This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance exchanges, Medicaid expansion and the provision allowing young adults to stay on their parents’ health plans until they turn 26 years old... HHS estimated that about 6.1 million young adults have gained coverage since 2010... CMS released the final rule concerning payment and parameters for health policies and exchanges.
House of Representatives
- House Looks at Legislation Ensuring Removal of Terminated Providers from Medicaid and CHIP
- Energy and Commerce Health Subcommittee Examines Financing and Delivery of Long-Term Care in U.S.
- House Energy and Commerce Oversight Subcommittee Holds Hearing on Zika Virus
- House Budget Chairman Price Releases Budget Proposal
- Senate Starts Debate on Bill Addressing Opioid Addiction
- Senate Finance Committee Postpones Vote on Wakefield Nomination
- Sens. Warren and Murray Push for Cures Funding
- Senators Ask FDA for Efficient Ways to Deliver Cancer Drugs
- Sen. Grassley Introduces Medicaid Directory of Caregivers Bill
- CMS Issues Final Rule for 2017 Notice of Benefit and Payment Parameters
- CMS Updates Guidance on HITECH
- CMS Releases Next Steps Toolkit for Providers on ICD-10 Progress
- HHS Met Goal for Alternative Payment Ahead of Schedule
- Food and Drug Administration Misses Deadline on Biosimilars
- OMB Reviewing Proposed Rule to Increase Medicare Appeals Efficiency
- Department of Justice Announces That Olympus Admits to Charges of Bribery in Medical Device Business
- The Courts
- State Activities
- Florida: Senate Passes Needle Exchange Program
- Illinois: Chicago Opening 24-Hour Triage Center
- Kentucky: Kentucky’s Medicaid Shortfall and the Transition Away From Kynect
- Maine: Maine Lawmakers Again Consider Medicaid Expansion
- New Hampshire: House Finance Committee Scheduled Work Sessions on Medicaid Expansion
- South Dakota: CMS Guidance Frees Up Funding for State’s Medicaid Expansion
- Regulations Open for Comment
- Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats
- HHS Posts Guidance for State Innovation Waivers
- CMS Issues Proposed Rule Expanding Access to Medicare Claims Data
- CMS Releases Proposed Updates to Medicare Advantage and Part D Programs
- CMS Releases Proposed Rule for Provider Enrollment Process
- ONC Releases Proposed Rule Expanding Role in Health IT Certification Program
- Op-Ed Suggests 340B Program Affecting Drug Pricing
- AARP Report Explains Trends in Retail Prices of Prescription Drugs
- Study Finds Zika Virus Causes Guillain-Barré Syndrome
- GAO Report Recommends CMS Update Medicaid NEMT Guidance
- Milliman Study Shows CMS Proposal Will Cut Medicare Advantage Spending Up to $870 Million
- ASPE Report Finds 20 Million People Gained Coverage Due to Affordable Care Act
House of Representatives
House Looks at Legislation Ensuring Removal of Terminated Providers from Medicaid and CHIP
On March 3, the House passed H.R. 3716, “The Ensuring Removal of Terminated Providers from Medicaid and CHIP Act,” authored by Rep. Larry Bucshon. This legislation would prevent doctors banned from Medicaid and CHIP in one state from participating in those programs in other states. It would accomplish this in part by requiring states to set up provider databases. The legislation came after an HHS Office of Inspector General (OIG) report in August found that Medicaid programs were still paying millions of dollars to terminated providers who continued participation in other states.
Specifically, OIG found that 12 percent of providers terminated for cause in 2011 were still participating in other states’ Medicaid programs in January 2014. These Medicaid programs paid $7.4 million to 94 providers for services performed after each provider’s termination for cause by the initial state. These physicians often found a way to work in another state through a managed care provider.
The legislation included provisions of H.R. 3821, the Medicaid Directory of Caregivers Act (Medicaid DOC Act), legislation Reps. Collins (R-NY) and Tonko (D-NY) introduced to improve access to doctors for Medicaid beneficiaries. This legislation requires states that operate a Medicaid fee-for-service or primary care case management program to include on the Medicaid program’s website a directory of physicians who served Medicaid patients in the prior year. The listing on the state’s Medicaid website will include the physician’s name, address, telephone number and specialty. This will help Medicaid beneficiaries easily identify doctors who can serve them.
