June 5

The Washington Weekly: June 5, 2015

House Ways & Means Committee Votes to Repeal Medical Device Tax

On Tuesday, June 2, the House Ways & Means Committee held a markup to vote on a bill, H.R. 160, which would repeal the 2.3% medical device tax. During the markup there was considerable debate on whether to offset the $24.4 billion cost of repealing the tax, but ultimately the bill was passed by a vote of 25-14, with only one Democrat, Congressman Ron Kind (D-WI), supporting the bill. The President has indicated he will veto the bill unless its cost is offset. The committee also voted on bills to repeal the Independent Payment Advisory Board (IPAB) and to improve or protect the integrity of the Medicare Advantage program.

These bills will now move to the House floor, where a vote is scheduled for the week of June 15. The 21st Century Cures Act is also expected to receive a floor vote that week.

Senate Judiciary Committee Passes Patent Reform Legislation

On Thursday, June 4, the Senate Judiciary Committee chaired by Chuck Grassley (R-IA) held a full committee markup of S. 1137, the Protecting American Talent and Entrepreneurship (PATENT) Act of 2015. The legislation aims to address abusive patent litigation by making it more difficult for so-called “patent trolls” to file frivolous lawsuits. Ahead of the Judiciary Committee’s markup, Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and five other committee members released a manager’s amendment which included technical changes to certain provisions of S.1137, primarily addressing concerns regarding post-grant review proceedings at the Patent and Trademark Office (PTO). Despite these changes, many stakeholders, including members of the life sciences community, maintain serious concerns with how the PATENT Act will affect the ability of legitimate patent holders to protect and enforce their innovative work. The Senate Judiciary Committee approved the PATENT Act by a 16-4 vote. The full markup can be found HERE.

CMS Issues Shared Savings Program ACO Final Rule

On Thursday, June 4, the Centers for Medicare and Medicaid Services (CMS) issued a final rule containing changes to Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs). Although the agency had proposed to reduce the amount of shared savings for Track 1 ACOs from 50 percent to 40 percent, CMS will allow ACOs to participate in Track 1 for an additional three years at the 50 percent savings level. The final rule also creates a new Track 3 model based on features of the Pioneer ACO program that will include higher rates of shared savings while taking on more risk. The advance copy of the final rule is available HERE.

Murphy (R-PA) Reintroduces Mental Health Bill Legislation

On Thursday, June 4, House Energy and Commerce Oversight and Investigations Chairman Tim Murphy (R-PA) reintroduced the Helping Families in Mental Health Crisis Act, H.R. 2646. The reintroduced bill builds on the version introduced in 2013 and aims to improve access, expand the workforce, drive evidence-based care and provide alternatives to institutionalization for those suffering from mental illness and their families. The new bill maintains provisions creating a new assistant secretary for mental-health and substance abuse disorders in the Department of Health and Human Services (HHS), but contains revised patient privacy language. In addition, the revised bill no longer mandates states establish court-ordered outpatient treatment programs to apply for certain Substance Abuse and Mental Health Administration grants, and instead incentivizes states to set up such programs. Full text of H.R. 2646 can be found HERE.

Senate Judiciary Committee Passes Patent Reform Legislation

On Thursday, June 4, the Senate Judiciary Committee chaired by Chuck Grassley (R-IA) held a full committee markup of S. 1137, the Protecting American Talent and Entrepreneurship (PATENT) Act of 2015. The legislation aims to address abusive patent litigation by making it more difficult for so-called “patent trolls” to file frivolous lawsuits. Ahead of the Judiciary Committee’s markup, Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and five other committee members released a manager’s amendment which included technical changes to certain provisions of S.1137, primarily addressing concerns regarding post-grant review proceedings at the Patent and Trademark Office (PTO). Despite these changes, many stakeholders, including members of the life sciences community, maintain serious concerns with how the PATENT Act will affect the ability of legitimate patent holders to protect and enforce their innovative work. The Senate Judiciary Committee approved the PATENT Act by a 16-4 vote. The full markup can be found HERE.

