This Week: Long-awaited CBO score for House repeal bill released…Senate Republicans find score shows how hard their job is as they begin drafting a different bill…Administration releases full budget and it is dead on arrival…Congress leaves town for Memorial Day recess.

*Due to Memorial Day recess, the next newsletter will be released on June 12.* 

1. Congress

House

CBO Releases Score on the American Health Care Act

On May 24, the Congressional Budget Office released its analysis of the American Health Care Act, the legislation to repeal and replace the Affordable Care Act.

Highlights include:

Coverage Highlights:

  • 23 million more uninsured by 2026
    • Net increase in uninsured: 1 million in 2017; 19 million in 2020; 23 million in 2026
  • Effects by insurance type
    • Medicaid : 9 million fewer covered in 2020; 14 million fewer in 2026
    • Nongroup : 10 million fewer covered in 2020; 6 million fewer in 2026
    • Employer-sponsored coverage : no reported change in 2020; 3 million fewer in 2026
  • Coverage rates: 17 percent of the nonelderly population uninsured in 2020; 18 percent uninsured in 2026
    • Under the ACA, about 10 percent are uninsured over the 2017-2026 period

Budgetary Highlights:

  • 10-year NET effect on the deficit is $119 billion in savings
    • $1,111 billion reduction in direct spending
    • $992 billion reduction in revenues
  • Medicaid cuts are $834 billion over 10 years
  • JCT finds that elimination of the unearned income Medicare contribution tax costs $172 billion over 10 years
  • COVERAGE:
    • Some plans under the AHCA do not meet CBO’s standard for health insurance coverage. CBO counts these people as uninsured.
      • “CBO and JCT estimate that a few million people would buy policies that would not cover major medical risks.
      • “The existence of tax credits in the nongroup market would encourage a second market to emerge to sell policies priced to closely match the size of the credits.”
    • Bill hurts the low-income near-elderly. Increase in uninsurance “disproportionately larger among older people with lower income—particularly people between 50 and 64 years old with income of less than 200 percent of the federal poverty level.”
    • Difference from last score: more people with ESI, fewer with nongroup because employers see nongroup plans as “less desirable alternatives.”
  • WAIVERS: CBO expects some states will adopt MacArthur amendment waivers to eliminate EHB and pre-ex protections.
    • “About half the population resides in states that would not request waivers regarding the EHBs or community rating, CBO and JCT project.”
    • “In particular, out-of-pocket spending on maternity care and mental health and substance abuse services could increase by thousands of dollars in a given year for the nongroup enrollees who would use those services. Moreover, the ACA’s ban on annual and lifetime limits on covered benefits would no longer apply to health benefits not defined as essential in a state.”
    • “Some enrollees could see large increases in out-of-pocket spending because annual or lifetime limits would be allowed .”
    • Spillover into ESI possible but unlikely. “That decision could allow annual and lifetime limits on benefits not included in the state’s EHBs. However, large employers already have considerable flexibility in the range of the benefits they include in their plans, so CBO and JCT expect that their benefit offerings would probably not be noticeably affected by the actions of states.
  • PRE-EX:
    • “The agencies estimate that about one-sixth of the population resides in areas in which the nongroup market would start to become unstable beginning in 2020.”
    • “CBO and JCT expect that, as a consequence, the waivers in those states would have another effect: Community-rated premiums would rise over time, and people who are less healthy (including those with preexisting or newly acquired medical conditions) would ultimately be unable to purchase comprehensive nongroup health insurance at premiums comparable to those under current law, if they could purchase it at all— despite the additional funding that would be available under H.R. 1628 to help reduce premiums .”
    • In some areas, the “market would be similar to the nongroup market before the enactment of the ACA, in which premiums were underwritten and plans often included high deductibles and limits on insurers’ payments and people with high expected medical costs were often unable to obtain coverage.”
  • PREMIUMS: will depend on state action.
    • In states without waivers: “average premiums in the nongroup market would be about 4 percent lower in 2026 than under current law, mostly because a younger and healthier population would be purchasing the insurance.”
      • In a state without waivers, a 64-year-old would pay $16,100 annually in premiums NET of tax credit in 2026
    • “About one-third of the population resides in states that would make moderate changes to market regulations. In those states, CBO and JCT expect that, overall, average premiums in the nongroup market would be roughly 20 percent lower in 2026 than under current law, primarily because, on average, insurance policies would provide fewer benefits.”
      • In a state with moderate changes, a 64-year-old would pay $13,600 annually in premiums NET of tax credit in 2026
    • In dual waiver states:
      • “Average premiums would be lower than under current law because a younger and healthier population would be purchasing the insurance and because large changes to the EHB requirements would cause plans to cover a smaller percentage of expected health care costs .”
      • Less healthy people would face extremely high premiums, despite the additional funding that would be available under H.R. 1628 to help reduce premiums. Over time, it would become more difficult for less healthy people (including people with preexisting medical conditions) in those states to purchase insurance because their premiums would continue to increase rapidly.”
      • NB: CAP previously published examples of premium surcharges for pre-existing conditions.
  • STABILITY FUNDS:
    • Patient and State Stability Fund “grants would exert substantial downward pressure on premiums in the nongroup market and would help encourage insurers’ participation in the market.”
    • Invisible risk-sharing “program would have a small effect on premiums in 2018 and a larger effect on premiums in 2019 after insurers had time to incorporate the availability of the funds into their prices.”
    • Availability of money in the Upton fund for waiver states “would increase the number of states choosing such a waiver.”
    • “Although CBO and JCT expect that federal funding would have the intended effect of lowering premiums and out-of-pocket payments to some extent, its effect on community rated premiums would be small because the funding would not be sufficient to substantially reduce the large increases in premiums for high-cost enrollees .”