Energy and Commerce Health Subcommittee Examines Financing and Delivery of Long-Term Care in U.S.
On March 1, the House Energy and Commerce Health Subcommittee held a hearing examining the financing and delivery of long-term care in the United States. In 2014, $340 billion was spent on long-term care, amounting to more than 13 percent of the almost $2.6 trillion spent on personal health expenditures. Subcommittee members and witnesses highlighted the fact that Americans are living longer. Also, with 10,000 baby boomers turning 65 every day, the demand for long-term care is expected to significantly increase. “While long-term care largely differs from health coverage or medical care, I know every member of this Committee wants to ensure that frail elderly seniors or disabled individuals across the country receive high-quality care,” stated Chairman Pitts.
Alice Rivlin, Ph.D.
Co-Chair, Long-Term Care Initiative, Bipartisan Policy Center
William J. Scanlon, Ph.D.
Consultant, West Health Institute and National Health Policy Forum
Ms. Anne Tumlinson
CEO, Anne Tumlinson Innovations
To see a related press release, click here.
House Energy and Commerce Oversight Subcommittee Holds Hearing on Zika Virus
On March 2, the House Energy and Commerce oversight subcommittee held a hearing examining the U.S. public health response to the Zika virus. Nine witnesses provided testimony, including Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC); Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response at the Department of Health and Human Services; and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Members raised concerns about education on and treatment of the virus. A key topic during the hearing was the administration’s emergency supplemental appropriation request to respond to Zika both domestically and internationally.
For more information and a full list of witnesses, click here.
To see a related press release, click here.
House Budget Chairman Price Releases Budget Proposal
On March 3, House Budget Chairman Tom Price (R-GA) formally laid out his budget proposal at a House GOP conference meeting. Price and Speaker Paul Ryan face an uphill battle to win over hard-right lawmakers. Passing a budget is a top priority for House GOP leaders this year, but they have been struggling to unify behind a plan.
At the meeting, Price told lawmakers that his committee would try to pass a budget that funds the government at $1.070 trillion, but includes $30 billion in mandatory savings — this would likely come from cuts to programs like Social Security, Medicare, Medicaid and food stamps. However, many said they do not see much to support in the proposal. If GOP leaders fail to get support from conservatives, it could prevent Ryan’s hope to approve 12 appropriation bills.
Senate Starts Debate on Bill Addressing Opioid Addiction
On March 1, the Senate voted to start debate on the Comprehensive Addiction and Recovery Act (CARA), but there is little agreement on how to handle amendments. Republicans argue that enough money was included in the year-end budget deal for opioid programs, and many anti-addiction groups want the bill to move forward with or without the new money.
The bill would not do much to address the epidemic unless it includes funding to support the effort, the White House said in a statement of administration policy on March 1. The administration’s proposed 2017 budget calls for $1 billion in new mandatory funding for opioids and $90 million in discretionary money to expand access to treatment — including medication-assisted treatment — and to make the overdose antidote naloxone more available. The Senate bill is similar, but differs in that it redirects already appropriated money rather than providing for new funding.
Additionally, the White House said that CARA could interfere with the Centers for Disease Control and Prevention’s (CDC) effort to finalize an opioid prescribing guideline. A CBO score released Feb. 26 estimates CARA would increase spending by $2 million through 2021. It has been endorsed by more than 130 anti-addiction groups.
On March 2, the Senate passed an amendment to CARA that would let Part D plans lock Medicare beneficiaries at risk of drug abuse into a single physician or pharmacy. Sen. Pat Toomey (R-PA) offered the Stopping Medication Abuse and Protecting Seniors Act (S. 1913) and said that the intention of the bill is to stop beneficiaries from getting multiple opioid prescriptions. The Government Accountability Office (GAO) found that 170,000 Medicare enrollees participated in “doctor shopping” in a single year. The measure meets opposition from the National Community Pharmacists Association but is widely used in state Medicaid programs and the private sector. CMS supports it.
Sen. Jeanne Shaheen’s amendment, which would have provided $600 million in emergency funds for first responders and treatment providers, failed.
