military personnel exemption is in place, and other exemptions may be considered for national security or public safety responsibilities. The memo caused some uncertainty on whether public health would be included in a public safety exemption. On January 31, 2017, the Office of Management and Budget (OMB) publicly released additional guidance on the initial executive memo. This guidance clarified that the Commissioned Officer Corp of the US Public Health Service is included in the military exemption as are internal career ladder promotions. Other exemptions include the US Postal Service, CIA and Office of the Director of National Intelligence. The Pentagon recently stated that jobs in military shipyards and depots are among exemption positions. This announcement came after concern from Congress that the sweeping executive order could result in thousands of layoffs in their congressional jurisdictions. In addition, the memo defined public safety responsibilities as "essential activities to the extent that they protect life and property," but the memo does not specifically call out public health activities. Within 90 days of the date of the original executive memo, OMB will recommend a "long-term plan to reduce the size of the Federal Government workforce through attrition."

Laboratory Developed Tests
Renewed interest to overhaul laboratory developed test (LDT) regulation has been expressed by both the House Energy and Commerce Health Subcommittee and the Senate Health, Education, Labor and Pensions Committee. Industry groups are gearing up for a coordinated effort to encourage Congress to revise the Clinical Laboratory Improvement Amendments (CLIA) to allow the Center for Medicare and Medicaid Services (CMS) greater jurisdiction over the review of LDTs. This comes on the tails of a letter that was sent on behalf of patient groups arguing that increased FDA oversight is necessary to ensure safe and effective devices. As the fight over which federal agency should be responsible for regulating LDTs renews, APHL will continue to communicate that any LDT regulation must preserve the critical and unique work of governmental public health laboratories as outlined in our position statement.

Washington Weekly
  

On January 20, 2017 the White House issued a memorandum for the heads of executive departments and agencies on a regulatory freeze. The memorandum allows the new Administration time to review any new or pending regulations with the exception of "emergency situations or other urgent circumstances relating to health, safety, financial or national security matters." The following steps must be taken immediately:

  1. Send no regulations to the Federal Register until a department or agency head appointed or designated by the President after noon on January 20, 2017 reviews and approves the regulation.
  2. Regulations that have been sent to the Federal Register but have not yet been published must be immediately withdrawn
  3. Regulations that have been published in the Federal Register but have not taken effect must temporarily postpone their effective date 60 days from January 20, 2017 for the purpose of reviewing questions of fact, law and policy.
  4. Regulations subject to statutory or judicial deadlines are excluded.

Please refer to the full text of the memorandum for further details.  
 
Impact on Public Health Laboratories
Related to public health laboratories, three regulations were published in the Federal Register over the last couple weeks.

  • On January 12, 2017 the Food and Drug Administration issued a final order (21 CFR 866) reclassifying antigen-based rapid influenza virus detection systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. The original effective date was February 13, 2017 and will now be March 21, 2017 to allow for review.
  • On January 19, 2017 the Centers for Disease Control and Prevention issued the final rule (42 CFR 73) not to finalize the proposed changes to the list of select agents and toxins. Other changes finalized amendments to address toxin permissible limits and the inactivation of select agents, biosafety regulations and clarified regulatory language around security, training, incident response and records. The original effective date was February 21, 2017 and will now be March 21, 2017 to allow for review.
  • On January 19, 2017 the Department of Health and Human Services (HHS) and 15 other agencies issued the final rule (10 CFR 745) on the body of regulations that protect human subjects involved in research known as the Common Rule. APHL believes the Common Rule would fall under the exclusion described in #4 above because a statutory deadline was imposed by the enactment of the Newborn Screening Saves Lives Reauthorization Act of 2014 (PL 113-240). PL 113-240 required the Secretary of HHS to update the Common Rule with respect to informed consent and the use of dried blood spots two years after enactment. 
Washington Weekly
  

On Friday, January 13, the House of Representatives approved the budget resolution that was passed by the Senate on Wednesday, January 11. The budget resolution includes reconciliation instructions, which require House and Senate committees to produce legislation by January 27, 2017 that will repeal, in whole or in part, the Patient Protection and Affordable Care Act (ACA). The Senate limits on debate in this situation make it quite likely that the ACA repeal will be successful.

APHL is engaging with public health organizations to document the importance of a portion of the ACA, the Prevention and Public Health Fund (PPHF), which has provided the Centers for Disease Control and Prevention (CDC) with an increasing portion of programmatic funding — and now is the source of almost $1 billion annually, or 14% of CDC's annual budget. The Epidemiology and Laboratory Capacity (ELC) grant program has received $40 million from those PPHF funds each year, and those monies have been distributed to state and six local public health laboratories where they were utilized for a number of improvements in personnel and information technology. It is widely expected that the PPHF will be eliminated if the ACA repealed. At this writing, several questions remain, with those related to timing at the top. 