Price Introduces Alternative to King v. Burwell

On Thursday, June 4, House Budget Committee Chairman Tom Price (R-GA) introduced the Restoring Equity, Save Coverage, and Undoing Errors (RESCUE) Act, H.R. 2650. The legislation aims to protect and provide options for those who may be adversely impacted if the Supreme Court rules in favor of the plaintiff in King V. Burwell. The bill would provide age-adjusted refundable tax credits to those who would lose their health insurance coverage, allow the creation of “individual health pools” that would make it easier for individuals and small employers to buy coverage, and repeal several pieces of the Affordable Care Act (ACA), including all insurance reforms in Title I. Price’s legislation would apply in states without subsidies, with all states having the option of terminating their exchanges in favor of this law. The Supreme Court’s decision in King v. Burwell is expected by the end of the month. Full text of H.R. 2650 can be found HERE.

CMS Reports 10.2 Million Paid for Exchange Coverage

On Tuesday, June 2, the Centers for Medicare and Medicaid Services (CMS) issued an updated enrollment report called the “March 31, 2015 Effectuated Enrollment Snapshot.” According to the report, out of the 11.7 million individuals previously reported to have selected exchange plans, approximately 10.2 million consumers had paid for their coverage as of March 31, 2015. The report also notes that 6.4 million individuals purchased plans using federal subsidies in the 34 states with federally-facilitated exchanges. This means that an estimated 6.4 million individuals would stand to lose their federal subsidies used to purchase coverage in the event the Supreme Court rules against the Administration in King v. Burwell in late-June. Additionally, the report lists updated enrollment figures by state, including average tax credits allotted for each state. The report is available HERE.

CMS Requests Comments on Proposed Out-of-Pocket Cost Comparison Tool for Federal Exchanges

On Thursday, June 4, the Centers for Medicare and Medicaid Services (CMS) issued a bulletin announcing an Out-of-Pocket (OOP) Cost Comparison Tool the agency is developing for consumer use on federally-facilitated exchanges (FFEs). The tool would allow consumers to understand potential tradeoffs between monthly premiums and OOP costs for plans at different metal levels and with different plan designs. CMS is requesting comments on the proposed OOP cost methodology and its incorporation into the FFEs’ websites. The comment deadline is June 29, 2015. The bulletin is available HERE.

CMS Posts Medicare Payment Data for Hospitals and Physicians

On Monday, June 1, the Centers for Medicare and Medicaid Services (CMS) posted public files containing aggregate Medicare Part A and Part B payment data for individual hospitals and physicians for 2013. The agency posted three separate data files: (1) inpatient hospital charge data; (2) outpatient hospital charge data; and (3) physician and other supplier payment data. The inpatient hospital data shows hospital-specific charges for the 100 most frequently billed discharges. The outpatient data includes estimated hospital-specific charges for 30 ambulatory payment classification (APC) groups paid under the hospital outpatient prospective payment system (HOPPS). The Part B physician payment data includes data for nearly 950,000 providers totaling about $90 billion and is organized by provider last name. CMS notes that the physician payment data may not be representative of a physician’s entire practice as it only includes information on Medicare fee-for-service beneficiaries. The data also does not account for the quality of care provided and is not risk-adjusted to account for differences in the underlying severity of diseases for patient populations. A fact sheet for the hospital utilization data with links to the data files is available HERE. A fact sheet for the physician payment data with a link to the data files is available HERE.