Senate Finance Committee Postpones Vote on Wakefield Nomination
The U.S. Senate Finance Committee postposed its vote on Mary Wakefield’s nomination to be deputy secretary of the U.S. Department of Health and Human Services (HHS). There was no reason given for the postponement, and Chairman Hatch hopes to reschedule in the near future, according to a committee spokesperson.
Sen. Chuck Grassley is opposed to Wakefield’s nomination because he says HHS has not answered questions about fetal-tissue practices at Planned Parenthood. Several investigations have found no wrongdoing at the organization. Wakefield has been the acting deputy secretary since last year.
Sens. Warren and Murray Push for Cures Funding
As part of the Senate HELP committee’s counterpart to the House 21st Century Cures Act, Sens. Elizabeth Warren and Patty Murray are set to introduce a bill that would give NIH and FDA $5 billion in additional funding each year for 10 years. The National Biomedical Research Act would direct money toward certain programs — including the cancer moon shot, the Precision Medicine initiative and the BRAIN initiative.
All Democrats on the HELP committee have signed on but there is still no word on whether the bill will be considered at the committee’s Cures markup March 9. To view the bill, click here.
Senators Ask FDA for Efficient Ways to Deliver Cancer Drugs
Sens. Amy Klobuchar and Jeanne Shaheen want the U.S. Food and Drug Administration (FDA) to change the way that drugs are packaged and distributed. This request comes after a BMJ study concluded that Medicare and private insurers waste almost $3 billion per year on leftover medication from cancer vials — which must be disposed of. “Because the drugs used to treat cancer are expensive, even small amounts of leftover medication can be extremely costly for patients and the health system,” they write to Robert Califf at FDA.
Sen. Grassley Introduces Medicaid Directory of Caregivers Bill
On March 2, Sen. Chuck Grassley (R-IA) introduced the Medicaid Directory of Caregivers bill (S. 2618) to ensure Medicaid programs give beneficiaries an updated list of participating doctors. The bill would require the publication of a provider directory in the case of states giving medical assistance on a fee-for-service basis or through a primary care case management system. The listing, on a state’s Medicaid website, would include the physician’s name, business address, telephone number and specialty. Grassley said Iowa already provides an updated directory through its fee-for-service Medicaid program and can serve as an example for other states. Provisions from the companion bill were passed by the House this week.
CMS Issues Final Rule for 2017 Notice of Benefit and Payment Parameters
On March 1, the Centers for Medicare and Medicaid Services (CMS) issued the final 2017 HHS Notice of Benefit and Payment Parameters for the 2017 coverage year, along with related guidance documents.
The rule finalizes provisions to: help consumers with surprise out-of-network costs at in-network facilities; provide consumers with notifications when a provider network changes; give insurance companies the option to offer plans with standardized cost-sharing structures; provide a rating on HealthCare.gov of each QHP’s relative network breadth (for example, “basic,” “standard” and “broad”) to support more-informed consumer decision-making; and improve the risk adjustment formula.
CMS also finalized the open enrollment period for future years. For coverage in 2017 and 2018, open enrollment will begin on Nov. 1 of the previous year and run through Jan. 31 of the coverage year. For coverage in 2019 and beyond, open enrollment will begin on Nov. 1 and end on Dec. 15 of the preceding year (for example, Nov. 1, 2018, through Dec. 15, 2018, for 2019 coverage).
The fact sheet with details on these key provisions and others can be found here.
In addition to the final Notice of Benefit and Payment Parameters for 2017, CMS released its final Annual Letter to Issuers. This provides issuers interested in offering coverage in states with a Federally-facilitated Marketplace information on key dates for the Qualified Health Plan (QHP) certification process; standards that will be used to evaluate QHPs for certification; and oversight procedures, consumer support policies and programs. The letter is available here.
Additionally, CMS released a bulletin on the Rate Filing Justifications for the 2016 Filing Year for Single Risk Pool Compliant Coverage. This bulletin provides guidance on the timing for state Departments of Insurance and health insurance insurers to submit Rate Filing Justifications for proposed rate increases in the individual and small group markets. The guidance, which offers states greater flexibility than the proposed bulletin, is available here.