The federal government is operating under a continuing resolution that expires on April 28, 2017 — which means Congress must agree and the president must sign another appropriations bill to prevent a shutdown of the federal government after April 28. Interestingly, the one exception to this funding deadline is the PPHF. The continuing resolution includes a provision that directs the Department of Health and Human Services (HHS) to expend all of the PPHF funds for fiscal year 2017, which ends September 30, 2017. Congress would have to act to reverse its earlier decision and rescind the PPHF monies — which seems unlikely though not an impossibility — for CDC to face an almost $1 billion shortfall during fiscal year 2017 because of the elimination of the PPHF. 

APHL has joined with other organizations to urge that elimination of the PPHF be delayed until an alternative to the massive programmatic funding reduction for CDC can be produced, and that it certainly not occur in federal fiscal year 2017. APHL will work independently and in coalition efforts to help Congress craft such an approach.

Washington Weekly
  

​LEGISLATION

Federal Funding Update
In an unexpected turn of events driven by the expectation that Congress is unlikely to meet the deadline of completing work on the appropriations bills for federal fiscal year 2018 (which begins October 1, 2017), President Trump entered into an agreement with the Congressional leadership on a funding measure that will continue the operations of the federal government until December, 8, 2017. Federal funding for HHS and its operating divisions, including CDC, HRSA and FDA, will be at the 2017 levels through that date. This agreement also includes increased federal funding of $15.25 billion for hurricane response and recovery, and a short-term increase in the debt limit. It is likely that the Congress will shortly approve legislation accomplishing these tasks, which enables them to continue to make progress on regular appropriations bills and on an appropriate increase in the debt ceiling.

ACA Repeal Update
No additional information to report.

HHS Operating Divisions Leadership Update
No additional information to report.

REGULATION

No additional information to report.

Washington Weekly
  

​LEGISLATION

ACA Repeal Update
The effort to repeal the Affordable Care Act (ACA) continues with surprising strength in the Senate as Senators Lindsay Graham (R-SC) and Bill Cassidy (R-LA) have produced new legislation that repeals ACA and at least appears to eliminate Medicaid after 2027 – but only after it is converted into a block grant program for states for the next ten years. As often as things change on the repeal front, the one enduring constant is the elimination of the Prevention and Public Health Fund (Prevention Fund) which is contained in Title II of the Graham-Cassidy bill with an effective date of federal fiscal year 2019.

At this writing, there appears to be a strong likelihood that the Senate will not agree to the Graham-Cassidy approach because Senator John McCain (R-AZ) has issued a statement indicating he cannot vote for it, and when combined with the likely no votes from Senators Susan Collins (R-ME) and Lisa Murkowski (R-AK), the bill would fail. That said, House Speaker Paul Ryan has made it clear that the House would quickly pass that bill if the Senate agreed to it and President Trump has indicated he would sign it into law.

APHL sent a letter to the Senate leaders this week urging them to address the funding shortfall to CDC that will occur with the elimination of the Prevention Fund and will continue to press the Administration and Congress on this issue.

Federal Funding Update
In better news, the Senate appropriations committee has produced a bill to fund HHS that largely rejects the cuts recommended by President Trump. Nonetheless, public health continues to be underfunded and there are cuts to some CDC programs that will be significant. With few exceptions, the Senate bill provides funding for CDC programs at the same level provided in fiscal 2017 but Global Disease Detection and Emergency Response is cut $3 million to $45.4 million. Next steps on the appropriations front will be for the Senate to pass its version of appropriations measures and then work with the House to resolve differences.

As a reminder, the operations of the federal government will continue beyond the end of fiscal year 2017 (September 30, 2017) under a continuing resolution funding agreement that runs through December 8, 2017. Federal funding for HHS and its operating divisions, including CDC, HRSA and FDA, will be at the 2017 levels through that date.

HHS Operating Divisions Leadership Update
No additional information to report.

REGULATION

No additional information to report.

Washington Weekly
  

LEGISLATION

ACA Repeal Update
As suggested in last week’s Washington Weekly, this week the Senate Republican leadership has decided not to vote on the Graham-Cassidy approach to repealing the ACA and eliminating Medicaid. Although this week’s transmittal email message suggests it, the APHL letter to the Senate leaders urging them to address the funding shortfall to CDC that would occur with the elimination of the Prevention Fund was probably not the only reason the leadership pulled the bill from consideration by the full Senate.

It seems likely that the effort to repeal the ACA will continue to be considered by Congress and APHL will continue to provide input in that consideration and will routinely report on any developments.

Federal Funding Update
Once again, the operations of the federal government will continue beyond the end of fiscal year 2017 (September 30, 2017) under a continuing resolution funding agreement that runs through December 8, 2017. Federal funding for HHS and its operating divisions, including CDC, HRSA and FDA, will be at the 2017 levels through that date.