Senate Finance Committee Passes Markup of the AFIRM Act

On Wednesday, June 3, the Senate Finance Committee held a markup of The Audit and Appeals Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015. The bill, introduced by committee Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR), aims to increase coordination and oversight of the Medicare audits and appeals process to address the significant amount of backlogged appeals and expedite the appeals process moving forward. In his opening statements, Chairman Hatch identified three ways the AFIRM Act will tackle these issues, including improving oversight at CMS to ensure better coordination between audit contractors and the agency; requiring CMS to incentivize auditor accuracy; and streamlining the appeals process without compromising quality. After all amendments were considered and others withdrawn, a vote commenced on the AFIRM Act, as amended, and was passed by a voice vote. Text of the entire bill can be found HERE. The online webcast of the markup can be found HERE.

NIH and BARDA Announce Antibiotic Resistance Contest

On Tuesday, June 2, the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) announced an up to $20 million prized competition for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The goal of the contest is to incentivize the development of one or more in vitro diagnostic tests that would be of significant clinical and public health utility. The submission period began Tuesday, June 2 at 9:00 a.m. EST and will conclude at 5:00 p.m. EST on Friday, July 17. Further information on the contest can be found HERE.

CMS Posts 2016 Proposed Rates for Individual and Small Business Insurance Plans

On Monday, June 1, the Centers for Medicare and Medicaid Services (CMS) posted proposed rate increases of 10 percent or more for individual and small business insurance plans for 2016. The proposed rate increases were submitted by insurers for plans both inside and outside the exchanges in all states. The rates are insurers’ initial requests and will likely change before becoming final in October. A CMS fact sheet on the proposed rate increases is available HERE.

OIG Releases Advisory Opinions on Device Manufacturer Subsidies for Patients in CED Research Studies, Charitable Entity’s Financial Assistance for Patients with Chronic Diseases

On Thursday, June 4, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion 15-07 regarding subsidies a medical device manufacturer provides to certain patients participating in a clinical research study. Under the facts of the Advisory Opinion, the Centers for Medicare and Medicaid Services (CMS) had issued a National Coverage Determination (NCD) stating that a lumbar spinal procedure could be covered by Medicare under the Coverage with Evidence Development (CED) Program when the procedure was administered pursuant to a clinical study approved by CMS. Subject to the parameters of this specific arrangement, OIG determined that the arrangement likely would not violate the Anti-kickback Statute, in part because the subsidies were necessary to allow for the appropriate clinical study pursuant to CMS’s conditions in the NCD. Advisory Opinion 15-07 is available HERE.

Also on Thursday, June 4, OIG issued Advisory Opinion 15-06 regarding a nonprofit, tax-exempt charitable organization’s proposal to provide financial assistance to individuals with chronic diseases, including cancer, to assist with the costs of health insurance and drug and device therapies. OIG determined that the arrangement likely would not violate the Anti-kickback Statute, subject to the parameters of the specific arrangement in the Advisory Opinion. OIG cited how the arrangement involved sufficient insulation so that the financial assistance would not be attributed to or influenced by the donors, and how qualification for the financial assistance would be based on financial need and would be on a first-come, first-served basis. Advisory Opinion 15-06 is available HERE.

CMS Announces Cardiovascular Disease Risk Reduction Model

On Thursday, May 28, the Centers for Medicare and Medicaid Services (CMS) announced a new payment model called the Cardiovascular Disease (CVD) Risk Reduction model as part of the agency’s Million Hearts initiative. The model will rely on predictive-modeling to assess Medicare beneficiaries’ CVD risk, which the providers will use to develop personalized modification plans. Providers will be paid for reducing the absolute risk for heart disease or stroke among the high-risk patients. The Federal Register notice and request for applications is available HERE.