Key dates for the 2016 calendar year can be found here.
CMS released a set of Frequently Asked Questions (FAQs) related to the Moratorium on the Health Insurance Provider Fee (enacted in the Consolidated Appropriations Act of 2016, P.L. 114-113), which suspends collection of this fee for the 2017 plan year. This guidance urges issuers to lower their administrative costs and premiums appropriately to account for the moratorium. The FAQs are available here.
Lastly, CMS released guidance addressing the transitional policy for plans that have been continuously renewed since 2014. To allow for a smooth wind-down of transition relief, states and issuers will have the option to renew nongrandfathered individual and small group health policies, but these policies must end no later than Dec. 31, 2017. This approach offers flexibility to states and issuers to align the end of these policies with open enrollment and the start of the calendar year, facilitating smooth transitions to Affordable Care Act-compliant policies. The guidance is available here.
CMS Updates Guidance on HITECH
On March 1, the Centers for Medicare and Medicaid Services (CMS) announced the availability of HITECH administrative matching funds to help professionals and hospitals eligible for Medicaid EHR incentive payments connect to other Medicaid providers. CMS issued a letter to states updating prior guidance on when state costs related to promoting Health Information Exchange (HIE) can be matched at the 90 percent HITECH — Health Information Technology for Economic and Clinical Health Act — administrative rate to support the coordination of care and transitions of care requirements in Meaningful Use modified Stage 2 and Stage 3.
The letter can be found here.
CMS Releases Next Steps Toolkit for Providers on ICD-10 Progress
On March 1, the Centers for Medicare and Medicaid Services (CMS) released the Next Steps Toolkit to help providers track and improve ICD-10 progress. The toolkit includes information and resources on how to:
- Assess ICD-10 progress using key performance indicators to identify potential productivity or cash flow issues
- Address opportunities for improvement
- Maintain progress and keep up to date on ICD-10
In the coming weeks, CMS will also release a companion infographic with simple steps from the Next Steps Toolkit.
For more information, click here.
HHS Met Goal for Alternative Payment Ahead of Schedule
The Obama administration met its goal of tying 30 percent of Medicare payments to alternative payment models almost a full year ahead of schedule, according to federal officials. In 2016, Medicare is projected to pay more than $117 billion to accountable care organizations, bundled payment programs and other alternatives to fee-for-service medicine. The shift to value-based care has apparently been aided by Obamacare’s delivery system reform provisions.
CMS wants to tie 50 percent of Medicare payments to alternative payment models by 2018. When the goal was first outlined in January 2015, around 20 percent of Medicare payments — $72.4 billion — in provider payments went through alternative models. Before the passage of the Affordable Care Act (ACA), Medicare paid almost nothing through alternative payment arrangements.
Food and Drug Administration Misses Deadline on Biosimilars
The U.S. Food and Drug Administration (FDA) missed the deadline to give lawmakers an estimated timeline of when FDA will finalize several biosimilar guidance documents. The timeline was required by the 2016 omnibus spending bill. Stakeholders have been waiting for FDA guidance on the interchangeability of biosimilars with their reference products, labeling of biosimilar product and the statistical approaches to evaluating analytical similarity data to support a demonstration of biosimilarity. Newly confirmed FDA Commissioner Robert Califf declined to provide details on the timing of the guidance at an appropriations hearing on March 2.
OMB Reviewing Proposed Rule to Increase Medicare Appeals Efficiency
The White House Office of Management and Budget (OMB) is reviewing a proposed rule to make Medicare appeals more efficient and curb the increase in appeals. The rule would change the appeals process in fee-for-service, managed care and the drug benefit programs — it does not, however, give details. The Office of Medicare Hearings and Appeals (OMHA) has struggled with a backlog, and the proposed rule would alleviate this issue. In its 2017 budget justification, OMHA stated that the number of appeals increased 1,222 percent between 2009 and 2014 and this has had a detrimental impact on the agency’s performance. OMB started reviewing the proposed rule on March 1 and typically has 90 days for review.