This is the third CBO score of AHCA (H.R. 1628). Before passing it, Republicans made changes to the bill that CBO didn’t have time to analyze. Those last-minute changes reduced savings by $32 billion over a decade, compared to the earlier version of the bill, and resulted in one million fewer people losing coverage. The previous scores both estimated that 24 million would lose coverage. The estimated 10-year deficit reduction fell from $337 billion in the first score to $150 billion in the second and to $119 billion in the May 24 score.

The estimated savings would have fallen another $68 billion had House Republicans not delayed by six years repeal of the 0.9 percent Medicare surtax on the wealthy (individuals with annual incomes of at least $200,000 and families with incomes of $250,000).

House Ways and Means Committee Advances Three Obamacare Repeal Bills

On May 24, the House Ways and Means Committee advanced three pieces of health care legislation that make up part of the Republicans’ larger Obamacare replacement strategy. The bills were written to work in conjunction with the GOP’s repeal bill, which is being fast-tracked through the budget reconciliation process.

The VETERAN Act (H.R. 2372), approved with no Democratic support, allows veterans to retain eligibility for Obamacare’s subsidies in the event that the American Health Care Act becomes law. Republicans billed the measure as a way to provide veterans with equal treatment and ensure their access to care. Democrats, however, blasted the legislation, saying it wouldn’t protect veterans with pre-existing medical conditions under the Republican bill to repeal Obamacare, which allows states to opt out of certain coverage protections.

The Broader Options for Americans Act (H.R. 2579) would allow tax credits available under the American Health Care Act to be applied to COBRA plans. The panel approved that measure with one Democrat, Ron Kind (D-WI), voting with Republicans.

The Verify First Act (H.R. 2581), approved with no Democratic support, would require individuals to verify their income eligibility and citizenship or legal immigration status with the Social Security Administration before accessing premium tax credits.

The votes came shortly after the CBO released its score of Republicans’ Obamacare repeal bill that passed the House last month. The CBO estimated the legislation would result in 23 million more people without health insurance by 2026, while trimming the deficit by $119 billion over 10 years.

Congressmen Urge Congress to Keep Gun Policy Riders Out of Funding Bills

A bipartisan group of 120 congressmen led by Rep. Mike Thompson (D-CA), chairman of the House Gun Violence Prevention Task Force, is asking leaders to ensure that all funding bills exclude gun policy riders.

The group sent a letter to House Speaker Paul Ryan and Minority Leader Nancy Pelosi asking to keep such riders, including the Dicky Amendment that bans the CDC from researching gun violence, out of must-pass legislation.