May 29

The Washington Weekly: May 29, 2015

CMS Issues Long-Awaited Medicaid Managed Care Proposed Rule

On Tuesday, May 26, the Centers for Medicare and Medicaid Services (CMS) issued the “Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability” proposed rule (“Medicaid Managed Care Proposed Rule”). The rule is the first significant update to Medicaid and Children’s Health Insurance Program (CHIP) managed care regulations since 2003. The proposals would revise the Medicaid managed care regulations to align with other statutory and regulatory provisions for exchange plans and fee-for-service (FFS) Medicaid, improve accountability of Medicaid managed care rates, ensure beneficiary protections, and incorporate statutory provisions passed since 2002 that impact Medicaid managed care. CMS also proposes to adopt minimum network adequacy standards similar to those used for exchanges. One of the more controversial proposals in the rule would create a minimum medical loss ratio (MLR) threshold of 85% for Medicaid managed care plans. The rule will be published in the Federal Register on June 1, 2015. CMS is accepting comments through July 27, 2015. An advance copy of the proposed rule is available HERE.

U.S. Supreme Court Declines to Hear Drug Disposal Law Challenge

On Tuesday, May 26, the U.S. Supreme Court declined to review a challenge by the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Biotechnology Industry Organization to the “Safe Drug Disposal Ordinance” passed by the Alameda County, CA Board of Supervisors in 2012. The ordinance, which was the first of its kind, requires manufacturers to create, operate and fully fund drug take-back programs throughout the county. Drug makers initially filed suit in federal court arguing that the ordinance violated the U.S. Constitution’s Commerce Clause, under which state and local governments may not enact regulations that unduly interfere with interstate commerce. The U.S. District Court denied the claim, finding that the ordinance does not place an undue burden. Industry then appealed, but the U.S. Court of Appeals for the 9th Circuit upheld the decision in favor of Alameda County. With the U.S. Supreme Court now refusing to hear the final appeal, other jurisdictions may be emboldened to pursue similar drug take-back legislation. If this is the case, Congress may feel increased pressure to address the issue at the federal level in the coming months.

California Exchange Adopts Caps on Out-of-Pocket Costs for High-Cost Specialty Drugs

On Thursday, May 21, California’s health insurance exchange, known as “Covered California,” became the first exchange to impose coinsurance limits for specialty drugs. Starting in 2016, individuals’ coinsurance for specialty drugs will be capped at $150 per month for individuals enrolled in silver plans and who earn up to 200% of the federal poverty level after the deductible. Costs will be capped at $250 per month after the deductible for other silver plans, as well as all gold and platinum plans. Bronze plans will have a $500 cap after a $500 pharmacy deductible. California Insurance Commissioner Dave Jones expressed disappointment that the board did not limit spending for bronze plans to $300 per month instead of the $500 cap adopted. A Covered California press release concerning the exchange board’s approval of the measure is available HERE.

CMS Issues July 2015 ASP Pricing File Update

On Wednesday, May 29, the Centers for Medicare and Medicaid Services (CMS) issued the July 2015 update of the average sales price (ASP) drug pricing files, which contain the payment amounts to be used to pay for Medicare Part B covered drugs for the third quarter of 2015. Compared to the previous quarters, the third quarter payment amounts remained relatively stable. On average, prices for the top Part B drugs increased by about 0.5%. The July 2015 ASP pricing file update is available for download HERE.

May 22

The Washington Weekly: May 22, 2015

E&C Committee Passes 21st Century Cures Act

On Thursday, May 21, the full House Energy & Commerce Committee held a markup of H.R. 6, the 21st Century Cures Act. During the discussion members praised the efforts of the Committee and the various provisions in the bill they sponsored. Several changes were made to the bill after it was reported out of the Health Subcommittee last week. While most of the changes were technical in nature, there were some substantive changes made to improve the sections regarding interoperability of electronic health records, which was a section of the bill included late in the process. During the markup a Manager’s Amendment was offered by Chairman Fred Upton (R-MI) which included some new policy provisions as well as provisions to provide $13 billion over ten years to fund the bill’s activities. The new policy provisions include the Food and Drug Administration Safety Over Sequestration (FDA SOS) Act, which exempts FDA user fees from being subject to the budgetary mechanism known as sequestration. The amendment also establishes a $550 million “Cures Innovation Fund” that will provide $110 million annually from FY 2016 to FY 2020 for FDA to carry out the new requirements in the bill.