Department of Justice Announces That Olympus Admits to Charges of Bribery in Medical Device Business
On March 1, the Justice Department announced that the medical equipment company Olympus, which produced endoscopes linked to hospital infections, will pay $646 million for making illegal payments to doctors and hospitals in the United States and Latin America. Olympus admitted to criminal charges that it won new business and rewarded sales by giving doctors and hospitals consulting payments, foreign travel, meals and millions of dollars in grants and free endoscopes. It also faced civil charges — under the False Claims Act — that its kickbacks caused false claims to be submitted to federal health care programs.
Olympus is entering into a three-year deferred prosecution agreement that will allow it to avoid conviction if it complies with certain requirements. It submitted to a corporate integrity agreement with HHS as well. The company will pay $623.2 million to resolve these criminal charges.
Olympus will also pay $22.8 million to resolve separate criminal charges related to the Foreign Corrupt Practices Act (FCPA) in Latin America. It paid nearly $3 million in bribes to practitioners in Central and South America from 2006 to 2011. There will be a separate deferred prosecution agreement to resolve those charges.
The company is under scrutiny from the U.S. Food and Drug Administration (FDA) because its endoscopes were linked to infections at two California hospitals in 2015.
- The Courts
SCOTUS Declines Origination Case
On Feb. 29, the Supreme Court refused to hear Hotze v. Burwell — a case challenging the Affordable Care Act (ACA), brought by an anti-gay Houston physician who warned that same-sex marriage would lead to sodomy among kindergarteners. The court rejected the case in a single-line order. The lawsuit alleged that the legislation started in the Senate and not the House, as the Constitution requires for bills that raise revenue. The denial was expected because the case has been dismissed by the lower courts.
Pay-For-Delay Court Rulings
The 1st Circuit became the second U.S. appeals court to rule that settlement deals in pharma patent cases involving noncash payment from a brand drug company to a generic drugmaker could constitute antitrust violations. This decision was based on the Supreme Court’s 2013 ruling in FTC v. Actavis. It reviewed a case involving Warner Chilcott’s oral contraceptive Loestrin 24 wherein Warner settled patent litigation with the generic company Watson Pharmaceuticals by entering into promotional deals with the generic company and promising not to introduce its own generic version of the drug. Watson then delayed selling its generic version. After that, Warner settled patent litigation with Lupin Pharmaceuticals over the birth control pill. Lupin agreed to postpone its generic entry in exchange for attorneys’ fees and Warner’s agreement to enter into favorable side deals.
Last June, the 3rd Circuit found that settlements involving a noncash payment — such as a brand company’s agreeing to not compete against the generic — can constitute a reverse payment under Actavis. GlaxoSmithKline and Teva petitioned the Supreme Court to take the 3rd Circuit case this week, arguing that it expanded Actavis beyond its intended bounds. If the ruling stands, it will destabilize patent rights and the ability to settle patent disputes in the pharma industry and beyond, the companies claim.
- State Activities
Florida: Senate Passes Needle Exchange Program
The Florida Senate approved a bill that allows the University of Miami to create a needle exchange to curb the spread of HIV. Needle exchanges are illegal under the state’s drug paraphernalia laws and this bill would make an exception. No taxpayer money could be used for the program. House lawmakers are preparing to vote on a companion measure. Similar bills have not passed before, but new language requires the program to direct people to drug treatment options and to make educational materials available.
Illinois: Chicago Opening 24-Hour Triage Center
Chicago is opening a 24-hour triage center to which police officers can take people experiencing mental health and substance abuse emergencies. This is part of an effort to reduce overcrowding at the Cook County Jail, which has been housing more behavioral health patients since some of the city’s mental health facilities have closed down. Advocates argue the triage center will be helpful if it is staffed with trained police officers who are able to respond to people experiencing behavioral health crises.
Kentucky: Kentucky’s Medicaid Shortfall and the Transition Away From Kynect
Kentucky’s Medicaid program is facing a $611 million deficit over two years. Kentucky Health Secretary Vickie Yates Brown Glisson gave an update though she could not speak to how the state plans to make up for the shortfall. Lawmakers have been promised there would be no cuts to benefits, employees or programs.