“Our communities have been devastated by gun violence, and the American people have had enough,” Thompson said in a statement. “After countless mass shootings and acts of violence in our communities, our nation is keeping a close eye on the actions we take to address our gun policies. Any changes to our laws should be taken seriously. Amendments should be debated and thoroughly vetted—not tacked on to must-pass appropriations bills. Attaching harmful riders would be irresponsible and disrespectful to those who lost their lives to gun violence.”

For more information, click here.

Republicans Urge Trump to Fire NIH Director Over Embryonic, Stem Cell Research

Forty House Republicans are urging President Donald Trump to fire the director of the NIH over his support for embryonic and stem cell research that they say conflicts with Trump’s “pro-life direction.”

The Republican House members, in a letter led by Rep. Jim Banks (R-IN), question NIH Director Francis Collins’ support for embryonic cloning and for stem cell research that involves the destruction of human embryos.

“While we deeply respect Dr. Collins’ Christian faith and commitment to public service, the stances that Dr. Collins has taken in the past regarding embryonic stem cell research and human cloning are not life-affirming and directly conflict with the pro-life direction of your new presidency,” the lawmakers wrote. “It is because of this troubling paradox that we ask you to re-consider his leadership role at NIH.”

Collins has led the NIH since 2009, when he was unanimously confirmed by the Senate.

It has been unclear whether Trump will keep Collins, who came in at the beginning of the Obama administration, at the helm of the biomedical research institution. But Collins has wide support from both Republicans and Democrats.

The 40 Republicans argue Collins does not share in their party’s position on embryonic research. They wrote that Collins’ stance is particularly disturbing considering that NIH’s funding for human embryonic stem cell research increased from $146 million in 2012 to $180 million in 2015.

Senate

Senate Democrats Express Concern Over Delaying Tobacco Rule

Senate Democrats expressed concerns to FDA Commissioner Scott Gottlieb over his agency’s decision to delay parts of an Obama-era regulation covering non-traditional tobacco products, including the electronic cigarette industry.

Sen. Patty Murray (D-WA), who pressed Gottlieb on the issue during his confirmation hearing, wrote with 10 colleagues that delaying compliance deadlines 92 days puts children’s health at risk.

“Every day that these products stay on the market with no assessment of their risks, we continue to put America’s youth in harm’s way,” the lawmakers wrote. In addition to Murray, others signing the letter included Sens. Jeff Merkley, Sherrod Brown, Tom Udall, Ed Markey, Sheldon Whitehouse, Jack Reed, Elizabeth Warren, Dick Durbin, Richard Blumenthal and Al Franken.

The FDA proposed and finalized a rule under which it would apply the Tobacco Control Act to bring products like e-cigarettes, cigars, hookah and pipe tobacco under the agency’s purview. Public health advocates and many Democrats have pushed for curbs on candy and fruit flavors they say e-cigarette companies use to target children, but did not get them in the final rule. The e-cigarette industry argued that the regulation would kill off small producers.

2. Administration

Administration Unveils Budget Detail

The Trump administration unveiled its budget on May 23, cutting deeply into programs for the poor, health care, science and other areas, while boosting defense 10 percent and spending more than $2.6 billion for border security as well has significant tax reductions. The budget document titled “A New Foundation for American Greatness” frames its plan as “reform the welfare system and replace dependence with dignity of work.”

The budget is seen as “dead on arrival” by Congress, but it serves as an outline for the administration’s priorities.

The proposal makes no changes to Medicare, an entitlement program that drives a significant percentage of the nation’s debt. However, it does reduce Medicaid spending.

The Trump administration would cap Medicaid’s federal funding for the first time, saving $610 billion over 10 years. States would receive fixed funding with new flexibility to administer their programs.

The budget also envisions saving funds—$250 billion—from Medicaid through the repeal of the Affordable Care Act.

In health care the budget does the following:

  1. FDA: The budget slightly increases the agency’s overall funding levels by $456 million. However it reduces taxpayer funding by about $854 million from 2017 levels. Industry user fees would be increased by more than the $1 billion drug and device manufacturers had already negotiated with Congress. It also includes $60 billion in funding previously authorized by the 21st Century Cures Act.
  2. Mental Health and Substance Abuse
  • The Substance Abuse Mental Health Services Administration would be reduced by $400 million
  • Community Mental Health Services Block Grant would be reduced by $116 million
  • State Mental Health Grants would be reduced by $136 million
  • Substance Abuse Treatment Grants for states would be reduced by $73 million
  • Public awareness programs would be reduced by $74 million
  1. National Institutes of Health funding would be reduced by almost $6 billion.
  • NIH funding is similar to the proposal the administration sent early this year, and comes weeks after Congress gave the agency a $2 billion boost in its 2017 spending bill.
  • The budget folds into NIH the Agency for Healthcare Research and Quality while maintaining the $272 million in discretionary funding for the agency’s work. It also restructures the way in which AHRQ processes grants to reduce overhead costs.
  1. Center for Disease Control and Prevention
  • The budget includes a $500 million health block grant for states to respond to public health threats.
  1. ONC budget is proposed to be reduced to $38 million.
  2. Office for Civil Rights would be reduced to $33 million though the office can generate more money for itself through aggressive HIPAA enforcement.

The budget also envisions a 3 percent growth rate in the economy. Many economists believe that percentage of growth is not achievable and that 1.9 percent is a more realistic figure.

FDA Hiring Freeze Lifted

The FDA is no longer subject to the hiring freeze the Trump administration imposed in late January, Commissioner Scott Gottlieb wrote in an email to agency staff.

“Senior leadership has worked very closely with the administration over the last several months, and just as I do, they see the critical importance of the FDA’s staff in achieving our mission,” Gottlieb wrote.

He added more details will be forthcoming about a new streamlined and efficient process for filling job openings. The FDA currently has about 1,000 vacancies.

The hiring freeze frustrated Republicans and Democrats who passed the 21st Century Cures legislation late last year with provisions to make it easier for FDA to recruit and retain staff to help the agency speed more drugs and devices to market.

OMB lifted the government-wide ban on hiring in mid-April, however HHS elected to continue the freeze. FDA was given the ability to hire for some positions funded by industry user fee dollars.

Gottlieb Launches Panel to Study Opioid Crisis

FDA Commissioner Scott Gottlieb has established a steering committee to address the opioid crisis and advise regulators on such steps as prescription limits.

Gottlieb, who said during his confirmation hearing that overuse of painkillers was his top priority, wrote in a blog post that the committee will address whether the FDA should mandate training for health professionals and work with providers to ensure the number of doses prescribed is closely related to the condition for which a patient is being treated.

Gottlieb mentioned how there are few situations when a patient needs a 30-day supply of opioids. The committee will also consider whether the agency’s drug review process for opioids adequately considers risk and the potential for abuse.

The actions are the first Gottlieb has taken on opioid misuse since taking the helm of the FDA. The steering committee will be made up of senior agency leaders and will solicit public comment. Gottlieb said the agency will also consider additional steps.

NIH to Launch Beta Test of Precision Medicine Initiative This Week

A beta test of the Precision Medicine Initiative will launch this week, its project leader said at an NIH panel meeting May 25.

PMI, in the initial rollout, will recruit the first 10,000 to 15,000 participants toward the eventual goal of 1 million. The beta effort will be spearheaded by the University of Pittsburgh Medical Center and will feature “real people, real protocol, and real training,” said project leader Eric Dishman. Only basic samples (like blood and urine) and measurements (like waist circumference and BMI) will be collected at first.

A national rollout is planned for next year. Some parts of the infrastructure are not ready yet. While the biobank at Mayo Clinic is close to accommodating a beta test, it can’t yet deal with a test of national scale. Meanwhile, the researcher portal—which allows academics to make inquiries of the data—isn’t ready yet either.

HHS Secretary Price Calls for Reforming World Health Organization

On May 22, while addressing the World Health Assembly, HHS Secretary Tom Price said the World Health Organization should be reformed to focus on preventing global health crises.

A reform effort means “taking a clear-eyed view of what needs to change for it to fulfill that most important mission: ensuring a rapid and focused response to potential global health crises,” he said.

WHO will elect a new director-general on Tuesday, replacing Margaret Chan, who has held the position since 2006.

3. Courts

Judge Orders HHS, OMB to Release Communications With Congress to American Oversight

On May 25, a federal judge ordered the Trump administration to review more than 13,000 pages of internal records related to Republicans’ health care legislation and to release relevant materials to American Oversight, a 501(c)(3) organization launched to scrutinize the Trump administration through Freedom of Information Act requests.