The offsets included in the Manager’s Amendment include changing the timing of reinsurance payments for Medicare Part D plans, selling oil from the Strategic Petroleum Reserve, limiting the federal Medicaid match for durable medical equipment to Medicare rates, and instituting payment penalties for the use of outdated X-ray technology.

Several other amendments were offered and discussed during the markup, but none were voted upon. The Committee then passed the bill as amended by a vote of 51-0. Text of the entire bill as debated during today’s markup can be found HERE. The full text of the Manager’s Amendment can be found HERE.

House Passes Bill Making R&D Tax Credit Permanent

On Wednesday, May 20, the House of Representatives voted 274-145 on H.R. 880, a bill to permanently extend the research and development (R&D) tax credit. 37 Democrats supported the measure. The measure is expected to cost $182 billion over ten years, but is not offset. The bill will now proceed to the Senate, where its fate is uncertain. The White House has threatened to veto the measure over its cost.

W&M Health Subcommittee Holds Hearing on Competition in Medicare

On Tuesday, May 19, the House Ways and Means (W&M) Health Subcommittee held the first in a series of hearings on competition in Medicare. Witnesses at the hearing, entitled “Improving Competition in Medicare: Removing Moratoria and Expanding Access,” included several hospital stakeholders and health policy experts. A key focus of the hearing was a measure introduced by Congressman Sam Johnson (R-TX) which supports repealing the ban on self-referral to physician-owned hospitals. The proposal sparked a strong response from subcommittee Democrats and the American Hospital Association (AHA) witness, who argued that changes to the current “Stark” anti-kickback law would not increase competition. The second proposal discussed, sponsored by Congressman Tom Price, MD (R-GA), seeks to alter the Medicare competitive bidding system for Durable Medical Equipment. Subcommittee Chairman Kevin Brady (R-TX) announced that the Health Subcommittee will continue to hold hearings on Medicare competition throughout the summer and fall.

W&M Oversight Subcommittee Holds Hearing on Administrative Actions in ACA Implementation

On Wednesday, May 20, the House Ways and Means (W&M) Subcommittee on Oversight held a hearing entitled, “Examining the Use of Administrative Actions in the Implementation of the Affordable Care Act.” The hearing featured testimony from several legal experts. Subcommittee Chairman Peter Roskam (R-IL) stated his concerns about how the Administration has made changes to the Affordable Care Act (ACA) without Congressional approval, and the impact of those changes. Roskam also discussed his Special Inspector General for Monitoring the Affordable Care Act (SIGMA) legislation, which would create a special inspector general position focused explicitly on ACA oversight. A companion bill authored by Senator Pat Roberts (R-KS) has been introduced in the Senate. Democrats expressed frustration at the hearing, saying that Congress should use its authority to oversee, improve, and build on the ACA.

GAO Issues Report Criticizing CMS’s Review of Physician Payments

On Thursday, May 21, the Government Accountability Office (GAO) issued a report examining the Centers for Medicare and Medicaid Services’ (CMS) process for reviewing the work relative values for Medicare physician services. GAO found that the American Medical Association/Specialty Society Relative Value Scale Update Committee’s (RUC) recommendations to CMS based on the committee’s review of physician payments may not be accurate because of process and data weaknesses. GAO recommends that CMS better document its process for establishing relative value units (RVUs) and develop a process for notifying the public of potentially misvalued services identified by the RUC. GAO also recommends that CMS develop a plan for using funds appropriated for collecting and using information on physician services to determine RVUs. The full report is available HERE.