It would cost $240,000 to transition from Kentucky’s state health exchange — Kynect — to HealthCare.gov, according to Gov. Matt Bevin’s analysis of the transition. Steve Beshear, Bevin’s predecessor, had projected that it would cost the state $23 million to transition from Kynect.
Maine: Maine Lawmakers Again Consider Medicaid Expansion
Lawmakers in Maine are considering Medicaid expansion for the sixth time, with a new plan being pitched. Republican state Sen. Tom Saviello’s legislation would include premiums for enrollees with incomes above the federal poverty level. The heroin crisis could alter the outcome of expansion, as supporters say expansion would help address the opioid abuse crisis. The Maine Legislature has approved the Medicaid expansion multiple times but Republican Gov. Paul LePage has vetoed it each time. He has made no indication of relenting.
New Hampshire: House Finance Committee Scheduled Work Sessions on Medicaid Expansion
The New Hampshire House Finance Committee scheduled two work sessions on legislation that has cleared the House floor once already. The meetings were held on March 1 and 2, and a committee vote occurred on the 3rd. The Finance Committee is the more conservative of two panels weighing whether to continue Medicaid expansion through 2018. The legislation will go to the House floor again for another vote before going to the Senate if it makes it through the panel.
South Dakota: CMS Guidance Frees Up Funding for State’s Medicaid Expansion
On Feb. 26, the Centers for Medicare & Medicaid Services (CMS) finalized guidance for providing full federal funding to states when Native Americans and Alaska Natives eligible for Medicaid look for care through the Indian Health Service. South Dakota Gov. Dennis Daugaard said this is key for getting Medicaid expansion in his state. South Dakota officials will present a Medicaid expansion plan to the governor by early summer that incorporates these recent federal policy changes. Daugaard lobbied the administration to make this change because it would free up funds in the state budget to pay for expansion. However, the CMS announcement came too late for state legislators to review a plan before the end of their session.
- Regulations Open for Comment
Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats
FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.
More information on FDA’s decision can be found in the agency’s press release.
HHS Posts Guidance for State Innovation Waivers
On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under Section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.
To see the guidance, click here.
CMS Issues Proposed Rule Expanding Access to Medicare Claims Data
The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program: Expanding Uses of Medicare Data by Qualified Entities.” The rule would expand access to Medicare information by permitting certain organizations to buy and share claims data. Created under Obamacare, Medicare’s qualified entity program allows providers, employers and others access to Medicare data to analyze the performance of providers and suppliers. The rule aims to help qualified entities make business decisions that reduce costs and improve quality of care. These changes were mandated in the Medicare Access and CHIP Reauthorization Act and CMS thinks the expansion of data sharing will stir more interest in the program. If the proposal is finalized, CMS estimates the number of qualified entities will go from 13 to 20. Comments will be accepted on the proposed rule until 5 p.m. on March 29, 2016.
CMS Releases Proposed Updates to Medicare Advantage and Part D Programs
On Feb. 19, the Centers for Medicare and Medicaid Services (CMS) released proposed updates to the Medicare Advantage (MA) and Part D programs for next year. The updates target high drug costs and the opioid abuse epidemic. CMS’s call letter encourages plans to notify patients about drugs that are added to formularies in the middle of the year, such as generics or other newly approved drugs, which could provide better value than existing options. It also aims to add a link from the Medicare Plan Finder website to the Medicare Drug Spending Dashboard by 2017. CMS is proposing for Part D plans to implement edits to prevent opioid overutilization at the point of sale, and says it will not approve benefit designs that hinder access to medication-assisted treatment through overly restrictive utilization management strategies or high cost-sharing. About one-third of enrollees are in Part D plans with quality rankings of at least four stars, compared to 27 percent in 2009. Comments must be submitted by March 4 and the proposal will be finalized April 4.
CMS Releases Proposed Rule for Provider Enrollment Process
On Feb. 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to implement additional provider enrollment provisions of the Affordable Care Act (ACA) to help make sure that entities and individuals who pose risks to the Medicare program are kept out of it or removed for extended periods. This rule is part of CMS’s effort to prevent questionable providers and suppliers from entering the Medicare program.
If finalized, the regulations would allow CMS to remove or prevent enrollment of those who try to circumvent enrollment requirements through name and identity changes or through inter-provider relationships. It will also address vulnerabilities such as when providers and suppliers avoid paying their Medicare debts by reenrolling as a different entity.