In March, American Oversight sent FOIA requests to both HHS and OMB, seeking the agencies’ internal communications with Congress about Republicans’ health care legislation. Because FOIA requests can take years to fulfill, American Oversight asked for expedited processing, which would have forced HHS and OMB to turn over the documents within weeks or months. But according to American Oversight’s complaint, the administration did not agree to expedite processing, which opened the case up for judicial review.

Judge Emmet G. Sullivan of the U.S. District Court of the District of Columbia agreed, andordered HHS and OMB to review and process about one-third of their communications by June 30, another one-third by July 31 and the remaining documents by Sept. 5. The agencies also were ordered to turn over nonexempt materials to American Oversight on a rolling basis on those dates.

CMS Staffers Charged With Insider Trading of Political Intelligence

On May 24, federal authorities filed charges against current and former CMS employees for allegedly committing insider trading involving so-called political intelligence.

From May 2012 through November 2013, Christopher Worrall, a senior staffer at the CMS office that sets Medicare reimbursement rates, gave nonpublic and potentially profitable information to his close friend and former colleague David Blaszczak, according to civil charges announced by the SEC. The U.S. Attorney’s office for the Southern District of New York announced related criminal charges.

Blaszczak, in turn, gave the information on the government’s plans to cut reimbursement rates to two clients, who were also charged, the SEC said. Those two individuals, Theodore Huber and Jordan Fogel, placed trades on behalf of certain hedge funds, yielding more than $3.9 million in illegal profits.

State AGs Reach Settlement in Generic Drug Price-Fixing Investigation

Two former pharmaceutical executives involved in a price-fixing scheme have agreed to cooperate with a broader investigation into allegations of widespread anticompetitive activity in the generic drug industry as part of a settlement reached with 41 states.

Former Heritage Pharma CEO Jeffrey Glazer and Jason Malek, the company’s former president, have agreed to provide information, documents, testimony, depositions and other evidence to support the states’ investigation. They will also each pay a $25,000 civil penalty to the states.

Glazer and Malek pleaded guilty to fixing prices of a popular antibiotic and a diabetes medication in January, as part of a federal investigation into alleged conspiracy among leading giants in the generic drug market.

The states say this scheme led to higher prices for consumers and state governments. The attorneys general have also filed suit against Aurobindo Pharma USA, Citron Pharma, Mayne Pharma, Mylan Pharmaceuticals and Teva Pharmaceuticals for their roles in the alleged conspiracy to artificially inflate and manipulate prices and reduce competition for these two drugs.

The federal investigation into price fixing is believed to include about two dozen drug companies.

Another 90-Day Delay for ACA Insurance Subsidies Suit

The Trump administration and House of Representatives today asked a federal court for another 90-day delay in a lawsuit over Obamacare insurance subsidies, undermining the future of the health care marketplaces as insurers look for certainty from the government before committing to offer coverage next year. If the request is approved, the parties would have to file another update in 90 days.

“The parties continue to discuss measures that would obviate the need for judicial determination of this appeal, including potential legislative action,” the House and White House wrote to the court (aca subsidies suit.pdf).

The suit, House v. Price, centers on Obamacare’s cost-sharing program, which reimburses health insurers to help low-income people make copayments at the doctor or hospital. The case was brought by House Republicans during the Obama administration. But the case has taken on added significance as Republicans try to repeal the health law: without the $7 billion in payments, insurers say they cannot remain afloat in the Obamacare markets.

President Donald Trump has argued that the markets are fatally flawed and will collapse no matter what his administration does. He also suggested that the ensuing chaos could entice Democrats to come to the bargaining table and help craft a health care overhaul.

The administration declined to say if it will make more cost-sharing reduction payments.

The subsidies have already been paid for May. If the request is approved, the parties would have to file another update in 90 days.

4. State Activities

California: Committees Approve 2017-18 Budgets

The California Assembly and Senate budget committees recently approved their own versions of the 2017-18 state budget, which uses a portion of tobacco tax funds to provide state Medicaid coverage to young adults up to age 26, regardless of immigration status. Those funds would also go toward increasing provider rates and restoring some previously cut services. This approach by the legislative committees stands in contrast to Gov. Jerry Brown’s proposed budget, which recommends using the new tax funds—expected to raise more than $1 billion for Medi-Cal improvements—to fund general Medi-Cal costs and help backfill some of the program’s shortfalls. Each house also agreed to use $50 million to increase rates specifically for Planned Parenthood and other family-planning providers who participate in a state program for low-income residents.