HHS Operating Divisions Leadership Update
No additional information to report.

REGULATION

No additional information to report.

Washington Weekly
  

LEGISLATION

ACA Repeal Update
Building upon their success with ACA repeal and replace, this week the House Republican leadership passed a bill through committee that uses the Prevention and Public Health Fund resources to extend federal support for community health centers and the National Health Service Corps. Both community health centers and the National Health Service Corps enjoy strong, bipartisan support in the House and in the Senate, which makes the decision to fund them from an account that the president and the House and Senate Republican leadership are actively seeking to eliminate curious, at best, and could cause one to ponder the sincerity of support for the health centers and the Service Corps.

Nonetheless, the Energy and Commerce Committee approved H.R. 3922, the CHAMPION Act, which would fund those activities by redirecting 57% ($6.35 billion) of Prevention Fund monies with only Republican votes. Neither the committee leadership nor the bill discuss the cut in critical CDC public health activities (CDC receives almost 90% of the Prevention Fund and that amount represents 12% of the total CDC budget) that would occur when the Prevention Fund is reduced by this amount. There is no companion bill in the Senate, and it is not clear that the House approach on funding the health centers and Service Corps would be well received.

Federal Funding Update
No additional information to report.

HHS Operating Divisions Leadership Update
Following the disclosure of questionable use of federal funds for travel expenses, Secretary of HHS Tom Price resigned. Acting Assistant Secretary for Health Don Wright has been named Acting Secretary, as the administration determines who to nominate for the position.

REGULATION

No additional information to report.

Washington Weekly
  

REGULATION

Common Rule Update: Delay Requested by HHS
When the final rule was issued for the Common Rule (45 C.F.R 46), the implementation date was set for January 2018. With an administration change and a general review of pending regulations, APHL was aware that the Common Rule was under scrutiny by the Department of Health and Human Services (HHS).

On October 7, 2017, HHS formally requested a one year delay of the implementation date, pushing the effective date to early 2019 while still allowing the use of three burden reducing provisions during the delay year. The request by HHS is currently under review by the Office of Management and Budget (OMB). Details about these provisions will not be public until OMB approves the request and publishes the details in the Federal Register. It is our understanding that the impact of this delay on public health laboratories is minimal for non-research related activities since nothing has changed. Federally funded research activities will continue to be under the purview of the Newborn Screening Saves Lives Reauthorization Act of 2014, Sec. 12 that states research on newborn dried blood spots shall be considered research on human subjects and entities will need to obtain informed consent if the research is conducted with Federal funds.  

Shortly after the enactment of the Newborn Screening Saves Lives Reauthorization Act of 2014, the public health laboratory community developed an assessment of newborn screening activities that added clarity to distinguish between those that are not research and those that are. 

APHL's Public Policy Program will continue to provide updates as more information is gathered. 

Updates to the Clinical Laboratory Fee Schedule
Last week, APHL joined 22 other laboratory organizations on a letter to Seema Verma, the Administrator for the Centers for Medicare and Medicaid Services (CMS) to express concern regarding proposed changes to the clinical laboratory fee schedule (CLFS).  

In April 2014, the Protecting Access to Medicare Act (PAMA) was signed into law which required a complete overhaul of the Medicare Part B CLFS since it was first established in 1984. Over the past few years, CMS has worked on rules to implement the Act and recently released a proposed version of the changes to the CLFS. Applicable laboratories reported private payor rates and test volumes for all laboratory services. CMS intends to phase in any reduction in rates that exceeds 10% over a period of 6 years, starting January 2018. 

APHL is working to better understand how national Medicare laboratory reimbursement rates impact state Medicaid laboratory reimbursement rates and the potential impact on public health laboratories. 

LEGISLATIVE 

HHS Operating Divisions Leadership Update
President Trump announced that Eric D. Hargan, recently confirmed Deputy Secretary of Health, will serve as acting Secretary of Health and Human Services.

Federal Funding Update

No additional information to report.

Washington Weekly
  

REGULATION

Clinical Laboratory Fee Schedule
APHL has developed a Regulatory Issue Brief on the proposed changes to the Clinical Laboratory Fee Schedule (CLFS) that was discussed in the October 13 Washington Weekly. Changes to the CLFS will impact public health laboratories that bill Medicare and Medicaid for clinical diagnostic tests. Significant reductions in reimbursement for many tests will go into effect January 2018.

APHL has joined a broader laboratory coalition to strategize advocacy efforts and next steps. 