Senate Aging Committee Holds Hearing on Hospital Observation Stays

On Wednesday, May 20, the Senate Special Committee on Aging held a hearing entitled, “Challenging the Status Quo: Solutions to the Hospital Observation Stay Crisis.” The hearing featured testimony from Sean Cavanaugh, Centers for Medicare and Medicaid Services (CMS); Mark E. Miller, Medicare Payment Advisory Commission (MedPAC); and several healthcare analytics stakeholders. To open the hearing, Committee Chairwoman Susan Collins (R-ME) discussed her legislation which would deem time spent in hospital observation status as inpatient care for the purpose of the Medicare three-day prior hospital stay requirement. During the first panel, CMS Director Cavanaugh defended the agency’s “two-midnight” rule and testified that the agency is working to reform the recovery audit program to reduce the burden on providers. Mark Miller, Executive Director of MedPAC, made recommendations for the Recovery Audit Contractor (RAC) process and beneficiary liability, including that CMS withdraw the two-midnight rule, target RAC audits to hospitals with high one-day patient stays, and consider allowing Medicare to count up to two outpatient observation days toward the skilled nursing care eligibility requirement. Testimony at the second panel of the hearing largely came from health care providers who were critical of RACs, which some see as a driving force behind the recent rise in hospital observation stays, and from the RACs who defended their practices. A full recording of the hearing can be found HERE.

GAO Issues Report on First Two Years of Pioneer ACO Program

On Friday, May 22, the Government Accountability Office (GAO) issued a report examining the first two years of the Pioneer Accountable Care Organization (ACO) program. According to the report, fewer than half of the ACOs in the program earned shared savings in 2012 and 2013, although the Pioneer ACO model overall produced net shared savings each year. GAO also found that ACOs that participated both years had higher quality scores in 2013 than in 2012 about two-thirds of the quality measures used to evaluate the ACOs. The full report is available HERE.

CMS Issues Final Rule to Strengthen its Oversight of Accrediting Organizations

On Thursday, May 21, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on CMS’s survey, certification, and enforcement procedures as they relate to the agency’s oversight of national accrediting organizations. The rule clarifies and improves CMS’s oversight of accrediting organizations that are granted approval for accreditation programs. The rule also provides a definition of “immediate jeopardy” as it pertains to certified providers and suppliers. The final rule is available HERE.

CMS Announces Hospital Outpatient Payment Panel Summer Meeting

On Thursday, May 21, the Centers for Medicare and Medicaid Services (CMS) announced the summer meeting of the Advisory Panel on Hospital Outpatient Payment (HOP) for 2015. The panel advises the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights and hospital outpatient therapeutic services supervision issues. The meeting is scheduled for Monday, August 24 and Tuesday, August 25, 2015. The meeting notice is available HERE.

May 15

The Washington Weekly: May 15, 2015

E&C Health Subcommittee Passes 21st Century Cures Act

On Thursday, May 14, the House Energy and Commerce Health Subcommittee chaired by Joe Pitts (R-PA) unanimously approved by a voice vote the 21st Century Cures Act. The bipartisan discussion draft was introduced by full committee Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Health Subcommittee Chairman Joe Pitts (R-PA), full committee Ranking Member Frank Pallone, Jr., (D-NJ), and Health Subcommittee Ranking Member Gene Green (D-TX). The bipartisan legislation aims to modernize health care innovation through streamlining the cures and treatments process so that patients receive the specialized care they need. A Manager’s Amendment to the 21st Century Cures Act was offered at the markup which included new provisions regarding the interoperability of electronic health records systems, regulation of combination products at the Food & Drug Administration (FDA), and providing 6-months of exclusivity for drugs that are repurposed for a rare disease indication. Also, there was no discussion regarding offsets for the package or a need for any additional exclusivity periods for the life-science industry. The full Energy and Commerce Committee markup is expected next week. The draft legislation can be found HERE.