Indiana: Gov. Holcomb Starting Work Requirements on Medicaid Beneficiaries

Indiana Gov. Eric Holcomb is getting a jump-start on the Republicans’ call to implement work requirements on Medicaid beneficiaries. The Republican governor said he is asking CMS officials for permission to require some Medicaid recipients to work or do work-related activities. CMS Administrator Seema Verma was a health care consultant in Indiana who helped create the Healthy Indiana Plan, the state’s conservative Medicaid expansion plan, which Indiana is seeking to extend for another three years. The state estimates the work requirement would affect about 30 percent of current recipients, and only those who are able bodied and younger than 60.

5. Regulations Open for Comment

FDA Considers Establishing New Office of Patient Affairs

The FDA is considering establishing a new Office of Patient Affairs that would centralize its work on patient involvement in the review and approval of drugs and medical devices, according to a March 14 notice in the Federal Register.

Comments on the new office are due by June 12, 2017.

CMS Releases Proposed Hospital Pay Rule

In a new proposed 2018 Medicare payment rule, CMS says it will look to cut hospital industry regulations and streamline oversight, and it’s asking hospitals themselves for help. The agency is soliciting ideas for changes to rules and procedures governing acute-care and long-term care hospitals. The initiative aims to “relieve regulatory burdens for providers,” as well as promote flexibility and innovation, CMS said in a statement.

The new proposed rule would suspend for one year a provision penalizing long-term care hospitals that receive more than 25 percent of patients from a single acute-care hospital. It would also reduce certain quality reporting requirements for hospitals that have implemented electronic health records.

CMS projects the rule would increase Medicare spending on inpatient hospital services by $3.1 billion in 2018, with operating payments to hospitals increasing 2.9 percent. Long-term care hospitals’ Medicare payments are projected to decrease by $173 million, or 3.75 percent, over the same period.

Comments on the rule must be submitted no later than 5 p.m. EDT on June 13, 2017.

CMS Proposes 2018 Payment and Policy Updates for Medicare Hospital Admissions

CMS is offering hospitals a 90-day meaningful use reporting period in 2018, according to a proposed payment rule released April 14.

The first major payment regulation released under HHS Secretary Tom Price marks a change from the back-and-forth over electronic health records meaningful use requirements seen under the Obama White House. The previous administration would typically propose a yearlong reporting period, then scale it back at the last minute after intense lobbying pressure. As a Republican congressman from Georgia, Price often pushed the Obama administration hard for 90-day meaningful use reporting periods.

In connection with the 21st Century Cures Act, CMS also is proposing to remove from meaningful use clinicians who see most of their patients at ambulatory surgery centers.

Price and CMS are also changing previously finalized requirements from electronic clinical quality measures. Under the proposed rule, hospitals can select six measures and report on them for the first three quarters of 2018.

For more information, click here.

CMS is Accepting Measure Submissions for the Advancing Care Information Performance Category until June 30

CMS is still accepting measures for the Advancing Care Information performance category of the Merit-based Incentive Payment System (MIPS). The Annual Call for Measures and Activities ends June 30, 2017.

CMS encourages providers to identify and submit measures for the MIPS Advancing Care Information performance category. To be considered, proposals must include specific criteria including, but not limited to, measure description, measure type and numerator and denominator descriptions.

CMS requests that stakeholders consider outcome-based measures, patient safety measures and cross-cutting measures that use certified EHR technology to support the improvement activities and quality performance categories of MIPS.

Use the Advancing Care Information Submission Form to propose measures for inclusion, and send the form to CMSCallforMeasuresACI@ketchum.com.

To learn more about the process for submitting measures, please visit the Call for Measures webpage, and review the Call for Measures and Activities fact sheet.

CMS Looks to Boost Medicare Payments to Rehab Hospitals, Nursing Facilities and Hospices

CMS could boost Medicare payments to a swath of rehabilitation hospitals, nursing facilities and hospices under a trio of new proposed rules.

On April 27, the agency floated a $390 million bump in federal payments to skilled nursing facilities in 2018—or roughly 1 percent higher than this year. Hospices, meanwhile, would receive a 1 percent increase worth $180 million.