Major provisions of the proposed rule include:
- Disclosure of Affiliations: Would require health care providers and suppliers to report affiliations with entities and individuals that: (1) currently have uncollected debt to Medicare, Medicaid or CHIP; (2) have been or are subject to a payment suspension under a federal health care program or subject to an Office of Inspector General (OIG) exclusion; or (3) have had their Medicare, Medicaid or CHIP enrollment denied or revoked. CMS could deny or revoke the provider’s or supplier’s Medicare, Medicaid or CHIP enrollment if CMS determines that the affiliation poses an undue risk of fraud, waste or abuse.
- Different Name, Numerical Identifier or Business Identity: CMS could deny or revoke a provider’s or supplier’s Medicare enrollment if CMS determines that the provider or supplier is currently revoked under a different name, numerical identifier or business identity.
- Abusive Ordering/Certifying: Would allow CMS to revoke a physician’s or eligible professional’s Medicare enrollment if he or she has a pattern or practice of ordering, certifying, referring or prescribing Medicare Part A or B services, items or drugs that is abusive, represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements.
- Increasing Medicare Program Re-enrollment Bars: Would improve protection of the Medicare Trust Funds and program beneficiaries by: 1) raising the existing maximum re-enrollment bar from three years to 10 years; 2) allowing CMS to add three more years to the provider’s or supplier’s re-enrollment bar if the provider attempts to re-enroll in Medicare under a different name, numerical identifier or business identity; and 3) imposing a maximum 20-year re-enrollment bar if the provider or supplier is being revoked from Medicare for the second time.
- Other Public Program Termination: Would permit CMS to deny or revoke a provider’s or supplier’s Medicare enrollment if: (1) the provider or supplier is currently terminated from participation in a particular Medicaid program or any other federal health care program under any of its current or former names, numerical identifiers or business identities; or (2) the provider’s or supplier’s license is revoked in a state other than that in which the provider or supplier is enrolled or enrolling.
- Expansion of Ordering/Certifying Requirements: Would permit CMS to require that physicians and eligible professionals who order, certify, refer or prescribe any Part A or B service, item or drug must be enrolled in or validly opted out of Medicare.
For more information, click here.
ONC Releases Proposed Rule Expanding Role in Health IT Certification Program
The Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would enable the agency to conduct direct reviews of certified health IT products. Such direct review would also include how certified health IT interacts with other systems. The rule increases ONC’s oversight of health IT testing bodies to improve alignment and more successfully deal with issues, and seeks to increase transparency associated with the surveillance — it plans to make results of surveillance of electronic health records (EHRs) publicly available. The reviews would focus on situations posing health or safety risks. Depending on the findings, the office says it may require corrective action or suspend or terminate certification for an EHR or health IT module.
ONC hopes this move will enhance public confidence in health IT testing and certification. The U.S. Department of Health and Human Services (HHS) said the rule will empower consumers by improving availability of certification information. ONC is proposing a “strict process” for health IT recertification or replacement versions, and a program ban for those that don’t fix problems pointed out by ONC. Comments on the rule will be accepted through May 2.
To see the proposed rule, click here.
Op-Ed Suggests 340B Program Affecting Drug Pricing
According to a New England Journal of Medicine op-ed, the 340B drug pricing program — which discounts outpatient drugs to safety net providers — is most likely driving up prices for all consumers because pharma companies pass along its costs. The program’s discounts — 20 to 50 percent — do not have to be passed on to patients. Additionally, providers can dispense the discounted drugs to any patient, regardless of insurance status. The report suggests lawmakers should embrace limiting 340B discounts to lower-income patients to help address drug prices.
Lawmakers should also consider making it legal for Medicare to use reference pricing for Part B drugs, according to the report. Setting a reference price low enough places pressure on drug companies to lower prices for drugs that have good substitutes. The authors of the study argue that affordability will always be compromised if prices are the only way return on investment is awarded.