Senate Finance Committee Holds Hearing on Chronic Care Reform

On Thursday, May 14 the Senate Finance Committee held a hearing entitled “A Pathway to Improving Care for Medicare Patients with Chronic Conditions.” Witnesses included Dr. Patrick Conway, Acting Principal Deputy Administrator for the Centers for Medicare & Medicaid Services (CMS); and Mark E. Miller, PhD, Executive Director, Medicare Payment Advisory Commission (MedPAC). At the hearing, Committee Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) announced the formation of a chronic care reform working group which will explore legislative options to improve care for Medicare patients with chronic conditions, a large and growing share of the Medicare population. The working group will be led by Senators Johnny Isakson (R-GA) and Mark Warner (D-VA) and will seek input from public and private sector stakeholders, with the goal of developing bipartisan legislation that can be introduced and marked up in the Finance Committee this year. With spending on chronic illnesses accounting for roughly 93% of all Medicare expenditures, both the Chairman and Ranking Member expressed their intention to make chronic care reform a priority for the Committee this year. Full video of the hearing can be found HERE.

HHS Issues Guidance on Cost-Sharing for Preventive Services, Including Contraceptives

On Monday, May 11, the Department of Health and Human Services (HHS) issued guidance on the coverage of preventive services under the Affordable Care Act (ACA), including cost-sharing requirements for contraceptives. The guidance specifies that insurers must cover with no cost-sharing at least one form of all of the 18 contraceptive methods approved by the Food and Drug Administration (FDA), as listed in FDA’s “Birth Control Guide,” available HERE. Additionally, where a provider recommends a specific option or product, the plan must cover the contraceptive with no cost-sharing.

On Thursday, May 14, the HHS Assistant Secretary for Planning and Evaluation (ASPE) issued a data report showing by state the numbers of privately insured lives with access to preventive services at no cost-sharing. ASPE reports that approximately 137 million individuals have private insurance coverage for preventive services without cost-sharing, including 55 million women. The report is available HERE.

House Democrats Urge For Repeal of Medical Device Tax

On Friday, May 1, Congressman Scott Peters (D-CA) drafted a medical device tax repeal letter calling on Speaker John Boehner (R-OH) and Minority Leader Nancy Pelosi (D-CA) to promptly take action on H.R. 160, the Protect Medical Innovation Act of 2015. Congressman Peters led 17 first and second term House Democrats pressing House leadership to advance the medical device tax repeal bill before the Memorial Day recess. All medical device manufacturers and importers are subject to the 2.3% controversial Obamacare tax. The letter can be found HERE. H.R. 160 can be found HERE.

FDA Announces Public Meeting on PDUFA VI Negotiations

On Wednesday, May 13, the Food and Drug Administration (FDA) announced that it will hold a public meeting on July 15, 2015, on the sixth iteration of the Prescription Drug User Fee Act (PDUFA) before negotiations with industry officially begin. PDUFA requires FDA to hold a public meeting followed by a 30-day comment period before beginning negotiations with manufacturers. FDA is seeking comments to questions concerning stakeholders’ assessment of the overall performance of PDUFA V and features of PDUFA that could be changed to improve the human drug review process. The Federal Register meeting notice is available HERE.

FDA Issues Biosimilars Draft Guidance

On Tuesday, April 12, the Food and Drug Administration (FDA) issued a revised draft guidance containing a series of questions and answers on biosimilar product development. The guidance touches on a variety of issues, including how a biosimilar manufacturer must demonstrate that the biosimilar is the same dosage as the reference product, as well as how manufacturers can address requirements for conducting pediatric studies. The draft guidance is open for public comment through July 13, 2015. The guidance is available HERE.

HHS Issues Guidance on Individual Out-of-Pocket Maximums

On Friday, May 8, the Centers for Medicare and Medicaid Services (CMS) issued guidance clarifying that insurers must limit each person’s out-of-pocket costs to the individual maximums established under the Affordable Care Act (ACA), even if the individual is enrolled in a family plan that has a higher out-of-pocket limit. For 2016, the annual out-of-pocket maximum for individuals is $6,850. CMS also clarified that issuers may offer family high deductible health plans (HDHP) with a $10,000 deductible as long as the insurer applies the maximum annual limitation on cost-sharing to each individual in the plan. The guidance is available HERE.

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