State Legislative Tracking Tool for Newborn Screening
APHL is assisting state public health laboratories to add three new disorders to their newborn screening (NBS) panels: Pompe, Mucopolysaccharidosis Type 1 (MPS-I), and X-linked Adrenoleukodystrophy (X-ALD). APHL’s Public Policy Program supports this initiative by identifying political and organizational trends between states and potential education gaps that may create barriers in implementing these disorders within a state. Using NewSTEPs’ four-phase model for implementing a NBS disorder, the team has focused on states in phase one: the legislative/mandate stage. These NBS programs require assistance to add new conditions to the required list in the state, including fee increases to support capital and legislative mandates.

Explore our real-time State Legislative Tracker that updates daily with introduced, proposed/drafted or signed NBS legislation for each state. This tool is meant to keep our membership abreast of bills that may impact their NBS labs.

LEGISLATION

No additional information to report.

Washington Weekly
  

​LEGISLATIVE

Federal Funding Update

On Friday, November 17, 2017, the White House submitted another request for emergency disaster response funding to Congress. This request includes funding for HHS activities and includes $96 million for CDC. CDC funds would be directed to public health response activities including support for vector-borne, food-borne, water-borne, and other infectious diseases. Also, $3.2 million would fund facility repairs at CDC's vector-borne disease facility in San Juan, Puerto Rico.

As a continuing reminder, funding for federal government operations for fiscal year 2018, the fiscal year that began on October 1, 2017, is being provided under a continuing resolution that expires at the end of December 8, 2017. This means that the Congress must pass and the president must sign legislation to provide funding beyond December 8. There are reports that progress is being made, but this week the Congressional leadership indicated that action may not be complete by that date, which would require another continuing resolution – possibly extending federal funding to a date in late December. It does not appear that there will be a shutdown of federal operations in December. 

More interesting reports from the Congressional leadership are that a two year budget agreement, for both fiscal years 2018 and 2019, which would increase the amounts of funding over those years by $182 billion – and translates into annual increases of $54 billion for defense spending and $37 billion for nondefense, which includes HHS. The nondefense increase would be measured from the $519 billion provided in 2017 and is significant. Hopefully, there will be continued developments on this agreement that will be included in future Washington Weekly reports.  

As another reminder, on November 3, 2017, the House passed legislation to renew funding for the Children's Health Insurance Program (CHIP), community health centers, the National Health Service Corps and other public health programs. Unfortunately, the bill includes a reduction of $6.4 billion in the Prevention and Public Health Fund as an "offset" for the expenses of these programs. In October, the Senate Finance committee approved similar legislation that did not include the Prevention Fund offset but no additional action has occurred in the Senate.   

HHS Operating Divisions Leadership Update

The president has nominated Alex Azar to be the Secretary, Health and Human Services and the Senate Health, Education, Labor and Pensions committee has announced that a hearing on Mr. Azar's nomination will occur on November 29, 2017. The Senate Finance committee has not yet announced a hearing date. 

REGULATION 

No additional information to report.

Washington Weekly
  

​LEGISLATIVE

Federal Funding Update

Congress has passed, and the president signed, another continuing resolution that provides funding for federal government operations for fiscal year 2018, the fiscal year that began on October 1, 2017, that expires at the end of December 22, 2017. There continue to be reports that the Congressional leadership are negotiating on a two year budget agreement, for both fiscal years 2018 and 2019, which would increase the amounts of funding over those years by at least $182 billion – and translates into annual increases of $54 billion for defense spending and $37 billion for nondefense, which includes HHS. The nondefense increase would be measured from the $519 billion provided in 2017 and is significant. Again, we hope there will be continued developments on this agreement that will be included in future Washington Weekly reports.

HHS Operating Divisions Leadership Update

No additional information to report.

REGULATION

No additional information to report.

Washington Weekly
  

​LEGISLATIVE

Federal Funding Update
Congress has passed, and the president signed, another continuing resolution (CR) that provides funding for federal government operations for fiscal year 2018, the fiscal year that began on October 1, 2017, that expires at the end of January 19, 2018. This CR also takes funding from the Prevention and Public Health Fund (The Fund) to assist in paying for the extension of other public health programs, including the CHIP program. The Fund, which supplies 12% of the CDC annual budget, loses $100 million of the $900 million slated for it, in fiscal year 2019. The Fund continues to receive only $800 million until fiscal year 2022 when it could go up to $1.25 billion. There is no indication from Congress or the administration on how the shortfall to CDC will be addressed.

There continue to be reports that the Congressional leadership are negotiating on a two year budget agreement, for both fiscal years 2018 and 2019, which would increase the amounts of funding over those years by at least $182 billion – and translates into annual increases of $54 billion for defense spending and $37 billion for nondefense, which includes HHS. The nondefense increase would be measured from the $519 billion provided in 2017 and is significant. Again, we hope there will be continued developments on this agreement that will be included in future Washington Weekly reports.

HHS Operating Divisions Leadership Update

No additional information to report.

REGULATION

No additional information to report.

Washington Weekly