AARP Report Explains Trends in Retail Prices of Prescription Drugs
A recent AARP report on drug prices places the blame for rising costs on brand drugs, not generics. The report found that retail prices for widely used prescription drugs increased, on average, between 2006 and 2013. The retail prices increased faster than general inflation every year, and are attributable to brand and specialty drug price increases, which more than offset decreases among generic drugs.
Study Finds Zika Virus Causes Guillain-Barré Syndrome
French scientists confirmed the Zika virus is causing a rise in the prevalence of Guillain-Barré syndrome — an autoimmune disorder that affects the nerves and can cause paralysis and even death. A team of clinicians, epidemiologists, virologists and immunologists confirmed the link by studying victims of the 2013-2014 epidemic of Zika virus in French Polynesia. This specific outbreak, which infected two-thirds of this population, came with many cases of the syndrome. The patients studied developed an “acute motor axonal form” of the syndrome — different from what is typically seen in Europe. The estimated risk to develop the syndrome is 2.4 per 10,000 Zika infections. According to the U.S. National Institutes of Health, the usual prevalence of Guillain-Barré is 6 to 40 cases per 1 million. Therefore, the risk of developing it when exposed to Zika is multiplied by up to 40.
These findings come from teams at Institut Pasteur, Cnam, Institut Louis Malardé and the public hospitals of Paris and French Polynesia.
GAO Report Recommends CMS Update Medicaid NEMT Guidance
On March 3, the Government Accountability Office (GAO) released a report entitled “Nonemergency Medical Transportation: Updated Medicaid Guidance Could Help States.” Medicare and Medicaid provide nonemergency medical transportation (NEMT) services to eligible beneficiaries who need transportation to scheduled nonemergency care. The Centers for Medicare and Medicaid Services (CMS) manages Medicare NEMT benefits and oversees Medicaid at the federal level. Spending on NEMT under these programs was $2.7 billion in 2013 — $1.2 billion for Medicare and $1.5 billion for Medicaid. Higher demand for NEMT because of increased Medicaid enrollment has led states to seek ways to more efficiently operate NEMT.
The GAO report examines: 1) key features of NEMT services under Medicare and Medicaid and how the services are delivered; 2) steps CMS has taken to oversee NEMT under Medicare as well as Medicaid; and 3) challenges in providing NEMT under Medicaid and steps that certain state Medicaid agencies have taken to address those changes. GAO reviewed documents and interviewed officials from CMS. It reviewed 15 selected states.
GAO made the recommendation that the Secretary of HHS direct CMS to assess current Medicaid NEMT guidance and update it as necessary. HHS agreed with the recommendation.
Milliman Study Shows CMS Proposal Will Cut Medicare Advantage Spending Up to $870 Million
According to a new industry-funded study by the actuarial firm Milliman, the 2017 payment proposal released by the Centers for Medicare and Medicaid Services (CMS) will cut spending for Medicare Advantage by up to $870 million for the 3.3 million Medicare beneficiaries in employer-sponsored plans. Spending on the plans will decrease by around $250 per person — 2.5 to 2.8 percent — under the proposal. The study concludes that the cut in federal funding will most likely result in increases to premiums and/or reduced benefits for Medicare Advantage enrollees. The administration’s analysis found that average rates for the entire Medicare Advantage population would increase by 1.35 percent.
The study was backed by the Coalition to Save Medicare Advantage Retiree Coverage — a new advocacy group whose membership includes Aetna and UnitedHealth Group. There are now three different groups trying to influence the administration’s Medicare Advantage policies for 2017, to be finalized on April 4.
ASPE Report Finds 20 Million People Gained Coverage Due to Affordable Care Act
On March 3, the Assistant Secretary for Planning and Evaluation (ASPE) released a report that finds the provisions of the Affordable Care Act (ACA) have resulted in an estimated 20 million people’s gaining health insurance coverage between the passage of the law in 2010 and early 2016. Those provisions include Medicaid expansion, Health Insurance Marketplace coverage and changes in private insurance allowing young adults to stay on their parents’ plans and requiring plans to cover people with pre-existing health conditions.
According to the report, 6.1 million uninsured young adults ages 19 to 25 have gained health insurance coverage because of the ACA, and gains in coverage were strong across all racial and ethnic groups.
To see the report, click here.
For the full HHS press release, click here.