CMS is planning to increase reimbursement to rehab hospitals by $80 million for 2018, in addition to eliminating a penalty on facilities that don’t submit certain data to the federal government on time.

Similar to proposed payment rules for other providers, CMS is asking the industries for input on regulations it should overhaul or eliminate. CMS Administrator Seema Verma and HHS Secretary Tom Price have pledged to review all of the agency’s rules in a bid to cut unnecessary or burdensome regulations.

Comments on the trio of rules must be received no later than 5 p.m. on June 26, 2017.

CMS Seeking Comments on Data Elements in IMPACT Act

CMS has contracted with the RAND Corporation to develop standardized patient/resident assessment data elements in alignment with the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act).

CMS seeks comments from stakeholders on data elements that meet the IMPACT Act domains of cognitive function and mental status; medical conditions and co-morbidities; impairments; medication reconciliation; and care preferences. The public comment period opens on April 26, 2017, and closes on June 26, 2017.

For more information, view the public comment webpage.

CMS Issues 2018 IPPS Proposed Rule

CMS issued the FY 2018 Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) rule on April 14, which proposes a number of changes to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

The proposals include:

  • For CY 2018, modifying the EHR reporting period from the full calendar year to a minimum of any continuous 90-day period for new and returning participants in the Medicare and Medicaid EHR Incentive programs.
  • Adding a new exception from the Medicare payment adjustments for Eligible Professionals (EPs), Eligible Hospitals and Critical Access Hospitals (CAHs) that demonstrate through an application process that complying with the requirement for being a meaningful EHR user is not possible because their certified EHR technology has been decertified under ONC’s Health IT Certification Program.
  • Implementing a policy in which no payment adjustments will be made for EPs who furnish “substantially all” of their covered professional services in an ambulatory surgical center (ASC); applicable for the 2017 and 2018 Medicare payment adjustments.
  • Using Place of Service (POS) code 24 to identify services furnished in an ASC as well as requesting public comment on whether other POS codes or mechanisms should be used to identify sites of service in addition to or in lieu of POS code 24.

Comments must be submitted by 5 p.m. on June 13, 2017.

To learn more, review the proposed rule or click here.

CMS Publishes Post-Acute Care Proposed Rules

On May 11, CMS published the following proposed rules:

6. Reports

GAO Testimony Finds Weaknesses in Programs Serving Indian Tribes

In a new testimony, GAO finds that actions are needed to address serious weaknesses in federal management of programs serving Indian tribes.

The Department of the Interior and the Department of Health and Human Services offer education, energy resource management, health care and other programs for Indian tribes and their members.

GAO testified on both departments’ weaknesses in managing these programs. These weaknesses have contributed to unsafe conditions at Bureau of Indian Education schools, limited or missed opportunities for tribes to use energy resources for their economic benefit, and inadequate oversight of federal health care facilities that serve tribes.

GAO’s 2017 High Risk report highlighted nearly 40 recommendations that could help address these issues.

GAO Releases Report on Electronic Cigarette Imports

In a new report, GAO analyzed data on U.S. imports of electronic cigarettes and found that the value of U.S. e-cigarette imports totaled about $342 million in 2016—and brought in about $9 million in tariff revenue.

E-cigarette devices accounted for nearly 60 percent of the value of these imports, parts for nearly 32 percent and liquid for almost 9 percent. And, although e-cigarettes were imported from 41 countries, China accounted for 91 percent of imports by value.

To see the report, click here.

GAO Releases Report on Responding to Zika Virus Disease Outbreaks

In a new report, GAO examines (1) information on what is known and not known about the epidemiology of the Zika virus, and any challenges with conducting surveillance and epidemiological studies; (2) characteristics of different diagnostic tests authorized during the outbreak, challenges test manufacturers and users faced, and the extent to which FDA and CDC followed their own communication guidance; and (3) the strengths and limitations of available mosquito control methods and challenges federal agencies face supporting these efforts.

GAO made five recommendations to FDA and CDC based on its findings, including that CDC establish a transparent process for providing test manufacturers access to diagnostic tests and that both agencies provide information to help ensure that users of diagnostic tests can compare performance.

To see the report, click here.

To read GAO’s testimony on the report, click here.

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